ADA: Sitagliptin Shows No Major Adverse CV Effects in T2DM, CVD
Findings among patients with type 2 diabetes and established cardiovascular disease
TUESDAY, June 9, 2015 (HealthDay News) -- For patients with diabetes and cardiovascular disease, the dipeptidyl peptidase 4 inhibitor sitagliptin does not appear to increase the risk of major adverse cardiovascular events, according to a study published online June 8 in the New England Journal of Medicine. The research was published to coincide with the annual meeting of the American Diabetes Association, held from June 5 to 9 in Boston.
Jennifer B. Green, M.D., from the Duke University School of Medicine in Durham, N.C., and colleagues randomized 14,671 patients with type 2 diabetes and cardiovascular disease to add sitagliptin or placebo to their existing therapy. A relative risk of 1.3 was used as the marginal upper boundary to determine whether sitagliptin was noninferior to placebo.
The researchers observed a small difference in glycated hemoglobin levels during a median follow-up of 3.0 years. The primary outcome (composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina) occurred in 11.4 percent of the sitagliptin group and 11.6 percent of the placebo group. For the primary outcome, sitagliptin was noninferior to placebo (hazard ratio, 0.98; 95 percent confidence interval, 0.88 to 1.09; P < 0.001).
"Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events," the authors write.
The study was funded by Merck Sharp & Dohme, the manufacturer of sitagliptin.