Rosiglitazone and Cardiovascular Risk: More Data from the RECORD Trial

Rosiglitazone does not appear to increase the risk for overall cardiovascular morbidity or mortality, according to the final planned analysis from the RECORD trial, published online in Lancet.

In the open-label, industry-funded trial, some 4500 patients with inadequate glucose control while taking metformin or a sulfonylurea were randomized to receive either both drugs (controls) or add-on rosiglitazone. Among the findings, after 5.5 years' follow-up:

• The time to first cardiovascular hospitalization or cardiovascular death did not differ significantly between the groups.

• MIs occurred more often with rosiglitazone, but the difference was not significant.

• Rosiglitazone was associated with significantly increased risks for heart failure and fracture.

Journal Watch Cardiology Editor-in-Chief Dr. Harlan Krumholz offers his perspective: "Unfortunately this study will not resolve the questions about the safety of rosiglitazone because of limitations in its design and adds little to the previously published interim analysis."