Rosaglitazone has recently made headlines, based on an analysis of 42 published and unpublished randomized trials showing that patients who received rosiglitazone were 43% more likely to have an MI than were patients who received either an active comparator drug or placebo during the course of 24–52 weeks of treatment (N. Engl. J. Med. 2007 [Epub doi:10.1056/NEJMoa072761]).
In a separate study of more than 33,000 patients with type 2 diabetes, researchers found that the incidence of hospitalizations for heart attack and/or for coronary revascularization for patients on rosiglitazone was the same as for patients on metformin or sulfonylurea (Pharmacoepidemiol. Drug Saf. 2007 [Epub doi: 10.1002/pds.1443]). The research involved an observational cohort study from a large U.S. managed care database and was commissioned by Glaxo-SmithKline. The study populations were matched to ensure that the cohort groups were similar in terms of their baseline risk factors for cardiovascular disease. Patients were followed for an average of slightly over a year.
In May, the Food and Drug Administration issued a safety alert regarding potential safety issues related to the drug. The agency noted that its “analyses of all available data are ongoing. FDA has not confirmed the clinical significance of the reported increased risk in the context of other studies.”