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Original Investigation
June 28, 2010

Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy: A Critical Reappraisal

Author Affiliations

Author Affiliations: Laboratoire Cœur and Nutrition, Faculty of Medicine, Université Joseph Fourier and Centre National de la Recherche Scientifique, Grenoble, France (Dr de Lorgeril and Ms Salen); Harvard Medical School, Boston, Massachusetts (Dr Abramson); Department of Obstetrics and Gynaecology, Laval University, Quebec City, Quebec, Canada (Dr Dodin); Department of Clinical Sciences, Institute of Natural Medicine, University of Toyama, Japan (Dr Hamazaki); Cardiology Department, Clinique Antoine Depage, Brussels, Belgium (Dr Kostucki); Open Research Center for Lipid Nutrition, Kinjo Gakuin University, Nagoya, Japan (Dr Okuyama); Réadaptation Cardiovasculaire, Centre Hospitalier de Machecoul, Machecoul, France (Dr Pavy); and Cardiology Department, Clinique de Genolier, Genolier, Switzerland (Dr Rabaeus).

Arch Intern Med. 2010;170(12):1032-1036. doi:10.1001/archinternmed.2010.184

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.