RECORD trial CV outcomes rosiglitazone

RECORD Trial: Rosiglitazone evaluated for CV outcomes for type 2 diabetes

The RECORD trial was a prospective, randomized, open-label trial that assessed if addition of rosiglitazone to either metformin or sulfonylurea increase the rate of adverse CV outcomes as compared to the combination of metformin and sulfonylurea in patients with T2DM. 4,447 patients with T2DM, age 40-75 years, BMI >25.0 kg/m2, HbA1c >7.0% and ≤9.0% on maximum tolerated monotherapy of metformin, glyburide/glibenclamide, gliclazide or glimepiride were randomized to rosiglitazone vs no rosiglitazone. Although the primary outcome of CV hospitalization or mortality was no different in both groups, rosiglitazone was found to be significantly associated with heart failure (P=0.0003). The authors of the RECORD trial concluded that the addition of rosiglitazone to glucose-lowering therapy in people with T2DM is confirmed to increase the risk of HF and of some fractures, mainly in women. Although the data are inconclusive about any possible effect on MI, rosiglitazone does not increase the risk of overall CV morbidity or mortality compared with standard glucose-lowering drugs.