Rosiglitazone and Outcomes for Patients with Diabetes and Coronary Artery Disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) Trial
Background—Rosiglitazone improves glycemic control for patients with type 2 diabetes, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease (CAD) remain unknown.
Methods and Results—To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes and CAD, we analyzed events among 2368 patients with type 2 diabetes and CAD in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction (MI), and stroke, and individual incidence of death, MI, stroke, congestive heart failure (CHF) and fractures, were compared during 4.5 yrs of follow-up among patients treated with rosiglitazone vs. patients not receiving a thiazolidinedione using Cox proportional hazards and Kaplan-Meier analyses including propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (HR 0.83; 95% CI, 0.58 to 1.18) while there was a lower adjusted incidence of composite death, MI, and stroke (hazard ratio (HR) 0.72; 95% confidence interval (CI), 0.55 to 0.93) and stroke (HR 0.36, 95% CI 0.16 to 0.86), and a higher incidence of fractures (HR 1.62, 95% CI 1.05 to 2.51); the incidence of MI (HR 0.77; 95% CI, 0.54 to 1.10) and CHF (HR 1.22, 95%CI, 0.84 to 1.82) were not significantly different. Among propensity matched patients rates of major ischemic cardiovascular events and CHF were not significantly different.
Conclusions—Among patients with type 2 diabetes and CAD in the BARI 2D trial, neither on-treatment nor propensity matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.
Clinical Trial Registration Information—http://www.clinicaltrials.gov. Identifier: NCT00006305.
- diabetes mellitus
- cardiovascular events
- drug therapy
- pharmaceutical safety
- Received December 18, 2012.
- Revision received June 3, 2013.
- Accepted June 14, 2013.