Empagliflozin in acute myocardial infarction in patients with and without type 2 diabetes: A pre‐specified analysis of the EMPACT‐MI trial

Abstract

AimsIn the EMPACT‐MI trial, empagliflozin reduced heart failure (HF) hospitalizations but not mortality in acute myocardial infarction (MI). Contemporary reports of clinical event rates with and without type 2 diabetes mellitus (T2DM) in acute MI trials are sparse. The treatment effect of empagliflozin in those with and without T2DM in acute MI is unknown.Methods and resultsA total of 6522 patients with acute MI with newly reduced left ventricular ejection fraction (LVEF) to <45%, congestion, or both, were randomized to empagliflozin 10 mg or placebo. The primary endpoint was time to first HF hospitalization or all‐cause death. Rates of endpoints with and without T2DM and the efficacy and safety of empagliflozin according to T2DM status were assessed. Overall, 32% had T2DM; 14% had pre‐diabetes; 16% were normoglycaemic; 38% had unknown glycaemic status. Patients with T2DM, compared to those without T2DM, were at higher risk of time to first HF hospitalization or all‐cause death (hazard ratio [HR] 1.44; 95% confidence interval [CI] 1.06–1.95) and all‐cause death (HR 1.70; 95% CI 1.13–2.56). T2DM did not confer a higher risk of first HF hospitalization (HR 1.22, 95% CI 0.82–1.83). Empagliflozin reduced first and total HF hospitalizations, but not all‐cause mortality, regardless of presence or absence of T2DM. The safety profile of empagliflozin was the same with and without T2DM.ConclusionPatients with acute MI, LVEF <45% and/or congestion who had T2DM were at a higher risk of mortality than those without T2DM. Empagliflozin reduced first and total HF hospitalizations regardless of the presence or absence of T2DM.