Rosiglitazone Seems to Heighten Cardiovascular Risk, Meta-Analysis Finds

Rosiglitazone (Avandia) may increase the risk for myocardial infarction and cardiovascular death among patients with type 2 diabetes, according to a meta-analysis released early by the New England Journal of Medicine.

Researchers analyzed data from roughly 28,000 patients participating in 42 randomized trials in which rosiglitazone was tested for at least 24 weeks against other drugs or placebo. Among the rosiglitazone users, the odds ratio for MI was a statistically significant 1.43. The OR for death from any cardiovascular cause was 1.64, but that result did not reach statistical significance.

Editorialists, describing the study's weaknesses — including its use of summary rather than patient-level data and the small number of events observed — write that "the authors properly emphasize the fragility of their findings." Nonetheless, they write that "in view of the potential cardiovascular risks and in the absence of evidence of other health advantages ... the rationale for prescribing rosiglitazone at this time is unclear."

The FDA has issued a safety alert, advising patients on the drug who have underlying heart disease to talk to their physicians. The manufacturer issued a statement saying it "strongly disagrees" with the article's conclusions.