"The original meta-analysis employed one statistical model, but there are other approaches that deserve consideration as well. At the conclusion of hearings, the panel recommended that Avandia carry new risk warnings but stopped short of calling for the drug to be removed from the market. 7.īoth physicians testified Monday, July 30, before a Food and Drug Administration advisory committee reviewing the data on rosiglitazone's safety. "Uncertain Effects of Rosiglitazone on the Risk of Myocardial Infarction and Cardiovascular Death" appeared online Aug. In an Annals of Internal Medicine article, cardiologists George Diamond, M.D., and Sanjay Kaul, MD, describe additional analyses that provide different perspectives on rosiglitazone's safety issues. The new analysis, conducted by researchers at Cedars-Sinai Medical Center, concludes "that only prospective clinical trials designed for the specific purpose of establishing the cardiovascular benefit or risk of rosiglitazone will resolve the controversy about its safety." Now, a re-analysis of the data used in the Nissen and Wolski analysis - using different statistical models - suggests that the earlier methodology may have resulted in inflated risk estimates. Steven Nissen and Kathy Wolski of 42 clinical trials involving 27,847 patients for whom rosiglitazone was prescribed. That article was based on a meta-analysis conducted by Dr. 8, 2007 - Rosiglitazone, a drug marketed by GlaxoSmithKline as Avandia® for the treatment of type 2 diabetes, came under fire after an article published online May 21 by the N ew England Journal of Medicine linked it to significantly increased risk of heart attack and cardiovascular death. Despite these limitations, patients and providers should consider the potential for serious adverse cardiovascular effects of treatment with rosiglitazone for type 2 diabetes.Ĭopyright 2007 Massachusetts Medical Society.Los Angeles - Aug. Our study was limited by a lack of access to original source data, which would have enabled time-to-event analysis. Rosiglitazone was associated with a significant increase in the risk of myocardial infarction and with an increase in the risk of death from cardiovascular causes that had borderline significance. In the rosiglitazone group, as compared with the control group, the odds ratio for myocardial infarction was 1.43 (95% confidence interval, 1.03 to 1.98 P=0.03), and the odds ratio for death from cardiovascular causes was 1.64 (95% CI, 0.98 to 2.74 P=0.06). In the 42 trials, the mean age of the subjects was approximately 56 years, and the mean baseline glycated hemoglobin level was approximately 8.2%. We tabulated all occurrences of myocardial infarction and death from cardiovascular causes.ĭata were combined by means of a fixed-effects model. Of 116 potentially relevant studies, 42 trials met the inclusion criteria. Criteria for inclusion in our meta-analysis included a study duration of more than 24 weeks, the use of a randomized control group not receiving rosiglitazone, and the availability of outcome data for myocardial infarction and death from cardiovascular causes. We conducted searches of the published literature, the Web site of the Food and Drug Administration, and a clinical-trials registry maintained by the drug manufacturer (GlaxoSmithKline). Rosiglitazone is widely used to treat patients with type 2 diabetes mellitus, but its effect on cardiovascular morbidity and mortality has not been determined.
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