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The results for a trial of a DPP-4 inhibitor are out, and the cardiovascular primary endpoints for the drug, sitagliptin (Januvia), were met.
And for secondary endpoints of the diabetes drug, there was no increase in hospitalization for heart failure when compared with placebo, according to the drugmaker Merck, which announced the results late on Monday. The complete results of the Trial Evaluating Cardiovascular Outcomes with Sitagliptin (TECOS) will be presented in early June at the annual meeting of the American Diabetes Association, the company .
The post-marketing trial included nearly 15,000 adults with type 2 diabetes and a history of cardiovascular disease from 38 different countries, with an average follow-up time of about 3 years. It was was designed to determine if treatment with sitagliptin was safe for cardiovascular outcomes when used as a long-term treatment in tandem with the dieting and exercise of usual diabetes care.
The primary endpoint was the composite of first time to cardiovascular-related death, nonfatal myocardial infarction, nonfatal stroke, or unstable angina requiring hospitalization.
In the post-marketing trial of another DPP-4 inhibitor, saxagliptin (Onglyza), researchers saw an increase in heart failure and all-cause mortality, prompting an FDA advisory committee to vote for new labeling of the drug 2 weeks ago. And in the EXAMINE trial, for another rival, alogliptin (Nesina), there was a trend towards an increase in heart failure.
Sitagliptin is not for the treatment of type 1 diabetes and it hasn't been studied in patients with pancreatitis, said Merck in the release. Three years ago, the FDA upbraided Merck for failing to do promised animal studies of pancreatitis risk associated with the drug.
"There have been postmarketing reports of acute pancreatitis, including fatal and nonfatal hemorrhagic or necrotizing pancreatitis, in patients taking Januvia," they wrote in their press release.
A study based on insurance claims, published last year, found that the use of sitagliptin was associated with a greater risk of hospitalization for heart failure in patients with previous heart failure and diabetes.