Trial offers 'reassuring' evidence of low Sitagliptin complications

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An analysis of a randomized clinical trial found patients with cardiovascular disease and type 2 diabetes who received sitagliptin had similar rates of heart failure or other cardiovascular complications compared with a placebo group.

Results of the TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) trial were presented on Aug. 31 in London at the European Society of Cardiology Congress.

The FDA approved sitagliptin (Januvia, Merck) in 2006 as an adjunct to diet and exercise for patients with type 2 diabetes. The drug is a dipeptidyl peptidase-4 (DPP-4) inhibitor taken orally once daily.

Previous studies had found DPP-4 inhibitors were associated with an increased risk of heart failure.

In TECOS, 14,671 patients with type 2 diabetes and cardiovascular disease were randomized to receive sitagliptin or placebo. Earlier this year, Merck announced the sitagliptin and placebo groups had similar rates of the composite of cardiovascular death, non-fatal MI, non-fatal stroke or hospitalization for angina. After adjusting for baseline heart failure status, the hospitalization rates for heart failure were similar between the two groups.

Unadjusted results and multivariable announced at the European Society of Cardiology Congress on Aug. 31 confirmed the previous findings that there was no difference in heart failure or cardiovascular complications.

“Through extensive complementary analyses, we observed the same reassuring signal of heart failure safety of sitagliptin when analyzing all heart failure events (first and recurrent); when analyzing heart failure in composite analyses with CV and all-cause death; and across extensive subgroup analyses of 22 factors-importantly including presence or absence of heart failure at baseline,” Darren McGuire, MD, a study author from the University of Texas Southwestern Medical Center in Dallas, said in a news release.