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Clinical trial JUPITER results

Reanalysis of a landmark cholesterol-lowering trial of people typically considered at low risk for heart attacks indicated that the results are flawed — and do not support the primary-prevention benefits that made headlines, authors of the review asserted.

The reanalysis of the massive JUPITER trial involving almost 18, 000 people with low or normal cholesterol but elevated levels of the inflammatory biomarker C-reactive protein (CRP) — turned up no evidence of the “striking decrease in coronary heart disease complications” reported by the trial investigators. Instead, the reanalysis has called into question the involvement of drug companies in such clinical trials, according to an article in the June 28 issue of the Archives of Internal Medicine.

Moreover, Michel de Lorgeril, MD, of Joseph Fourier University and the National Center of Scientific Research in Grenoble, France, and co-authors argue that a major discrepancy exists between the JUPITER trial’s report of significant reductions in nonfatal stroke and myocardial infarction (MI) but a lack of effects on fatal stroke or MI. Moreover, cardiovascular mortality and the case-fatality rate for MI fell far below predicted rates.

“The JUPITER data set appears biased, ” de Lorgeril and co-authors concluded.

Paul Ridker, MD, of Harvard Medical School and Brigham and Women’s Hospital in Boston, a major proponent of high-sensitivity CRP (hsCRP) as a marker of coronary risk, dismissed de Lorgeril’s criticisms. Ridker initially reported the JUPITER results at the American Heart Association meeting in 2008.

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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