Anne Peters: The Year in Diabetes

Anne L. Peters, MD; Mark Harmel, MPH


December 10, 2013

In This Article

DPP-4 Inhibitors Clear FDA's Cardiovascular Hurdle

The message from the 2 big cardiovascular safety outcome trials, SAVOR[18] and EXAMINE,[19] is that the 2 new dipeptidyl peptidase 4 (DPP-4) inhibitors saxagliptin and alogliptin neither increased nor reduced the risk for the primary outcome of cardiovascular death, myocardial infarction, or ischemic stroke when compared with placebo.

These 2 very large trials involved participants from around the world. The SAVOR trial included more than 16,000 individuals and looked at saxagliptin vs placebo in patients who either had a history of or were at high risk for cardiovascular disease. The EXAMINE trial enrolled more than 5000 patients who were randomly assigned to receive either alogliptin or placebo. Patients in the EXAMINE trial were sicker than those in SAVOR; these patients had recently had a myocardial infarction or a hospitalization for unstable angina.

It would be nice if either DPP-4 inhibitor reduced the risk for cardiovascular events, but that was not the case. Furthermore, there was a slight increase in congestive heart failure requiring hospitalization in the patients on saxagliptin. This unexpected finding will need to be explored further. On the positive side, the DPP-4 inhibitors also did not increase the risk for pancreatitis or pancreatic cancer in these trials.

For more on the DPP-4 inhibitor trials, you can listen to extended comments in my recent Medscape video.


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