Smertefulle bivirkninger i musklene (apollon.uio 28.11.2006)
Gjør kolesterollegemidler noe godt? (businessweek.com 17.1.2008)
Legemiddel mot kolesterol knyttet til søvnforstyrrelser (drugs.com 7.11.2007)
According to researchers at the University of Toronto, eating a certain 'portfolio' of foods including fish, oatmeal, almonds and lean meats can help reduce artery-clogging LDL cholesterol as much as statin drugs. The study, published on Wednesday in the American Journal of Clinical Nutrition, followed 55 overweight middle-aged men and women for a year. (netdoctor.co.uk 9.3.2006)
Legemidler mot høyt kolesterol kan forårsake Parkinsons sykdom (Cholesterol Drugs May Cause Parkinson's - Report) (newsmax.com 22.1.2007)
- For lavt kolesterol kan føre til kreft (vg.no 25.7.2007)
Crestor minskar inte risken att dö (lakemedelsvarlden.se 6.11.2007)
- Statiner: Er det i virkeligheten på tide at man revurderer nytte og risiko?
Statins: Is It Really Time to Reassess Benefits and Risks? (Statiner: Er det i virkeligheten på tide at man revurderer nytte og risiko?)
Allison B. Goldfine, M.D.
N Engl J Med 2012; 366:1752-1755May 10, 2012
No drug provides health benefits without some degree of risk, and risk–benefit assessments require ongoing review as new data become available. This is certainly the case for the use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors — statins — and the risk of new-onset diabetes.
Cardiovascular disease is the leading cause of illness and death in patients with type 2 diabetes. There is no doubt that for persons who have had an acute coronary syndrome or who have other risk factors for atherosclerotic coronary artery disease, statins effectively reduce the risks of death from any cause, death due to cardiovascular disease, fatal myocardial infarction, the need for revascularization, and stroke (see figure Effect of Statins on Cardiovascular Event Rates, According to Reduction in LDL Cholesterol of 1 Millimole per Liter.). Over a period of 4 years of statin use, a reduction of 1 mmol per liter (39 mg per deciliter) in the level of low-density lipoprotein (LDL) cholesterol translates into a 9% reduction in the risk of death from any cause among patients with diabetes and a 13% reduction among those without diabetes.1 Benefits are realized within the first year of use but increase over time. Few drugs have had such a dramatic effect on health outcomes. (...)
The Statin Controversy: Too Dangerous or Worth the Risk? (Statinuenigheten: For farlig eller verdt risikoen?)
ivanhoe.com 11.5.2012
(Ivanhoe Newswire) -- A meta-analysis of multiple trials has left the medical world and patients concerned about statins and whether or not their benefits are worth their potentially harmful side effects.
Statins are a class of drugs that lower the amount of LDL cholesterol in the body by blocking the enzyme in the liver that makes cholesterol. Recently, there have been several studies that linked the drugs to an increased risk for new-onset diabetes.
One such study was the JUPITER study (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin; ClinicalTrials.gov number, NCT00239681). The study included 17,802 participants without diabetes that had LDL cholesterol levels below 3.4 mmol per liter and high-sensitivity C-reactive protein levels of 2.0 mg per liter or higher. It was revealed that the hazard ratio for newly diagnosed diabetes increased 25% in the Rosuvastatin group versus the placebo group. Despite this fact, the participants who had a low risk for cardiovascular events had important health improvements over the following period of approximately 2 years, with a hazard rate 44% lower than the placebo group for cardiovascular events. Rates for treated participants were lower for the key secondary outcomes as well: 54% for myocardial infarction, 48% for stroke, 46% for revascularization, and 20% for death from any cause. Other studies confirm this trend in diabetes risk increase; a meta-analysis of six statin trials that included 57,593 participants showed a 13% increase in relative risk, and another meta-analysis of 13 randomized statin trials with 91,140 participants showed an odds ratio of 1.09 for a new diagnosis of diabetes.
The meta-analysis suggests a strong correlation between the risk of diabetes and the use of statins, but also raises an important question: should the risk of diabetes and the risk of cardiovascular events be weighted in a similar manner? 255 patients were treated with statins for 4 years, which resulted in one additional case of diabetes. Given the fact that statins are used by approximately 24 million Americans, the population-attributable risk for diabetes is considerably large. The good news is that 5.4 cardiovascular events out of 255 patients were prevented, and this must be considered in context with the negative findings. (...)
- Nytte av utbredt bruk av statiner oppveier risiko: studie
Forskare ifrågasätter riktlinjer om statiner
dagensmedicin.se 18.5.2012
Statinbehandling kan göra nytta hos fler personer utan tidigare hjärt-kärlsjukdom. Det kommer forskare fram till i en ny analys i tidskriften Lancet.
Hos tidigare hjärtfriska individer begränsar i dag europeiska och amerikanska riktlinjer behandling med statinläkemedel till dem med minst 20 procent risk att drabbas av allvarliga hjärt-kärlhändelser inom en 10-årsperiod.
Men det ifrågasätts nu av forskare inom nätverket Cholesterol Treatment Trialists’ Collaboration. I en metaanalys drar de slutsatsen att nyttan med behandling är stor även hos individer med lägre risk.
Till grund för analysen ligger 27 studier med 175 000 deltagare och en uppföljningstid på runt fem år i median. (...)
Benefits of Widespread Statin Use Outweigh Risks: Study (Nytte av utbredt bruk av statiner oppveier risiko: studie)
news.yahoo.com 17.5.2012
THURSDAY, May 17 (HealthDay News) -- Statins -- commonly used cholesterol-lowering drugs -- can significantly lower the risk for heart disease in people with no history of vascular disease, according to a new study.
Researchers from the University of Oxford in England found the medication reduced the risk of major heart-related problems, such as hearts attacks and strokes, in men and women of all ages with heart disease -- as well as those with no previous history of the condition -- by about 20 percent. (...)
For their study, researchers examined 27 randomized trials involving 175,000 people. They investigated the effects of lowering LDL cholesterol with statins by grouping the patients into risk categories and comparing results. The researchers specifically explored whether statins were used and, if so, the intensity of the patients' therapy.
The study revealed that statins reduced the risk of serious vascular events by 21 percent in each of the five risk groups the researchers identified, including those at lowest risk for vascular disease.
The study was published online Wednesday in The Lancet. (...)
- Gjør statiner det vanskelig å trene?
Simvastatin impairs ADP-stimulated respiration and increases mitochondrial oxidative stress in primary human skeletal myotubes (Simvastatin svekker ADP-stimulert respirasjon og øker mitokondrielt oksidativt stress i primære menneskelige skjelett myotuber)
Free Radic Biol Med. 2012 Jan 1;52(1):198-207. Epub 2011 Oct 25.
Abstract Statins, the widely prescribed cholesterol-lowering drugs for the treatment of cardiovascular disease, cause adverse skeletal muscle side effects ranging from fatigue to fatal rhabdomyolysis. The purpose of this study was to determine the effects of simvastatin on mitochondrial respiration, oxidative stress, and cell death in differentiated primary human skeletal muscle cells (i.e., myotubes). Simvastatin induced a dose-dependent decrease in viability of proliferating and differentiating primary human muscle precursor cells, and a similar dose-dependent effect was noted in differentiated myoblasts and myotubes. Additionally, there were decreases in myotube number and size following 48 h of simvastatin treatment (5 μM). In permeabilized myotubes, maximal ADP-stimulated oxygen consumption, supported by palmitoylcarnitine+malate (PCM, complex I and II substrates) and glutamate+malate (GM, complex I substrates), was 32-37% lower (P<0.05) in simvastatin-treated (5 μM) vs control myotubes, providing evidence of impaired respiration at complex I. Mitochondrial superoxide and hydrogen peroxide generation were significantly greater in the simvastatin-treated human skeletal myotube cultures compared to control. In addition, simvastatin markedly increased protein levels of Bax (proapoptotic, +53%) and Bcl-2 (antiapoptotic, +100%, P<0.05), mitochondrial PTP opening (+44%, P<0.05), and TUNEL-positive nuclei in human skeletal myotubes, demonstrating up-regulation of mitochondrial-mediated myonuclear apoptotic mechanisms. These data demonstrate that simvastatin induces myotube atrophy and cell loss associated with impaired ADP-stimulated maximal mitochondrial respiratory capacity, mitochondrial oxidative stress, and apoptosis in primary human skeletal myotubes, suggesting that mitochondrial dysfunction may underlie human statin-induced myopathy. (...)
(Anm: Muskelsykdom (myopati) (nevro.legehandboka.no).)
(Anm: Mitochondria (mitokondrie). (mintankesmie.no).)
Do Statins Make It Tough to Exercise? (Gjør statiner det vanskelig å trene?)
well.blogs.nytimes.com 14.3.2012
Can a statin ruin your workout?
For years, physicians and scientists have been aware that statins, the most widely prescribed drugs in the world, can cause muscle aches and fatigue in some patients. What many people don’t know is that these side effects are especially pronounced in people who exercise. (...)
To learn more about the effect statins have on exercising muscles, scientists in Strasbourg, France, recently gave the cholesterol-lowering drug Lipitor to a group of rats for two weeks, while a separate control group was not medicated. Some of the rats from both groups ran on little treadmills until they were exhausted.
It was immediately obvious that the medicated animals couldn’t run as far. They became exhausted much earlier than the rats that had not been given statins.
The differences were even more striking at a cellular level. When the scientists studied muscle tissues, they found that oxidative stress, a measure of possible cell damage, was increased by 60 percent in sedentary animals receiving statins, compared with the unmedicated control group.
The effect was magnified in the runners, whose cells showed 226 percent more oxidative stress than exercising animals that had not been given statins. (...)
Statins’ safety has come under considerable scrutiny in recent weeks. Last month, the Food and Drug Administration added safety alerts to prescribing information for statins, warning of risks for memory loss and diabetes, as well as muscle pain. (Read more about those concerns here.) (...)
Advarer mot kolesterolmedisiner
vg.no 5.3.2012
Mulige bivirkninger: Hukommelsestap, diabetes og muskelsmerter (...)
I 2011 fikk 500000 nordmenn kolesteroldempende medisiner som inneholder statiner. (...)
- Statiner kan forhindre muskelreperasjon (- Muskelskader fra statiner kan gjemme seg bak normale laboratorietester)
Zocor (simvastatin): increased risk of muscle injury with high doses (Zocor (simvastatin): økt risiko for muskelskader ved høye doser)
fda.gov 19.3.2010
Simvastatin is sold as a single-ingredient generic medication and as the brand-name, Zocor. It is also sold in combination with ezetimibe as Vytorin; and niacin as Simcor.
[Posted 03/19/2010] FDA notified healthcare professionals and patients that, based on review of data from a large clinical trial and other sources, there is an increased risk of muscle injury in patients taking the highest approved dose of the cholesterol-lowering medication, Zocor (simvastatin) 80 mg, compared to patients taking lower doses of simvastatin and possibly other drugs in the "statin" class. FDA is also reviewing data from other clinical trials, observational studies, adverse event reports, and data on prescription use of simvastatin to better understand the relationship between high-dose simvastatin use and muscle injury. (...)
Statins can Damage Muscles (Statiner kan skade muskler)
Ivanhoe.com 10.7.2009
(Ivanhoe Newswire) -- Because of their importance in reducing the risk of cardiovascular disease, statins are one of the most widely prescribed medications in the world. One well-known side effect of taking statins is muscle weakness and pain. Researchers are now finding that structural muscle damage may be present in patients who have statin-associated muscle complaints. In some cases, muscle biopsies have shown underlying structural injury to the muscles even in patients who had discontinued medication before the biopsies were taken.
A new study by researchers from the University of Bern, Switzerland, and the Tufts-New England Medical Center in Boston, Massachusetts, looked at muscle biopsies from 83 patients, 20 of whom had never taken statins. They found significant muscle injury in patients who had taken statins, including several who had discontinued medication before the biopsy. (...)
Muscle Injury from Statins Can Hide Behind Normal Lab Tests (Muskelskader fra statiner kan gjemme seg bak normale laboratorietester)
medpagetoday.com 6.7.2009
SAN FRANCISCO, July 6 -- Persistent muscle pain in patients taking statins may indicate structural damage to the muscles even when laboratory tests are normal, researchers found.
Biopsy-assessed muscle fiber damage was seen in about 57% of patients with statin-related myopathy compared with 0% in controls (P<0.001), Annette Draeger, MD, of the University of Bern, Switzerland, and colleagues, reported in the July 7 issue of CMAJ.
But only one of these 44 myopathy patients in the study had abnormal serum creatine phosphokinase levels.
Muscle pain associated with statin therapy has typically been dismissed as a minor adverse effect by both patients and physicians, the researchers noted. (...)
Only one patient -- a case of overt rhabdomyolysis that required hospitalization -- had a creatine phosphokinase above the upper limit of normal (57,657 U/L) and these levels alone did not distinguish patients who had and had not taken statins, they said.
One potential distinguishing feature was the significantly higher expression of ryanodine receptor 3 mRNA in patients with structural muscle damage than in those without damage (P=0.039).
However, the mechanistic and diagnostic implications of this are unclear, Dr. Draeger's group said. (...)
Statins Can Hinder Muscle Repair (Statiner kan forhindre muskelreperasjon)
healthfinder.gov 25.9.2008
Small number of patients taking them will experience damage, experts say. (...)
THURSDAY, Sept. 25 (HealthDay News) -- Statins, taken by millions to lower cholesterol, may hinder the body's ability to repair muscles, University of Alabama researchers report.
The most frequently reported side effect of statin therapy is fatigue, with about 9 percent of patients reporting muscle pain. As doses of the medication are increased, and physical activity is added, these effects can be more pronounced. These side effects are found in all commonly used statins. (...)
Results of the study were presented Thursday at a meeting of the American Physiological Society, in Hilton Head, S.C.
For the study, Thalacker-Mercer's team exposed muscle cells to varying doses of simvastatin.
The researchers found as the dosage increased, the ability of these cells to multiply decreased. For the equivalent of 40 milligrams a day, growth of new muscle cells was reduced by 50 percent. (...)
Between 2 percent and 8 percent of patients report having muscle aches in response to statins, Fonarow noted. "Significant muscle damage as result of statin treatment rarely occurs, but if it does, there can be serious consequences," he noted. (...)
- Smertefulle bivirkninger i musklene
Smertefulle bivirkninger i musklene
Forskningsartikkel
apollon.uio 28.11.2006
OVERSER PROBLEMET: Professor Anders Åsberg ved Farmasøytisk institutt sier at legene i stor grad overser problemet med at medisiner mot kolesterol kan føre til muskelsmerter.
300 000 nordmenn tar kolesteroldempende medisiner. Hver tiende får smertefulle og influensalignende bivirkninger i musklene. (...)
Det viser seg at hver tiende nordmann som bruker kolesteroldempende legemidler, får muskelsmerter på kjøpet. Det kan dreie seg om alt fra ”giktsmerter” til så vonde influensalignende smerter i musklene at man ikke orker å gå i trapper. For de uheldigste, og det skjer ti til femten ganger hvert år, går muskelcellene i stykker og lekker ut stoffer i blodet som kan ødelegge nyrene. Dødsfall har forekommet.
De to farmasøytene undersøkte bivirkningene til verdens mest solgte kolesterolsenkende medisin, Lipitor, men undersøkelsen er sannsynligvis også gyldig for lignende medisiner som Zocor, Pravachol og Lescol. De inneholder alle det kjemiske stoffet statin. (...)
- Gjør statiner deg dum?
Kolesterolpiller giver huskebesvær
bt.dk 30.3.2012
(...) Ikke færre end 600.000 danskere tager kolesterolsænkende midler. Medicin med en del bivirkninger. Ny rapport fortæller om bl.a. flere med hukommelsesbesvær.
Op imod 600.000 danskere tager medicin mod forhøjet kolesterol - et meget højt tal. Medicin, som ofte har bivirkninger i form af muskelømhed, fordøjelsesbesvær, hovedpine, søvnløshed, forstyrrelser i sexdriften o.a. Senest har sundhedsmyndighederne i USA - Food and Dryg Administration - advaret om flere bivirkninger i form af hokommelsessvigt og øget risiko for at få type 2 diabetes. (...)
Do Statins Make You Stupid? (Gjør statiner deg dum?)
nytimes.com 17.2.2008
Cholesterol-lowering statin drugs have had a rough time of it lately.
There was the headline-making trial of the statin-combination drug Vytorin, which rattled conventional wisdom about the value of lowering cholesterol. Business Week weighed in with a report that asked: “Do Cholesterol Drugs Do Any Good?” And my Well column in Science Times last month pointed out that there’s no data to show that statins prolong the lives of many people who use them. (...)
To read the full article, click here. (...)
Can a Drug That Helps Hearts Be Harmful to the Brain?
online.wsj.com 12.2.2008
Cognitive side effects like memory loss and fuzzy thinking aren't listed on the patient information sheet for Lipitor, the popular cholesterol-lowering drug. But some doctors are voicing concerns that in a small portion of patients, statins like Lipitor may be helping hearts but hurting minds. (...)
- Tror at mitokondrieskader kan føre til Alzheimers sykdom
Mitochondria, Diabetes, and Alzheimer’s Disease
Diabetes 2012; 61(5): 991-992 (May)
Alzheimer’s disease (AD) is the most common neurodegenerative disease as well as the leading cause of dementia (1,2). Identification of disease-causing mutations in the amyloid precursor protein, presenilin 1, and presenilin 2 has unraveled the molecular basis of some forms of familial AD, but the etiology and pathogenesis of sporadic AD remain elusive and controversial. Epidemiological data suggest that diabetes increases the risk of developing AD (2–4). These data are corroborated by clinical and laboratory findings. Indeed, diabetic subjects show signs of cognitive dysfunction, leukoariosis, and more severe hippocampal atrophy than control subjects (5). In addition, neuritic plaques and neurofibrillary tangles, the pathological hallmarks of AD, accumulate more abundantly in the brains of diabetic patients relative to control subjects. The association between diabetes and AD pathology seems even stronger among carriers of the apolipoprotein E ε4 allele, a variant that by itself carries an increased risk for AD (6). (...)
Abnormal Mitochondrial Dynamics in the Pathogenesis of Alzheimer's Disease
J Alzheimers Dis. 2012 Apr 24. [Epub ahead of print]
Abstract Mitochondrial dysfunction is one of the most early and prominent features in vulnerable neurons in the brain of Alzheimer's disease (AD) patients. Recent studies suggest that mitochondria are highly dynamic organelles characterized by a delicate balance of fission and fusion, a concept that has revolutionized our basic understanding of the regulation of mitochondrial structure and function which has far-reaching significance in studies of health and disease. Tremendous progress has been made in studying changes in mitochondrial dynamics in AD brain and models and the potential underlying mechanisms. This review highlights the recent work demonstrating abnormal mitochondrial dynamics and distribution in AD models and discusses how these abnormalities may contribute to various aspects of mitochondrial dysfunction and the pathogenesis of AD. (...)
Tror at mitokondrieskader kan føre til Alzheimer
dagensmedicin.se 17.2.2011
Nye funn antyder at skade av mitokondrielt arvemateriale kan gi nevrodegenerativ sykdom.
Doktorgradsstipendiat Knut Husø Lauritzen har funnet interessante assosiasjoner mellom mitokondrielt DNA (mtDNA) og hjernefunksjon hos mus.
Skadelig protein
Ved å gi dyrene en diett med et protein som skader mtDNA, kunne Husø Lauritzen studere effektene av dette.
Han fant at nevroner i hippocampus, senteret i hjernen som er assosiert med læring og hukommelse og som er sterkt preget i sykdommmer som Alzheimers, i stor grad påvirkes av skader på mtDNA.
Nervecellene dør
Mitokondrier er viktig for nervevev som har et høyt energibehov. Husø Lauritzen fant at skadene på arvematerialet i disse energiproduserende organellene ga nedbrytning og død av nerveceller.
Nettopp dette karakteriserer nevrodegenerative sykdommer.
Nedsatt læringsevne
Hos musene ble det observert en uvanlig adferd med nedsatt læringsevne. Det ble også blant annet oppdaget kollaps av mitokondriell dynamikk og distribusjon, med opphoping av mitokondrier i den nervecellekroppen og påfølgende reduksjon i synapseområder der energi er viktig for overføring av nervesignaler.
Husø Lauritzen disputerer for sin doktorgrad ved Universitetet i Oslo 21. februar. (...)
(Anm: Mitochondria (mitokondrie). (mintankesmie.no).)
Mitokondrienes rolle ved Alzheimers sykdom
Tidsskr Nor Legeforen 2009; 129:400 (26.2.2009)
Mitokondrienes selvdestruksjonsmekanisme medvirker trolig til utvikling av Alzheimers sykdom.
Man vet at avleiring av β-amyloide plakk i hjernen er viktig i patogenesen ved Alzheimers sykdom. Man vet også at mitokondriene skades av løselig β-amyloid. En amerikansk forskergruppe har nå vist ved cellestudier at løselig β-amyloid i mitokondriene interagerer med proteinet cyklofilin D (CypD), og dette øker mitokondrielt stress. Funnene indikerte i tillegg at interaksjonen mellom løselig β-amyloid og CypD åpner poren mPTP i den indre mitokondriemembranen, noe som medfører en influks av kalsiumioner med påfølgende mitokondrieskade (1). (...)
(Anm: Alzheimers sykdom og andre årsaker til demens. (mintankesmie.no).)
Kolesterol-debatten
Hjerteforeningen kritiseres for at overdrive kolesterolfrygt
b.dk 22.4.2012
En af Danmarks største patientforeninger, Hjerteforeningen, møder nu skarp kritik fra flere sider. Det sker, efter foreningen i søndags meddelte, at 30.000 danskere vil dø inden for en tiårig periode, hvis ikke yderligere 900.000 danskere begynder at tage kolesterolsænkende medicin.
Men det budskab bliver nu udfordret af en række eksperter, der sætter store spørgsmålstegn ved lødigheden af Hjerteforeningens videnskabelige grundlag i rapporten, som er udarbejdet af Børge Nordestgaard, professor ved Herlev Hospital. Det fortæller TV 2 Nyhederne.
Jens Søndergaard, speciallæge i lægemidler og professor ved SDU, har gennemgået rapporten, og han har fundet i alt 11 kritikpunkter. (...)
Legemiddelbruk i Norge – for lite, for mye eller passe?
Madsens blogg - Steinar Madsen er medisinsk fagdirektør ved Statens legemiddelverk. Han er utdannet lege og har arbeidet ved Bærum sykehus og Rikshospitalet. Ved siden av Legemiddelverket har han deltidsstilling som privatpraktiserende spesialist i indremedisin og hjertesykdommer.
dagensmedisin.no 17.4.2012
(...) Som hjertespesialist er jeg glad for at det kolesterolsenkende legemidlet simvastatin nå er så billig at det kanskje ville være samfunnsøkonomisk lønnsomt å helle det i drikkevannet. Forebygging av tidlig død av hjerte- og karsykdom har vært svært vellykket de siste 20-30 årene. (...)
Legemiddelverket advarer mot kolesterolmedisiner
tv2nyhetene.no 5.3.2012
Mange eldre bruker kolesterolmedisin uten at det er nødvendig, og medisinen kan dessuten gi alvorlige bivirkninger, advarer Legemiddelverket.
– Vi ser en tendens til at mange eldre som ikke har hatt hjertesykdom, får kolesterolmedisiner med såkalte statiner, uten at de har noen nytte av dem, sier fagdirektør Steinar Madsen i Legemiddelverket til VG. (...)
Risk of Diabetes, Cognitive Problems With Statins Sparks Debate About Overuse (Risiko for diabetes, kognitive problemer med statiner utløser debatt om overforbruk)
JAMA 2011 (March 5)
Updated US Food and Drug Administration (FDA) warnings that use of cholesterol-lowering statins can increase the risk of developing diabetes, liver injury, cognitive problems, and muscle injury for some patients have renewed criticism about overuse of this class of medications.
Last week, the FDA announced changes to the labels of statin medications, which include atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin, and combination products containing these drugs. The label changes indicate that these products may be associated with memory loss or confusion, an increased risk of developing type 2 diabetes, and increased risk of muscle injury when used in combination with drugs for the treatment of HIV or hepatitis C virus infection. (...)
FDA adds diabetes, memory loss warnings to statins (FDA tilføyer advarsler om diabetes, hukommelsestap for statiner)
reuters.com 28.2.2012
(Reuters) - Health regulators are adding warnings to the labels of widely used cholesterol lowering drugs, such as Lipitor, to say they may raise levels of blood sugar and could cause memory loss.
The Food and Drug Administration announced on Tuesday the changes to the safety information on the labels of statins such as Pfizer Inc's Lipitor, AstraZeneca's Crestor and Merck & Co's Zocor that are taken by tens of millions of people.
Statins have been shown to significantly reduce the risk of heart attack and heart disease, and the FDA said the new information should not scare people into stopping taking the drugs. (...)
Safety Alerts Cite Cholesterol Drugs’ Side Effects (Sikkerhetsadvarsel opplyser om sideffekter for kolesterollegemidler)
nytimes.com 1.3.2012
Federal health officials on Tuesday added new safety alerts to the prescribing information for statins, the cholesterol-reducing medications that are among the most widely prescribed drugs in the world, citing rare risks of memory loss, diabetes and muscle pain.
Federal health officials said these widely prescribed drugs could cause elevated blood sugar and problems with memory.
It is the first time that the Food and Drug Administration has officially linked statin use with cognitive problems like forgetfulness and confusion, although some patients have reported such problems for years. Among the drugs affected are huge sellers like Lipitor, Zocor, Crestor and Vytorin. (...)
Poor Cognitive Function and Risk of Severe Hypoglycemia in Type 2 Diabetes
Post hoc epidemiologic analysis of the ACCORD trial
Diabetes Care 2012 (Published online before print February 28, 2012)
(...) OBJECTIVE Self-management of type 2 diabetes including avoidance of hypoglycemia is complex, but the impact of cognition on safe self-management is not well understood. This study aimed to assess the effect of baseline cognitive function and cognitive decline on subsequent risk of severe hypoglycemia and to assess the effect of different glycemic strategies on these relationships. (...)
CONCLUSIONS Poor cognitive function increases the risk of severe hypoglycemia in patients with type 2 diabetes. Clinicians should consider cognitive function in assessing and guiding their patients regarding safe diabetes self-management regardless of their glycemic targets. (...)
Risiko for udvikling af diabetes hos patienter i statinbehandling
laegemiddelstyrelsen.dk 19.1.2012
Den Europæiske Bivirkningskomité, PhVWP, har afsluttet en undersøgelse vedrørende en mulig risiko for udvikling af diabetes hos patienter i behandling med HMG-CoA reducatsehæmmere (statiner).
Konklusionen på undersøgelsen blev, at der er evidens for en kausal sammenhæng mellem brug af HMG-CoA reducatasehæmmere og udvikling af diabetes hos patienter, som er i højrisiko for udvikling af diabetes. Konklusionen blev imidlertid også, at fordelene fortsat stærkt opvejer de mulige risici ved behandlingen, også hos patienter, som er i højrisiko for udvikling af diabetes, eller som allerede har diabetes ved initiering af behandlingen.
Produktinformationen for alle godkendte statiner i EU bliver opdateret med:
• En advarsel om, at HmG-CoA reductasehæmmere kan øge blodsukkerniveauet hos patienter, som er i højrisiko for udvikling af diabetes.
• Patienter i statinbehandling, som er i højrisiko for udvikling af diabetes – fx har fasteblodsukker på 5.6-6.9 mmol/l, BMI >30, forhøjede triglycerider eller hypertension, bør monitoreres tæt både klinisk og biokemisk.
Endvidere vil diabetes mellitus blive inkluderet som en almindeligt forekommende bivirkning, det vil sige opstår hos mere end 1 ud 100 patienter og mindre end 1 ud 10 patienter.
Læs mere i PhVWP’s månedsrapport fra december 2011.
Statins Up Diabetes Risk in Older Women (Statiner øker diabetesrisko hos eldre kvinner)
medpagetoday.com 9.1.2012
Older women who take statins may be at an increased risk for developing type 2 diabetes, researchers found.
In an analysis of data from the Women's Health Initiative, postmenopausal women who were on a statin at study entry had almost a 50% greater risk of diabetes than those who weren't on the cholesterol-lowering drugs, Yunsheng Ma, MD, PhD, of the University of Massachusetts School of Medicine, and colleagues reported online in the Archives of Internal Medicine.(...)
Statin Use and Risk of Diabetes Mellitus in Postmenopausal Women in the Women's Health Initiative
Arch Intern Med. 2012 (Published online January 9)
Background This study investigates whether the incidence of new-onset diabetes mellitus (DM) is associated with statin use among postmenopausal women participating in the Women's Health Initiative (WHI). (...)
Conclusions Statin medication use in postmenopausal women is associated with an increased risk for DM. This may be a medication class effect. Further study by statin type and dose may reveal varying risk levels for new-onset DM in this population. (...)
Statins Tied to Lung Damage in Smokers (Statiner knyttet til lungeskade hos røykere)
medpagetoday.com 6.1.2012
Statin use appears to be associated with interstitial lung abnormalities among current and former smokers, researchers found.
Among individuals with a history of at least 10 pack-years of smoking, statin use was associated with a 60% increase in the odds of having abnormalities on CT scans (OR 1.60, 95% CI 1.03 to 2.50), according to Gary Hunninghake, MD, MPH, of Brigham and Women's Hospital in Boston, and colleagues.
The findings were independent of a history of high cholesterol, coronary heart disease, or a number of other cardiovascular risk factors, the researchers reported online in the American Journal of Respiratory and Critical Care Medicine. (...)
Kolesterolverdier: Høyere dødelighet under fem
dagensmedisin.no 27.10.2011
Totaldødeligheten for kvinner med totalkolesterol under fem er høyere enn ved totalkolesterol på syv eller mer. Resultatene sår tvil om gjeldende risikoberegninger og retningslinjer, mener forskeren bak en norsk studie.
TRONDHEIM: For hver 1.0 mmol/l økning i totalkolesterol er det en statistisk signifikant reduksjon for totaldødelighet på 6 prosent for kvinner, men ikke for menn. Totaldødeligheten ved kolesterolnivå under 5 er også signifikant høyere enn ved totalkolesterol på 7, men bare for kvinner.
Dette fremgår av en norsk studie som ble presentert på Nidaroskongressen i forrige uke. Studien er nylig forhåndspublisert på nett i Journal of Evaluation in Clinical Practice. (...)
Den store kolesterolfuser
information.dk 17.7.2011
Godt en halv million danskere tager kolesterolsænkende medicin. Næsten halvdelen gør det uden grund eller effekt. Eksperterne ryster på hovedet og kalder pillerne for et produkt af det moderne risikosamfund, hvor der bliver tjent penge på folks frygt. (...)
»Når lægerne udskriver medicin til almindelige, raske mennesker, så tror jeg, de fleste af dem ræsonnerer på den måde, at ‘jeg skal have medicin, altså er jeg syg’, og vi er kede af, hvis folk begynder at opfatte sig selv som patienter, når de er friske og raske og burde nyde livet,« siger Niels Christian Heebøll- Nielsen. (...)
Data Mining Approach Shows Promise in Detecting Unexpected Drug Interactions
JAMA. 2011;306(2):144 (July 20)
Up to 1 million patients in the United States may be taking 2 medications that can lead to unexpected increases in blood glucose levels when used simultaneously. Data mining techniques have revealed that the combination of the antidepressant paroxetine and the cholesterol-lowering medication pravastatin may cause this adverse effect (Tatonetti NP et al. Clin Pharmacol Ther. doi: 10.1038/clpt.2011.83 [published online ahead of print May 25, 2011]).
“If a physician has a patient on these 2 medications and their diabetes becomes harder to control, the physician may want to consider changing the medications,” said principal investigator Russ Altman, MD, PhD, professor of bioengineering, genetics, and medicine at Stanford University. (...)
(Anm: Seroxat (Paxil) (paroxetine; paroksetin) (SSRI) (mintankesmie.no).)
F.D.A. Issues Safety Alert on Zocor (FDA utsteder sikkerhetsadvarsel for Zocor)
prescriptions.blogs.nytimes.com 8.6.2011
The Food and Drug Administration on Wednesday announced new safety restrictions on high-dose simvastatin, also known as Zocor, a cholesterol-lowering drug taken by an estimated 2.1 million Americans.
The agency said the 80-milligram dose caused a potentially severe muscle disease, called myopathy, especially in the first year of taking the medication.
No new patients should be put on the high dosage, the F.D.A. said, recommending that existing patients should continue only if they have used the drug for more than a year without experiencing muscle pains. Alternative statins may be safer, the agency said. (...)
Helsefarlige budskap
KJETIL RETTERSTØL - overlege, Lipidklinikken, Oslo Universitetssykehus
aftenposten.no 19.5.2011
Høyt kolesterol er farlig, sier
noen, ikke noe å bry seg
om, hevder andre. Det forskes
kontinuerlig på feltet. I
1985 fikk Michael S. Brown
og Joseph L. Goldstein Nobelprisen
for arbeid med
kolesterols metabolisme.
Akkumulerte kunnskapsbaser består nå av mer enn 1,5 millioner søkbare vitenskapelige artikler om emnet. Ny kunnskap nyanserer, men et budskap har likevel holdt seg godt i 50 år: Mettet fett øker blodkolesterol og risiko for hjerte- og karsykdom. Likevel finnes det unntak, slik er vitenskap. Problemet er når unntakene dominerer informasjonsbildet. (...)
VG glemte å måle kolesterolet
journalisten.no 6.5.2011
På venstre side advares det fra redaksjonen mot kolesterol, mens det på høyre side foreslås en løsning fra annonseavdelingen.
Slo helsealarm på redaksjonell plass og tipset om redningen på annonseplass rett ved siden. Klart brudd, mener Kokkvold.
Annonsen, som er kjøpt av Boots, Elixia, Grete Roede, Vita hjertegod og Nasjonalforeningen for folkehelsen, er som den berømte hånden i hansken for lesere med kolesterolangst. Men for presseetikeren smaker den heller dårlig.
– Dette er et klart brudd på god presseskikk og en uakseptabel kobling, sier generalsekretær Per Edgar Kokkvold i Norsk Presseforbund til Journalisten.
Han viser til tekstreklameplakatens punkt fem om at man ikke skal ta inn kommersielt materiale på en slik måte at skillelinjen mellom redaksjonelt innhold og markedsplass svekkes. (...)
Legene advarer mot kolesteroltest
aftenposten.no 5.5.2011
Nasjonalforeningen for folkehelsen ber alle voksne måle kolesterolet sitt på apotek. Legeforeningen er rystet over kampanjen og sier at den vil føre til helseangst i befolkningen.
Fra i dag kan alle over 18 år sjekke kolesterolnivået i blodet gratis på enkelte apoteker. Nasjonalforeningen for folkehelsen har etablert dette tilbudet sammen med fire kommersielle aktører og sier de gjør det for å redde liv. Men Legeforeningen anklager dem for å ville tjene penger på folks angst.
Bakgrunnen for kolesterolkampanjen «Har du under 5?» er at gjennomsnittsnordmannen har et kolesterolnivå på 5,8 mmol/l. Ifølge nasjonale retningslinjer er et tilfredsstillende nivå under 5,0. (...)
Leder for Norsk forening for allmennmedisin,(NFA), som representerer allmennlegene i Legeforeningen, Gisle Roksund, er oppgitt og opprørt over kampanjen. Han frykter at kommersielle interesser står bak. (...)
– Legene overser statinbivirkninger
dagensmedisin.no 4.5.2011
– Leger overser bivirkningsrisiko og bør være mer oppmerksomme på forsiktighetsregler ved statiner, mener farmasøyt og seniorrådgiver Kirsten Myhr i Relis. (...)
Minst 50.000 plages
Nye tall fra Reseptregisteret viser at 478.000 nordmenn tar kolesterolsenkende medisin.
Minst 50.000 opplever plagsomme bivirkninger. (...)
Birgitte (47) ble syk av kolesterol-medisin
tv2nyhetene.no 4.5.2011
Som 50.000 andre nordmenn fikk hun plagsomme bivirkninger. Men det hele kunne vært løst med en kopp kaffe.
Nesten en halv million nordmenn medisineres for høy kolesterol. Det er en økning på 47 prosent siden 2004. Mange opplever store plager på grunn av medisinene. Et mer bevisst forhold til kaffe kunne redusert problemet, mener en ernæringsprofessor. (...)
– Bør heller endre kosthold
Farmasøyt Kirsten Myhr mener norske leger overser bivirkningsrisikoen og er for ukritiske når de skriver ut statiner.
– Man bør først prøve seg med livstilsendringer som å endre kosthold, trene mer og slutte å røyke. Jeg tror det er viktig å prøve det før man tar en pille, sier Myhr.
– For kjapp med å medisinere
Birgitte Kallhovd fikk aldri opplysninger fra sin lege om at hun kunne få bivirkninger. Nå vil hun endre kostholdet og droppe medisinene totalt.
– De setter oss pasienter litt for raskt på medisiner istedet for å se på kostholdet vårt. Jeg kommer ikke til å gå tilbake til medisiner, jeg tør ikke. Jeg er blitt redd, så jeg velger heller diett, sier Kalhovd.
(...)
Så mange epler bør du spise hver dag
kk.no 15.4.2011
Fire epler om dagen
Forskerne ble overrasket over eplenes potensiale da de fant ut at de kan redusere kolesterolnivåene hos kvinner. Epler kan både virke slankende, og kutte det dårlige kolesterolet i blodet, ifølge DailyMail.
De fant ut at kvinner som spiste 75 gram tørket eple om dagen i seks måneder fikk redusert det dårlige kolesterolet i blodet med 25 prosent. Det er gode nyheter for tilstoppede blodårer. (...)
Kolesterol – hvornår er forebyggende behandling med statin indiceret?
irf.dk 10.4.2011 (Institut for Rationel Farmakoterapi (IRF)
Det er værdierne kun, såfremt analysesvar ligger udenfor normalværdierne/referenceværdierne. Og disse normalværdier skal efter vores mening selvfølgelig anføres i prøvesvarene.
Når man indsender en blodprøve til analyse, vil resultatet sædvanligvis blive efterfulgt af et referenceinterval i parentes. Referenceintervallet eller normalområdet indeholder 95 % af raske personers værdier. (...)
Advarer mot kolesterolhysteri
aftenposten.no 8.4.2011
Ber fastlegene nekte å ta målinger
Friske eldre spiser kolesterolsenkende medisiner som aldri før. Leger mener mange blir skremt til å ta medisiner de ikke har bruk for.
Svært mange mennesker er redd for høyt kolesterolnivå og ber legene måle nivået. – Fastleger burde ha nektet å måle kolesterolet når folk er blitt rundt 65 år, om de ikke er i en risikogruppe, sier Ottar Nygård, professor ved institutt for indremedisin ved Haukeland Universitetssykehus.
– Det er meningsløst hvis alle skal sjekke kolesterolet. Det er ikke nødvendig. Vi vet blant annet at høyt kolesterol alene ikke er noen risikofaktor hos hjertefriske som har passert 65 år, sier Espen Rostrup, lege ved Hjerteavdelingen på Haukeland Universitetssykehus.
– Norske studier har vist at det er altfor mange friske, eldre som spiser kolesterolsenkende medisiner og tror at det forlenger livet deres. Det er en misforståelse som skremmer de eldre til å spise disse medisinene, sier Nygård. (...)
Blodet sladrer i kodesprog om sygdom
b.dk 27.2.2011
Ny dansk forskning peger på et overset tal, der måske kunne redde førlighed og liv.
Det er ikke ét fedt, hvordan vi bruger den test af fedtstoffer i blodet, der kan forudsige risiko for blodpropper, og som de fleste af os jævnligt går til lægen efter, fra vi rammer midalderen.
Lægerne har f.eks. længe undret sig over, at der ikke er en klar sammenhæng mellem forhøjet kolesterol i blodprøven og blodprop i hjernen, selv om kolesterolsænkende medicin klart sænker risikoen for at få et slagtilfælde.
Nu peger dansk forskning på, at gådens løsning ligger i triglyceriderne, som er det tal, vi sædvanligvis ignorerer i blodprøverne. (...)
- Kolesterol farligst for menn
nrk.no 24.2.2011
Høyt kolesterol øker risikoen for hjerneslag hos menn, mens kvinner må passe seg for fettstoffene triglycerider. Heldigvis hjelper fysisk aktivitet på begge deler.
Kolesterolnivået har lite å si for hjerneslag hos kvinner, ifølge ny dansk forskning. (...)
Studien er publisert i tidsskriftet Annals of Neurology. (...)
- For mange tar kolesterolmedisin
nrk.no 20.1.2011
Bivirkningene kan være verre enn gevinsten, ifølge en ny studie.
Rundt 400.000 nordmenn bruker medisiner mot høyt kolesterol, også kjent som «statiner».
Høyt kolesterol er en risikofaktor for hjerte/karsykdommer, og det blir derfor ansett som viktig å få ned kolesterolverdiene.
Men ifølge en ny metastudie fra det anerkjente Cochrane Library, mangler det vitenskapelige bevis for at slike medisiner reduserer risikoen for å dø av hjerte/karsykdommer - med mindre man har påvist hjerte/karlidelser.
Forskerne har gjennomgått 14 publiserte studier med tilsammen 34.272 deltakere. (...)
Analys ifrågasätter preventiv behandling med statiner
lakemedelsvarlden.se 19.1.2011
Det finns idag inte något bevis för att patienter utan tidigare historia av hjärtkärlsjukdom ska behandlas med statiner. Det är slutsatsen i en Cochrane-översikt.
Forskarna från Cochrane Heart Group har i en systematisk översikt gått igenom 14 studier med totalt drygt 34 000 patienter som behandlats med statiner i preventivt syfte, färre än 10 procent av patienterna hade en historia av hjärtkärlsjukdom.
Cochraneforskarnas slutsats är att mycket lite talar för att det är kostnadseffektivt att som primärprevention behandla patienter med statiner. Resultatet av översikten, i vilken man kombinerade data från åtta studier av studierna med totalt 28 000 patienter, är att statiner i den här gruppen minskar risken att dö från nio till åtta per tusen personer som behandlas varje år. (...)
Statins may raise stroke risk in some: study (Statiner kan ifølge studie øke risiko for hjerneslag hos enkelte)
reuters.com 10.1.2011
(Reuters) - People who have had a type of stroke caused by bleeding in the brain should avoid taking cholesterol-lowering drugs known as statins, U.S. researchers said on Monday.
Although statins are commonly used to prevent heart attacks and strokes, they said the drugs could increase the risks of a second stroke in these patients, outweighing any other heart benefits from the drugs.
"Our analysis indicates that in settings of high recurrent intracerebral hemorrhage risk, avoiding statin therapy may be preferred," Dr. Brandon Westover of Massachusetts General Hospital and Harvard Medical School and colleagues wrote in the Archives of Neurology. (...)
Læger slår alarm: Ny 'ond kolesterol' truer
bt.dk 2.8.2010
Farligt blodfedt er en bombe under din sundhed
Lægelige eksperter efterlyser langt mere fokus på blodfedtet triglycerid, der anses for endnu farligere end det såkaldt onde kolesterol.
En række førende eksperter advarer nu om, at den farligste type kolesterol er helt overset, selv om hver fjerde dansker er i farezonen.
B.T. skriver, at mange læger overser det andet blodfedt, triglycerid, der indeholder en anden type kolesterol, som er endnu farligere end det, vi i dag kalder det onde kolesterol. (...)
Statins and All-Cause Mortality in High-Risk Primary Prevention (Statiner og dødelighet av alle årsaker i høyrisiko primær forebygging)
Arch Intern Med. 2010;170(12):1024-1031 (June 28)
Background Statins have been shown to reduce the risk of all-cause mortality among individuals with clinical history of coronary heart disease. However, it remains uncertain whether statins have similar mortality benefit in a high-risk primary prevention setting. (...)
(Konklusjon Disse litteraturbaserte metaanalyser fant ingen bevis for nytte av statinterapi på alle årsaker til død innen høyrisiko primær forebygging.) (...) (Conclusion This literature-based meta-analysis did not find evidence for the benefit of statin therapy on all-cause mortality in a high-risk primary prevention set-up.)
(Anm: Hva er forebygging? (forebygging.no).)
Sjukdomar kopplas till statiner – men fördelarna överväger
dagensmedicin.se 21.5.2010
(...) Forskarna har analyserat data från en stor primärvårdsdatabas med mer än 2 miljoner patienter från England och Wales, varav runt 225 000 nyligen hade inlett behandling med statiner. Patienterna följdes under perioden januari 2002 till juni 2008.
Forskarna konstaterar att statinanvändning ökade risken för grå starr, muskelsjukdom, akut njursvikt och förhöjda levervärden. De tre sistnämnda tillstånden är sedan tidigare kända biverkningar av statiner. (...)
Riskökningarna gällde då forskarna kontrollerade för faktorer som ålder, rökstatus och andra sjukdomar.
På den positiva sidan fann forskarna att statiner tycktes skydda mot matstrupscancer och – som väntat – mot hjärt-kärlsjukdom. (...)
Cholesterol drug side effects need watching: study (Det er behov for å overvåke kolesterollegemidlers sideeffekter)
reuters.com 20.5.2010
(Reuters) - People using cholesterol-lowering statins have a higher risks of liver dysfunction, kidney failure, muscle weakness and cataracts and such side effects of the drug should be closely tracked, doctors said on Friday. (...)
The findings, published in the British Medical Journal, are unlikely to affect the use of best-selling medicines like Pfizer's Lipitor and AstraZeneca's Crestor, but the study's authors said patients taking statins should be "proactively monitored" for side effects. (...)
Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database (Uønskede effekter av statiner hos menn og kvinner i i England og Wales befolkningbasert kohortstudie ved bruk av QResearch databasen)
BMJ 2010;340:c2197 (20 May)
(...) Conclusions Claims of unintended benefits of statins, except for oesophageal cancer, remain unsubstantiated, although potential adverse effects at population level were confirmed and quantified. Further studies are needed to develop utilities to individualise the risks so that patients at highest risk of adverse events can be monitored closely. (...)
Risks Seen in Cholesterol Drug Use in Healthy People (Risiko registrert ved bruk av kolesterollegemidler hos friske mennesker)
nytimes.com 31.3.2010
With the government’s blessing, a drug giant is about to expand the market for its blockbuster cholesterol medication Crestor to a new category of customers: as a preventive measure for millions of people who do not have cholesterol problems.
Some medical experts question whether this is a healthy move.
They point to mounting concern that cholesterol medications — known as statins and already the most widely prescribed drugs in the United States — may not be as safe a preventive medicine as previously believed for people who are at low risk of heart attacks or strokes. (...)
But for healthy people who would take statins largely as prevention — which would be the case for the new category of Crestor patients — other experts suggest the benefits may not outweigh any side effects. (...)
Simvastatin gitt i høyeste dose 80 mg gir økt bivirkningsrisiko
legemiddelverket.no 26.3.2010
USAs Food and Drug Administration (FDA) advarer om at simvastatin gitt i høyeste dose øker risiko for muskelbivirkninger. Legemiddelverket ønsker å minne om at risikoen for bivirkninger øker ved de høyeste dosene for alle statiner. Den nye studien viser en mulig økning ved bruk av 80 mg simvastatin, men nytten ansees fremdeles å være større enn risikoen.
Rhabdomyolyse er en meget sjelden muskelbivirkning som er rapportert ved bruk av alle statiner. I 2009 fikk totalt 356.615 personer utlevert simvastatin fra norske apotek, hvorav 17.525 i dosen 80 mg. Samlet sett er risiko for bivirkninger relativt lav selv om høy dose gir høyere risiko for bivirkninger enn lavere doser.
(Anm: rhabdomyolysis ; rabdomyolyse, ødeleggelse av skjelettmuskulatur. Årsaker Rabdomyolyse sees ved kirurgisk skade, trykkskade på grunn av redusert bevissthet, iskemi (lokal blodmangel) på grunn av nedsatt sirkulasjon, etter kramper, og i forbindelse med hypertermi (overoppheting) og forgiftninger. (...) Kilde: Store norske leksikon.)
(Anm: rabdomyolyse; nedbryting eller oppløysing av tverrstripete muskulatur som gir auka innhald i serum av myoglobin og ymse muskelvevsenzym; kan stundom koma som skadeverknad ved bruk av glutetimid, amfetamin, salisylat, fencyclidin, teofyllamin eller andre medikament eller pga virussjukdommar, slangebit, sterk muskelrøyning m v; kan vera årsak til farleg hyperkalemi, kan gi nyresvikt pga myoglobinopphoping i nyrene; kan stundom skuldast mangel på carnitinpalmityltransferase, eit enzym i feittstoffskiftet; jf Meyer-Betz' sjukdom
EN rhabdomyolysis Kilde: Norsk medisinsk ordbok.)
Advarer mot kolesterolmedisin
nrk.no 24.3.2010
(...) Det amerikanske legemiddelverket advarer mot alvorlige bivirkninger ved bruk av en kolesterolmedisin som brukes av over 350.000 nordmenn.
Legemiddelet Simvastatin brukes for å senke kolesterolnivået i blodet og redusere faren for hjerteinfarkt.
En ny amerikansk undersøkelse viser at høye doser kan føre til muskelskader og, i sjeldne tilfeller, nyreskader som i verste fall kan være dødelige.
Amerikanske Food and Drug Administration (FDA) ber nå pasienter som tar en daglig dose på 80 milligram om å være ekstra oppmerksomme på symptomer på bivirkningene, skriver Daily Telegraph. (...)
Legemiddelverket har fortsatt ikke bestemt seg om de vil gå ut med nærmere informasjon eller en advarsel til norske pasienter. (...)
Statiner ger ökad diabetesrisk
lakemedelsvarlden.se 17.2.2010
Personer som behandlas med blodfettssänkande statiner har nio procents högre risk at drabbas av diabetes visar en brittisk studie. Resultaten visar att det är viktigt att följa patienter som behandlas med statiner och inte sätta in det slentrianmässigt. (...)
Cholesterol drugs up diabetes risk slightly: study
reuters.com 16.2.2010
LONDON (Reuters) - People on cholesterol-lowering statins are 9 percent more likely to develop diabetes, but this small absolute risk is outweighed by the drugs' heart-protecting properties, researchers said on Wednesday. (...)
Är kolesterol en riskfaktor?
LARS WERKÖ - Professor emeritus i invärtesmedicin, tidigare chef vid SBU, TORE SCHERSTÉN - Professor emeritus i kirurgi, tidigare sekreterare i Medicinska Forskningsrådet, RALF SUNDBERG - Docent i transplantationskirurgi
svd.se 14.7.2009
Gott – och skadligt? Slutsatserna i den senaste kolesterolforskningen är färgad av läkemedelföretagens sponsring, hävdar artikelförfattarna. Hypotesen om att kolesterol är farligt bör förkastas, säger de.
”FARLIGT” KOLESTEROL Flera vetenskapliga studier har visat att infarktpatienter har lägre kolesterolvärden än normalbefolkningen och att dödligheten dessutom är högre vid låga värden. Nu är det dags att förkasta hypotesen om sambandet mellan höga kolesterolnivåer och hjärtinfarkter och kanske också dags att utreda vad som lett till detta vetenskapliga haveri, skriver Lars Werkö, Tore Scherstén och Ralf Sundberg. (...)
Storforbrug af medicin blandt raske
politiken.dk 1.1.2009
Siden 2003 er salget af kolesterolsænkende medicin steget med 233 procent. Årsag: Raske mennesker sygeliggøres, vurderer eksperter. (...)
»I dag er anbefalingen et kolesteroltal under 5. Med den grænse har de fleste voksne et ’for højt’ kolesteroltal. Og derfor gør vi en stor del af befolkningen til patienter uden grund«, siger Mats Lindberg, læge og talsmand for netværket Læger Uden Sponsor. (...)
Bare et fåtall har nytte av statiner
TOR OLE KJELLEVAND, lege
aftenposten.no 22.8.2008
Erik Øie skriver 18. august at de som har et avvikende syn på effekten av kolesteroldempende
statiner, gjør pasientene rådville. De vet ikke lenger om de skal ta statiner eller ikke. Hvis dere hadde fortalt
pasientene hele sannheten om statinene, ville det ikke vært så mye tvil. (...)
Hvis du ikke har hjertesykdom, har statinene beviselig ingen effekt. Dette er slått fast av The Internatonal Society of Drug Bulletins. De hadde gått gjennom alle tilgjengelige vitenskapelige data. Dette anerkjente organet er imidlertid ikke sponset av noe legemiddelfirma og er vel kanskje ikke til å stole på, dr. Øie? (...)
Til beste for pasientene
ERIK ØIE, lege, dr.med., Asker
aftenposten.no 18.8.2008
(...) Kolesteroldebatten. Et søk på de mest brukte helsebibliotekene på internett viser noe helt annet. De store behandlingsstudiene med statiner er riktignok organisert og finansiert av legemiddelfirmaer, og dette skyldes ganske enkelt at det bare er legemiddelfirmaer som har økonomiske midler til å gjennomføre slike studier som koster flere hundre millioner kroner. (...)
Om å ta mannen og ikke ballen
Tor Ole Kjellevand, lege, Oslo
aftenposten.no 9.8.2008
Jeg blir igjen angrepet på grunn av min overbevisning i kolesteroldebatten. Denne gang av dr. Erik Øie. (...)
Til det vil jeg bare si at jeg har ikke mottatt en eneste krone av dette firmaet eller av andre vitamin- eller kosttilskuddsprodusenter, hverken i form av penger, reisetilskudd, forskningsstøtte eller noe annet. Ikke engang i form av gratis vitaminer. Dem kjøper jeg selv. Jeg håper dr. Øie kan si det samme når det gjelder hans forhold til legemiddelindustrien. (...)
Statiner minsker risikoen
aftenposten.no 6.8.2008
ERIK ØIE, lege, dr.med., Nesøya
Tor Ole Kjellevand har gjennom avisinnlegg og intervjuer argumentert for at det er en myte at kolesterol er farlig og at denne myten har fått leve videre fordi legemiddelindustrien tjener store penger på å selge kolesterolsenkende medisiner; de såkalte statinene. (...)
Denne interessekonflikten bør Aftenpostens lesere ha in mente når de leser innlegg fra Kjellevand. (...)
Kan svekke minnet
DAG VILJEN POLESZYNSKI, dr.philos., fagredaktør, Mat&helse
aftenposten.no 9.7.2008
Leder av Nasjonalforeningen for folkehelsen, John Kjekshus, hevder i Aftenposten 2. juli: "Kolesterolsenkende medikamenter (statiner) påvirker ikke hukommelsen".
Debatten om kolesterolmedisiner. Han har muligens glemt (eller ikke lest) litteraturen som klart dokumenterer at statiner ikke bare kan føre til kortvarig hukommelsestap, men også kan gi mange andre bivirkninger. (...)
Er jeg blitt glemsk av pillene jeg tar?
Leiv Ose, Seksjonsoverlege, Lipidklinikken, Medisinsk avdeling, Rikshospitalet
aftenposten.no 4.7.2008
Spurte Frid Ingulstad 28. juni. Er det en bivirkning av de nye kolesterolmedisinene (statiner) mange må ta? (...)
Av de millioner som spiser statiner i USA, er det rapportert om 60 med glemskhet uavhengig av type statin som er brukt. Glemskheten kom i løpet av to måneder hos halvparten av de 60 rapporterte pasientene. Glemskheten forsvant igjen hos 14 av de 25 som ble glemske når de stoppet med statin. (...)
Tallene over viser til mange individuelle lege/pasientrapporter, men placebokontrollerte studier hvor mer enn 24 000 pasienter har deltatt, har ikke kunnet vise noen påvirkning av glemskhet eller kognitive funksjoner. (...)
Farlige medisiner
Tor Ole Kjellevand, lege
aftenposten.no 3.7.2008
I Aftenposten 28. juni etterlyser Frid Ingulstad informasjon fra "landets fremste fagfolk" om en type kolesterolmedisin, statiner, kunne være årsak til hennes økende glemsomhet. (...)
Om statinene er årsak til at akkurat hun opplever at hun er mer glemsk, er vanskelig å svare på. Vi blir alle litt mer glemske med alderen. Når det gjelder om statiner kan forårsake økende glemsomhet, er det liten tvil om at så er tilfelle. Statinene senker det livsviktige kolesterolet som er en viktig byggesten i kroppen vår, særlig i hjernen. Mange pasienter som er satt på statin har opplevd denne effekten, men den blir oversett av legene fordi de "vet" at statinene er ufarlige.
Men hvorfor tar du i det hele tatt statiner? Det er ikke påvist at de gjør noen nytte hos kvinner overhodet. Høyt kolesterol er ikke farlig og skal ikke behandles. Statiner kan ha en viss effekt hos menn med etablert kransåresykdom. Ikke fordi de senker kolesterolet, men fordi de har mange andre effekter. Når jeg hører om diskusjonen blant dine venner, om at de har klart å senke sitt kolesterol med så og så mye, blir jeg bare trist. Her snakker vi om friske mennesker som er gjort til pasienter av en overivrig lege. (...)
Påvirker ikke hukommelsen
JOHN KJEKSHUS, professor emeritus, leder i Nasjonalforeningen for folkehelsen
aftenposten.no 2.7.2008
Frid Ingulstad er bekymret over sitt pillebruk i sin Signert- artikkel 28. juni. Kolesterolsenkende medikamenter (statiner) påvirker ikke hukommelsen. Den første store undersøkelsen med et kolesterolsenkende medikament, simvastatin, ble utført i Norge for snart 20 år siden. (...)
Skeptikerne henviser til meldinger om bivirkninger som benbrudd, selvmord, kreft og nedsatt hukommelse, dette skyldes tilfeldigheter. I vår og mange andre kontrollerte undersøkelser fant man tvert imot færre av de påståtte bivirkningene i gruppen som fikk statiner enn i gruppen som fikk inaktiv medisin (placebo). Statinene har meget få og beskjedne bivirkninger selv hos gamle og svake pasienter. (...)
Etter hvert som vi blir eldre, er det normalt at mange av oss glemmer ord og avtaler, men det er bare 10 prosent som blir demente. (...)
Blir jeg glemsk av pillene jeg tar?
FRID INGULSTAD, forfatter
aftenposten.no 28.6.2008
KOLESTEROL. Vi tar piller for så mangt. Jeg tar mot for høyt kolesterol. Men nå er jeg blitt fortalt at jeg kan bli glemsk av pillene. Er det virkelig sant, en medisin som tar hukommelsen? (...)
Drugs Alone Don't Lower Heart Disease Risks for Overweight Americans
healthfinder.gov 12.5.2008
Study finds signs of trouble show up even when statins, blood pressure meds are used.
SOURCES: Gregory L. Burke, M.D., professor and director, division of public health sciences, Wake Forest University, Winston-Salem, N.C.; Lona Sandon, M.Ed., RD, assistant professor, clinical nutrition, University of Texas Southwestern Medical Center, Dallas; May 12, 2008, Archives of Internal Medicine)
MONDAY, May 12 (HealthDay News) -- Daily doses of statins and blood pressure medications will not be enough to prevent heart disease among the ever-growing number of Baby Boomers who are overweight or obese, a new study suggests.
The simple truth, experts say, is that pounds must also be shed to keep cardiovascular trouble away.
"There is a debate out there about whether this generation is going to live as long as their parents, and the truth is they probably won't," said study author Dr. Gregory L. Burke, director of the division of public health sciences at Wake Forest University School of medicine in Winston-Salem, NC. (...)
In Denial
forbes.com 9.4.2008
The latest cholesterol mess shows how big pharma just can't seem to face up to bad results.
When questions first emerged about a small study testing their $5 billion cholesterol pills Zetia and Vytorin, Merck (nyse: MRK - news - people) and Schering-Plough (nyse: SGP - news - people) pooh-poohed its importance. "I don't know why this would have any impact on mainstream use," Schering Chief Executive Fred Hassan told analysts in January. But newly released results say that these two immensely lucrative drugs don't impede plaque buildup in arteries. The New England Journal of Medicine even published two editorials telling doctors to use them as a last resort (a conclusion Merck and Schering disputed vigorously; the study showed no safety problems). (...)
Kolesterol-faren en bløff?
dagbladet.no 31.3.2008
Oppsiktsvekkende studie om bestselger-medisin lagt fram på internasjonal hjertekongress. (...)
Den såkalte Enhance-undersøkelsen, som omfatter 720 personer med familiær hyperkolesterolemi skulle i første rekke teste en ny type blodfettsenkende medikament - Ezetrol - (som i USA selges i en kombinasjonen med simvastatin under navnet Vytorin)- og sammenligne dette med det 'gamle' kolesterolsenkende middelet simvastatin (originalproduktet heter Zocor). (...)
Vytorin Makes Merck And Schering Swoon
forbes.com 31.3.2008
(...) On Sunday, The New England Journal of Medicine released the full results of a study called ENHANCE that showed Vytorin was no more effective than the older Zocor. Vytorin is a $5.2 billion joint-venture cholesterol drug that combines Merck's Zocor with Merck/Schering-Plough drug Zetia. Zocor is available in a less-expensive generic form. (...)
Sector Snap: Cholesterol Drug Makers
forbes.com 31.3.2008
A flurry of positive and negative study data for cholesterol drugs pushed shares of Merck & Co. and Schering-Plough Corp. to record lows Monday, while Abbott Laboratories and AstraZeneca PLC shares caught a boost. (...)
Journal Issues Warning on Two Cholesterol Drugs
nytimes.com 30.3.2008
CHICAGO — Two widely prescribed cholesterol-lowering drugs, Vytorin and Zetia, may not work and should be used only as a last resort, The New England Journal of Medicine said in an editorial published on Sunday. (...)
Merck and Schering-Plough, the companies that make Vytorin and Zetia, said on Sunday that despite the results of the trial, they would continue to promote their medicines as first-line treatments for high cholesterol. (...)
Hårreisende påstand av overlege
aftenposten.no 5.9.2007
Uffe Ravnskov, dr.med., dosent Lund, Sverige
Dr. Leiv Oses påstand at en mann med arvelig høyt kolesterol (FH) har 85 % risiko for å få et hjerteinfarkt før han blir 60 år, har ingen basis i virkeligheten. (...)
Det er ikke det høye kolesterolnivået som er farlig. Risikoen for personer med FH er nemlig den samme eller større (!) med lett forhøyet kolesterol som med et som er 2-3 ganger høyere enn normalt. Den økte dødeligheten av hjerteinfarkt skyldes at noen med FH også arver forstyrrelser i koagulasjonssystemet, ikke at de har høyt kolesterol. (...)
Hvem skal vi tro på?
Margaretha Gøransson Hamrin, leder FH Norge
aftenposten.no 31.8.2007
Det ser ut til at røntgenlegen Tor Ole Kjellevand nå søker å posisjonere seg som en norsk kolesterolekspert. (...)
Så hvem skal folk flest og spesielt de som er i risikogruppen for hjertedød, velge å tro på? (...)
Bare én type kolesterol
TOR OLE KJELLEVAND -
Tidligere overlege
aftenposten.no 24.8.2007
Jeg blir angrepet av lederen i foreningen for familiær hyperkolesterolemi (FH) i Norge i tirsdagsavisen. Skandale var ordet hun brukte.
Jeg har gjort noe utilgivelig, nemlig vært uenig i Lipidklinikkens og Rikshospitalets offisielle syn i kolesteroldebatten. (...)
Betegnelsen "godt" og "dårlig" kolesterol er altså noe som er funnet på av tilbederne av kolesterolmyten. (...)
Det er ingen sammenheng mellom kolesterolnivået hos FH-pasientene og insidensen av hjertedød. Altså, FH-pasienter med forholdsvis lavt kolesterol dør like ofte som de med skyhøyt kolesterol. Hvorfor, hvis kolesterolnivået skulle være det viktigste for å overleve?
Statinene har nok en viss beskyttende virkning hos pasienter med FH. Ikke på grunn av kolesterolsenkningen, men på grunn av alle de andre effektene statinene har. (...)
When 'Good' Cholesterol Goes Bad (Når "god" kolesterol blir dårlig)
healthfinder.gov 22.8.2007
(SOURCES: Jay Heinecke, M.D., professor, medicine, University of Washington, Seattle; Aug. 22, 2007, American Chemical Society annual meeting, Boston)
WEDNESDAY, Aug. 22 (HealthDay News) -- It looks like HDL, the "good" cholesterol that supposedly protects against cardiovascular disease, might have a harmful side. (...)
Inflammation is the major villain in the new picture. Arteries are not only blocked because of the gradual growth of plaque. Instead, there comes a moment when plaque ruptures, causing a clot to form and block blood flow, Heinecke said. Proteins called proteases play a major role in these ruptures. (...)
So, measuring blood levels of LDL and HDL cholesterol is not as predictive of cardiac risk, as has been assumed, Heinecke stressed. "Protein composition [in HDL cholesterol] may be a better handle on whether someone is at risk," he added. (...)
Kolesterol på liv eller død
aftenposten.no 21.8.2007
Margaretha Gøransson Hamrin Leder for FH-Norge, pasientorganisasjon for familiær hyperkolesterol
En skandale. At en overlege fra Rikshospitalet offentlig og i sjikanøse ordelag går ut mot Lipidklinikken, som er landets viktigste behandlingssenter for den arvelige genfeilen familiær hyperkolesterolemi (FH), er intet mindre enn en skandale som sykehuset må rydde opp i. (...)
- Gjør kolesterollegemidler noe godt?
Do Cholesterol Drugs Do Any Good? (Gjør kolesterollegemidler noe godt?)
businessweek.com 17.1.2008
Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated
Med unntak for høyrisiko hjertepasienter, tyder forskning på at nytten av statiner slik som Lipitor er overdrevet) (...) (Research suggests that, except among high-risk heart patients, the benefits of statins such as Lipitor are overstated)
Such drugs are the best-selling medicines in history, used by more than 13 million Americans and an additional 12 million patients around the world, producing $27.8 billion in sales in 2006. Half of that went to Pfizer (PFE) for its leading statin, Lipitor. (...)
- Forlenger det livet?
WELL
Great Drug, but Does It Prolong Life?
nytimes.com 29.1.2008
Statins are among the most prescribed drugs in the world, and there is no doubt that they work as advertised — that they lower not only cholesterol but also the risk for heart attack. (...)
Kaiser Daily Health Policy Report Highlights Scrutiny Over Benefit of Using Statins
kaisernetwork.org 29.1.2008
Prescription Drugs
Two newspapers on Tuesday reported on scrutiny of statin use and whether the drugs provide prolonged life or benefits to patients with high cholesterol. Summaries appear below.
• New York Times: In the "fallout from the headline-making trial of Vytorin, a combination drug that was found to be no more effective than a simple statin in reducing arterial plaque, many people are asking a more fundamental question about statins in general: Do they prolong your life?" the Times reports. According to the Times, middle-aged men with cardiovascular disease were less likely to die if they were taking a statin compared to those taking a placebo. However, "many statin users don't have established heart disease; they simply have high cholesterol," and "there is little evidence, if any, that taking a statin will make a meaningful difference in how long" people without heart disease live, the Times reports. In addition, "critics say there's no evidence that statin users have a better quality of life than other people," according to the Times. Mark Ebell, a professor at the University of Georgia and deputy editor of the journal American Family Physician, said, "High-risk groups have a lot to gain" from taking statins, but "patients at low risk benefit very little, if at all. We end up overtreating a lot of patients" (Parker-Pope, New York Times, 1/29).
• Philadelphia Inquirer: Cholesterol-lowering drugs have been shown to "reduce the risk of death, heart attack and other problems in patients with cardiovascular disease, but it is less clear that they help patients ... who don't yet have heart disease," the Inquirer reports. According to the Inquirer, two analyses of scientific literature have shown that between "200 and 250 people with high cholesterol but no known cardiovascular disease must take a statin daily for three to five years to prevent one death." However, a similar analysis that tracked patients for an average of more than six-and-a-half years found that if 68 patients with high cholesterol "followed a more careful diet, one death could be avoided," according to the Inquirer. The Inquirer reports, "Given the financial stakes -- cholesterol-lowering drugs generated $21.6 billion from U.S. sales in 2006 -- some wonder whether studies that question the benefits of the medications ever reach the public" (Goldstein, Philadelphia Inquirer, 1/29). (...)
- Undersøkelse viser at leger avviser pasienters klager om bivirkninger
Is Your Doctor in Denial? (Nekter din lege å erkjenne fakta?)
washingtonpost.com 28.8.2007
Undersøkelse viser at leger ofte avviser klager om legemidlers sideeffekter (Survey Finds Physicians Often Dismiss Complaints About Drugs' Side Effects)
Mange engstelige pasienter gir detaljopplysninger på nettforum og pratekanaler på internett om muskelsmerter og hukommelsestap, som de har erfart etter at de begynte med statiner for å senke sitt kolesterol. En ny studie antyder at disse mennesker kanskje har en god grunn til å søke en bekreftelse: Noen klager ville ellers gå upåaktet hen. (On many online message boards and Internet chat rooms, anxious patients share details about the muscle pain and memory loss they have noticed since they started taking statins to lower their cholesterol. A new study suggests these people may be seeking validation for good reason: Some of their complaints might otherwise be going unheard.)
Ifølge en undersøkelse av 650 pasienter publisert sist uke om legemiddelsikkerhet, et fagfellevurdert tidsskrift, ignorerer eller avviser leger ofte pasienters bekymringer om slike sideeffekter. Studien viser et reaksjonsmønster som også gjelder andre legemidler. (According to a survey of 650 patients published last week in Drug Safety, a peer-reviewed journal, doctors frequently ignored or dismissed patients' concerns about such side effects. The study suggests this pattern of reaction goes beyond statins to other drugs.)
Når leger ikke erkjenner pasienters symptomer som en sideeffekt av legemiddelet, er også pasienten utsatt for risiko. På grunn av at legen ikke fyller ut og sender en "bivirkningsrapport" til Food and Drug Administration, kan legemiddelkontrollen undervurdere problemet, og andre leger og pasienter antar at legemiddelet er tryggere enn det er. (When doctors fail to recognize a patient's symptoms as drug side effects, more than that patient's care is put at risk. Because the doctor makes no "adverse event report" to the Food and Drug Administration, the regulatory agency may underestimate the problem, and other doctors and patients may assume the drug is safer than it is.)
Forskerne ved University of California at San Diego gransket sideeffekter for statiner da ble oppmerksomme på problemet. (...) (Researchers from the University of California at San Diego had been investigating the side effects of statins when they noticed the problem.)
Jerry Avorn -- professor ved Harvard Medical School og forfatter av boken "Powerful Medicines: Nytte, risiko og kostnader for reseptbelagte legemidler" -- sa at "der er en skrekkelig underrapportering av sideeffekter," og legger til at 90 til 99% av "alvorlige sideeffekter ikke rapporteres av leger." (...) (Jerry Avorn -- a Harvard Medical School professor and author of the book "Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs" -- said that "there is horrendous underreporting of side effects," adding that 90% to 99% of "serious side effects are not reported by doctors.")
- På helsa løs?
På helsa løs
Kjetil Retterstøl overlege dr. med Lipidklinikken Rikshospitalet
Dagbladet 28.9.2005
NRKs Pulsredaksjon fremstår som en gjeng Fedonister snarere enn seriøse helseopplysere, skriver Kjetil Retterstøl. (...)
Usaklige personangrep
dagbladet.no 12.10.2005
Fedon Lindberg trekker seg som kostholdsekspert i Puls.
OVERLEGE KJETIL Retterstøl fra Lipidklinikken gikk i et debattinnlegg i Dagbladet av 28.9. til angrep på meg personlig og redaksjonen i NRK Puls med en rekke påstander. Bakgrunnen for angrepet var et innslag i NRK Puls den 19.9. om matens betydning for helsen. Da nevnte jeg at en stor sveitsisk metaanalyse tydet på at omega-3 fettsyrer, som finnes i fiskefett, så ut til å forebygge dødelighet av alle årsaker og av hjertesykdom spesielt, samt at det så ut til at omega-3 reduserte slik dødelighet mer enn statiner, de nye kolesterolsenkende og hjertesykdomforebyggende medikamenter.
Etter å ha forsøkt å tillegge meg meningsløse og fullstendig feilaktige kommersielle motiver bak min presentasjon av denne studien, sendte jeg et tilsvar som ble publisert den 2.10. i Dagbladet.
Helsejournalistikk - ikke reklame
dagbladet.no 2.10.2005
Egil Sundvor Prosjektsjef i NRK Fakta
OVERLEGE KJETIL RETTERSTØL ved Lipidklinikken hevder at NRKs «Puls»-redaksjon er «en gjeng fedonister snarere enn seriøse helseopplysere» i Dagbladet 28.09. Retterstøl anklager redaksjonen for å løpe Fedon Lindbergs ærend, og ikke journalistikkens.
Dessuten mener han at «Puls» er helt uten kildekritikk og at omtalen av det gode fettet er helseskadelig. (...)
Diverse artikler
Doubt Cast on the ‘Good’ in ‘Good Cholesterol’
nytimes.com 16.5.2012
The name alone sounds so encouraging: HDL, the “good cholesterol.” The more of it in your blood, the lower your risk of heart disease. So bringing up HDL levels has got to be good for health.
Or so the theory went.
Now, a new study that makes use of powerful databases of genetic information has found that raising HDL levels may not make any difference to heart disease risk. People who inherit genes that give them naturally higher HDL levels throughout life have no less heart disease than those who inherit genes that give them slightly lower levels. If HDL were protective, those with genes causing higher levels should have had less heart disease.
Researchers not associated with the study, published online Wednesday in The Lancet, found the results compelling and disturbing. Companies are actively developing and testing drugs that raise HDL, although three recent studies of such treatments have failed. And patients with low HDL levels are often told to try to raise them by exercising or dieting or even by taking niacin, which raised HDL but failed to lower heart disease risk in a recent clinical trial. (...)
People's Pharmacy: Statins and memory loss
seattletimes.nwsource.com 15.1.2012
People's Pharmacy answers queries from readers about statins and memory loss; nitroglycerin patches for osteoporosis; and beta blockers contributing to cold hands and feet. (...)
Overvurderer statineffekten
dagensmedisin.no 30.12.2011
Et flertall av fastlegene overvurderer levetidsgevinsten ved statinbehandling.
Hele tre av fire allmennleger overvurderer betydningen av statinbehandling for en pasient i en gitt kasuistikk.
Dette fremgår av en studie som ble presentert på Nidaroskongressen i oktober av Peder A. Halvorsen ved Universitetet i Tromsø. Han er førsteforfatter av studien, og medforfattere er Olaf G. Aasland og Ivar Sønbø Kristiansen.
- Dette er en type effektmål som allmennleger ikke er så vant til å forholde seg til, så vi bør ikke trekke konklusjonen for langt. Det kan godt hende vi ville ha funnet samme tendens ved andre legemidler. Studien vår antyder i hvert fall et behov for at slike tall blir tilgjengelige og at legene læres opp i å bruke dem, sier Peder A. Halvorsen til Dagens Medisin.
Han er forsker ved Universitetet i Tromsø og fastlege ved Nordlys legesenter i Alta. (...)
The Heart Pill Debate
ivanhoe.com 19.12.2011
CLEVELAND, OH (Ivanhoe Newswire) -- A landmark study has changed how some cardiologists view a popular drug used to lower bad cholesterol. Some are now prescribing it to patients with normal cholesterol, but some doctors think it might do more harm than good. (...)
After less than two years the five year study was cut short because of those findings. Cleveland clinic cardiologist Steven Nissen says the study changed the way he practices medicine. He tells us before the results, he and a lot of other doctors occasionally did blood tests for inflammation.
“Well, we’re making that measurement more often now,” Dr. Nissen said.
Doctors may use the results to prescribe statins to prevent heart disease. But, University of California - San Diego, Dr. Beatrice Golomb says it is not known with longer term use and in real world users, whether the benefits outweigh the real risks.
“It's portrayed as being so fantastically safe it should be put in the water supply. The real world use this drug causes problems not infrequently,” Beatrice Alexandra Golomb, M.D., Ph.D., an, associate professor of medicine at the University of California - San Diego School of Medicine, said.
Golomb tells us while some people benefit from statins others have reported symptoms similar to Alzheimer’s. Muscle weakness, nerve damage, and cognitive problems have also been issues.
For people in the Jupiter study...
“There was evidence of a significant increase in incident diabetes,” Dr.Golomb said.
She wants to see more studies on the drug’s long term effects on patients with inflammation, but Dr. Nissen still believes in most of those cases statins work.
“It’s taken more to convince others and I respect people who are cautious,” Dr.Nissen said.
Dr.Golomb says she would like to see other, potentially safer, anti-inflammatory agents like low-dose aspirin tested to see if the effects are similar or even better than statins. As for people with normal cholesterol, other risk factors for heart disease inflammation blood tests are inexpensive and available at just about every hospital. (...)
Zocor (simvastatin) tablets
fda.gov (October 2011)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November, March and April 2010, June and
WARNINGS AND PRECAUTIONS
Myopathy/Rhabdomyolysis
Zocor therapy should be discontinued if markedly ...
Amiodarone added to TABLE 1
Liver Dysfunction
There have been rare postmarketing reports of fatal and non-fatal hepatic failure in patients...
Endocrine Function
Increases in HbA1c and fasting serum glucose levels have been reported ... (...)
Statins and diabetes
Risk of diabetes from statins may be higher in women
BMJ 2011;343 (8 November)
In their editorial Byrne and Wild grapple with the “paradox that arises” when statins, targeted to lower cardiovascular risk, increase diabetes, one of the most potent cardiovascular risk factors.1 They suggest that statins reduce all cause mortality by citing a statistical exercise with questionable assumptions from which no long term effect (or numbers needed to treat) can be calculated for women.2
Indeed, no study or meta-analysis has shown that statins have a beneficial effect on all cause mortality in women.3
The pleiotropic effect of statins seems to underlie their diabetogenic action, while other pleiotropic actions also explain their benefit, primarily by promoting the nitric oxide-endothelial nitric oxide synthase pathway (mimicked by glyceryl trinitrate).4
In the JUPITER study, for example, which showed a 25% increase in the incidence of type 2 diabetes,5 the only benefit for women was the need for fewer revascularisation operations.6 Statins’ known effects on nitric oxide-endothelial nitric oxide synthase are likely to reduce angina symptoms and could explain the reduced need for revascularisation.
In women, therefore, the main or only cardiovascular benefit of statins may be a reduction in the symptoms of angina, while increasing diabetes by 25%. If so, the long term diabetogenic effects of statins do not support Byrne and Wild’s suggestion that the benefit for those at “moderate” risk outweighs potential harm. (...)
Cholesterol Level and Statin Use in Alzheimer Disease
Arch Neurol. 2011;68(10):1239-1244 (October )
During the last 2 decades, evidence has accumulated that a high cholesterol level may increase the risk of developing Alzheimer disease (AD). With the global use of statins to treat hypercholesterolemia, this finding has led to the anticipation that statins could prove useful in treating or preventing AD. However, the results of work on this topic are inconsistent: some studies find beneficial effects, but other studies do not. In this first segment of a 2-part review, we examine the complex preclinical and clinical literature on cholesterol level and AD. First, we review epidemiological research on cholesterol level and the risk of AD and discuss the relevance of discrepancies among studies with regard to participants' age and clinical status. Second, we assess studies correlating cholesterol level with neuropathological AD type. The potential molecular mechanisms for the apparent adverse effects of cholesterol on the development of AD are then discussed. Third, we review preclinical studies of statin use and AD. Therefore, this first part of our review provides the background and rationale for investigating statins as potential therapeutic agents in patients with AD, the subject of the second part. (...)
A randomized, double-blind, placebo-controlled trial of simvastatin to treat Alzheimer disease
Neurology. 2011 Aug 9;77(6):556-63. Epub 2011 Jul 27.
BACKGROUND: Lowering cholesterol is associated with reduced CNS amyloid deposition and increased dietary cholesterol increases amyloid accumulation in animal studies. Epidemiologic data suggest that use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) may decrease the risk of Alzheimer disease (AD) and a single-site trial suggested possible benefit in cognition with statin treatment in AD, supporting the hypothesis that statin therapy is useful in the treatment of AD. (...)
CONCLUSION: Simvastatin had no benefit on the progression of symptoms in individuals with mild to moderate AD despite significant lowering of cholesterol. (...)
Diabetesrisiko ved høye statindoser
dagensmedisin.no 22.8.2011
Høyeste anbefalte dose av statin er forbundet med økt risiko for diabetes, sammenlignet med moderat statindose.
Det fremgår av en metaanalyse som ble publisert i JAMA i sommer (David Reiss m.fl.) I alt fem tidligere studier inngår i analysen, som inkluderer over 32.700 personer. (...)
Astrazeneca shares fall on Crestor results
forbes.com 2.9.2011
Shares of AstraZeneca PLC fell Friday after a study meant to show its cholesterol drug Crestor was better at preventing plaque buildup in heart arteries than rival drug Lipitor found no clear advantage for its drug.
THE SPARK: The study compared Crestor with Pfizer Inc.'s Lipitor in high-risk patients with hardening of the arteries, a condition that can cause strokes or heart attacks. Astrazeneca said preliminary results indicated Crestor showed a greater percentage reduction in the volume of plaque in coronary arteries, the study's main goal. But the result was not statistically significant, meaning it could have occurred by chance. The study did produce a statistically significant reduction in a secondary goal, reduction of total plaque volume.
THE BACKGROUND: AstraZeneca was gambling that the study would show Crestor was better than Lipitor, the world's top-selling drug. That would have given the British drug maker a strong argument that doctors and patients shouldn't defect from Crestor to generic Lipitor when it becomes available on Nov. 30, offering big savings. (...)
Finding a Better Barometer of Heart Attack, Stroke Risk
JAMA 2011 (August 18)
Filed under: Cardiovascular System,Cardiovascular Disease/Myocardial Infarction,Stroke,Public Health,Cerebrovascular Disease — Rebecca Voelker @ 6:01 pm
Heart scans can detect coronary artery calcium (arrowhead), which is shown in a new study to better predict heart attack and stroke risk than C-reactive protein. (Image: Allen J. Taylor, MD/Washington Hospital Center)
Looking for calcium in the coronary arteries of people with normal levels of “bad” cholesterol is a more accurate way to predict their risk of having a heart attack or stroke than testing their blood for a marker of inflammation, according to a new study. The findings could help physicians fine-tune important decisions about which patients need cholesterol-lowering statin medications. (...)
Increased risk of glucose intolerance and type 2 diabetes with statins
BMJ 2011; 343:d5004 (8 August)
In people with a moderate or high risk of cardiovascular disease, benefits of statins still outweigh the risks
Statins are considered a 21st century panacea to the extent that some people propose they should be taken by everyone over 55 years of age.1 Convincing evidence shows that statins reduce all cause mortality and prevent or postpone cardiovascular disease,2 and that in general they are well tolerated, with 11 cases of myopathy (the most serious side effect) occurring per 100 000 person years of treatment.3 (...)
Despite uncertainties about the precise mechanisms responsible for reduced glucose tolerance with statins, clinicians should be reassured that, for most people at moderate or high risk of cardiovascular disease, the benefits of statins outweigh the risks. For every 1000 people treated with statins for secondary prevention for an average of 4.2 years, about 37 can expect to have a cardiovascular event prevented, and five can expect a serious adverse event (such as rhabdomyolysis or myopathy).11 The meta-analysis described above suggests that about four extra people for every 1000 treated with statins can be expected to develop diabetes compared with an untreated group.7 (...)
No clear link between statins and kidney cancer
reuters.com 29.7.2011
(Reuters Health) - The cholesterol-lowering statin drugs are not linked to an increased risk of kidney cancer, suggests a new study. But there also isn't enough evidence to say that they offer any protection against the disease, researchers say.
One in four adults age 45 and older in the U.S. takes a statin to lower cholesterol and protect against heart disease. Some researchers were concerned when the drugs first hit the market that they might up cancer risks.
So far, the evidence on such a link "has been all over the place," said study author Dr. Toni Choueiri, from Harvard Medical School in Boston.
For kidney cancer in particular, "you had studies that showed increased risk (and) studies that showed no association," he told Reuters Health. (...)
CT Scan Detects Silent CV Risk
medpagetoday.com 11.7.2011
Coronary calcium buildup detected by coronary artery CT scan was associated with an increased risk of heart attack or stroke even in asymptomatic patients with low LDL cholesterol, researchers found.
Calcium in the coronaries predicted a 4.23-fold risk of heart disease events in such patients (95% CI 2.28 to 7.86), Khurram Nasir, MD, MPH, of Yale University, and colleagues reported.
This effect was independent of traditional prognostic factors, suggesting incremental prognostic value, the group noted in the July 19 issue of the Journal of the American College of Cardiology. (...)
Statin interactions 'common' in GP prescribing
pulsetoday.co.uk 11.7.2011
GP co-prescribing of statins and interacting drugs is common in primary care, research suggests.
A study examining the co-prescribing of statins and CYP3A4 inhibitors – which is associated with an increased risk of adverse drug reactions – found 11% of patients in general practice were prescribed the two drug types concomitantly. (...)
Dr Ameet Bakhai, consultant in cardiology at Barnet Hospital in London, concluded: ‘Co-prescribing of CYP3A4-metabolised statins and CYP3A4 inhibitors is common in UK primary care. This co-prescribing suggests limited appreciation of potential interactions and MHRA safety advice, with the potential to increase the likelihood for side effects amongst patients despite the availability of suitable alternative agents for lowering cholesterol. Education should be targeted at prescribers and pharmacists in order to improve the situation.' (...)
Common drug combo increases diabetes risk (Vanlig kombinasjon av legemidler øker risikoen for diabetes)
newscientist 27.5.2011
A combination of two common drugs – one an antidepressant, the other used to lower blood cholesterol – may put people at risk of developing diabetes. This unexpected finding shows the benefits of data mining to discover hidden hazards lurking in our medicine cabinets.
Interactions between drugs can be hazardous or even fatal. When a particular combination of drugs is known to be dangerous a warning appears on the drugs' labelling, but there are many potential hazards that are not yet known about.
To look for drug combinations that might trigger diabetes, Nicholas Tatonetti and Russ Altman of Stanford University in California turned to a database called the Adverse Event Reporting System (AERS), run by the US Food and Drug Administration (FDA).
AERS contains reports from doctors whose patients have experienced drug side effects, but some researchers dismiss it as being too "noisy" to yield useful insights. One problem is that many adverse drug reactions never get reported. "There's a pretty big threshold for a physician to decide to submit a report to the FDA," Tatonetti explains.
And when a drug's hazards become well known, the database gets flooded with "me too" reports – for instance, AERS contains more than 70,000 reports about Vioxx, an anti-inflammatory painkiller that was withdrawn from sale in 2004 after being linked to deaths from heart attacks and stroke. (...)
(Anm: paroksetin (paroxetine); markesføres i Norge under handelsnavn som bl.a. Seroxat; Paxil i USA.)
Cochrane review questions evidence for statins for primary prevention in low risk groups
BMJ 2011; 2011; 342:d480 (24 January)
A Cochrane review published on 18 January questions the evidence for prescribing statins for primary prevention in people at low cardiovascular risk, after finding selective reporting of outcomes, failure to report adverse events, and inclusion of people with cardiovascular disease in published studies.
The reviewers analysed randomised controlled trials of statins in adults with no requirements for participants to have particular LDL or HDL cholesterol concentrations and where no more than 10% of participants had a history of cardiovascular disease (Cochrane Database of Systematic Reviews 2011;(1):CD004816, doi:10.1002/14651858.CD004816.pub4). All studies included also had to have a minimum duration of one year and follow-up of six months. (...)
Statin Use Following Intracerebral Hemorrhage
Arch Neurol. Published 2011 (January 10)
Context Statins are widely prescribed for primary and secondary prevention of ischemic cardiac and cerebrovascular disease. Although serious adverse effects are uncommon, results from a recent clinical trial suggested increased risk of intracerebral hemorrhage (ICH) associated with statin use. For patients with baseline elevated risk of ICH, it is not known whether this potential adverse effect offsets the cardiovascular and cerebrovascular benefits. (...)
Conclusions Avoiding statins should be considered for patients with a history of ICH, particularly those cases with a lobar location. (...)
Meta-analysis: Statin Therapy Does Not Alter the Association Between Low Levels of High-Density Lipoprotein Cholesterol and Increased Cardiovascular Risk
Ann Intern Med2010;153:800-8 (December)
Background: Low levels of high-density lipoprotein cholesterol (HDL-C) are associated with an increased risk for myocardial infarction (MI). Although statins reduce the risk for MI, most cardiovascular events still occur despite statin treatment. (...)
Conclusion: Statins do not alter the relationship between HDL-C level and cardiovascular risk, such that low levels of HDL-C remain significantly and independently associated with increased risk despite statin treatment. The remaining risk seen in statin-treated patients may be partly explained by low HDL-C levels or other factors associated with low levels of HDL-C. (...)
Ingen kreftrisiko ved statiner
dagensmedisin.no 31.8.2010
Den hittil største studien i sitt slag finner ikke holdepunkter for at kolesterolsenkende medisin er forbundet med økt risiko for kreft. Resultatene ble offentliggjort på den europeiske hjertekongressen. (...)
Professor Colin Baigent sier at å redusere LDL-kolesterol med statiner ikke har bivirkninger relatert til kreftutvikling, i det minste ikke over en periode på fem år. (...)
A Burger, Shake, and Some Statins
medpagetoday.com 13.8.2010
Patrons of fast-food restaurants may see packets containing statins next to the ketchup and salt at the self-serve counter if the suggestion of British researchers becomes reality.
Emily Ferenczi, BMBCh, of Imperial College London, and colleagues calculated that most daily statin regimens would be enough to neutralize the increased cardiovascular risk associated with eating a quarter-pounder with cheese and small milkshake every day.
Because statins are cheap, relatively safe even at high doses, and effective for reducing cardiovascular risk across patient subgroups, offering them to individuals who choose to eat an unhealthy diet against best medical advice might make sense, they argued in an editorial in the American Journal of Cardiology.
"It cannot ... be reasonably argued on safety grounds that individuals should be free to choose to eat lipid-rich food but not be free to supplement it with a statin," they wrote. (...)
Statins, Painkillers May Upset PSA Test Results (Statiner, smertestillende legemidler kan forstyrre testresultater for PSA)
health.msn.com 6.8.2010
Common medications might affect prostate cancer diagnoses, researchers say (Vanlige legemidler kan påvirke kreftdiagnoser for prostata, ifølge forskere)
FRIDAY, Aug. 6 (HealthDay News) -- Some of the most widely prescribed drugs in the United States may skew results of prostate cancer screening tests, possibly causing errors in diagnoses, a new study finds.
A prostate cancer diagnosis is typically based on an elevated PSA (prostate-specific antigen)level, but new research shows that common drugs, including cholesterol-lowering statins and certain painkillers, may lower PSA levels. (...)
New Links Between Cholesterol And Depression In The Elderly (Nye linker mellom kolesterol og depresjon hos eldre)
medicalnewstoday.com 22.7.2010
Most people know that high cholesterol levels place them at increased risk for heart disease and stroke. Prior research has shown that particular types of strokes contribute to one's risk for depression, and that abnormal blood lipid levels can increase the risk of depression in the elderly.
However, new findings by French researchers, published in Biological Psychiatry, suggest the link between increased cholesterol and depression may be complicated. They evaluated a large population of elderly men and women (aged 65 and over) over a seven year follow-up period, assessing them for symptoms of depression and measuring their lipid levels. (...)
Sju av ti har for høyt kolesterol
dagbladet.no 26.7.2010
11 000 er arvelig belastet uten å vite det. Sjekk om du er i faresonen.
Sju av ti 40-åringer har for høyt kolesterolnivå i blodet. Blant 60-åringer er andelen åtte av ti. Kolesterol er livsnødvendig, men om nivået i blodet er for høyt, kan det være livstruende.
— Høyt kolesterolnivå i blodet er den viktigste risikofaktoren for hjerteinfarkt. Det er ingen automatisk kobling mellom de to, men andelen som får hjerteinfarkt er langt større blant de med høyt kolesterolnivå, sier Jan I. Pedersen, professor i ernæringsvitenskap ved Universitetet i Oslo. (...)
Good cholesterol may mean little for statin users
reuters.com 21.7.2010
(Reuters) - People with high levels of the so-called good cholesterol HDL tend to have fewer heart attacks but HDL may offer little protective benefit in people who take statins to lower harmful LDL cholesterol, U.S. researchers said on Wednesday.
An analysis of a large study of healthy people who took AstraZeneca's statin drug Crestor to prevent heart attacks found having high HDL was not a good predictor of heart attack risk.
"HDL is a very powerful predictor of future risk" of heart disease, said Paul Ridker of Brigham and Women's Hospital in Boston, whose study appears in the journal Lancet. (...)
Uvitande om kolesterolnivå
nrk.no 19.7.2010
Det tek tre minutt å måla kolesterolet med dette apparatet.
75 prosent av den voksne befolkninga i Norge har høgare kolesterol enn tilrådd. (...)
Høyt kolesterol - hjelper kostendringer og trening?
nhi.no 17.6.2010
Mange får påvist høyt kolesterol og blir oppfordret til å gjøre kostendringer og drive med fysisk trening. Men hvor godt hjelper slike tiltak?
Høyt kolesterol, hyperlipidemi, er en viktig risikofaktor for å utvikle hjertekarsykdom. Ikke-medikamentell behandling anbefales ofte før man starter med fettsenkende (lipidsenkende) legemidler hos de som har for høye lipidverdier. (...)
Det tar tid fra du legger om livsstilen gjennom kostendringer og økt fysisk trening, til det foreligger målbare resultater. Derfor bør slik behandling pågå i minst seks måneder før man tar stilling til om livsstilsendringene virker, eller om man bør starte med lipidsenkende midler, såkalte statiner. Unntaket er pasienter med etablert hjerte/karsykdom der man ofte vil begynne med medikamentell behandling og livsstilomlegging samtidig. (...)
FDA warns Pfizer over reporting side effects (FDA advarer Pfizer over rapportering av sideeffekter)
pharmatimes.com 10.6.2010
Regulators in the USA have issued Pfizer with a warning over what they claim is the company’s failure to report serious and unexpected potential side effects from some of its drugs in a timely fashion.
In a 12-page letter addressed to Pfizer chief executive Jeffrey Kindler, the US Food and Drug Admininstration says delays in reporting side effects date back from 2004 and have increased since then. The treatments cited in the letter include the cholesterol-lowering blockbuster Lipitor (atorvastatin) and the erectile dysfunction drug Viagra (sildenafil).
Ronald Pace, chief of the agency's New York office, writes that the FDA “expects drug manufacturers to establish and implement reasonable mechanisms to assure that all serious and unexpected experiences are promptly recorded and investigated”. For example, while Viagra was known to cause serious visual problems, Pfizer failed to report cases within the agency's 15-day deadline “by misclassifying and/or downgrading reports to non-serious without reasonable justification." (...)
Ingen blodtrykkssenkende tilleggseffekt av statiner
Notiser
Tidsskr Nor Legeforen 2010; 130 (3.6.2010)
Statiners beskyttelse mot hjerte- og karsykdom antas å skyldes endring i lipidprofilen og muligens også antiinflammatoriske og antiproliferative effekter. I tillegg er det forslått at statiner kan senke blodtrykket. Dette har nå vært undersøkt av italienske forskere (BMJ 2010; 340: c1197).
508 pasienter i alderen 45–70 år med mild hypertensjon og hyperkolesterolemi ble randomisert til blodtrykkssenkende behandling med og uten pravastatin i tillegg. Studien viste at pravastatin ikke hadde blodtrykkssenkende effekt når det ble gitt til hypertensive pasienter som fikk effektiv hypertensjonsbehandling. Dette tyder på at de beskyttende kardiovaskulære effektene av statiner ikke er avhengig av en blodtrykkssenkende virkning. (...)
Uvitende om farlig høyt kolesterol
nrk.no 4.3.2010
Over 10.000 nordmenn har arvelig høyt kolesterol uten å vite om det. Det første symptomet kan være et dødelig hjerteinfarkt i ung alder. (...)
Study Raises Questions About Cholesterol Drug’s Benefit
nytimes.com 15.11.2009
ORLANDO, Fla. — For patients taking a statin to control high cholesterol, adding an old standby drug, niacin, was superior in reducing buildup in the carotid artery to adding Zetia, a newer drug that reduces bad cholesterol, according to a new study.
The results of the study, published in The New England Journal of Medicine, were presented here Sunday night at an annual meeting of the American Heart Association.
The study has been a polarizing topic here and has also attracted the attention of a powerful senator who has been investigating the conduct of two drug makers, Merck and Schering-Plough, in relation to their sales and marketing of Zetia and a combination cholesterol drug, Vytorin, which includes Zetia. The drug makers merged this month. (...)
Difficult lipid control is let down by poor evidence
All you need to read in the other general journals
BMJ 2009;339:b4610 (11 November)
(...) Difficult lipid control is let down by poor evidence
Ann Intern Med 2009;151:622-30 [Abstract/Full Text]
When people taking statins fail to achieve their lipid targets, doctors can either increase the dose or add another lipid modifying drug such as a fibrate or ezetimibe. A systematic review looking for the best option found plenty of trials (102), but they weren’t particularly helpful. Only a handful compared the effect of the two strategies on mortality (no difference), and none included other important clinical outcomes such as heart attack, stroke, or need for revascularisation. The mortality data were too weak to be conclusive. (...)
Many trials failed to report side effects or adherence systematically. They were generally small and brief. Few targeted the high risk patients who stand to gain most from strict control of their serum lipids. As usual, there is much more work to be done, say the authors. (...)
Muskelskade etter statinbruk
Tidsskr Nor Legeforen 2009; 129:2208 (5.11.2009)
Bruk av statiner kan medføre muskelskade, men CK-nivå i blod sier lite om skadeomfanget. (...)
AASLD: Antibiotics Top Cause of Drug-Induced Liver Failure (AASLD: Antibiotika topper årsaker til legemiddelindusert leversvikt) (AASLD: The American Association for the Study of Liver Diseases)
medpagetoday.com 5.11.2009
BOSTON -- Antimicrobial agents are the most common cause of drug-induced liver failure, with most cases ending in death or transplant, a researcher said here.
A prospective analysis of some 1,200 cases of acute liver failure found that half of those caused by drugs were associated with antituberculosis, antifungal, sulfa drugs, and other antibiotics, according to Adrian Reuben, MBBS, of the Medical University of South Carolina in Charleston.
Herbal supplements, anticonvulsants, and statins also were relatively common causes of drug-induced liver injury (DILI), Reuben told attendees here at the American Association for the Study of Liver Diseases' annual meeting. (...)
Statins May Worsen Fatigue in Heart Failure Patients
health.msn.com 3.11.2009
But no one's suggesting the drugs should be stopped
TUESDAY, Nov. 3 (HealthDay News) -- Statins may boost the risk of fatigue and shortness of breath in some patients with heart failure, a new study suggests. But a second report found the cholesterol-reducing drugs reduce the risk of clots in those with cardiovascular disease, and experts think the benefits outweigh the risks.
Dr. Gregg C. Fonarow, a professor of cardiology at the University of California at Los Angeles, said patients shouldn't reconsider their use of the statins based on the results of the small U.S. study.
"Patients with heart failure who have an indication for statin therapy, such as coronary artery disease or diabetes, should remain on physician-prescribed statin therapy," Fonarow said. (...)
Statin therapy and risk of developing type 2 diabetes: a meta-analysis.
Diabetes Care. 2009 Oct;32(10):1924-9.
OBJECTIVE: Although statin therapy reduces cardiovascular risk, its relationship with the development of diabetes is controversial. The first study (West of Scotland Coronary Prevention Study [WOSCOPS]) that evaluated this association reported a small protective effect but used nonstandardized criteria for diabetes diagnosis. (...)
CONCLUSIONS: Although statin therapy greatly lowers vascular risk, including among those with and at risk for diabetes, the relationship of statin therapy to incident diabetes remains uncertain. Future statin trials should be designed to formally address this issue. (...)
Merck, Schering-Plough in $42M Vytorin settlement
pharmpro.com 6.8.2009
NEW YORK (AP) — Merck and Schering-Plough say they will pay $41.5 million to settle class-action lawsuits filed by patients taking the cholesterol drugs Vytorin and Zetia.
The lawsuits claim that the companies purposefully delayed the release of study results showing the cholesterol treatments were no more effective than older, less expensive medications. The companies do not acknowledge any wrongdoing or liability as part of the settlement.
The settlement deal comes while Whitehouse Station, N.J.-based Merck & Co. is in the process of buying Kenilworth, N.J.-based Schering-Plough Corp. for $41.1 billion. (...)
Merck, Schering-Plough Reach Vytorin Settlement With State AGs
Thompson.com 17.7.2009
Merck & Co., Schering-Plough Corp. and their cholesterol joint venture Merck/Schering-Plough Pharmaceuticals reached a civil settlement with the attorneys general (AGs) of 35 states and the District of Columbia concerning the companies’ promotion of the drugs Vytorin and Zetia and the alleged delay in releasing the results of a related clinical trial.
According to the state enforcement officials, a nearly two-year delay in the release of the full results of the so-called ENHANCE clinical trial violated state consumer protection laws. The trial determined that Vytorin, a cholesterol-lowering drug consisting of a combination of the drugs Zetia and Simvastatin, was no more effective in reducing the formation of plaque in carotid arteries than the cheaper, generically available Simvastatin alone. During the delay in the release of the trial results, the companies heavily promoted Vytorin in direct-to-consumer (DTC) advertisements. (...)
Data About Zetia Risks Was Not Fully Revealed (Data for Ezetrol (Zetia) ble ikke fullstendig offentliggjort)
nytimes.com 21.12.2007
New evidence shows that the drug makers Merck and Schering-Plough have conducted several studies of their popular cholesterol medicine Zetia that raise questions about its risks to the liver, but the companies have never published those results.
Partial results of the studies, alluded to in documents on the Food and Drug Administration’s Web site, raise questions about whether Zetia can cause liver damage when used long term with other cholesterol drugs called statins.
Most of the millions of people who use Zetia take it along with a statin like Lipitor, Crestor or Zocor. Or they take it in a single pill, Vytorin, that combines Zetia with Zocor. (...)
(Anm: Zetia (ezetimibe); markesføres i Norge under handelsnavnet Ezetrol (Zetia i i USA.)
(Anm: Vytorin (ezetimibe and simvastatin); Vytorin er en kombinasjon av Schering-Ploughs Zetia (ezetimibe; fornorsket ezetimib) og Mercks Zocor (simvastatin).)
Ældre har ingen gavn af kolesterolmedicin
hjerteforeningen.dk 31.5.2009
Raske over 70 år får intet ud af at tage medicin mod et for højt kolesterol
Har du passeret de 70 år, er måske ældre, men i øvrigt hjerterask, er der ingen grund til at tage kolesterolsænkende medicin. Også selvom du skulle have et forhøjet indhold af kolesterol i blodet. Nye tal fra Østerbroundersøgelsen slår nu fast, at risikoen ved forhøjet kolesterol daler jo ældre, du er. Og det budskab fortjener, at blive taget alvorligt, mener en af forfatterne bag undersøgelsen Peter Schnohr, hjertelægelæge og dr.med. og i mange år aktiv i Hjerteforeningen:
- Er du rask og fyldt 80 år er det ligegyldigt om dit kolesterol er 4 eller over 8. Er man mellem 70 og 80 skal man blot holde sig under 8. Denne gruppe ældre har bestået den biologiske prøve, hvor det ikke betyder noget, om de har et forhøjet indhold af kolesterol i blodet. Alle der har åreforkalkning, skal dog behandles uanset alder, siger Peter Schnohr. (...)
Ingen forskjellar i føreskriving av kolesteroldempande middel mellom dei med høg og låg utdanning
fhi.no 31.3.2009
Menneske med låg utdanning brukar meir kolesteroldempande middel i form av såkalla statin enn dei som er høgt utdanna. Men etter at funna vart justerte for skilnadar i risikofaktorar for hjarte-karsjukdom, var det ingen forskjell i konsum dei to gruppene imellom. Dette viser ein fersk studie frå Folkehelseinstituttet. (...)
Statin use and its association with musculoskeletal symptoms—a cross-sectional study in primary care settings
Family Practice 2009 26(2):88-95
Introduction. Musculoskeletal complaints are very common in primary care settings. Lipid-lowering drugs are one of several causes of musculoskeletal symptoms. However, data showing an association of lipid-lowering drug therapy and increased odds of musculoskeletal complaints in primary care patients are lacking. (...)
Results. The prevalence of lipid-lowering drug prescription was 23% (n = 239) and that of muscular complaints was 40% (n = 411). In all, 44% (n = 106) of the patients with lipid-lowering drug prescription had muscular complaints compared to 39% (n = 305) of the patients without lipid-lowering drug therapy. Statin prescription and 10 variables remained in the final model. Statin prescription is associated with a 1.5-fold odds of musculoskeletal complaints compared to non-prescription {odds ratio [OR] = 1.5 [95% confidence interval (CI), 1.1–2.0], P = 0.02}.
Conclusion. Having a statin prescription appears to be an independent factor associated with musculoskeletal symptoms in primary care settings. Statin use may be more often associated with musculoskeletal complaints than previously assumed. (...)
Cholesterol Drugs Linked to Increased Fatigue
healthday.com 12.3.2009
(...) In the study, researchers led by Beatrice Golomb, associate professor of medicine at the University of California, San Diego, randomly divided 1,016 adults without heart disease or diabetes into three groups and gave them daily doses of 20 milligrams of simvastatin (Zocor), 40 milligrams of pravastatin (Pravachol), or a placebo for six months.
On average, the subjects were in their mid-50s during the study, which took place between 2000 and 2005.
The researchers found that people on simvastatin reported reduced energy and activity levels, while those on pravastatin reported reduced energy levels only. On average, Golomb said that those who took the statins reported levels of energy that were 5 percent lower than those who took a placebo.
(...)
Tight control of blood glucose in long standing type 2 diabetes
BMJ 2009;338:b800 (5 March)
Reducing glycated haemoglobin below 7% is not supported by evidence and may even be harmful
During the past year, three important studies have provided evidence that tighter glycaemic control (to <7% glycated haemoglobin) in older adults with type 2 diabetes does not provide substantial benefit and may increase the risk of adverse outcomes. These findings, which some experts and policy makers found surprising, should lead to the re-evaluation of recommendations about what constitutes high quality care for these patients. (...)
Endelig uten bivirkninger
vg.no 1.3.2009
SANDEFJORD (VG) Etter å ha prøvd åtte ulike statiner som alle ga bivirkninger, ble Hypocol redningen for Else-Marie Ivarsen Ottemo (72). (...)
Kolesterolsenkende medisin kan gi øresus
vg.no 21.2.2009
Sammenhengen mellom kolesterolsenkende midler og øresus er lite kjent.
Tinnitus - øresus - har vært assosiert med bruk av statiner og er nevnt som en mindre vanlig bivirkning i preparatomtalen til en av produsentene.
Gjelder alle statiner
Ifølge de Regionale legemiddelinformasjonssentre (RELIS) er det i bivirkningsdatabasen til Verdens Helseorganisasjon (WHO) rapportert tinnitus som bivirkning av alle statinene. (...)
Low Cholesterol, Depression Linked To Early Death
medpagetoday.com 11.2.2009
New Geisinger research shows that men with a combination of low total cholesterol and depression were seven times more likely to die prematurely from unnatural causes, such as suicide and accidents.
The study, which was published recently in Journal of Psychiatric Research, found that men with low total cholesterol (165 milligrams of cholesterol per deciliter or less) and depression were at very high risk for premature death from "external causes" including suicide, drug overdose, accidental poisoning and unintended injuries.
"While it's generally understood that having low cholesterol is a good health sign, combined with other factors, it could actually put a person at risk," said Geisinger senior investigator Joseph Boscarino, PhD, MPH. (...)
Vil gi kolesterol-medisin til friske personer
SIGRID ANNA EGGEN
aftenposten.no 10.2.2009
Tusenvis av liv kan reddes ved å gi friske personer statiner, hevder britisk hjerteekspert.
At statiner er et effektivt legemiddel mot hjerte- og karsykdommer, har lenge vært kjent. I en ny studie uført av israelske forskere, kommer det imidlertid fram at det kolesterolnedsettende middelet er langt mer effektivt en tidligere antatt, melder BBC
Ifølge studien kan statiner nesten halvere risikoen for hjerteinfarkt. (...)
Taking Statins Faithfully Lengthens Life
healthfinder.gov 9.2.2009
But experts note finding colored by fact that these folks take better care of themselves generally.
(SOURCES: Mark A. Hlatky, M.D., professor, health research policy and medicine, Stanford University, Stanford, Calif.; Erica Spatz, M.D., fellow, Robert Wood Johnson Clinical Scholars Program, Yale University, New Haven, Conn.; Feb. 9, 2009, Archives of Internal Medicine)
MONDAY, Feb. 9 (HealthDay News) -- A massive Israeli study finds that people with high cholesterol levels who faithfully take statins are less likely to die over four to five years than those who neglect the therapy.
But that finding is not necessarily a tribute to the effectiveness of the cholesterol-lowering therapy, American experts said. Previous studies have shown that people who follow doctors orders about taking drugs are more likely to follow other rules of good health, they said. (...)
Statins Don't Cut Cancer Risk
healthfinder.gov 5.2.2009
Animal study found 2 popular cholesterol-lowering drugs had little effect on tumors.
THURSDAY, Feb. 5 (HealthDay News) -- Statins have clearly proven their mettle against heart disease, but the cholesterol-lowering drugs don't appear to possess cancer-fighting powers, a new animal study shows.
"We certainly didn't see any positive effects," said Ronald Lubet, program director in the division of cancer prevention at the National Cancer Institute. He led the study using mice and rats, which was published in the February issue of Cancer Prevention Research. (...)
FDA Says ENHANCE Results Do Not Shake Cholesterol Theory
medpagetoday.com 8.1.2009
ROCKVILLE, Md., Jan. 8 -- When it comes to cholesterol, lower is still better and lowest may be the best, according to the FDA, which said today that it has completed its review of data from the ENHANCE trial.
In that study, the simvastatin/ezetimibe combination Vytorin lowered LDL by 56% but did not translate into a measurable reduction in atherosclerotic plaque.
When the results of ENHANCE -- which compared simvastatin alone to the combination drug in patients with heterozygous familial hypercholesterolemia -- were announced at a press conference a year ago, they touched off a series of controversies, not the least of which was a debate over the real benefit of cholesterol-lowering interventions. (See coverage of the ENHANCE controversy.) (...)
FOXSexpert: 4 Common Drugs That Sabotage Your Sex Life
foxnews.com 11.12.2008
(...) 1. Cholesterol-Lowering Medications
To love someone with all your heart can't be taken literally when you're on this type of medication. Cholesterol-lowering meds have impotence and decreased sexual desire as primary sexual side-effects. They can make it harder to make love.
As published in Family Practice, a 2002 systematic review of the literature on erectile dysfunction (ED) and lipid-lowering drugs found that the evidence supports the link between both statins, like Lipitor and Zocor, and fibrates, like TRICOR, and ED.
While some people cannot forego cholesterol-lowering medications, all individuals taking them should seek natural ways to lower cholesterol. These include switching to a low-fat, high-fiber diet and increasing the amount of weekly exercise.
Case in point: To avoid increasing his dosage, my father started walking eight miles a day. Two weeks later, he had lost 10 pounds. Two months later, he was told that he’d brought down his cholesterol. I have yet to ask him how it affected his love life ... (...)
Eat Your Statins
forbes.com 16.11.2008
New research makes a pretty conclusive case for putting millions more Americans on cholesterol drugs.
Want to avoid a heart attack? Stop taking your vitamins and switch to a cholesterol-lowering statin drug instead. (...)
The drugs have side effects, including muscle weakening, that can be dangerous in some cases. Nobody is advocating putting really healthy patients on statins. (...)
The immediate hype surrounding the Jupiter study is about adding the new blood test, for C-reactive protein (CRP). It measures inflammation in the arteries that can cause heart attacks. But far more important will be the way this massive trove of data--18,000 patients' information--solidifies the already rosy view cardiologists have of statin drugs; it will also be invaluable for silencing critics. Jupiter lead author Paul Ridker discloses he has patents on the test. Some researchers quoted here, including Ridker, have financial links to drugmakers. (...)
One statin critic not backing down is John Abramson, author of Overdosed America. He points out that patients on Crestor had the same rate of serious illnesses requiring hospitalization as those on placebo. "You haven't improved their net health," says Abramson. Instead, he argues, you're trading heart attacks and strokes for other serious illnesses. And he contends that not offering weight-loss counseling to an overweight population created an "artificial situation" that exaggerated the benefits of the drug. He's not alone. Stephen Colbert of Comedy Central's fake news show The Colbert Report joked the study was "a great breakthrough in the battle to find things to prescribe to people who don’t need them." (...)
Statins and primary prevention of cardiovascular events
BMJ 2008;337:a2576 (14 November)
No change in strategy is needed despite the hype surrounding the recent JUPITER study (...)
The relative risk reduction (44%) was also much higher than in previous trials. Although the authors suggest that measuring C reactive protein allows the selection of a group of patients who benefit more than others, alternative explanations should be considered. Because participants in both the intervention and control groups had low concentrations of LDL-C, controls were presumably not taking non-study statins. This is in contrast to many previous trials, where up to 17% of patients in the control group were taking non-study statins, which diluted the positive effect. 2 3 Moreover, a four week placebo run-in phase allowed the JUPITER investigators to select highly compliant patients. This also limits the external validity of the trial. (...)
Missing The Point On Crestor
forbes.com 13.11.2008
I think a lot of the debate on the Jupiter study of AstraZeneca's Crestor is way off-base in all sorts of ways, on all sides. But here's a key distinction health wonks and investors should both make. The study will increase statin use and Crestor sales, but not for the same reasons.
Jupiter will increase the use of statins (many of them generic) because it provides the strongest evidence yet that a statin will reduce just about anybody's relative risk of getting a heart attack or stroke. So the only question is whether your absolute risk is high enough to justify getting it down. (...)
A New Age Of Statins?
forbes.com 9.11.2008
A new study could lead millions more Americans to take cholesterol-lowering drugs and generate billions in sales for AstraZeneca, which funded it. But first comes a furious debate. (...)
Because the patients in the study had a relatively low risk of heart attack, the absolute benefit of taking Crestor was still very small. There were only 400 heart attacks, strokes or heart surgeries among all 18,000 patients in the study. Overall, 95 patients had to be treated with Crestor for two years to prevent one angioplasty procedure, heart attack or other cardiovascular "event." (...)
Justice Department Investigates Vytorin Marketing, More Lawsuits Face Merck, Schering
kaisernetwork.org 5.11.2008
Merck and partner Schering-Plough face an investigation by the U.S. Department of Justice and an increasing number of lawsuits over their marketing of cholesterol drug Vytorin, according to a filing to the Securities and Exchange Commission on Monday, the AP/Miami Herald reports. Merck and Schering, after being pressured by congressional investigators, in January released results of a "long-delayed" study that found Vytorin was no more effective than the generic cholesterol drug Zocor, which costs one-third as much. The findings resulted in investigations by the Senate Finance Committee and the House Committee on Energy and Commerce Subcommittee on Oversight and Investigations regarding whether the companies deliberately delayed the results to maintain sales of Vytorin and Zetia. (...)
Statin side effects: Weigh the benefits and risks
mayoclinic.com 30.10.2008
Statin side effects can be very uncomfortable, making it seem like the risks outweigh the benefits of these powerful cholesterol-lowering medications. Consider the risks and benefits.
Because of their effectiveness, statins are often prescribed for people with high cholesterol to lower their total cholesterol and reduce their risk of a heart attack or stroke. Most people who are prescribed statins will take them for the rest of their lives, which can make statin side effects difficult to manage.
For some people, statin side effects can make it seem like the benefit of taking a statin isn't worth it. Before you decide to stop taking a statin, discover how statin side effects can be reduced. (...)
Medisinsk forskning og doping
Tidsskr Nor Legeforen 2008; 128:2224 (9.10.2008)
I 2004 laget ni eksperter nye retningslinjer for hva som skulle være behandlingstrengende høyt kolesterolnivå i USA. Retningslinjene ville medføre at nye millioner amerikanere ville bli satt på statiner. Problemet var at åtte av de ni kolesterolekspertene var på statinfabrikantenes lønningslister (1). Spørsmålet er om disse ekspertene er i stand til å lage retningslinjer uavhengig av den industrien de er knyttet til. (...)
Blir man glemsk av statiner?
Tidsskr Nor Legeforen 2008; 128:2224
I sommer fant det sted en debatt i Aftenpostens spalter om bivirkning av statiner (1 - 3) som jeg synes det kunne være verdt å bringe videre. Blir man glemsk av statiner? For den som vil lese en utfyllende oppsummering av dagens viten på dette området, henviser jeg i første rekke til en oversiktsartikkel fra 2006 (4). Selv har jeg også skrevet om emnet (5). (...)
Statins Linked to Increased Risk of Postoperative Delirium
medpagetoday.com 22.9.2008
TORONTO, Sept. 22 -- Older patients who take statins regularly, particularly those past 70, have an increased risk of delirium following elective surgery, researchers here reported.
After adjusting for other variables -- including age and length of surgery -- statin use was associated with a 28% increased risk of postoperative delirium (P<0.001), according to Donald A. Redelmeier, M.D., of Sunnybrook Health Services Center of the University of Toronto, and colleagues.
The association emerged from a population-based retrospective cohort analysis of 284,158 consecutive elective surgery patients older than age 65, Dr. Redelmeier and colleagues reported in the Sept. 23 issue of the Canadian Medical Association Journal. (...)
Ikke lavere dødelighet med statiner (12.09.08)
legemiddelsiden.no 12.9.2008
Statiner har ingen effekt på overlevelsen hos pasienter med hjertesvikt, ifølge en ny studie. - Dette viser at statiner ikke har noen rutineplass ved oppstart av behandling for hjertesvikt, mener professor og seksjonsoverlege Lars Gullestad. (...)
Omega-3 bättre än läkemedel vid hjärtsvikt
dn.se 31.8.2008
Kapslar med omega-3-fettsyror ger personer med hjärtsvikt ett visst skydd mot hjärtsjukdom och plötslig död. Men det gör inte det kolesterolsänkande läkemedlet Crestor. Det visar två italienska studier från den pågående hjärtkongressen i München.
DET ÄR INGEN IDÉ för personer som har relativt allvarlig hjärtsvikt att ta det kolesterolsänkande läkemedlet Crestor. Den slutsatsen går att dra av en italiensk studie som har testat behandlingen på över 4.500 personer med allvarlig hjärtsvikt.
Hälften fick Crestor, 10 milligram per dag, och hälften placebo, verkningslös behandling. Efter nästan fyra års behandling kunde forskarna konstatera att det inte var någon skillnad i sjuklighet och dödlighet mellan de som fått läkemedlet och de som inte fått det.
Fyndet bekräftar en tidigare publicerad studie berättar Lars Wallentin, professor i kardiologi (läran om hjärtat) vid Uppsala kliniska forskningscentrum och Akademiska sjukhuset i Uppsala. (...)
FDA to Explore Possible Vytorin-Cancer Link
webmd.com 21.8.2008
(...) In the trial, called SEAS, 4.1% of patients taking Vytorin died of cancer -- more than the 2.5% of patients who received an inactive placebo. A July statement issued by the study investigators noted that these differences "are small and could have occurred as a result of chance."
Vytorin is jointly marketed by Merck and Schering-Plough. Merck has provided the study data to independent researchers for analysis. Now the FDA says it is conducting its own safety review. (...)
SLCO1B1 Variants and Statin-Induced Myopathy — A Genomewide Study
NEJM 2008;359:789-799 (August 21)
Background Lowering low-density lipoprotein cholesterol with statin therapy results in substantial reductions in cardiovascular events, and larger reductions in cholesterol may produce larger benefits. In rare cases, myopathy occurs in association with statin therapy, especially when the statins are administered at higher doses and with certain other medications. (...)
Cholesterol drugs linked to muscle pain (Kolesterollegemidler linket til muskelsmerte)
seattletimes.nwsource.com 10.8.2008
Q: I was on Lipitor for a number of years and have severe muscle and nerve damage to the extent that I am in a power wheelchair. Do you think Lipitor could be to blame?
A: Statin-type cholesterol-lowering drugs such as Crestor (rosuvastatin), Lipitor (atorvastatin), Mevacor (lovastatin) and Zocor (simvastatin) are linked to muscle pain, weakness and nerve damage. Most physicians have assumed that muscle problems are an extremely rare side effect.
New research (New England Journal of Medicine online, July 23, 2008) suggests that some people are highly susceptible to muscle-related complications from high-dose statins. This genetic vulnerability may affect up to one-fourth of the population. (...)
FDA Issues Alert on Rhabdomyolysis Risk When Combining Simvastatin with Amiodarone (Advarsel fra FDA om risiko for rabdomyolyse når Simvastatin kombineres med Amiodarone)
medpagetoday.com 8.8.2008
ROCKVILLE, Md., Aug. 8 -- The FDA has again warned of a dose-dependent increased risk of rhabdomyolysis when simvastatin (Zocor) at more than 20 mg is used in combination with amiodarone (Cordarone, Pacerone).
The simvastatin label was modified in 2002 to add a warning about the increased risk, but the FDA said today that it continues "to receive reports of rhabdomyolysis in patients treated concurrently with amiodarone and simvastatin, particularly with simvastatin doses greater than 20 mg daily."
The FDA said the precise mechanism was unknown, but was related to the fact that amiodarone inhibits the cytochrome P450 3A4 (CYP3A4) enzyme. This is the same enzyme that metabolizes simvastatin. (...)
(Anm: rabdomyolyse;
nedbryting eller oppløysing av tverrstripete muskulatur som gir auka innhald i serum av myoglobin og ymse muskelvevsenzym; kan stundom koma som skadeverknad ved bruk av glutetimid, amfetamin, salisylat, fencyclidin, teofyllamin eller andre medikament eller pga virussjukdommar, slangebit, sterk muskelrøyning m v; kan vera årsak til farleg hyperkalemi, kan gi nyresvikt pga myoglobinopphoping i nyrene; kan stundom skuldast mangel på carnitinpalmityltransferase, eit enzym i feittstoffskiftet; jf Meyer-Betz' sjukdom
EN rhabdomyolysis Kilde: Norsk medisinsk ordbok.)
Cholesterol Drugs May Protect Memory (Kolesterollegemidler kan beskytte hukommelse)
ivanhoe.com 30.7.2008
(Ivanhoe Newswire) -- Drugs commonly used to fight cholesterol may also ward off dementia and memory loss. (...)
The statins the participants took included atorvastatin, cerivastatin, fluvastatin, lovastatin, pravastatin, rosuvavstatin and simvastatin. Headaches, nausea, fever and muscle pain are the most common side effects of the drugs. (...)
Statins May Spur Dementia (Statiner kan tilskynde demens)
newsmax.com 25.7.2008
(...) Statin drugs, which are used to lower cholesterol, may adversely affect a particular group of brain cells important to the health of aging brains, according to researchers at the University of Rochester Medical Center. “There has been a great deal of discussion about a link between statins and dementia, but evidence either way has been scant,” said Steven Goldman, M.D., Ph.D., the research team leader. “This new data provides a basis for further exploration.”
The team looked specifically at the effect of statins on “glial progenitor cells.” These are flexible brain cells held in reserve which the brain can change and customize according to whatever type of cell it needs to stay healthy. The researchers found that statin drugs spur the glial progenitor cells, which are similar to stem cells, to become a particular kind of cell and to lose their crucial ability to change. In other words, statins cause the cells to take a final form of some kind which the brain can no longer modify or transform. (...)
Kolesterol-medicin kan ødelægge dit sexliv
bt.dk 23.7.2008
Ny forskning afslører alvorlige bivirkninger - bl.a. depression og seksuelle problemer - i 500.000 danskeres medicin
Den mest anvendte medicin i Danmark - kolesterolsænkende midler - viser sig nu at have meget alvorlige bivirkninger. 'Mirakelmidlet', som det er blevet udråbt til fra alle sider, kan bl.a. smadre din hukommelse og dit sexliv.
De såkaldte statiner, som mere end en halv million voksne danskere hver dag tager for at sænke kolesterol -tallet og for at undgå blodpropper, kan i nogle tilfælde være årsag til en alvorlig og måske ligefrem livstruende lungesygdom, og mange af brugerne har vist sig at få alvorlige depressioner, søvnforstyrrelser, hukommelsessvigt og seksuelle problemer.
I forvejen er det kendt, at kolesterol -medicinen kan give både muskelsmerter og muskelsvaghed.
- Der er tale om så alvorlige bivirkninger, at vi nu i EU-regi vil stille krav om, at der laves nye indlægssedler i pilleæskerne med advarsler. (...)
Læger advarer mod kolesterolmedicin
netdoktor.com/dk 22.7.2008
En bestemt type kolesterolnedsænkende medicin, statiner, kan have alvorlige bivirkninger som for eksempel depression, søvnforstyrrelser, hukommelsessvigt og seksuelle problemer. Det viser nye test og en række indberetninger fra læger.
”Der er tale om så alvorlige bivirkninger, at vi nu i EU-regi vil stille krav om, at der laves nye indlægssedler i pilleæskerne med advarsler”, oplyser Dorte Stenver afdelingschef i Lægemiddelstyrelsen,
Dorte Stenver er i øjeblikket i London, hvor hun deltager i et udvalg under EUs lægemiddelkomité, der skal se nærmere på det lægemiddel, som en halv million danskere hver dag tager.
Dorte Stenver vil dog ikke råde folk til stoppe med pillerne, men i stedet diskutere eventuelle bivirkninger og finde en individuel løsning i samråd med egen læge.
Læge og docent Uffe Ravnskov, der forsker i kolesterol, er dog meget skeptisk over for bivirkningerne.
”Der er tale om så alvorlige bivirkninger, at jeg personligt ville tænke mig rigtig godt om, før jeg fortsatte med at tage pillerne. Bivirkningerne – risikoen ved medicinen – overskygger helt klart de positive virkninger, siger Uffe Ravskov. (...)
Knasket piller for åtte milliarder
dinside.no 21.7.2008
Sjekk hvilke vi spiser mest av. (...)
- Legemiddelforbruket i 1. halvår er 15 prosent høyere enn for fire år siden, mens kostnadene er ca ti prosent høyere. (...)
Statiner, et legemiddel mot forhøyet kolesterol, er blant de legemidlene som øker mest. Bruken av det vanligste statinet, simvastatin, har økt med hele 27 prosent fra i fjor til i år. (...)
Simvastatin vs therapeutic lifestyle changes and supplements: randomized primary prevention trial
Mayo Clin Proc. 2008 Jul;83(7):758-64.
CONCLUSION: Lifestyle changes combined with ingestion of red yeast rice and fish oil reduced LDL-C in proportions similar to standard therapy with simvastatin. Pending confirmation in larger trials, this multifactorial, alternative approach to lipid lowering has promise for a subset of patients unwilling or unable to take statins. (...)
Norsk studie ryster Wall Street
dn.no 21.7.2008
Aksjene i de to legemiddelgigantene Schering-Plough og Merck falt brutalt etter offentliggjøringen av en norskledet studie.
Allerede i mars ble det sådd tvil om kolesterolpillen Vytorin hadde noen effekt. Nå blir en ny studie, som knytter legemiddelet til økt fare for kreft, offentliggjort langt tidligere enn det som var planlagt, skriver Bloomberg News.
Vytorin, som er et legemiddel som er en kombinasjon av Mercks Zocor og Schering-Ploughs Zetia, var antatt å ha en reduserende effekt på komplikasjoner knyttet til hjerteklaffsykdommer.
Uten effekt
Studien som ble ledet av Terje Pedersen ved Ullevål Universitetssykehus, viser at legemiddelet synes å redusere én type hjertesykdom (coronary artery-tilstander), men ikke utviklingen av hjerteklaff-sykdommer (aortic valve disease). Det første stemmer med tidligere funn, men den ferkseste studien var utviklet nettopp for å stadfeste om legemiddelet hjalp på en hjertesyk som kalles aortic stenosis, som innebærer at aortaklaffen smalner.
Salget av Vytorin har falt med en tredel siden det i mars ble stadfestet at Vytorin ikke var mer effektiv enn det ene legemiddelet alene. (...)
Ezetimibe/Simvastatin (Vytorin) Misses Major Cardiovascular Endpoints in SEAS Trial
medpagetoday.com 21.7.2008
LONDON, July 21 -- Treatment with ezetimibe/simvastatin (Vytorin) has revealed no slowing of progression of aortic stenosis in asymptomatic patients but found an association with a lower risk of ischemic events, researchers here reported.
At the same time, in the 1,800-patient SEAS study (Simvastatin and Ezetimibe in Aortic Stenosis), investigators found a marked increase in the number of malignancies, reported Terje Pedersen, M.D., of Ulleval University Hospital in Oslo, Norway. (...)
Dr. Peto analyzed data culled from the two ongoing trials and concluded that those data do not support an increased risk of cancer. Moreover, he said it was highly unlikely that a risk factor could explain a 50% increase in cancer in only three years. But that type of increase could be explained by the play of chance. At a press conference, Dr. Peto said he had forwarded his findings to the FDA and other regulatory agencies worldwide. (...)
Statin drug no aid for a learning disability: study
reuters.com 15.7.2008
CHICAGO (Reuters) - One form of statins, the cholesterol fighter that is the world's top selling drug, does not appear to help children overcome a common, genetically linked learning disability, researchers said on Tuesday. (...)
AAN: Statins Hold No Beneficial Effects for Alzheimer's Disease
medpagetoday.com 17.4.2008
Atorvastatin (Lipitor) was associated with no significant improvement in cognitive scores (P=0.26) or global function scores (P=0.73), reported Howard Feldman, M.D., of the University of British Columbia in Vancouver, and colleagues here at the American Academy of Neurology meeting.
These findings from the LEADe study provided much-needed randomized, placebo-controlled evidence, Dr. Feldman said. (...)
Sen. Grassley Requests Information on Delay of Results of Study on Cholesterol Medication Vytorin
kaisernetwork.org 1.4.2008
Senate Finance Committee ranking member Chuck Grassley (R-Iowa) on Monday sent a letter to the CEOs of Merck and Schering-Plough that requested additional information about their decision to wait for more than one year to release the results of a study on the cholesterol medication Vytorin, marketed by a joint venture between the companies, the Wall Street Journal reports (Winslow, Wall Street Journal, 4/1). (...)
TRIAL AND ERROR
Delays in Drug's Test (Forsinkelser i legemiddeforsøk)
wsj.com 24.3.2008
Fuel Wider Data Debate
In January, Merck & Co. and Schering-Plough Corp. disclosed surprising news: A long-overdue study of their blockbuster cholesterol drug Vytorin found it was no better at fighting heart disease than a far-cheaper generic. Doctors and public officials questioned whether the companies had delayed the results for more than a year to protect billion of dollars in sales. (...)
The Vytorin study has fueled two broad controversies, both likely to be stoked this week as the findings are formally presented for the first time. Its handling has sharpened the debate over how much control sponsors should wield in clinical trials that influence doctors and regulators. And the study's results have led some skeptical doctors to question the value of cholesterol-lowering drugs that have become the front-line medical weapon against heart disease, the Western world's leading killer. (...)
Dutch researcher John Kastelein, the outside scientist who led the study, has called it "a trial from hell." (...)
Probing Mitochondria for Statin Myopathy Mystery
medpagetoday.com 25.2.2008
BOSTON, Feb. 25 -- Studies of the mitochondria have offered hints into the etiology of the myopathy that strikes a small percentage of those who take lipid-lowering statins -- heretofore a puzzle for clinicians.
A new way to look at mitochondria devised by Vamsi Mootha, M.D., of Harvard Medical School, and colleagues suggests a cause for the unusual condition and may explain why some studies were unable to find an association.
Dr. Mootha and colleagues reported online in Nature Biotechnology a chemical-genomic method that allows researchers to probe the activity of mitochondria organelles while they are in living muscle cells. (...)
The technique allows them to "read out" several elements of mitochondrial function, including levels of adenosine triphosphate (ATP), production of reactive oxygen species, and electron flux in and out of the organelle, he said.
The method also allows them to monitor expression of about 40 mitochondrial and nuclear genes involved in energy homeostasis, Dr. Mootha said.
"It's a really rich read-out of what's happening to mitochondria in different conditions," Dr. Mootha said. (...)
Unreported cholesterol drug data released by company
BMJ 2008;336:180-181 (26 January)
The makers of a popular cholesterol lowering drug have posted results of a study showing it was ineffective—but only after a Congressional inquiry was set up to look into why they had not published their results two years after the study was completed.
Merck and Schering-Plough Pharmaceuticals, manufacturers of ezetimibe (Zetia), posted results on their websites earlier this month showing that 356 people treated with ezetimibe (10 mg) plus simvastatin (80 mg) fared no better than 360 who had received simvastatin alone (www.sch-plough.com/schering_plough/news/release.jsp?releaseID=1095943). (...)
Patients sue over cholesterol drug marketing
msnbc.msn.com 24.1.2008
Lawsuits claim drugmakers misled consumers about effectiveness
TRENTON, N.J. - The makers of popular cholesterol drugs Vytorin and Zetia are being sued in at least four states over allegations that Merck & Co. and Schering-Plough Corp. misled consumers into thinking the drugs were more effective than generic ones. (...)
Vytorin Ad Shame Taints Entire Marketing Industry
adage.com 21.1.2008
Cholesterol Drug's Ad Campaign Turns Into PR Nightmare, Fanning Flames of Public Mistrust of DTC (...)
Study sees no Alzheimer's protection from statins
reuters.com 16.1.2008
WASHINGTON (Reuters) - Cholesterol-lowering drugs called statins do not protect against Alzheimer's disease as some previous research has suggested, a study published on Wednesday said. (...)
At the beginning, 119 of the participants were taking a statin drug. Over the course of the study, 191 people developed Alzheimer's disease, the researchers reported in the journal Neurology.
"We did not find that statins were associated with a lower risk of Alzheimer's disease, with less decline in thinking ability, or with Alzheimer's disease changes in the brain at time of death," Arvanitakis, part of the Rush Alzheimer's Disease Center, said in a telephone interview.
Taking statins also did not protect against memory loss, Arvanitakis added. (...)
Cholesterol as a Danger Has Skeptics
nytimes.com 17.1.2008
For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.
But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say. (...)
Drug trials under pressure
usatoday.com 16.1.2008
On the eve of a date with congressional investigators, executives from Merck and Schering-Plough acknowledged Monday that their blockbuster cholesterol drug, Vytorin, offered no benefit over Zocor.
The news that Vytorin fell short of an old stand-by statin drug, now sold as a cheap generic, sent worried patients scurrying to call their doctors for reassurance and advice. (...)
Don't panic over heart drug news, U.S. group advises
reuters.com 15.1.2008
WASHINGTON (Reuters) - News that the popular cholesterol drug Vytorin may not work to protect arteries and may in fact worsen clogging should not cause patients to panic, the American College of Cardiology said on Tuesday. (...)
Study Reveals Doubt on Drug for Cholesterol
nytimes.com 15.1.2008
A clinical trial of a widely used cholesterol drug has raised questions both about the medicine’s effectiveness and about the behavior of the pharmaceutical companies that conducted the study, cardiologists said Monday.
Merck and Schering-Plough, which make the drug, Zetia, and a pill that contains it, Vytorin, said Monday morning that Zetia had failed to benefit patients in a two-year trial that ended in April 2006.
Merck and Schering repeatedly missed their own deadlines for reporting the results, leading cardiologists around the world to wonder what the study would show. At the same time, millions of patients have continued taking Zetia and Vytorin.
The drug companies blamed the complexity of the data for the delay. Now, barely a month after news articles noted the delay and Congress pressured the companies to disclose the study’s findings, the results are out.
(...)
Dr. Steven E. Nissen, the chairman of cardiology at the Cleveland Clinic, said the results were “shocking.”
“This is as bad a result for the drug as anybody could have feared,” said Dr. Nissen, a widely published researcher and senior consulting editor to the Journal of the American College of Cardiology. (...)
Solo drug as good as cholesterol combo
usatoday.com 14.1.2008
NEWARK — A controversial trial of the popular and costly cholesterol-lowering drug Vytorin showed that it offered no benefit over an older drug available in generic form, Merck and Schering-Plough said Monday. (...)
What's Next For Vytorin?
forbes.com 15.1.2008
When Merck and Schering-Plough revealed Monday that the active ingredient in their top-selling cholesterol meds Zetia and Vytorin had flunked a clinical trial measuring its effect on artery plaque, they opened themselves up to a barrage of attacks. (...)
Statins Can Boost Brain Hemorrhage Risk After Stroke
healthfinder.gov 13.12.2007
For most patients, small risk is outweighed by the benefits, experts say. (...)
The report is published in the Dec. 12 online edition of Neurology.
In the study, Goldstein's group analyzed data from the Stroke Prevention with Aggressive Reduction in Cholesterol Levels (SPARCL) trial. In SPARCL, 4,731 people received 80 milligrams of Lipitor daily or placebo. (...)
Trial of Cholesterol Drug Gets House Scrutiny
nytimes.com 12.12.2007
A Congressional committee is investigating Merck and Schering-Plough for their handling of a critical clinical trial of Zetia, their blockbuster cholesterol-lowering drug.
On Tuesday, the House Committee on Energy and Commerce demanded more information about delays in the trial, which was completed in April 2006 but whose results have not yet been released.
In a letter to Merck and Schering, the committee’s top two members asked officials at both companies to agree to talk to investigators and said both companies should retain important documents about the trial, called Enhance. (...)
Cholesterol seen tied to heart disease, not stroke (Kolesterol knyttet til hjerteykdom, ikke slag)
reuters.com 29.11.2007
WASHINGTON (Reuters) - Researchers aiming to establish whether high cholesterol raises the risk of stroke said on Thursday they were baffled by findings indicating lower cholesterol levels were not linked to reduced stroke deaths.
They said their analysis of 61 previous studies involving almost 900,000 adults, conducted mostly in western Europe and North America, clearly showed that people with lower total blood cholesterol levels had a lower heart disease death rate.
But the researchers found no relationship between total cholesterol levels and risk of stroke death, especially at older ages and among people with higher blood pressures. (...)
Cardiologists Question Delay of Data on 2 Drugs
nytimes.com 21.11.2007
Prescriptions for the cholesterol-lowering drugs Zetia and Vytorin are written for almost 800,000 Americans every week, at a cost this year of about $4 billion. Yet it still is not clear how well the drugs work.
Nearly two years after the medicines’ makers, Merck and Schering-Plough, completed a clinical trial of the drugs, they still have not released the findings.
The delay has led to a growing chorus of complaints from cardiologists. And yesterday, the companies responded by promising to publish a portion of the results next March — but not the entire set of data. (...)
Cholesterol Drug Tied to Sleep Disturbances (Legemiddel mot kolesterol knyttet til søvnforstyrrelser)
drugs.com 7.11.2007
A new report found that the statin Zocor disrupts sleep patterns in some users.
"The study suggests that simvastatin [Zocor] is more likely to have sleep disruption," said Dr. Sidney Smith, past president of the American Heart Association and director of the Center for Cardiovascular Science and Medicine at the University of North Carolina School of Medicine. "The extent to which this would be a significant problem for patients is uncertain, but this should raise awareness that symptoms could be related to therapy." (...)
Crestor minskar inte risken att dö
lakemedelsvarlden.se 6.11.2007
Aztrazenecas statinpreparat Crestor påverkar inte dödligheten hos patienter med hjärtsvikt. Det visar den stora internationella Corona-studien. (...)
Snabb ökning av förebyggande hjärtläkemedel till unga
lakemedelsvarlden.se 1.11.2007
En amerikansk studie visar att användning av kolesterolsänkande och blodtryckssänkande läkemedel ökar snabbt bland yngre personer. Experter varnar för ökad livslång förebyggande läkemedelsbehandling hos allt fler allt tidigare. (...)
The Secrets Of Pfizer's Toxic Pill
forbes.com 5.11.2007
(...) Researchers speculating about what went wrong thought perhaps torcetrapib made HDL that didn't work, or that HDL itself (short for high-density lipoprotein, and often called "good cholesterol") was less powerful than they thought. Now the results from that trial are finally in, published in the New England Journal of Medicine and presented here at the annual scientific meeting of the American Heart Association. (...)
Mom's Low Cholesterol Tied to Preemie Births
healthfinder.gov 1.10.2007
Nutritional deficiencies and genetics may be to blame, researchers suggest.
(SOURCES: Max Muenke, M.D., chief, medical genetic branch, U.S. National Human Genome Research Institute, National Institutes of Health, Bethesda, Md.; Robert Welch, M.D., chairman and program director, obstetrics and gynecology, St. John Health's Providence Hospital, Southfield, Mich.; October 2007, Pediatrics)
MONDAY, Oct. 1 (HealthDay News) -- While lower cholesterol is generally considered a good thing, new research suggests that very low cholesterol levels in pregnant women may harm the health of the fetus.
Expectant mothers whose total cholesterol levels were under 159 milligrams per deciliter (mg/dL) gave birth -- on average -- to babies weighing about one-third of a pound less than babies born to mothers whose cholesterol levels exceeded 159 mg/dL, the researchers found. (...)
Pfizer study shows risk of cholesterol pill switch
today.reuters.com 5.9.2007
VIENNA (Reuters) - Patients switching from Pfizer's branded cholesterol pill Lipitor to Merck & Co's Zocor -- now available as a cheap generic -- are more likely to have a heart attack or die, according to a Pfizer-backed study. (...)
Pfizer's study covered records from 1997 to 2005 and compared outcomes for 2,511 patients who took Lipitor for six months and then switched to simvastatin -- the generic name for Zocor -- with 9,009 who stayed on Lipitor.
The conclusion was that switching was associated with a 30 percent increase in the relative risk of major cardiovascular events, including heart attacks, strokes and death.
The reasons for switching were not given and patients were not randomly assigned to each arm of the study, limiting its significance. Nonetheless, Pfizer said it raised concerns. (...)
Statins may help lower risk of getting Alzheimer's, says study - 29/08/2007
pharmatimes.com 29.8.2007
Mass medicating with statins would 'slash' CV disease (...)
Cutting Cholesterol, an Uphill Battle
PERSONAL HEALTH
nytimes.com 21.8.2007
Last December, a routine nonfasting blood test revealed that my total cholesterol level, which had long wavered between 190 and 205 milligrams per deciliter of blood serum, was now 222 and flagged as “high” by the laboratory’s computer. A heart-healthy reading should be under 200. (...)
- Høyt kolesterol forlenger livet
dagbladet.no 20.8.2007
(Dagbladet.no:) Overlege Tor Ole Kjellevand ved Hjertemedisinsk avdeling på Rikshospitalet tar et kraftig oppgjør med legestandens oppfatning av at høyt kolesterol fører til hjertesykdom. I et debattinnlegg i Aftenposten i dag legger han ikke fingrene imellom:
«Sannheten er nemlig at kolesterol ikke er et skadelig stoff. Det er faktisk et av de viktigste stoffene vi har i kroppen. Hjernen vår er avhengig av det, cellemembranene, som er vårt forsvar mot infeksjoner og kreftsykdommer, er avhengig av det», skriver Kjellevand og understreker:
«Å mene at dette stoffet er farlig, ja likefrem en 'silent killer', er så hinsides all fornuft at jeg ikke har ord for det.» (...)
Kjellevand mener myten om det farlige kolesterolet har fått leve videre fordi legemiddelindustrien tjener store penger på å selge kolesterolsenkende medisiner, såkalte statiner. (...)
Kolesterol - venn eller fiende
Av Tor Ole Kjellevand, overlege,
Hjertemedisinsk avdeling, Rikshospitalet
aftenposten.no 19.8.2007
Under overskriften "Hva skal vi holde oss til?" har Knut Utstein Kloster et meget betimelig innlegg i Aftenposten 14. august. Sannheten er at så lenge Lipidklinikken og dens forkjempere får dominere mediene, vil sannheten ikke komme frem. (...)
Legemiddelindustrien lever høyt av å selge kolesterolsenkende medisiner, statinene. Det er en milliardindustri som man ikke er villig til å gi opp så lett. Så har man slike folk som driver Lipidklinikken, som lever av folks frykt for kolesterolet. (...)
Eksplosiv vekst i salget av kolesterolmedisiner
dagsavisen.no 25.7.2007
– Vi ligger på verdenstoppen i å behandle pasienter med kolesterolsenkende medisiner, sier hjertespesialist og avdelingsoverlege Steinar Madsen i Statens legemiddelverk.
I fjor var det over 360.000 nordmenn som fikk kolesterolsenkende medikamenter. (...)
Sterk vekst i salget av kolesterolmedisiner
vg.no 25.7.2007
Salget av kolesteroldempende preparater har i løpet av fire år økt med over 100 prosent. Dette er bra, mener Legemiddelverket. (...)
- Vi ligger på verdenstopen i å behandle pasienter med kolesterolsenkende medisiner, sier hjertespesialist og avdelingsoverlege Steinar Madsen i Statens legemiddelverk til Dagsavisen. (...)
- For lavt kolesterol kan føre til kreft
vg.no 25.7.2007
(VG Nett) Ved å redusere kolesterolet i et forsøk for å redusere faren for hjertesykdommer kan du øke faren for kreft, tror forskere. (...)
Specialists debunk statin link to cancer (Spesialister linker statin til kreft)
pharmatimes.com 24.7.2007
Heart patients were last night told to keep taking their statin tablets despite the emergence of data from the US suggesting that the cholesterol-lowering tablets might slightly increase users’ risk of cancer.
The study, published in the latest issue of the Journal of the American College of Cardiology had set out to examine how statins damage liver and muscle tissue. (...)
Study links low cholesterol levels and cancer
today.reuters.com 24.7.2007
LONDON (Reuters) - The heart benefits of taking so-called statin drugs to reduce cholesterol might be offset by a slightly increased risk of cancer, although the evidence is by no means clear, U.S. scientists said on Tuesday.
A new pooled, or meta, analysis of past studies involving 41,000 patients on statins found one additional incident of cancer per 1,000 patients with low levels of LDL, or "bad" cholesterol, compared to those with higher LDL.
The results will be published in the July 31 issue of the Journal of the American College of Cardiology. (...)
Interaksjoner mellom statiner og makrolidantibiotika
Tidsskr Nor Lægeforen 2007; 127: 1660-1 (14.6.2007)
Det er beskrevet flere tilfeller av rabdomyolyse etter kombinert bruk av statiner og makrolidantibiotika. Nye hendelser kan forebygges med enkle tiltak, men det krever oppmerksomhet rundt denne typen interaksjoner i klinisk praksis. (...)
Does pravastatin promote cancer in elderly patients? A meta-analysis
CMAJ 2007;176 (5) (February 27)
Background: An increase in the incidence of cancer among elderly people assigned to pravastatin therapy has been reported in a randomized controlled trial; however, this finding has been attributed to chance. Our aim was to assess the effect of pravastatin therapy on cancer risk and to examine whether the effect varies according to age by performing a detailed meta-analysis and meta-regression analysis of randomized controlled trials. (...)
Interpretation: Our findings suggest an association between pravastatin therapy and cancer in elderly patients. However, given the importance of this potential association, further verification is warranted. (...)
Painkillers, cholesterol linked
newsday.com 13.2.2007
Vioxx, Bextra found to cause lipid buildup, possible risk to heart
Certain pain-relieving drugs that belong to a group of medications called COX inhibitors may impair the ability of human blood cells to rid themselves of cholesterol, according to research published Jan. 23 in the journal Arthritis Research & Therapy. (...)
Study Links Certain Painkillers to High Cholesterol Levels (Studie linker visse smertestillende legemidler til høye nivåer av kolesterol)
newsinferno.com 13.2.2007
A new study published last month in the journal Arthritis Research & Therapy sheds new light on why the class of painkillers known as COX-2 inhibitors may lead to an increased incidence of heart attacks. Researchers at Winthrop-University Hospital in Long Island have determined that controversial drugs such as Vioxx and Bextra may impede the body’s ability to purge excess cholesterol.
“To our knowledge, this is the first study that describes the effects of COX inhibition on reverse cholesterol transport proteins,” the authors wrote. “Our results suggest that the cardiovascular hazard observed with COX inhibitors may result not only from enhanced platelet aggregation [blood clots], but also from interference with cholesterol outflow.” (...)
Forbruget af kolesterolsænkende medicin eksploderer
berlingske.dk 29.1.2007
Medicin mod forhøjet kolesterol er et af de mest brugte lægemidler. 300.000 er i behandling mod 50.000 for fem år siden. Forbrugerrådet maner til forsigtighed.
Danskerne er gået til kamp mod kolesterol.
På et år, fra 2005 til 2006, er forbruget af kolesterolsænkende medicin steget med 30 procent, viser tal fra Apotekerforeningen.
Mere end 300.000 danskere var sidste år i behandling, og den udvikling glæder Hjerteforeningen. Her siger lægefaglig chef Mogens Lytken Larsen, at der i mange år har væren en tendens til at underbehandle patienter med hjerte-kar-sygdomme. (...)
Cholesterol Drugs May Cause Parkinson's - Report (Legemidler mot høyt kolesterol kan forårsake Parkinsons sykdom)
newsmax.com 22.1.2007
WASHINGTON -- New research showing a strong link between Parkinson's disease and low levels of "bad" cholesterol are so worrying that U.S. researchers are launching a study to look into it.
The team at the University of North Carolina is planning clinical trials involving thousands of people to see whether statin drugs, which lower low density lipoprotein, or LDL, might actually cause Parkinson's in some people.
Other research has for several years suggested that people with abnormally low levels of LDL might be at higher risk of Parkinson's.
Xuemei Huang and colleagues found that patients with low levels of LDL cholesterol are at least three and a half times more likely to develop Parkinson's disease than those with higher LDL levels.
Writing in the journal Chemistry & Industry, they said they plan a bigger study of patients taking statins, the biggest-selling drugs in the world. (...)
Big Cholesterol Leads to Better Brains
ivanhoe.com (December 2006)
(Ivanhoe Newswire) -- When most people think of cholesterol, they think about high levels causing heart disease and stroke.
But research also suggests a role for cholesterol in longevity, and now investigators from Albert Einstein College of Medicine in New York have extended those findings by linking the substance to cognitive functioning in old age as well.
Cholesterol levels aren't the key factor, however. It's all about the size of the cholesterol particles. (...)
Statin-related adverse events: a meta-analysis.
Clin Ther. 2006 Jan;28(1):26-35
CONCLUSIONS: Statin therapy was associated with greater odds of AEs compared with placebo but with substantial clinical benefit. Similar rates of serious AEs were observed between statin and placebo. (...)
Clinical perspectives of statin-induced rhabdomyolysis.
Am J Med. 2006 May;119(5):400-9
Fear of muscle toxicity remains a major reason that patients with hyperlipidemia are undertreated. Recent evaluations of statin-induced rhabdomyolysis offer new insights on the clinical management of both muscle symptoms and hyperlipidemia after rhabdomyolysis. The incidence of statin-induced rhabdomyolysis is higher in practice than in controlled trials in which high-risk subjects are excluded. (...)
Lawsuits Filed Over Lipitor Side Effects
washingtonpost 8.6.2006
NEW YORK -- Two men who believe they suffered lasting muscle damage from taking the popular anti-cholesterol drug Lipitor are suing medication's maker, Pfizer Inc., claiming the company didn't issue loud enough warnings about potential side effects.
Charles M. Wilson, a former insurance executive from Atlanta, and Michael Mazzariello, an attorney from New York City, said in separate lawsuits that they began experiencing debilitating pain, weakness and memory problems after taking the drug.
"It ruined my life," said Mazzariello, 47. He said that within weeks of going on the medication, he couldn't walk without a cane, tend his garden or lift his 1-year-old child.
The symptoms subsided once Mazzariello stopped taking the medication - he stood under his own power at a news conference Thursday at a Manhattan hotel - but he said he still suffers from pain, fatigue and a tingling sensation in his hands and feet.
Pfizer called the two suits "baseless" and vowed to fight them in court. (...)
UK cholesterol drugs policy 'ineffective'
netdoctor.co.uk 22.5.2006
The UK's policy on the use of cholesterol-beating drugs is not effective in reducing instances of heart disease, researchers have claimed.
Statins – drugs that cut cholesterol levels – are typically prescribed to middle-aged men and women who are deemed at high risk of developing heart disease.
However, in the UK their limited use is only resulting in a nine per cent reduction in heart disease cases, according to researchers writing in the journal Heart.
This is significantly less than the reductions achieved by the US and Europe where much greater statin use has resulted in drops in heart disease of 22 per cent and 19 per cent respectively. (...)
However the researchers, led by Professor Paul Durrington, admit that widespread use of statins in the hope of reducing heart disease rates "raises philosophical, psychological, and economic considerations".
Statins already cost the NHS more than any other prescribed drug – an average of over £150 per patient per year, costing a total of £769 million annually.
Detractors say that widening their use will therefore only increase the financial burden of the NHS. (...)
Effects of Early Treatment With Statins on Short-term Clinical Outcomes in Acute Coronary Syndromes
JAMA. 2006;295:2046-2056
(…) Data Synthesis Twelve trials involving 13 024 patients with ACS were included in the meta-analysis. The risk ratios for the combined end point of death, MI, and stroke for patients treated with early statin therapy compared with control therapy were 0.93 (95% confidence interval [CI], 0.80-1.09; P = .39) at 1 month and 0.93 (95% CI, 0.81-1.07; P = .30) at 4 months following ACS.
(…) Conclusion Based on available evidence, initiation of statin therapy within 14 days following onset of ACS does not reduce death, MI, or stroke up to 4 months. (...)
Foods lower cholesterol as much as medication
netdoctor.co.uk 9.3.2006
Eating a combination of heart-healthy foods can lower cholesterol as much as medication, according to new Canadian research.
According to researchers at the University of Toronto, eating a certain 'portfolio' of foods including fish, oatmeal, almonds and lean meats can help reduce artery-clogging LDL cholesterol as much as statin drugs.
The study, published on Wednesday in the American Journal of Clinical Nutrition, followed 55 overweight middle-aged men and women for a year.
It was found that after a year, one third of the group had lowered their LDL cholesterol by 20 per cent or more - a similar effect to that achieved by cholesterol-lowering statin drugs.
Another third that had followed the eating plan less strictly achieved an average reduction of 15 per cent, while those with the least compliance achieved an average of ten per cent.
The researchers hope that this will give patients a new reason to ask for dietary advice rather than medication at the first sign of high cholesterol levels.
"This study is exciting because it shows an effective dietary approach to lowering cholesterol isn't as hard or as intimidating as we previously thought it was," commented study co-author Dr David Jenkins.
"The patients who followed the Portfolio Eating Plan ate things that the average person eats every day."
The American Heart Association estimates that 99.9 million Americans have blood cholesterol values considered borderline-high risk to high risk. (...)
Kognitive bivirkninger ved statinbehandling?
irf.dk 7.6.2006
Konklusion
Store kliniske forsøg viser, at statiner ikke har effekt på kognitive funktioner. Kasuistikker medgiver dog muligheden for, at der i nogle sjældne tilfælde er sammenhæng mellem statinbehandling og kognitiv forringelse samt hukommelsestab.
Forskningsresultater omkring serum kolesterols påvirkning af hukommelsen er inkonstistente. (...)
Studies: Statins Don't Lower Cancer Risk
abcnews.go.com 3.1.2006
Two New Studies Say Cholesterol-Lowering Statin Drugs Don't Lower Cancer
CHICAGO - Two new studies deal a double blow to hopes that cholesterol-lowering statin drugs could help prevent cancer as well as heart disease.
In one report, researchers analyzed 26 rigorous, randomized studies involving more than 73,000 patients and concluded that drugs such as top-selling Lipitor and Zocor had no effect on the risk of developing or dying from any form of cancer.
The findings appear in Wednesday's Journal of the American Medical Association. (...)
Lipidsänkning hjälpte inte hjärtinfarktpatienter
netdoktor.passagen.se 17.11.2005
Kraftig sänkning av blodfetterna hos patienter med hjärt-kärlsjukdom minskade inte risken för dessa att drabbas av ytterligare hjärtproblem. Det visar en stor europeisk studie som presenteras i den prestigefyllda medicinska tidskriften Journal of American Medical Association. 8888 patienter ingick i studien och samtliga av dessa hade vid studiens början haft hjärtinfarkt. Dessa fick lipidbehandling med antingen Simvastatin i normaldos eller hög dos av Lipitor. Resultaten visar att kraftig kolesterolsänkning, vilken åstadkoms men hög dos av Lipitor, inte minskade risken för ytterligare hjärtproblem. (...)
Lipitor or Generic? Billion-Dollar Battle Looms
New York Times 15.10.2005
The Lipitor war is about to begin.
Starting next June, insurers and government agencies will have the opportunity to save billions of dollars by moving patients from Lipitor, a cholesterol-lowering drug by Pfizer that is the world's top-selling medication, to an inexpensive generic version of Zocor, a similar but less potent drug now made by Merck. (...)
Pfizer Wins a Big One in Britain
businessweek.com 13.10.2005
A court rejects Ranbaxy's patent challenge to Lipitor, forestalling a generic version of the blockbuster. Next: A similar battle in the U.S.
Pfizer (PFE) investors are breathing easier. On Oct. 12, a British court handed the drugmaker a big victory, rejecting an effort by generic-drug maker Ranbaxy Laboratories to launch a generic version of Lipitor, Pfizer's $12.5 billion blockbuster cholesterol-lowering drug. (...)
Low cholesterol linked to Parkinson's risk in men
NEW YORK (Reuters Health) 29.9.2005
- Is it possible to have too low a level of cholesterol? A cholesterol profile that reduces the risk of heart disease may increase the risk for Parkinson's disease -- at least for men -- researchers report.
Going back several years, studies have uncovered associations between low cholesterol and suicide, stroke, depression, even violence. While the findings in most cases did not stand up to scrutiny, the suspicion remains that very low cholesterol might influence mental function.
Now, at the annual meeting the American Neurological Association held this week in San Diego, California, Dr. Xuemei Huang described a possible link to Parkinson's disease.
Huang and colleagues, from the University of North Carolina at Chapel Hill, measured the lipid levels of 124 Parkinson's patients and a group of 112 similar people free of Parkinson's disease. (...)
- Statinvedtaket kom for tidlig
Dagens Medisin 18.8.2005
- Av helsemessige årsaker burde myndighetene ha ventet med statinvedtaket, sier Leiv Ose ved Lipidklinikken i Oslo.
Norske helsemyndigheter har vedtatt at simvastatin skal være førstevalg til alle pasienter som trenger medikamentell behandling av høyt kolesterol. (...)
Førstevalg
I Norge skal også pasienter som allerede står på andre statiner bytte til simvastatin dersom ikke tungtveiende medisinske grunner sier noe annet. Bakgrunnen er at simvastatin, som har gått av patent, er et billigere legemiddel enn atorvastatin slik at det vil spare samfunnet for store utgifter. Samtidig mener myndighetene at simvastatin gir god behandling.
Hvorfor dyrt?
- Vi har retningslinjer for hvor mye kolesterolet bør senkes. Hvis vi når de målene med et billig statin, hvorfor skal en da velge et langt dyrere legemiddel? spør avdelingsoverlege Steinar Madsen i Statens legemiddelverk.
- Simvastatin er bra og velegnet i veldig mange tilfeller. Av våre høyrisikopasienter vil cirka halvparten kunne ha hjelp av legemidlet. De andre bør ha atorvastatin i høyere dose, sier seksjonsoverlege Leiv Ose ved Lipidklinikken på Rikshospitalet.
Venter på IDEAL
Ose mener at statinvedtaket kom for tidlig.
- Vi mangler ennå data for å kunne fastslå at simvastatin er like bra som atorvastatin. IDEAL-studien, som legges frem på American Heart i november, kan resultere i resultater som gjør at man bør velge atorvastatin til store pasientgrupper. Av helsemessige årsaker mener jeg derfor at myndighetene burde ha ventet med vedtaket, sier Ose.
Ikke relevant
Steinar Madsen er ikke enig:
- Det vil alltid komme nye studier. Dessuten er slike studier gjort av industrien og er ofte utformet for å gi ett legemiddel en fordel på bekostning av andre. IDEAL-studien har målt et statin i høydose mot et annet statin i lavdose. Skulle det ha vært relevant i denne sammenhengen, burde man ha brukt maksimal dose av simvastatin sammenlignet med maksimal dose av atorvastatin.
Cholesterol Drugs May Harm Ill Diabetics
Washington Post 20.7.2005
-- Cholesterol-lowering statin drugs do not help severely ill diabetics, and may even raise their risk of a deadly stroke, a study found. In the study, patients on Lipitor were twice as likely to die of a stroke.
It was the first major test of statins in diabetics who need dialysis machines to remove wastes from their bloodstream because their kidneys cannot do the job. The results are surprising because previous research showed Lipitor helped less severely ill diabetics. (...)
Ezetimibe, muscle link highlighted
australiandoctor.com 10.8.2005 (Australian Doctor)
CONCERNS about muscle disorders linked to the lipid-lowering drug ezetimibe (Ezetrol) have been flagged in the latest Australian Adverse Drug Reactions Bulletin.
The Adverse Drug Reactions Advisory Committee drew attention to side effects such as myalgia, muscle cramps, weakness and pain associated with the drug in the August edition of the bulletin.
Forty-four incidents of muscle disorders have been reported to ADRAC since ezetimibe was registered in June 2003. In almost half of cases, the symptoms developed within two weeks of starting the medication. Twenty-one patients had a history of muscle disorders or increased creatine kinase associated with statin use. Myalgia and myopathy are listed as possible adverse effects of ezetimibe when used with statins. (...)
Study: Lipitor no better than rivals
The Associated Press/DUESSELDORF, Germany
Study: Lipitor no better than rivals
BusinessWeek 4.9.2005
SEP. 4 4:53 P.M. ET Pfizer Inc.'s cardiovascular treatment Lipitor, the world's best-selling drug, is no more effective than similar drugs and in some cases has worse side effects, according to a study by an independent German institute.
The results come from a survey of previous studies worldwide, rather than new clinical tests on patients. It was released Saturday by Institut fuer Qualitaet und Wirtschaftslichkeit im Gesundheitswesen.
IQWiG is an independent institution that studies value-for-money in health care, set up at the instigation of the German government. (...)
Pfizer Earnings Rise 21%, Exceeding Estimates
nytimes.com 21.7.2005
Pfizer reported earnings yesterday that exceeded analysts' estimates, on increased demand for medicines to treat the ailments of an aging population.
Net income at Pfizer, the world's largest drug company, rose 21 percent in the second quarter on higher sales of Lipitor, the cholesterol medicine.
Pfizer, which is based in New York, said its net income increased to $3.46 billion, or 47 cents a share, from $2.86 billion, or 38 cents, a year earlier. (...)
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