Although a meta-analysis of statins suggests that healthy people over 50 take cholesterol-lowering drugs as a preventative measure, some researchers argue the benefits may not outweigh the risks
?| May 21, 2012?|
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Everyone over 50 should take statins to lower their cholesterol, an editorial argued last week in The Lancet. The piece based its recommendation on a meta-analysis of 27 clinical trials published in the same issue that concluded statins significantly reduce the risk of heart attacks and other cardiovascular events in healthy people without posing substantial risks. Subsequent articles heralding the meta-analysis's findings were published in the Guardian, Forbes and the U.K. Telegraph. But based on the numbers, many experts still aren't convinced that the drugs' benefits outweigh their risks.
There's no question that statins save lives when they are prescribed to people with cardiovascular disease. But whether the drugs should also be given to healthy people who do not have high cholesterol or other cardiovascular risk factors has been a long-standing and controversial question. One large clinical trial known as JUPITER reported in 2008 that rosuvastatin (Crestor) lowers the risk of heart attacks and other events by 44 percent in healthy subjects but experts have since raised questions about its methodology in part because the trial was stopped early, which might have created the effect of overestimating the drug's benefits. The current meta-analysis was designed to help put the issue to rest. "Our aim was to bring together all the available evidence," explains co-author Colin Baigent, an epidemiologist at the University of Oxford in England.
After pooling the results of 27 trials involving 165,149 people, the meta-analysis reported that people are 21 percent less likely to suffer a serious vascular event such as a heart attack, stroke or bypass surgery after their cholesterol drops by the amount that might be expected after taking statins for a year than are similar people who do not take the pills. But such outcomes are rare in healthy individuals anyway, so the risk reduction actually translated to a small clinical benefit?reducing the overall risk from 4.04 percent to 3.27 percent per year, a difference of 0.77 percent.
In other words, approximately 130 people need to take statins for a year to prevent just one unwanted health outcome, and 500 people have to take them to prevent a single death. "Once you get down to very low levels of risk, the benefits are very small," Baigent admits.
Experts also raise questions about the subjects included in the meta-analysis. Although the review was supposedly designed to assess the effects of statins in people at low risk of vascular disease, 60 percent of its participants in fact already had vascular disease. "Why combine people who have heart disease with people who don't? It's really misleading," says Kausik Ray, a cardiologist at Saint George's University of London. In 2010 Ray and his colleagues published a meta-analysis of 11 statin clinical trials involving 65,229 subjects without cardiovascular disease and concluded that statins do not reduce the risk of death in healthy people. (By including people who had vascular disease, the Lancet meta-analysis overestimated statins' benefits: a subgroup analysis reveals that among people who did not have vascular disease, statins only reduced the absolute risk of a cardiovascular event by 0.4 percent per year.)
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