Abstract
TECOS is a randomised, double-blind study, which involved 14,671 patients, where either sitagliptin or placebo were added to their existing therapy. Open-label use of antihyperglycaemic therapy was encouraged as required, aimed at reaching individually appropriate glycaemic targets in all patients.
The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalisation for unstable angina. During a median follow-up of 3.0 years, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years).
Sitagliptin was non-inferior to placebo for the primary composite cardiovascular outcome (HR 0.98; 95% CI 0.89-1.08; P < 0.001). Rates of hospitalisation for heart failure did not differ between the two groups (HR 1.0; 95% CI 0.83-1.20; P = 0.98).
There were no significant between-group differences in the rates of acute pancreatitis or pancreatic cancer. Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to their usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalisation for heart failure, or other adverse events.
Thanks to the TECOS study, sitagliptin has become an antidiabetic agent with significant data on both efficacy and safety. These two properties should be differentiated and evaluated separately.
The efficacy of sitagliptin has been demonstrated by a set of randomised, placebo-controlled Phase II and III studies. The TECOS study confirms its safety.
Gliptins are a big step forward in the treatment of diabetes with significant benefits. There are no obstacles to the inclusion of this group as the second choice after metformin.