Jan. 28, 2011 – Doctors should think twice before prescribing statins – a cholesterol-lowering drug – to prevent a first cardiac event in people at low risk of heart disease.
This is the warning issued by the American magazine Cochrane1 – renowned for its scientific rigor and neutrality – in the light of an analysis of 14 studies on the effectiveness of this drug on 34,000 people.
Statins are a family of drugs commonly prescribed to lower blood cholesterol levels to reduce the risk of heart attacks, such as heart attacks.
If these studies conclude that there is a slight protective effect on the risk of death from all causes, this effect is essentially the result of “methodological errors that they include”, write the authors.
They identified certain elements that could bias the results of the studies analyzed:
- up to 10% of participants recruited for these studies had a history of heart disease or were at high risk of heart disease (eg, diabetes, high cholesterol, hypertension);
- more than half of the studies listed make no mention of the side effects that may result from taking the drug;
- the two studies with the most participants were stopped prematurely, leading to an overestimation of the results;
- all studies except one were sponsored by a pharmaceutical company.
Little data on side effects
“All of these errors undermine the validity of the results,” writes English researcher Carl Henegan in an editorial.2 accompanying the analysis of the 14 studies.
He also considers “unacceptable” that so many studies fail to report the adverse effects of statins on patients.
“It is becoming difficult to rely on these studies to weigh the benefits and dangers of these drugs for low-risk patients,” he adds.
The authors of the analysis of the 14 studies go even further. “In people at high risk (risk of death 20% or more over 10 years), the benefits outweigh the potential short-term damage, but the long-term side effects are unknown. “
According to them, this lack of information on long-term side effects is all the more worrying as statins are increasingly prescribed to adults under the age of 50 who are at high risk of heart disease.
Finally, the researchers say they are worried about the participation of the pharmaceutical industry in the financing and development of clinical trials on the effect of statins.
“It is well established that industry-sponsored studies are more likely to report results that prefer the drug over placebo,” they conclude.
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What does it mean to be “low risk”? A person is considered to be at low risk when, over a 10-year perspective, the risk of dying from any cause is less than 10% and the risk of having a heart event (fatal or not) is less than 20%. |
Martin LaSalle – PasseportSanté.net
1. Taylor F, Ward K, Moore THM, et al, Statins for the primary prevention of cardiovascular disease, Cochrane Database of Systematic Reviews, January 19, 2011, CD004816, DOI: 10.1002 / 14651858.CD004816.pub4.
2. Heneghan C, Considerable uncertainty remains in the evidence for primary prevention of cardiovascular disease (editorial), The Cochrane Library, January 19, 2011.
