Empagliflozin, a medication used to manage and treat type 2 diabetes, is known to improve cardiovascular outcomes in patients with heart failure, chronic kidney disease, or type 2 diabetes with high cardiovascular risk. Published in the New England Journal of Medicine and simultaneously presented at the American College of Cardiology’s Annual Scientific Session in April 2024, the EMPACT-MI trial sought to examine if empagliflozin is safe and effective in patients who have had an acute myocardial infarction, commonly known as a heart attack.
EMPACT-MI randomized a total of 6,522 patients from 451 sites in 22 countries (including 327 patients from 27 sites in Canada) in a 1:1 ratio to receive either empagliflozin or placebo. Patients participating in the study were 18 years of age or older, were recently hospitalized for an acute myocardial infarction, and were at risk for heart failure. They received either a 10 mg daily dose of empagliflozin or a placebo along with standard care within 14 days of being admitted to the hospital. The study’s primary endpoint was a composite of hospitalization for heart failure or death from any cause.
Study results showed that, when compared to placebo, empagliflozin did not significantly lower the risk of a first hospitalization for heart failure or death from any cause in this patient population. Although the study did not meet its primary endpoint, two simultaneous secondary analyses suggest that empagliflozin could be beneficial in a more targeted group of patients. Published in Circulation and the Journal of the American College of Cardiology, these two exploratory analyses demonstrated that in patients with acute myocardial infarction who have left ventricular dysfunction or congestion, empagliflozin reduced the risk of both first and reoccurring heart failure events and hospitalizations.
“While it’s always disappointing to not achieve the primary outcome of a trial, EMPACT-MI nicely addressed a missing piece in the puzzle and now we have a clear answer regarding the role of SGLT2 inhibition in secondary prevention after a recent myocardial infarction,” said Dr. Shaun Goodman, CVC Co-Director. “Patients with heart failure, Type 2 diabetes, and chronic kidney disease should be strongly considered for SGLT2 inhibitor treatment, and I believe that EMPACT-MI shows us that this approach early after a heart attack is safe and can potentially prevent heart failure hospitalizations, even though we did not see an impact in this trial on mortality.”
In addition to being co-authors of the EMPACT-MI study publications, Dr. Goodman also served as a Canadian National Coordinator for the study together with Dr. Shelley Zieroth (University of Manitoba), and Dr. Jacob Udell was a member of the Executive Committee and the overall trial Coordinating Investigator. The CVC’s clinical operations team (including Jodi Parrotta, Kaitlynn Braulio, Kalli Belseck, and Tracy Temple,) skillfully managed the Canadian contributions to this study, and were ably supported by our monitoring team.
