Avandia

The Food and Drug Administration (FDA) issued an alert on May 21, 2007 informing healthcare providers of a potential cardiovascular safety issue raised by a recent meta-analysis (Nissen, 2007). Nissen and Wolski reviewed 42 randomized, controlled studies (each >6 months duration) in patients with type 2 diabetes or impaired glucose tolerance. Each study included compared rosiglitazone (as monotherapy or in combination regimens that include a sulfonylurea, metformin, and/or insulin) to a control group (another diabetic agent or placebo). The meta-analysis tabulated the number of myocardial infarctions and cardiovascular deaths from each trial. Of the 42 studies, 38 reported at least 1 MI and 22 reported at least 1 CV related death. The meta-analysis evaluated 15,560 patients who received regimens that included rosiglitazone and 12,283 patients in the group without rosiglitazone. In comparing the rosiglitazone group to the control group, the odds ratio for myocardial infarction was 1.43 (95% CI 1.03 to 1.98; p=0.03). The odds ratio for death from cardiovascular disease was 1.64 (95% CI, 0.98 to 2.74; p=0.06). Rosiglitazone was associated with a significant risk of myocardial infarction in this pooled analysis. The clinical significance of these initial results is unclear and the data has not been reviewed by the FDA. The agency is currently assessing the information. Healthcare providers should be aware of these developments and await further information as more becomes available.