Letters

Statins as the new aspirin

BMJ 2002; 324 doi: http://dx.doi.org/10.1136/bmj.324.7340.789 (Published 30 March 2002) Cite this as: BMJ 2002;324:789

Conclusions from the heart protection study were premature

  1. Uffe Ravnskov, independent researcher
  1. Magle Stora Kyrkogata 9, S-22350 Lund, Sweden uffe.ravnskov@swipnet.se
  2. West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital NHS Trust, Birmingham B18 7QH

    EDITOR—With reference to the news item by Kmietowicz, in their press release the directors of the heart protection study did not mention that their results were substantially worse than in the previous Scandinavian simvastatin survival study (4S) (table). 1 2 3

    Absolute risk reduction (%) in two trials of simvastatin

    View this table:

    The way the results were presented exaggerates the benefit for the individual patient. The most interesting figure is survival because most myocardial infarctions heal with minimal cardiac dysfunction, if any. Tell a patient that his chance not to die in five years without statin treatment is 85.4% and that simvastatin treatment can increase this to 87.1 %. With these figures in hand I doubt that anyone should accept a treatment whose long term effects are unknown. For example, it was claimed that the study presented uniquely reliable evidence that simvastatin is not carcinogenic. But the study went on for about five years only, just like other statin trials. It is not possible to say anything about the risk of cancer because it takes decades to disclose chemical carcinogenesis in human beings. Heavy smoking, for example, does not induce lung cancer in five years. All the statins and also the fibrates have proved carcinogenic in rodents, and it scares me that, if the new American guidelines for cholesterol treatment are followed strictly, half of mankind may take statins in a few years and for the rest of their lives.4

    Low cholesterol concentrations have been related to depression, cognitive impairment, and suppression of the immune system. Does a reduction of 1.7 % in mortality balance these risks? As in the previous trials, the effect of simvastatin was independent of the initial cholesterol concentration; patients with low concentrations benefited just as much (or just as little) as patients with high concentrations. The best results were seen in patients older than 75 years, an age group in which the lowest quartile of cholesterol concentration had the highest total and cardiovascular mortality.5

    That statin treatment works in patient and age groups in whom a high cholesterol concentration is not a risk factor for cardiovascular disease shows that the benefit is not the result of cholesterol lowering. High or low cholesterol concentrations are markers for other, more important disease factors; they are not causal factors themselves.

    References

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    National Institute for Clinical Excellence should assess statins

    1. Christopher Anton, administrative coordinator (christopher.anton{at}cityhospbham.wmids.nhs.uk)
    1. Magle Stora Kyrkogata 9, S-22350 Lund, Sweden uffe.ravnskov@swipnet.se
    2. West Midlands Centre for Adverse Drug Reaction Reporting, City Hospital NHS Trust, Birmingham B18 7QH

      EDITOR—Although the heart protection study is good news, it is premature to say that statins are the new aspirin.1 An aspirin tablet a day costs just over 1p whereas simvastatin costs £1.06 at the doses used, and it would cost the NHS almost £400m each year to treat 1 million people. Also, although the trial was large, it would only detect adverse reactions that occur more often than about one in 3000 patients and rare, serious reactions that may occur when a large population is exposed to the drug will have been undetectable.2

      Cerivastatin was voluntarily withdrawn by Bayer in 2000 after reports of 31 deaths from rhabdomyolysis in the United States. This disorder has also occurred with other statins. It sounds as if the National Institute for Clinical Excellence needs to weigh up the risks, benefits, and costs of using statins.

      References

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