Merck announced the primary results of a large heart safety study (TECOS) -- a placebo-controlled study of the cardiovascular safety of its DPP-4 inhibitor, Januvia, added to usual care in more than 14,000 patients. The study demonstrated that adding Januvia to usual care did not increase major heart problems any more than adding a placebo.
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, according to a press release. 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 today at the 75th Scientific Sessions of the American Diabetes Association and were also published in the New England Journal of Medicine.
JANUVIA is indicated, as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Read the full release