Two Studies Demonstrate Cardiac Risks of Rosiglitazone

But authors come to different conclusions on whether drug increases risk of mortality
By Rick Ansorge
HealthDay Reporter

MONDAY, June 28 (HealthDay News) -- New evidence suggests that rosiglitazone is associated with an increased risk of adverse cardiovascular outcomes, according to two studies published online June 28 in the Journal of the American Medical Association and the Archives of Internal Medicine. The studies were released online ahead of publication because of their relevance to an upcoming U.S. Food and Drug Administration meeting intended to review the safety of rosiglitazone.

In the Journal of the American Medical Association study, David J. Graham, M.D., of the FDA in Silver Spring, Md., and colleagues studied 227,571 Medicare beneficiaries who initiated treatment with rosiglitazone or pioglitazone. After an up to three-year follow-up, they found that rosiglitazone was associated with an increased risk of stroke, heart failure, and all-cause mortality, and an increased risk of the composite of acute myocardial infarction, stroke, heart failure, or all-cause mortality (adjusted hazard ratios, 1.27, 1.25, 1.14, and 1.18, respectively).

In the Archives of Internal Medicine study, Steven E. Nissen, M.D., and Kathy Wolski, of the Cleveland Clinic Foundation, conducted a meta-analysis of 56 randomized controlled trials of rosiglitazone of at least 24 weeks' duration that reported cardiovascular adverse events. Compared to control therapy, they found that rosiglitazone therapy significantly increased the risk of myocardial infarction (odds ratio, 1.28; P = .04) but not cardiovascular mortality (odds ratio, 1.03; P = .86).

"Accumulating concerns about rosiglitazone make it difficult to advance a cogent argument regarding why, exactly, a patient might want to receive the drug or why a physician would choose to prescribe it when there is an available and quite possibly safer alternative," states the author of an accompanying editorial in the Journal of the American Medical Association.

Nissen disclosed research support from AstraZeneca, Atherogenics, Eli Lilly, Novartis, Pfizer, Resverlogix, Takeda, Daiichi-Sankyo, and Sanofi-Aventis.

Abstract - Graham
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Abstract - Nissen/Wolski
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