[FONT=verdana, arial, helvetica, sans-serif]Cholesterol Lowering, Cardiovascular Diseases, and the Rosuvastatin-JUPITER Controversy[/FONT][FONT=verdana, arial, helvetica, sans-serif]A Critical Reappraisal [/FONT]
[FONT=verdana, arial, helvetica, sans-serif] Michel de Lorgeril, MD; Patricia Salen, BSc; John Abramson, MD; Sylvie Dodin, MD; Tomohito Hamazaki, PhD; Willy Kostucki, MD; Harumi Okuyama, PhD; Bruno Pavy, MD; Mikael Rabaeus, MD [/FONT]
[FONT=verdana, arial, helvetica, sans-serif] Arch Intern Med. 2010;170(12):1032-1036. [/FONT]
[FONT=verdana, arial, helvetica, sans-serif] 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. [/FONT]
[FONT=verdana, arial, helvetica, sans-serif]Methods Careful review of both results and methods used in the trial and comparison with expected data. [/FONT]
[FONT=verdana, arial, helvetica, sans-serif]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. [/FONT]
[FONT=verdana, arial, helvetica, sans-serif]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.[/FONT]
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