Do statins save lives in essentially healthy people? (No)

Statins are drugs that reduce cholesterol. They also reduce risk of heart disease and stroke. That does not mean, though, that they do they via their cholesterol-reducing effect. There are several lines of evidence which actually suggest otherwise. For example, statins can have clinical benefit before they reduce cholesterol levels. They also have been purported to reduce risk of heart events (like heart attack) in individuals who have ‘normal’ (non-elevated) cholesterol. And then we have the fact that cholesterol reduction through other means (other drugs, diet) has been shown to have no broad benefits for health (see here and here for more about this).

The fact the statins are unlikely to ‘work’ due their cholesterol-reducing effects is not a reason not to take then, however. It is a reason, however, to perhaps take the focus off cholesterol-reduction and put it on things that work better. And, of course even if statins do reduce the risk of cardiovascular disease, it at least makes sense to weigh up their risks and benefits over time.

A recent study in the British Medical Journal assessed the risks/benefits of statin therapy [1]. Here, in short, are the findings of this study:

For women, for every 10,000 high risk individuals treated with statins, there would be approximately 271 fewer cases of cardiovascular disease, 8 fewer cases of oesophageal cancer; 23 extra patients with acute renal [kidney] failure, 307 extra patients with cataracts; 74 extra patients who experience liver dysfunction; and 39 extra patients with myopathy [muscle pain and/or weakness].

For men, for every 10,000 high risk individuals treated with statins, there would be approximately 301 fewer cases of cardiovascular disease, 9 fewer cases of oesophageal cancer; 29 extra patients with acute renal failure, 191 extra patients with cataracts; 71 extra patients who experience liver dysfunction; and 110 extra patients with myopathy.

So, even in individuals at high risk of cardiovascular disease (i.e. those most likely to benefit from statin therapy), you have to treat lots of people with statins for one to benefit. But the reality is, more people will end up with a serious adverse effect as a result of treatment. Now, some would regard having a shot at preventing cardiovascular disease outweighs the other ‘less important’ risks. However, I suggest there are also those who would look at these statistics and reason that there really is little or no overall benefit to taking statins (and who could blame them). More about this later.

However, some will argue that it’s clear that statins benefits outweigh their harm on the basis that the reduce risk of death (overall mortality). Actually, there is an element of truth in this. However, it is important here to define better the sort of people who might take statins. Statin therapy broadly divides into two main approaches:

Primary prevention – where statins are given to essentially healthy people with no known cardiovascular disease (i.e. there is no evidence of arterial disease and no history of a heart attack and/or stroke)

Secondary prevention – where statins are given to people with known arterial disease and/or a history of heart attack and/or stroke

This distinction is important because individuals in the secondary prevention category are at generally high risk of further problems, and stand to benefit most from statin therapy. On the other hand, individuals in the primary prevention category are at generally low risk of cardiovascular disease issues (such as heart attack and stroke), and may therefore not benefit much from a strategy or treatment intended to prevent cardiovascular disease. This primary prevention category is particularly important when one considers that the vast majority of people taking statins are in this category, and if the pharmaceutical industry and some of its hired hands in the scientific and medical community have their way, increasing numbers of people will be taking statins in the future.

OK, back to the evidence…

There is indeed evidence that in secondary prevention, statins have the ability to save lives. One meta-analysis (pumping together or similar studies), for instance, found that in people with know heart disease, statin therapy reduced risk of death by 16 per cent [2].

But what about the more numerous primary prevent people? Do statins reduce risk of death in this population? That was the question asked by a study published this week in the Archives of Internal Medicine [3]. This study was a meta-anlaysis of 11 trials that included data on more than 65,000 people. An accompanying editorial [4] described this meta-analysis as “to date the cleanest and most complete meta-analysis of pharmacological lipid lowering for primary prevention.”

Cleanest, because the reviewed studies included primary prevention individuals only. The reason why this is important is highlighted by the authors in the following passage: “Limiting the analysis to patients without existing coronary disease is critical because studies that include both groups of patients may appear to show benefit for all patients, when all the benefit accrues to those with existing disease.”

This huge and relevant study showed that statin use is NOT associated with a reduced risk of mortality in the primary prevention setting.

The editorial also points out attention to the fact that in trials, individuals deemed to be at high risk of adverse effects, who take other medications and/or have other complicating illnesses are usually disallowed from taking part. However, this is not the case in the real world, where doctors commonly prescribe statins to more-or-less anyone with a raised cholesterol level (and increasingly, to people with normal cholesterol levels too). As a result, serious adverse effects may manifest that were not detected in the healthier trial subjects.

The editorial also highlights the fact that the trials are generally short (5-7 years), while use in the real world can go on for decades.

Some argue for statins on the basis that benefits are likely to accrue over time. But, this stance has no basis in science as, again, the editorial points out (we simply do not know one way or the other). The editorial authors also comment that the meta-anlaysis “…makes it clear that in the short term, for true primary prevention, the benefit, if any, is very small”.

I’m not against statins (though I would not take them myself). What I am against, however, is individuals given one-sided or misleading information about their risks and benefits. I’ve found in practice that once individuals are given a more complete picture about the effects of these drugs, the vast majority of people are happy not to take them.

References:

1. Hippisley-Cox J, et al. Unintended effects of statins in men and women in England and Wales: population based cohort study using the QResearch database BMJ 2010;340:c2197

2. Wilt TJ, et al. Effectiveness of statin therapy in adults with coronary heart disease. Arch Intern
Med 2004;164(13):1427-36

3. Ray KK, et al. Statins and all-cause mortality in high-risk primary prevention: a meta-analysis of 11 randomized controlled trials involving 65 229 participants. Arch Intern Med. 2010;170(12):1024-1031

4. Green LA. Cholesterol-Lowering Therapy for Primary Prevention – Still Much We Don’t Know. Arch Intern Med. 2010;170(12):1007-1008.

18 Responses to Do statins save lives in essentially healthy people? (No)

  1. Dr John Briffa 30 June 2010 at 3:37 pm #

    Jamie

    The first of these links to the study that is the focus of this blog post (reference 3 above).

    I have seen the second study you link to, and contemplated writing about this too. I may do so, but resolved that there’s only so much negative information about statins one can cope with at one time!

  2. Jamie 30 June 2010 at 11:39 pm #

    Ha! Right you are! Missed that when you original post appeared as mostly italics!

    I recently had a post-menopausal female patient present with generalised aches and pains, peripheral neuropathy, and malaise. She had been prescribed Crestor based on a high cholesterol reading and previous heart issues. On review her cholesterol, her total was high due to a very high HDL. Crestor withdrawn, problems gone. Her comment – she is feeling the best she has in a very long time!

  3. Dan 2 July 2010 at 2:02 am #

    Benefits of statins acrue over time??? What kind of voodoo to they base that claim on?

    I have type 2 diabetes and have been prescribed statins, though I refuse to take them. Some point to the CARDS study as proof that diabetics benefit from statins. It was terminated early because of the “great” results. The MI risk reduction was from 9% in the control group to 5.8% in the treatment group. (Not that impressive anyway.) There have been criticisms of this study, namely that the subjects had several risk factors. Longer term studies show less risk reduction, such as 11% to 9% or no statistically significant risk reduction. Discounting the criticisms of the CARDS study, this would suggest diminishig returns from statin therapy, not increasing benefit. I’ll take my chances without statins.

  4. Radiant Lux 2 July 2010 at 6:51 pm #

    “For women, for every 10,000 high risk individuals treated with statins, there would be approximately 271 fewer cases of cardiovascular disease, 8 fewer cases of oesophageal cancer; 23 extra patients with acute renal [kidney] failure, 307 extra patients with cataracts; 74 extra patients who experience liver dysfunction; and 39 extra patients with myopathy [muscle pain and/or weakness]. ”

    This is brilliant!
    10,000 high risk people
    279 people don’t get the illness it is prescibed for
    420 people get other illnesses
    9301 – spend money for nothing and risk serious side effects

    That doesn’t add up! This is laboratory results, so it doesn’t factor in all the people taking multiple drugs. Why is it so readily prescribed? This is the drug for people bad at mathematics.

  5. Liz Smith 2 July 2010 at 8:01 pm #

    A colleague whose husband had a heart attack, had never had any cholesterol problems ever. The medical profession insisted on him taking statins. I suggested that they read up on this medication and give it thought before taking it. I was quickly told that as I was not a doctor my opinion was not required.

    Sadly he’s now on the register for a kidney transplant with dyalasis being considered first. He never had anything of this nature before his heart attack. This has all happened in two years. He has other problems too, diabetes 2 has been mentioned.

  6. LSewell 2 July 2010 at 9:00 pm #

    Why is it that when ‘high cholesterol’ is measured it is often reported to patients in such an alarmist and non-specific manner? As other contributors have posted, there is a signicant difference between types of cholesterol and then there are triglycerides to factor in. How can we trust the medical profession if we are ‘mislead’ into believing there are ‘problems’ that may not be problems and if the blanket response is to throw a pill at a battery of results indiscriminately without proper investigation and consultation?
    Wouldn’t money be better spend in giving patients more time with doctors who will be expected to explain and justify BEFORE they prescribe?

  7. Odille Esmonde-Morgan 2 July 2010 at 9:25 pm #

    Great article. My mother suffered the myopathy with quite a bit of pain, and it even affected her eyes, she could not focus and the lids drooped. Yet still the doctors wanted to persist and force her to take them. I feel they also adversely affected her personality – where previously she was bright, inquisitive and outgoing, she now finds it a chore to get out of bed, cannot be bothered with her cryptic crosswords any longer, and is listless and disinterested and with a much reduced attention span.

    I really feel, very strongly, that the researchers use us, the general public, as their guinea pigs in many cases, and that we are given drugs where the long term effects cannot be known as not enough people have taken them. I eat very little processed food, preferring to prepare from fresh as I have some bad reactions to additives, and I am healthy and take no medications at all. I think lifestyle changes and much gretaer interference in the food gathering and treatment process, with resultant additives, must play some role in the upswing of many conditions and syndromes.

  8. Richard Feinman 4 July 2010 at 11:49 pm #

    This is a great summary of the issues although I would add that given how much statins are being pushed, we may not have needed a meta-analysis because there should not have been any studies at all that show no effect while there are actually several in the meta-analysis. I also think that it does matter whether reduction in cholesterol correlates with reduction in CVD because one is prescribed statins on the basis of cholesterol measurements. Nissen, et al. (NEJM 352: 29 (2005)) is a bizarre paper saying that reduction in atherosclerosis is related to LDL and presents a snow-job of undecipherable statistics but somewhere says that the correlation coefficients are about 0.14. You can go to Wikipedia and look under “correlation coefficients” to see how ridiculous this is.

  9. Mo 5 July 2010 at 12:33 pm #

    I blogged about this myself a while ago. It seems that statins may simply be analogs of vitamin D, which explains their anti-inflammatory effects: http://www.ncbi.nlm.nih.gov/pubmed/17398180

    I’ve been on sufficient doses of vitamin D for 3.5yrs now, and guess what? My good cholesterol rose, while other values receded as I reached an optimal level. The reason for this is simply because my liver does not need to produce as much cholesterol for conversion into D from sunlight because it’s entering orally. So it’s not reduction I’m experiencing, but natural inhibition.
    When people talk about cholesterol clogging arteries, they’re simply wrong. This is actually arterial calcification. The whole cholesterol hypothesis actually makes my blood boil.

  10. Dr Stephen Arvay 8 August 2010 at 5:03 am #

    An Appeal for Support and Conformation of MRI Results

    My daughter has lived with ALS-like symptoms for almost 3 years. The worst of the symptoms began when her simvastatin was increased to 80mg in 2008.
    Her MRIs show LESIONS in the brain stem, specifically in the PONS area of her brain.
    Of course, her 4 physicians refuse to believe that a statin is involved. They are all satisfied with the diagnosis of “Ataxia”.

    My daughter needs to know that she is not alone in her suffering. She needs to know that she is not the only one crippled, and that there may be hope for her condition.

    My Appeal is to all those who are/were on statins and have similar brain lesions as shown and documented in MRIs. Please reply here, or contact her father directly: Dr Stephen Arvay, stephenx11@cogeco.ca

  11. Susan Hopkinson 11 December 2010 at 6:03 am #

    I went to the Doctors and my blood pressure was high
    I am now on 5mgs of tablets to reduce this. Amlovasc.
    He also prescribed Satins – Simvastatin 20 mgs.
    Blood tests were taken at this time and was 6.5.
    Ten years ago blood tests were taken and also 6.5.
    My Doctor at this time did not prescibe any Satins at this time.
    Heart attack is in my family history but I am wary about taking satins – I am fit,but suffer from joint problems and prefer to take herbal tablets to reduce this with diet.
    Any comments please.

  12. wolf 20 January 2011 at 7:55 pm #

    Susan read this blog: http://heartscanblog.blogspot.com/

Trackbacks/Pingbacks

  1. Fast food to be served with a side-order of statins? No thanks | Dr Briffa's Blog - 13 August 2010

    [...] And to what end? Well, as we now know, while statins can reduce the risk of heart attack, they do not reduce overall risk of death for the vast majority of people who take them (individuals who are essentially healthy with no history of ‘cardiovascular disease’). For more on this, see here. [...]

  2. British Medical Journal highlights unhealthy links between doctors and the drug industry | Dr Briffa's Blog - 7 September 2010

    [...] Don’t forget too, that treating essentially healthy people with statins does not save lives. [...]

  3. Cholesterol researchers make up the rules as they go along | Dr Briffa's Blog - 7 October 2010

    [...] We hear repeatedly the assertion that cholesterol-reducing drugs known as statins can reduce the risk of cardiovascular disease and even death due to cardiovascular disease. However, in essentially healthy people (those without pre-existing cardiovascular disease), statins do not reduce overall mortality. [...]

  4. Researchers urge caution in prescribing statins to healthy people | Dr Briffa's Blog - 20 January 2011

    [...] of data from individuals in the primary prevention category published just last year [2] (reported here), no reduction in overall risk of death was found with statin [...]

  5. Medical journal editors brand statins as ‘without known benefit but with definite risk’ for most | Dr Briffa's Blog - A Good Look at Good Health - 30 September 2011

    [...] prevention only. To date, only one meta-analysis has done this [3]. I have written about this study here. The most notable result from this meta-analysis is that statins (in primary prevention) do not [...]

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