Empagliflozin After Acute Myocardial Infarction
Clinical question: Does empagliflozin improve cardiovascular outcomes in patients who have had an acute myocardial infarction?
Background: Studies have shown that empagliflozin improves cardiovascular outcomes in patients with heart failure (HF), type 2 diabetes mellitus at high cardiovascular risk, and chronic kidney disease (CKD). The safety and efficacy of empagliflozin in improving outcomes in patients after acute myocardial infarction has not been determined.
Study design: Event-driven, double-blinded, randomized, placebo-controlled trial
Setting: 451 sites in 22 countries across North America, Latin America, Europe, and Asia
Synopsis: The EMPACT-MI trial enrolled patients hospitalized with acute myocardial infarction and either symptoms of HF or newly identified left ventricular ejection fraction below 45%. Inclusion required one additional heart failure risk factor. 3,260 patients were randomized to receive empagliflozin 10 mg daily and 3,262 to receive placebo. The primary endpoint was the composite of the first hospitalization for heart failure and death from any cause. Secondary endpoints included the total number of cardiac or noncardiac hospitalizations, and death from any cause.
The composite endpoint occurred in 8.2% of the empagliflozin group and 9.1% of the placebo group (hazard ratio, 0.90; 95% confidence interval, 0.76 to 1.06; P=0.21). The occurrence of secondary endpoints and serious adverse events did not differ between groups. Median follow-up was 17.9 months, and 6,328 patients (97%) were followed until the end of the trial. Limitations included a lack of analysis of outpatient HF events and the underrepresentation of racial and ethnic minorities. As in other recent trials, findings differ from patients with established HF, suggesting further study is warranted.
Bottom line: Treatment with empagliflozin in patients with increased risk of HF after acute myocardial infarction did not lead to a significantly lower risk of first hospitalization for heart failure or death compared to placebo.
Citation: Butler J, et al. Empagliflozin after acute myocardial infarction. N Engl J Med. 2024;390(16):1455-1466. doi: 10.1056/NEJMoa2314051.
Dr. Levin is an academic hospitalist in the section of hospital medicine at UPMC Presbyterian Hospital, and a clinical professor of medicine at the University of Pittsburgh School of Medicine, both in Pittsburgh.