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Medical Forum / General / Cardiology / December 2007Cholesterol
Have we been conned about cholesterol? by MALCOLM KENDRICK - http://www.dailymail.co.uk/pages/live/articles/health/healthmain.html?in_article _id=430682&in_page_id=1774&in_page_id=1774&expand=true#StartComments Last updated at 19:59pm on 24th January 2007 "When it comes to heart disease, we have been sold a pup. A rather large pup. Actually, it's more of a full-grown blue whale. We've all been conned. If you've got a raised risk of heart disease, the standard medical advice is to take a cholesterol-lowering statin drug to cut your chances of having a heart attack because, as we all know, cholesterol is a killer. ..... .......But is it all worth it? According to an article being published in the medical journal The Lancet this week, the answer is probably no. A leading researcher at Harvard Medical School has found that women don't benefit from taking statins at all, nor do men over 69 who haven't already had a heart attack. There is a very faint benefit if you are a younger man who also hasn't had a heart attack - out of 50 men who take the drug for five years, one will benefit. ........ ....... what your doctor should be saying, is the following: * A high diet, saturated or otherwise, does not affect blood cholesterol levels. * High cholesterol levels don't cause heart disease. * Statins do not protect against heart disease by lowering cholesterol - when they do work, they do so in another way. * The protection provided by statins is so small as to be not worth bothering about for most people (and all women). The reality is that the benefits have been hyped beyond belief. * Statins have many more unpleasant side effects than has been admitted, while experts in this area should be treated with healthy scepticism because they are almost universally paid large sums by statin manufacturers to sing loudly from their hymn sheet."........More at link ..... Interesting to note that since this article a Lancet study has found that ..Statins do not reduce stroke mortality rates in middle age men may increase stoke mortality in the elderly. Thanks Vince > A leading researcher at Harvard Medical School has found that women > don't benefit from taking statins at all, nor do men over 69 who > haven't already had a heart attack. This is a bit of an overstatement. He raised certain questions about these issues in a commentary published in The Lancet. > Interesting to note that since this article a Lancet study has found > that ..Statins do not reduce stroke mortality rates in middle age > men may increase stoke mortality in the elderly. Say what? I do not believe such a study exists. Marilyn The Lancet 2007; 369:168-169 Comment Are lipid-lowering guidelines evidence-based? J Abramson a and JM Wright b The last major revision of the US guidelines, in 2001,1 increased the number of Americans for whom statins are recommended from 13 million to 36 million, most of whom do not yet have but are estimated to be at moderately elevated risk of developing coronary heart disease.2 In support of statin therapy for the primary prevention of this disease in women and people aged over 65 years, the guidelines cite seven and nine randomised trials, respectively. Yet not one of the studies provides such evidence. For adults aged between 30 and 80 years old who already have occlusive vascular disease, statins confer a total and cardiovascular mortality benefit and are not controversial. The controversy involves this question: which people without evident occlusive vascular disease (true primary prevention) should be offered statins? With about three- quarters of those taking statins in this category,3 the answer has huge economic and health implications. In formulating recommendations for primary prevention, why do authors of guidelines not rely on the data that already exist from the primary prevention trials? We have pooled the data from all eight randomised trials that compared statins with placebo in primary prevention populations at increased risk.4 Unfortunately, our analysis is imperfect because these trials are not solely primary prevention: 8·5% of patients had occlusive vascular disease at baseline.5 We used two outcomes to estimate overall benefit (benefit minus harm): total mortality and total serious adverse events (SAEs). Total mortality was not reduced by statins (relative risk 0·95, 95% CI 0·89-1·01). In the two trials that reported total SAEs, such events were not reduced by statins (1·01, 0·97-1·05) (data on SAEs from the other trials were not reported). The frequency of cardiovascular events, a less encompassing outcome, was reduced by statins (relative risk 0·82, 0·77-0·87). However, the absolute risk reduction of 1·5% is small and means that 67 people have to be treated for 5 years to prevent one such event. Further analysis revealed that the benefit might be limited to high-risk men aged 30-69 years. Statins did not reduce total coronary heart disease events in 10990 women in these primary prevention trials (relative risk 0·98, 0·85-1·12).6 Similarly, in 3239 men and women older than 69 years, statins did not reduce total cardiovascular events (relative risk 0·94, 0·77-1·15).7 Our analysis suggests that lipid-lowering statins should not be prescribed for true primary prevention in women of any age or for men older than 69 years. High-risk men aged 30-69 years should be advised that about 50 patients need to be treated for 5 years to prevent one event. In our experience, many men presented with this evidence do not choose to take a statin, especially when informed of the potential benefits of lifestyle modification on cardiovascular risk and overall health.8 This approach, based on the best available evidence in the appropriate population, would lead to statins being used by a much smaller proportion of the overall population than recommended by any of the guidelines.9 Why the disagreement? The current guidelines are based on the assumption that cardiovascular risk is a continuum and that evidence of benefit in people with occlusive vascular disease (secondary prevention) can be extrapolated to primary prevention populations. This assumption, plus the assumption that cardiovascular risk can be accurately predicted, leads to the recommendation that a substantial proportion of the healthy population should be placed on statin therapy. A similar set of assumptions underlie the conclusions of the Cholesterol Treatment Trialists' (CTT) collaboration, a group that undertakes periodic meta-analyses of individual participants' data on morbidity and mortality from all relevant large-scale randomised trials of lipid-modifying treatment.5 The CTT Collaborators included seven trials of statins for secondary prevention and seven trials of statins for mostly primary prevention. However, instead of analysing these two groups of studies separately, they combine all the studies and report the overall effect. Because they have individual participants' data, the CTT Collaborators have the unique opportunity to analyse the data for the 41354 people in the true primary prevention group that they have identified as included in these studies.5 However, they do not report on this pure primary prevention population. Instead they calculate and report the absolute benefit of statins in 47925 patients with no coronary heart disease at baseline; however, this group includes about 6570 patients with pre-existing cerebrovascular or peripheral vascular disease. Combination of these secondary prevention patients (5-year frequency of major vascular events 25-30%) with the true primary prevention group (5-year incidence of major vascular events 9%) inflates the estimate of absolute benefit from 1·5% (our estimate) to 2·5%. The CTT collaborators have primary prevention outcome data that can resolve the issues we raise. Subpopulations of particular interest include: men, women, men aged 70 years or older, women below the age of 70 years, people with diabetes mellitus, 20% of people with the lowest bodyweight, people taking more than five drugs, and tertiles of cardiovascular risk at baseline. The following are the outcomes that would be most informative: total mortality, total SAEs, total incidence of cancer, and total cardiovascular events. This analysis would answer the key outstanding questions. First, do the data on primary prevention confirm that there is no overall benefit in adult women of any age and in men aged 70 years and older? And, second, is there significant heterogeneity between the statin treatment effect in primary prevention subgroups compared with that in secondary prevention subgroups? If the answer to both these questions is yes, the assumption that the benefits for secondary prevention populations can be extrapolated to primary prevention populations is false and the cholesterol treatment guidelines based on this assumption should be revised. JMW declares no conflict of interest. JA is an expert consultant to plaintiffs' attorneys on litigation involving the drug industry, including Pfizer for its marketing of atorvastatin. References 1. Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood pressure in adults (adult treatment panel III) final report: table II. 2-3. September, 2002: http://www.nhlbi.nih.gov/guidelines/cholesterol (accessed Jan 2, 2007).. 2. Third report of the National Cholesterol Education Program (NCEP) expert panel on detection, evaluation, and treatment of high blood cholesterol in adults. Adult treatment panel III, final report. September, 2002: http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3ful... (accessed Jan 2, 2007).. 3. Savoie I, Kazanjian A. Utilization of lipid-lowering drugs in men and women: a reflection of the research evidence?. J Clin Epidemiol 2002; 55: 95-101. Abstract | Full Text | Full-Text PDF (62 KB) | MEDLINE | CrossRef 4. Jauca C, Wright JM. Therapeutics letter: update on statin therapy. Int Soc Drug Bull Newsletter 2003; 17: 7-9. 5. Cholesterol Treatment Trialists' (CTT) Collaborators. Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90056 participants in 14 randomised trials of statins. Lancet 2005; 366: 1267-1278. Abstract | Full Text | Full-Text PDF (162 KB) | CrossRef 6. Walsh JME, Pigame M. Drug treatment of hyperlipidemia in women. JAMA 2004; 291: 2243-2252. CrossRef 7. Shepherd J, Blauw GJ, Murphy MB, et al. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360: 1623-1630. Abstract | Full Text | Full-Text PDF (113 KB) | MEDLINE | CrossRef 8. Chiuve SE, McCullough ML, Sacks FM, Rimm EB. Healthy lifestyle factors in the primary prevention of coronary heart disease among men: benefits among users and nonusers of lipid lowering and antihypertensive medications. Circulation 2006; 114: 160-167. CrossRef 9. Manuel DG, Kwong K, Tanuseputro P, et al. Effectiveness and efficiency of different guidelines on statin treatment for preventing deaths from coronary heart disease: modelling study. BMJ 2006; 332: 1419-1422. Back to top Affiliations a. Harvard Medical School, Cambridge, Massachusetts, USA b. Department of Anesthesiology, Pharmacology & Therapeutics and Medicine, University of British > Interesting to note that since this article a Lancet study has found > that ..Statins do not reduce stroke mortality rates in middle age > men may increase stoke mortality in the elderly. Is this the study you're referring to? You must not have read it very carefully. Marilyn The Lancet 2007; 370:1829-1839 Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55 000 vascular deaths Prospective Studies Collaboration ‡Collaborators listed in full at end of paper Summary Background Age, sex, and blood pressure could modify the associations of total cholesterol (and its main two fractions, HDL and LDL cholesterol) with vascular mortality. This meta-analysis combined prospective studies of vascular mortality that recorded both blood pressure and total cholesterol at baseline, to determine the joint relevance of these two risk factors. Methods Information was obtained from 61 prospective observational studies, mostly in western Europe or North America, consisting of almost 900 000 adults without previous disease and with baseline measurements of total cholesterol and blood pressure. During nearly 12 million person years at risk between the ages of 40 and 89 years, there were more than 55 000 vascular deaths (34 000 ischaemic heart disease [IHD], 12 000 stroke, 10 000 other). Information about HDL cholesterol was available for 150 000 participants, among whom there were 5000 vascular deaths (3000 IHD, 1000 stroke, 1000 other). Reported associations are with usual cholesterol levels (ie, corrected for the regression dilution bias). Findings 1 mmol/L lower total cholesterol was associated with about a half (hazard ratio 0·44 [95% CI 0·42–0·48]), a third (0·66 [0·65–0·68]), and a sixth (0·83 [0·81–0·85]) lower IHD mortality in both sexes at ages 40–49, 50–69, and 70–89 years, respectively, throughout the main range of cholesterol in most developed countries, with no apparent threshold. The proportional risk reduction decreased with increasing blood pressure, since the absolute effects of cholesterol and blood pressure were approximately additive. Of various simple indices involving HDL cholesterol, the ratio total/HDL cholesterol was the strongest predictor of IHD mortality (40% more informative than non- HDL cholesterol and more than twice as informative as total cholesterol). Total cholesterol was weakly positively related to ischaemic and total stroke mortality in early middle age (40–59 years), but this finding could be largely or wholly accounted for by the association of cholesterol with blood pressure. Moreover, a positive relation was seen only in middle age and only in those with below-average blood pressure; at older ages (70–89 years) and, particularly, for those with systolic blood pressure over about 145 mm Hg, total cholesterol was negatively related to haemorrhagic and total stroke mortality. The results for other vascular mortality were intermediate between those for IHD and stroke. Interpretation Total cholesterol was positively associated with IHD mortality in both middle and old age and at all blood pressure levels. The absence of an independent positive association of cholesterol with stroke mortality, especially at older ages or higher blood pressures, is unexplained, and invites further research. Nevertheless, there is conclusive evidence from randomised trials that statins substantially reduce not only coronary event rates but also total stroke rates in patients with a wide range of ages and blood pressures. Quite interesting readings about cholesterol: http://www.thincs.org/ Taka Taka <taka0038@gmail.com> wrote in news:9b6d71ec-01ae-4280-b3b2- 0aabee5126c9@r60g2000hsc.googlegroups.com: > Quite interesting readings about cholesterol: > > http://www.thincs.org/ > > Taka "The International Network of Cholesterol Skeptics" Guess that sort of sums it all up. Cholesterol information to educate yourself best is at http://www.keep-cholesterol-control.com/index.html keep-cholesterol-control.com > Taka <taka0...@gmail.com> wrote in news:9b6d71ec-01ae-4280-b3b2- > 0aabee512...@r60g2000hsc.googlegroups.com: [quoted text clipped - 8 lines] > > Guess that sort of sums it all up. get pumping <hiya365@gmail.com> wrote in news:149615cc-08d8-48c2-b272- b9eaf0858d4a@e6g2000prf.googlegroups.com: > Cholesterol information to educate yourself best is at > http://www.keep-cholesterol-control.com/index.html > > keep-cholesterol-control.com The most rudimentary information acommpanied by ads to push products, all wrapped up in a horribly designed website. One thing I've noticed about that the "cholesterol skeptics" is that they don't seem interested in the molecular-level evidence. I've tried to contact several of these people. Two responded. One stated explicitly that he just didn't understand the evidence, and he said that he would talk to someone else about it, but then I never heard back from him. The other acted like a "know it all," and it was clear that he was too closed-minded for a serious discussion. This is why I created my free site. There, you can see the molecular-level evidence, along with my attempts to make it more comprehensible to those who don't have much of a background in these areas. >> Interesting to note that since this article a Lancet study has found >> that ..Statins do not reduce stroke mortality rates in middle age [quoted text clipped - 43 lines] > range of cholesterol in most developed countries, with no apparent > threshold. This study is the final nail in the coffin of the cholesterol sceptics, IMHO.  SignatureJuhana Ravintoblogini: http://ruohikolla.blogspot.com/ > >> Interesting to note that since this article a Lancet study has found > >> that ..Statins do not reduce stroke mortality rates in middle age [quoted text clipped - 49 lines] > -- > Juhana The only statistic not presented was all cause mortality ; a common bone of contention, perhaps I missed that data Thanks Vince - "This study is the final nail in the coffin of the cholesterol sceptics, IMHO." Juhana: If you wish to debate formally this issue, I would be willing to act as moderator, and to host it on my site. From the statement you made (quoted above) it appear that you think you have the requisite knowledge to do so, and I think it would be easy to get one of the "sceptics" to debate you. The first thing you need to do is to state your case concisely and explicitly. What, exactly, are you contending? Are you even taking into account the molecular-level evidence? Fantastic! What a giggle! Could you provide 4 references willing to testify that you are not a self deluding little twit? > "This study is the final nail in the coffin of the cholesterol > sceptics, [quoted text clipped - 10 lines] > contending? Are you even taking into account the molecular-level > evidence? The cholesterol skeptics were there. So were the physicians who challenge the safety and necessity of cholesterol-lowering drugs. And then there were the lipid researchers whose findings totally contradict the prevailing dietary advice to the public: Avoid saturated fats, limit cholesterol, and use more polyunsaturated oils. Their presentations were met with enthusiastic approval at a conference held last spring in Arlington, Virginia. But then again, the attendees were not the usual people who show up at a conference billed as "Heart Disease in the 21st Century: Beyond the Lipid Hypothesis." They were practicing physicians, biochemists, farmers, greenmarket activists, researchers, cooks, parents of young children, and people who have been told their cholesterol is too high. The general message was: Fats are extremely important to good health...the right kinds of fat, that is. http://www.keep-cholesterol-control.com/index.html For decades, enormous human and financial resources have been wasted on the cholesterol campaign, more promising research areas have been neglected, producers and manufacturers of animal food all over the world have suffered economically, and millions of healthy people have been frightened and badgered into eating a tedious and flavorless diet or into taking potentially dangerous drugs for the rest of their lives. As the scientific evidence in support of the cholesterol campaign is non-existent, we consider it important to stop it as soon as possible. http://www.americanvistas.com/health.html > Fantastic! What a giggle! Could you provide 4 references willing to testify > that you are not a self deluding little twit?<monty1...@lycos.com> wrote in message [quoted text clipped - 17 lines] > > - Show quoted text - > > Interesting to note that since this article a Lancet study has found > > that ..Statins do not reduce stroke mortality rates in middle age > > men may increase stoke mortality in the elderly. > > Is this the study you're referring to? You must not have read it very > carefully. Lets look at the relevent parts > Marilyn > [quoted text clipped - 4 lines] > studies with 55 000 vascular deaths > Prospective Studies Collaboration >Total cholesterol was weakly positively related to > ischaemic and total stroke mortality in early middle age (40–59 [quoted text clipped - 5 lines] > Hg, total cholesterol was negatively related to haemorrhagic and total > stroke mortality. > > Interpretation >.. The absence of an > independent positive association of cholesterol with stroke mortality, > especially at older ages or higher blood pressures, is unexplained, > and invites further research. Overall the study found no overall benefit on stroke mortality. Elderly people had a negative effect .The only subgroup that had a positive effect where middle age men with below average blood pressure .. I'm surprised you do not use the subgroup principle The overall study showed no benefit even middle age men showed no benefit when the effects of blood pressure are considered, elderly may have more fatal strokes. I read it carefully . Thanks Vince > > independent positive association of cholesterol with stroke mortality, > > especially at older ages or higher blood pressures, is unexplained, [quoted text clipped - 8 lines] > more fatal strokes. I read it carefully . > \ This study says nothing about whether statins lower stroke risk. It only relates to whether there is an association between total cholesterol levels and stroke. Marilyn > Is this the study you're referring to? You must not have read it very > carefully. > The Lancet 2007; 370:1829-1839 > Blood cholesterol and vascular mortality by age, sex, and blood > pressure: a meta-analysis of individual data from 61 prospective > studies with 55 000 vascular deaths > Prospective Studies Collaboration > Findings > 1 mmol/L lower total cholesterol was associated with about a half [quoted text clipped - 3 lines] > range of cholesterol in most developed countries, with no apparent > threshold. ... 1 nmol/L of cholesterol is equivalent to 38 mg/dL of cholesterol as usually reported to patients (in the US?). -- Ron |
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