The TECOS study – the effect of sitagliptin on cardiovascular events in patients with type 2 diabetes mellitus

Czech version

Authors: J. Špinar ^1,2; L. Špinarová ³; J. Vítovec ³
Authors‘ workplace: Interní kardiologická klinika LF MU a FN, Brno ¹; Mezinárodní centrum klinického výzkumu, FN u sv. Anny v Brně ²; I. interní kardioangiologická klinika LF MU a FN u sv. Anny v Brně ³
Published in: Kardiol Rev Int Med 2015, 17(3): 257-261
Category: Cardiology Review

Overview

Background:
Sitagliptin, a dipeptidyl peptidase 4 inhibitor, is currently used in the treatment of patients with type 2 diabetes, however data are lacking on its long-term effect on cardiovascular events.

Methods:
In this randomised, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycaemic therapy was encouraged as required, aimed at reaching individually appropriate glycaemic targets in all patients. To determine whether sitagliptin was non-inferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and/or hospitalisation for unstable angina.

Results:
During an average follow-up of 3.0 years there was only a small decrease in glycated haemoglobin levels of 0.29 percentage points. Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%) and 851 patients in the placebo group (11.6%). Sitagliptin was non-inferior to placebo for the primary composite cardiovascular outcome (HR 0.98; p < 0.001). The rates of hospitalisation for heart failure did not differ between the two groups (p = 0.98). There were no significant between-group differences in the rates of acute pancreatitis (p = 0.07) or pancreatic cancer (p = 0.32).

Conclusions:
Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to the usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalisation for heart failure, or other adverse events.

Keywords:
diabetes mellitus – sitagliptin – heart failure

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