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Arch Intern Med. 2010 Jun 28;170(12):1032-6. doi: 10.1001/archinternmed.2010.184.

Cholesterol lowering, cardiovascular diseases, and the rosuvastatin-JUPITER controversy: a critical reappraisal.

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  • 1Laboratoire Coeur and Nutrition, Faculty of Medicine, Universit√© Joseph Fourier and Centre National de Recherche Scientifique, Grenoble, France. michel.delorgeril@ujf-grenoble.fr

Abstract

BACKGROUND:

Among the recently reported cholesterol-lowering drug trials, the JUPITER (Justification for the Use of Statins in Primary Prevention) trial is unique: it reports a substantial decrease in the risk of cardiovascular diseases among patients without coronary heart disease and with normal or low cholesterol levels.

METHODS:

Careful review of both results and methods used in the trial and comparison with expected data.

RESULTS:

The trial was flawed. It was discontinued (according to prespecified rules) after fewer than 2 years of follow-up, with no differences between the 2 groups on the most objective criteria. Clinical data showed a major discrepancy between significant reduction of nonfatal stroke and myocardial infarction but no effect on mortality from stroke and myocardial infarction. Cardiovascular mortality was surprisingly low compared with total mortality-between 5% and 18%-whereas the expected rate would have been close to 40%. Finally, there was a very low case-fatality rate of myocardial infarction, far from the expected number of close to 50%. The possibility that bias entered the trial is particularly concerning because of the strong commercial interest in the study.

CONCLUSION:

The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.

PMID:
20585068
[PubMed - indexed for MEDLINE]
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