The TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) trial, a randomized, double-blinded, placebo-controlled, international, multi-centric trial, evaluated the cardiovascular safety of sitagliptin and included patients from 38 countries.

The study population comprised patients with type 2 diabetes (T2D) having a history of cardiovascular disease (CVD). Here, participants received either sitagliptin or placebo along with their usual therapy – within the 3-year follow-up period, as an add-on to usual therapy. 

Non-inferiority analysis revealed that sitagliptin was non-inferior to placebo for the primary CV outcome – the composite of CV death, nonfatal myocardial infarction (MI), nonfatal stroke, or hospitalization for unstable angina. Meanwhile, both the treatment and the control groups had similar rates of hospitalization.

This landmark trial confirmed previous reports of CV safety of sitagliptin – as observed in randomized controlled trials and observational cohort studies in real life.

Source: Revue Medical de Liege. 2015 Oct;70(10):511-6.