Gliptin Safety a 'Good Thing'

In New Trials, Saxagliptin and Alogliptin Clear FDA Hurdle on Cardiovascular Safety

Anne L. Peters, MD, CDE

September 13, 2013

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Hi. I am Dr. Anne Peters from the University of Southern California, and today I am going to talk about the SAVOR^[1] and EXAMINE^[2] trials. These are big cardiovascular outcome studies examining whether DPP-4 (dipeptidyl peptidase 4) inhibitors are safe in terms of cardiovascular events 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 cardiovascular disease or were at high risk for cardiovascular disease. The EXAMINE trial enrolled more than 5000 patients who were randomly assigned to either alogliptin or placebo. Patients in the EXAMINE trial were sicker than those in SAVOR; they were patients who recently had a myocardial infarction or a hospitalization for unstable angina.

Now let me start with the headline. In terms of the primary outcome, which is cardiovascular death, myocardial infarction, or ischemic stroke, neither DPP-4 inhibitor increased the risk for any of those events; they were neutral and neither increased nor decreased the risk for these cardiovascular events, which is a good thing. It would be nice if they reduced the risk for cardiovascular events, but that was not the case.

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