There was good news this week for Merck & Co’s blockbuster diabetes drug Januvia and indeed the whole class of DPP-4 inhibitors, after long-term clinical data backed the drug’s heart safety.
Merck said top-line results from the near 15,000-patient TESCOS CV study showed that Januvia (sitagliptin) was non-inferior to usual diabetes care on the time to a composite of confirmed cardiovascular events, thereby meeting its primary endpoint.
Also, among secondary targets, there was no increase in hospitalisation for heart failure in the Januvia group versus placebo, the firm noted.
Complete results of the trial are due to be presented on June 8 at the 75th Scientific Sessions of the American Diabetes Association, but the fact that the long-awaited top-line data show no increased CV risk will come as a huge relief to both the firm and the diabetes community.
The heart safety of DPP-4 inhibitors has been under close scrutiny of late, but recent data is promising; AstraZeneca’s offering Onglyza was deemed by US regulators to have an “acceptable” CV risk profile, while a review of outcomes data for Takeda's Nesina (alogliptin) also did not find a significantly increased risk of death.