Januvia Heart Failure

Edmonton, ABRecent Januvia (Sitagliptin) studies have shown that type 2 diabetes patients with pre-existing heart failure and sitagliptin use were not associated with an increased risk of all-cause hospitalizations or death. However, Januvia users were more likely to be hospitalized for heart failure.

Januvia (sitagliptin) is a class of drugs called dipeptidyl peptidase (DPP)-4 inhibitor made by Merck. While research and subsequent Januvia lawsuits have linked the diabetes drug to pancreatitis and pancreatic cancer (since 2006, cases of pancreatitis have been reported to the FDA), studies are now focusing on Januvia’s association with heart failure.

More evidence of Januvia heart failure was published in the Journal of American College of Cardiology (JACC). Daniala L. Weir, BSc, from the University of Alberta in Canada, and colleagues analyzed insurance claims from a database of more than 7,600 patients with diabetes and heart failure, and said that said their finding “is likely clinically relevant.” In an editorial accompanying the paper, Deepak Bhatt, Professor at Harvard Medical School, notes that Weir’s results “add to a small but growing body of evidence that suggests DPP-4 inhibitors as a class of drugs, and possibly diabetes drugs in general, may increase the risk of heart failure.” At the same time, he added that the “increase in absolute risk, if present at all, appears to be small,” according to Forbes (July 2).

Weir said the study might have an impact on the choice of add-on therapy for heart failure patients with diabetes, but more research is needed.

And more research is ongoing. Duke Clinical Research Institute and Oxford Diabetes Trials Unit have been conducting a Sitagliptin Cardiovascular Outcome Study (TECOS), sponsored by Merck, since 2008, and is due to be completed in December 2014. TECOS is a Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control on Mono- or Dual Combination Oral Antihyperglycemic Therapy.

On its website, Merck explains that the TECOS study is “a long-term, event-driven, non-inferiority, cardiovascular outcomes trial evaluating the impact of sitagliptin when added to usual diabetes care in a large, high-risk population across multiple countries and in typical clinical practice environments.”

The trial’s primary goal is to help establish whether the class of DPP-4 inhibitors, which includes Januvia, actually causes heart failure (HF). Its secondary goal is “Time to congestive HF.” Januvia patients with congestive heart failure may be filing Januvia HF claims in 2015…