The glucose-lowering drug sitagliptin did not result in any increase in the risk of cardiovascular events or heart failure, a large trial of nearly 15,000 patients with type 2 diabetes and cardiovascular disease has shown.
The three-year study – reported at the American Diabetes Association annual conference and published in NEJM – was designed specifically to test the cardiovascular safety of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor.
Investigators said the results showed sitagliptin posed no increased risk of cardiovascular complications in patients already at heightened cardiovascular disease (CVD) risk – although they added that further follow-up would be needed to check whether longer treatment would have any benefit or risks attached.
The trial randomly assigned patients to sitagliptin or placebo as part of their glucose-lowering regimen, aimed at achieving appropriate glycemic control.
During the three-year follow-up, there was no difference in the primary CVD endpoint – a composite of CVD death, nonfatal MI, nonfatal stroke, or hospitalisation for unstable angina – between the groups, at 11.4% in the sitagliptin group compared with 11.6% in the placebo group.
Rates of hospitalisation for heart failure were also statistically no different between the two groups.
The study investigators concluded: ‘Our study results showed that sitagliptin may be used in a diverse group of patients with type 2 diabetes who are at high cardiovascular risk without increasing rates of cardiovascular complications, but these results cannot exclude possible benefits or risks with longer durations of therapy or in patients with more complicated co-existing illnesses.’