TECOS, Merck’s Cardiovascular Safety Trial of Januvia (Sitagliptin), Met Primary Endpoint in Patients with Type 2 Diabetes

Merck (MSD) has announced the primary results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS), a placebo-controlled study of the cardiovascular (CV) safety of Merck’s DPP-4 inhibitor, Januvia (sitagliptin), added to usual care in more than 14,000 patients.

The study achieved its primary composite CV endpoint of non-inferiority (defined as the time to the first confirmed event of any of the following: CV-related death, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for unstable angina) compared to usual care without sitagliptin.

Overall, the primary endpoint occurred in 11.4% (n=839) of sitagliptin-treated patients compared with 11.6% (n=851) of placebo-treated patients in the Intention-to-Treat (ITT) analysis (HR=0.98; 95% CI [0.89-1.08]), and in 9.6% of patients (n=695) in both the sitagliptin and placebo groups in the Per Protocol (PP) analysis (HR=0.98; 95% CI [0.88-1.09]; p<0.001 for non-inferiority). In addition, there was no increase in hospitalization for heart failure and rates of all-cause mortality were similar in both treatment groups, which were two key secondary endpoints. These data were presented at the 75th Scientific Sessions of the American Diabetes Association and were also published in the New England Journal of Medicine.