- Amidst concerns about the effects of DPP-4 inhibitors, used to treat diabetes, Merck has reported that Januvia (sitagliptin) does not increase hospitalization related to heart failure.
- Previously, the FDA looked at reports of the impact of two other DPP-4 inhibitors (saxagliptin from AstraZeneca and alogliptin from Takeda) and also found no specific impact on cardiovascular (CVD) outcomes based on the study protocol.
- Despite those findings, there was a signal in the two studies showing a potentially increased risk for heart failure and all-cause mortality.
The results of the latest study from Merck are encouraging, especially considering the psychological impact that not knowing has had on the ability of physicians to prescribe DPP-4 inhibitors. These inhibitors are oral hypoglycemic meds that have been found to be very effective in facilitating blood-glucose control.
Concerns about the impact of DPP-4 inhibitors on CVD health have been ongoing, even as some researchers have also evaluated whether this class of drugs could actually improve heart health. CVD-related concerns are relevant on both fronts, considering the fact that adults with type 2 diabetes are two to four times more likely to have heart disease than people without diabetes.
The FDA has decided not to add new restrictions on use or marketing of DPP-4 inhibitors, a class of drugs that continues to grow. Currently, there are eight DPP-4 inhibitors approved for use, with more in development. But staff did recommended new heart failure warnings for AZ's Onglyza and Takeda's Nesina.