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. These French authors performed a critical appraisal of the methods and results of this trial.
They found: "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."
The authors concluded: "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."
It was clearly a mistake to stop the JUPITER trial early.
For the full abstract, click here.
Arch Intern Med 170(12):1032-1036, 28 June 2010 © 2010 to the American Medical Association
Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy-A Critical Reappraisal. Michel de Lorgeril, Patricia Salen, John Abramson, et al. Correspondence to Dr. de Logeril: michel.delorgeril@ujf-grenoble.fr
Category: K. Circulatory, T. Endocrine/Metabolic/Nutritional. Keywords: rosuvastatin, primary prevention, cholesterol, mortality, myocardial infarction, stroke, re-analysis of randomized controlled trial, journal watch.
Synopsis edited by Dr Linda French, Toledo, Ohio. Posted on Global Family Doctor 20 July 2010
