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

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.

• Authors: Michel de Lorgeril, Patricia Salen, John Abramson, Sylvie Dodin, Tomohito Hamazaki, Willy Kostucki, Harumi Okuyama, Bruno Pavy, Mikael Rabaeus
• Journal: Archives of internal medicine (Arch Intern Med) Vol. 170 Issue 12 Pg. 1032-6 (Jun 28 2010) ISSN: 1538-3679 [Electronic] United States
• PMID: 20585068 (Publication Type: Journal Article, Review)

Chemical References

• Anticholesteremic Agents
• Fluorobenzenes
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Pyrimidines
• Sulfonamides
• Rosuvastatin Calcium
• Cholesterol

Topics

• Anticholesteremic Agents (therapeutic use)
• Cardiovascular Diseases (blood, epidemiology, prevention & control)
• Cholesterol (blood)
• Drug Therapy, Combination
• Fluorobenzenes (therapeutic use)
• France (epidemiology)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Incidence
• Pyrimidines (therapeutic use)
• Randomized Controlled Trials as Topic
• Risk Factors
• Rosuvastatin Calcium
• Sulfonamides (therapeutic use)