Mortality findings from the EXAMINE Trial [abstract 1090-P]
- View All
The EXAMINE trial patients had elevated cardiovascular (CV) risk due to type 2 diabetes and a recent (15-90 days) acute coronary syndrome (ACS). We evaluated the risk of CV death in patients randomized to treatment with alogliptin or placebo and following major non-fatal CV events that occurred during the trial. In 5380 patients, overall rates of CV death were 4.1% for alogliptin and 4.9% for placebo (HR = 0.85, 95% CI, 0.66-1.10). Patients were followed until the first post-randomized non-fatal CV event of myocardial infarction (MI), stroke, hospitalized heart failure (HHF), and hospitalization for unstable angina (UA) and then to death or censoring. Time-updated multivariable Cox models were used to estimate the risk of death following each event. There were a total of 736 patients (13.7%) who experienced at least one first non-fatal CV event (5.9% MI, 1.1% stroke, 3.0% HHF, and 3.8% UA). CV death occurred subsequently in 8.2% of those experiencing an MI event, 20.1% of those experiencing a HHF event, 8.8% of those experiencing a stroke, and 3.4% of those experiencing UA, versus 3.7% (n = 172) of the 4644 patients without a non-fatal CV event. Compared with patients who did not experience a non-fatal event, the adjusted hazard ratio for death was 1.83 (95% CI, 1.29-2.59, p = 0.006) after MI, 3.91 (95% CI, 2.77-5.51, p < 0.0001) after HHF, 1.74 (95% CI, 0.77-3.94, p = 0.186) after stroke, and 0.81 (95% CI, 0.41-1.58, p = 0.527) after admission for UA. Mortality rates following a non-fatal event were comparable on alogliptin and placebo. In EXAMINE, the majority of deaths occurred in patients who did not experience a non-fatal CV event, although the risk of death was markedly higher following a non-fatal event, particularly HHF. These findings illustrate ongoing opportunities to reduce mortality in patients with type 2 diabetes and CV diseases.