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

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* Corresponding author 1 PRETA TIMC-IMAG - Techniques de l-Ingénierie Médicale et de la Complexité - Informatique, Mathématiques et Applications Grenoble 2 HMS 3 Centre de Recherche 4 Department of Clinical Sciences 5 Cardiology Department 6 Open Research Center for Lipid Nutrition 7 Réadaptation Cardiovasculaire 8 Cardiology Department

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.

Autor: Michel De Lorgeril - Patricia Salen - John Abramson - Sylvie Dodin - Tomohito Hamazaki - Willy Kostucki - Harumi Okuyama - Bruno



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