Merck & Co. reports detailed results from Januvia cardiovascular outcomes study

Merck & Co. presented further results at the Scientific Sessions of the American Diabetes Association (ADA) from a cardiovascular (CV) outcomes study of the DPP-4 inhibitor Januvia (sitagliptin), which the company announced in April met its main goal of non-inferiority for the composite CV endpoint.

The TECOS trial randomised 14 735 patients with type 2 diabetes who had established CV disease in the coronary, cerebral or peripheral arteries to receive Januvia or placebo, both in addition to existing therapy. Merck noted median patient follow-up was three years, with a maximum follow-up of 5.7 years. The study's primary endpoint was the composite of time to the first of any of the following confirmed events: CV-related death, non-fatal myocardial infarction, non-fatal stroke or unstable angina requiring hospitalisation.

Results presented at the ADA meeting showed that the primary endpoint occurred in 11.4 percent of Januvia patients versus 11.6 percent in the placebo group. In addition, data indicated that there was no difference between Januvia and placebo for the secondary endpoint of hospitalisation for heart failure, which was reported in 3.1 percent of patients in both groups. Meanwhile, all-cause mortality was similar in both treatment groups, occurring in 7.5 percent of those who received Januvia and 7.3 percent in the placebo group.

"We can be reassured we can use this drug for glucose lowering without affecting the already high cardiovascular risk in people with type 2 diabetes," commented Rury Holman, the study's lead investigator. "For the heart failure concern raised by other agents in the class there is no difference (with placebo)," Holman added.

Earlier this year, an FDA advisory panel voted to recommend that the labels of AstraZeneca's Onglyza (saxagliptin) and Kombiglyze (saxagliptin/metformin), as well as Takeda's Nesina (alogliptin), include a warning regarding a potential risk of heart failure and death. Meanwhile, the panellists also voted that AstraZeneca and Takeda's DPP-4 inhibitors carry an acceptable heart safety profile.

Further results from TECOS demonstrated that there was no significant difference between Januvia and placebo in infections, cancer, kidney failure or severe hypoglycaemia. Although the number of cases of acute pancreatitis were higher with Januvia, at 23 patients versus 12 for placebo, the difference was not significant. "Numerically this is hardly a major risk, just something we need to keep an eye on," Holman remarked.

Januvia generated sales of about $4 billion in 2014, while Janumet, which combines sitagliptin with metformin, garnered revenue of $1.8 billion. For related analysis, see ViewPoints: Merck & Co.'s Januvia comes out ahead once again.

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