Author + information
Background: The EXAMINE trial was conducted to evaluate the CV safety of alogliptin in patients with type 2 diabetes and a recent acute coronary syndrome (ACS). It is known that the 6 months following an ACS is a particularly high risk period for CV and hospitalized heart failure (HHF) events. We sought to study the safety of alogliptin in this high risk period.
Methods: The trial randomized 5380 patients who had had an ACS within 15-90 days of randomization (median, 45 days) to alogliptin or placebo; median follow-up was 18 months. We compared alogliptin and placebo on the risk of CV (CV death, non-fatal myocardial infarction, and non-fatal stroke) and HF (CVD or HHF) events in the high risk period (0 to ≤ 6 months) and used a landmark analysis > 6 months.
Results: Of the total 672 CV events, 42% (283) occurred within the first 6 months. Furthermore, 40% of CV death (97/242), 44% of CV death or HHF (191/426), and 47% of HHF (103/217) occurred within the first 6 months. CV outcomes were comparable on alogliptin vs placebo (HR 0.96 95% CI 0.76, 1.21; Figure 1a) in the early high risk period. Similar results were seen with a composite that included CVD and HHF (Figure 1b).
Conclusions: For patients with type 2 diabetes who have had a recent ACS, a substantial number of secondary CV and HF events occur within the first 6 months. Alogliptin does not increase the risk of CV or HF events in this high risk period, confirming its safety in these patients.
Poster Hall, Hall C
Saturday, March 18, 2017, 9:45 a.m.-10:30 a.m.
Session Title: Cardiac Arrest, Diabetes, and Other High Risk Features of Patients With Acute Coronary Syndrome
Abstract Category: 2. Acute and Stable Ischemic Heart Disease: Clinical
Presentation Number: 1204-340
- 2017 American College of Cardiology Foundation