Last year, an FDA advisory panel called for an updated label for saxagliptin, but the agency is still gathering information.
An analysis of claims data found no association between the use of DPP-4 inhibitors and hospitalization for heart failure, according to a study published this week in Diabetes Care.
The study adds to the confusion over saxagliptin, marketed as Onglyza, which in 2014 was the subject of an FDA drug safety communication. Last April, an advisory panel recommended a label change, and the full FDA is still gathering information.
Dipeptidyl peptidase-4 (DPP-4) inhibitors are among the newer class of medications for type 2 diabetes that require post-marketing studies to rule out harmful cardiovascular effects. Saxagliptin received a drug safety warning after early results showed it might result in a higher likelihood of hospitalization for heart failure, while its chief competitor, sitagliptin, marketed by Merck as Januvia, thus far has not shown such effect.
The study in Diabetes Care is not a randomized clinical trial but an observational study of claims data, both commercial and Medicare. Researchers looked at claims from August 1, 2010, to August 30, 2013, comparing patients taking DPP-4 inhibitors to sulfonylureas in 218,556 patients, and then comparing the 2 main DPP-4 inhibitors—saxagliptin and sitagliptin—head-to-head in 112,888 patients.
The primary outcome was hospitalization for heart failure, with a secondary outcome of acute myocardial infarction, hospitalization for stroke, unstable angina, coronary revascularization or a composite of the outcomes.
In comparing the 2 DPP-4 inhibitors, among patients with baseline cardiovascular disease (CVD) there was no statistical difference in hospitalization rates. And in patients without baseline CVD, there was a significantly lower hospitalization hazard for patients treated with DPP-4 inhibitors compared with sulfonylureas. Those treated with DPP-4 inhibitors had lower hazards of the secondary outcomes as well than those treated with sulfonylureas.
Stephen S. Johnston, corresponding author of the study, reports ties to AstraZeneca, the manufacturer of saxagliptin.
Fu AZ, Johnston SS, Ghannam A, et al. Association between hospitalization for heart failure and dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes: an observational study. Diabetes Care [published online January 6, 2016]. 2016; doi:10.2337/dc13-0764.