Article
Author: Jones, W Schuyler ; Zwiener, Isabella ; Mattheus, Michaela ; Gotcheva, Nina ; Udell, Jacob A ; Amir, Offer ; Sumin, Mikhail ; Anker, Stefan D ; Butler, Javed ; Schou, Morten ; Steg, P Gabriel ; Bayes-Genis, Antoni ; van der Meer, Peter ; Petrie, Mark C ; Jeong, Myung Ho ; Rossello, Xavier ; Brueckmann, Martina ; Chopra, Vijay K ; Vinereanu, Dragos ; Goodman, Shaun G ; Ge, Junbo ; Bahit, M Cecilia ; Goto, Shinya ; Hernandez, Adrian F ; Januzzi, James L ; Parkhomenko, Alexander ; Chen, Yundai ; Figtree, Gemma ; Jamal, Waheed ; Szachniewicz, Joanna ; Simic, Dragan ; Parikh, Puja B ; Bhatt, Deepak L ; Harrington, Josephine ; Lopatin, Yuri ; Zieroth, Shelley ; Ponikowski, Piotr ; Bauersachs, Johann ; Merkely, Béla ; Gasior, Tomasz ; Lopes, Renato D
BACKGROUND:Empagliflozin improves cardiovascular outcomes in patients with heart failure, patients with type 2 diabetes who are at high cardiovascular risk, and patients with chronic kidney disease. The safety and efficacy of empagliflozin in patients who have had acute myocardial infarction are unknown.
METHODS:In this event-driven, double-blind, randomized, placebo-controlled trial, we assigned, in a 1:1 ratio, patients who had been hospitalized for acute myocardial infarction and were at risk for heart failure to receive empagliflozin at a dose of 10 mg daily or placebo in addition to standard care within 14 days after admission. The primary end point was a composite of hospitalization for heart failure or death from any cause as assessed in a time-to-first-event analysis.
RESULTS:A total of 3260 patients were assigned to receive empagliflozin and 3262 to receive placebo. During a median follow-up of 17.9 months, a first hospitalization for heart failure or death from any cause occurred in 267 patients (8.2%) in the empagliflozin group and in 298 patients (9.1%) in the placebo group, with incidence rates of 5.9 and 6.6 events, respectively, per 100 patient-years (hazard ratio, 0.90; 95% confidence interval [CI], 0.76 to 1.06; P = 0.21). With respect to the individual components of the primary end point, a first hospitalization for heart failure occurred in 118 patients (3.6%) in the empagliflozin group and in 153 patients (4.7%) in the placebo group (hazard ratio, 0.77; 95% CI, 0.60 to 0.98), and death from any cause occurred in 169 (5.2%) and 178 (5.5%), respectively (hazard ratio, 0.96; 95% CI, 0.78 to 1.19). Adverse events were consistent with the known safety profile of empagliflozin and were similar in the two trial groups.
CONCLUSIONS:Among patients at increased risk for heart failure after acute myocardial infarction, treatment with empagliflozin did not lead to a significantly lower risk of a first hospitalization for heart failure or death from any cause than placebo. (Funded by Boehringer Ingelheim and Eli Lilly; EMPACT-MI ClinicalTrials.gov number, NCT04509674.).