Sitagliptin noninferior to placebo in cardiovascular outcomes study

Merck announced that the primary endpoint of noninferiority for the composite cardiovascular endpoint had been met in a study that evaluated sitagliptin, an oral dipeptidyl peptidase-4 inhibitor.

The primary endpoint was the time to first confirmed cardiovascular event, which included a composite of cardiovascular-related death, nonfatal MI, nonfatal stroke or unstable angina requiring hospitalization.

The company also said hospitalization for heart failure was similar in patients who received sitagliptin and those who received placebo.

Results of the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) study are scheduled to be presented at the American Diabetes Association Scientific Sessions on June 8 in Boston.

The FDA already approved sitagliptin for adults with type 2 diabetes. The agency requires pharmaceutical companies to conduct postmarketing studies that examine heart failure.

The TECOS study included 14,724 patients from 38 countries who enrolled between Dec. 2008 and July 2012. All patients had type 2 diabetes, a history of cardiovascular disease and a hemoglobin A1c level between 6.5 percent and 8 percent.

Patients were randomized to receive one 50 mg or 100 mg tablet of sitagliptin once daily or a matching placebo. The mean follow-up was approximately three years.