BACKGROUND: Alogliptin, a dipeptidyl-peptidase 4 inhibitor, is approved for the treatment of patients with type 2 diabetes. EXAMINE was a randomized-controlled clinical trial designed to demonstrate the cardiovascular safety of alogliptin. In the trial, 5380 patients with established T2DM who had a recent ACS event (between 15-90 days) were randomized to treatment with either alogliptin or placebo. HYPOTHESIS: To better understand and describe the cardiovascular (CV) safety of alogliptin, we analyzed data from the EXAMINE randomized clinical trial to determine whether treatment with alogliptin affected recurrent and total CV events. METHODS: Poisson regression analysis was performed to compare the total number of occurrences of CV death, MI, stroke, unstable angina, and coronary revascularization between all patients randomized to alogliptin versus placebo groups. RESULTS: Patients with recurrent CV events were older and more likely to have renal disease and history of heart failure. There were 1100 first CV events and an additional 666 recurrent events over a median of 18 months of follow-up. There were no significant differences with regard to the total number of events in patients treated with alogliptin (n=873) or placebo (n=893; p=0.52). Furthermore, there were no differences in the types of events seen in patients treated with alogliptin or placebo. CONCLUSION: Alogliptin did not increase the risk of either first or recurrent CV events when compared to placebo in patients with type 2 diabetes and recent ACS. These data support the CV safety of alogliptin in patients who are at increased risk of future CV events.
CORE (COnnecting REpositories)
CORE (COnnecting REpositories)