Cholesterol-Busting Statins: Study Raises New Concerns

De Lorgeril and coauthors concluded that "the results of the JUPITER trial are clinically inconsistent and therefore should not change medical practice or clinical guidelines. The results of the JUPITER trial support concerns that commercially sponsored clinical trials are at risk of poor quality and bias."

Adding to the controversy, authors of another article in the same issue of Archives reported that a review of 11 large primary-prevention trials showed no effect of statin therapy on deaths in high-risk patients.

The JUPITER trial has stood alone in its finding of a significant benefit in patients with no evidence of coronary heart disease. The trial examined the effect of rosuvastatin in patients with normal or low cholesterol levels but elevated levels of CRP.

Investigators randomized 17,802 apparently healthy men and women to receive either the statin rosuvastatin or a placebo, and then they studied these groups to compare how many suffered heart attacks, strokes and other heart-related problems. The trial ended early when an interim analysis showed a 44 percent reduction in these events in the group taking the statins; with results this positive, the logic went, why continue the study?

But de Lorgeril and his coauthors cited the early termination as one of several methodologic problems with JUPITER. Although prespecified early stopping points are a well-accepted feature of clinical trials, the rules for stopping should be clearly described. That was not the case in the published description of the JUPITER protocol.

"Indeed, we still do not know which endpoint was used to define [the rules for stopping], or which level of benefits ... was required to justify early termination," de Lorgeril and coauthors wrote.

The authors also expressed concern that the trial ended early despite the fact that the data were not consistent with a large difference between the actual drug and the placebo.

On the basis of their review, de Lorgeril and coauthors concluded that "the time has come for a critical reappraisal of cholesterol-lowering and statin treatments for the prevention of CHD complications. The emphasis on pharmaceuticals for the prevention of CHD diverts individual and public health attention away from the proven efficacy of adopting a healthy lifestyle, including regular physical activity, not smoking, and a Mediterranean-style diet."

The meta-analysis reported in the same issue of the journal, led by Dr. Kausik Ray of the University of Cambridge in England, examined the findings of 11 randomized clinical trials involving a total of 65,229 patients to see if statins cut death rates among intermediate and high-risk people with no history of cardiovascular disease. In this study, too, the support for statin use was lacking.

In an editorial that accompanied the two articles, Dr. Lee Green of the University of Michigan in Ann Arbor said the de Lorgeril and Kay studies add fuel to a high-stakes debate.

"In the long term, although sincere advocates on both sides will try to convince us otherwise we really must admit that we do not know," Green wrote. "We need good research to find out, and, as de Lorgeril and colleagues point out, that search must be free of incentives to find any particular desired answer."

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