Cardiovascular issues with Merck & Co’s DPP-4 inhibitor Januvia (sitagliptin) can now by ‘put to bed’, according to investigators in a major safety study of the diabetes drug.
The TECOS trial, which involved over 14,500 patients and ran for three years, found that type 2 diabetes patients with established cardiovascular diseases were not at greater risk of major adverse CV events.
It also found no increase in hospitalisation for heart failure in Januvia patients, similar rates of all-cause mortality and non-inferiority for the primary composite CV endpoint of non-inferiority.
This was defined as the time to the first confirmed CV-related death, nonfatal myocardial infarction, nonfatal stroke or hospitalisation for angina, one of which occurred in 11.4% of Januvia patients and 11.6% of those on placebo.
Investigators also found that pancreatic cancer and pancreatitis were rare and even lower in the Januvia group, thought the difference was not statically significant.
Professor Rury Holman from Oxford University and joint chair of the study, said: “TECOS provides reassurance that sitagliptin may be used safely to improve blood glucose levels in a diverse group of type 2 diabetes patients at high cardiovascular risk without impacting on rates of cardiovascular complications or heart failure.”
Full results from the ‘Trial Evaluating Cardiovascular Outcomes with Sitagliptin’ (TECOS) were published in the New England Journal of Medicine.
The study was also presented yesterday at the American Diabetes Association’s Scientific Session in Boston, shortly after a presentation of the ELIXA safety trial of Sanofi’s Lyxumia (lixisenatide).
The CV safety of diabetes drugs, and DPP-4 inhibitors like Januvia, has been put under close scrutiny after signals of a possible negative impact on cardiovascular health were observed in several studies.
Earlier this year FDA advisers recommended two DPP-4 inhibitors, AstraZeneca’s Onglyza (saxagliptin) and Takeda’s Nesina (alogliptin), should have their labelling updated to indicate a link to heart failure.
Just last month another class of diabetes treatments came under pressure. The FDA warned that SGLT2 inhibitors – which include Invokana (canagliflozin) from Johnson & Johnson and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) – could be linked to high levels of blood acids that could require hospitalisation.