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Randomized Controlled Trial
. 2022 Nov 1;43(41):4421-4432.
doi: 10.1093/eurheartj/ehac494.

Empagliflozin in acute myocardial infarction: the EMMY trial

Dirk von Lewinski  1 , Ewald Kolesnik  1 , Norbert J Tripolt  2   3 , Peter N Pferschy  2   3 , Martin Benedikt  1 , Markus Wallner  1 , Hannes Alber  4 , Rudolf Berger  5 , Michael Lichtenauer  6 , Christoph H Saely  7 , Deddo Moertl  8   9 , Pia Auersperg  8   9 , Christian Reiter  10 , Thomas Rieder  11 , Jolanta M Siller-Matula  12 , Gloria M Gager  12 , Matthias Hasun  13 , Franz Weidinger  13 , Thomas R Pieber  2 , Peter M Zechner  14 , Markus Herrmann  15 , Andreas Zirlik  1 , Rury R Holman  16 , Abderrahim Oulhaj  17   18 , Harald Sourij  2   3
Affiliations
Randomized Controlled Trial

Empagliflozin in acute myocardial infarction: the EMMY trial

Dirk von Lewinski et al. Eur Heart J. .

Abstract

Aims: Sodium-glucose co-transporter 2 inhibition reduces the risk of hospitalization for heart failure and for death in patients with symptomatic heart failure. However, trials investigating the effects of this drug class in patients following acute myocardial infarction are lacking.

Methods and results: In this academic, multicentre, double-blind trial, patients (n = 476) with acute myocardial infarction accompanied by a large creatine kinase elevation (>800 IU/L) were randomly assigned to empagliflozin 10 mg or matching placebo once daily within 72 h of percutaneous coronary intervention. The primary outcome was the N-terminal pro-hormone of brain natriuretic peptide (NT-proBNP) change over 26 weeks. Secondary outcomes included changes in echocardiographic parameters. Baseline median (interquartile range) NT-proBNP was 1294 (757-2246) pg/mL. NT-proBNP reduction was significantly greater in the empagliflozin group, compared with placebo, being 15% lower [95% confidence interval (CI) -4.4% to -23.6%] after adjusting for baseline NT-proBNP, sex, and diabetes status (P = 0.026). Absolute left-ventricular ejection fraction improvement was significantly greater (1.5%, 95% CI 0.2-2.9%, P = 0.029), mean E/e' reduction was 6.8% (95% CI 1.3-11.3%, P = 0.015) greater, and left-ventricular end-systolic and end-diastolic volumes were lower by 7.5 mL (95% CI 3.4-11.5 mL, P = 0.0003) and 9.7 mL (95% CI 3.7-15.7 mL, P = 0.0015), respectively, in the empagliflozin group, compared with placebo. Seven patients were hospitalized for heart failure (three in the empagliflozin group). Other predefined serious adverse events were rare and did not differ significantly between groups.

Conclusion: In patients with a recent myocardial infarction, empagliflozin was associated with a significantly greater NT-proBNP reduction over 26 weeks, accompanied by a significant improvement in echocardiographic functional and structural parameters.

Clinicaltrials.gov registration: NCT03087773.

Keywords: Clinical trial; Empagliflozin; Heart failure; Myocardial infarction; NT-proBNP; Randomised controlled trial.

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Conflict of interest statement

Conflict of interest: H.S. is on the advisory board and speakers bureau of by Boehringer Ingelheim, NovoNordisk, Sanofi-Aventis, Amgen, AstraZeneca, Bayer, Eli Lilly, Kapsch, MSD, and Daiichi Sankyo. D.V.L. is on the advisory board and speakers’ bureau of Abiomed, AstraZeneca, Bayer, Daiichi Sankyo, Orion, Sanofi, and Servier and receives consulting fees from Recardio Inc, Bayer, TLL, Vaxxinity Inc. P.M.Z. received speaker fees from AstraZeneca, Pfizer, Medtronic, and Boehringer Ingelheim. R.R.H. reports research support from AstraZeneca, Bayer and Merck Sharp & Dohme, and personal fees from Anji Pharmaceuticals, AstraZeneca, Novartis, and Novo Nordisk. M.W. receives speaker fees from Bayer, Novartis and consulting fees from Radcliff Cardiology. A.Z. receives fees from Boehringer Ingelheim, AstraZeneca, NovoNordisk, Bayer, Daiichi Sankyo, Amgen, and Sanofi. C.R. receives payment or Honoria for lectures from Boehringer Ingelheim, Pfizer, and AstraZeneca and support for attending meetings from Boehringer Ingelheim and Pfizer. T.R.P. receives consulting fees and payment of honoraria for lectures from Arecor and Novo Nordisk and grants from Arecor, Sanofi, and Novo Nordisk. H.A. receives Honoria for lectures from Boehringer Ingelheim and AstraZeneca and financial support for attending meetings and transport from Boehringer Ingelheim and AstraZeneca. P.A. reports speakers’ fee from Bayer and Pfizer. J.M.S.M. received speaker or consultant fees from Chiesi, Boehringer Ingelheim, Biosensors, P&F, Gruenenthal, Bayer, Medtronic, and Boston Scientific within the last 3 years. D.M. receives consulting fees from AstraZeneca, Bayer, Boehringer Ingelheim, and Vifor, further he receives payment for lectures from AstraZeneca, Bayer, Boehringer Ingelheim, Vifor, and BMS. C.H.S. reports grants and consulting fees from AstraZeneca, Boehringer Ingelheim, and MSD. M.L. receives consulting fees from Johnson and Johnson and support for attending meetings from MSD. R.B. received a grant from Abbott and speaker or consultant fees from Abbott, Amgen, AstraZeneca, Biotronik, Bayer, Boehringer Ingelheim, Novartis, and Vivorpharma within the last 3 years. The remaining authors have no relevant conflict of interest.

Figures

Structured graphical abstract
Structured graphical abstract
A total of 476 people with acute myocardial infarction were randomized to either empagliflozin 10 mg or matching placebo once daily within 72 h of acute percutaneous coronary intervention. The change in NT-proBNP concentrations as well as echocardiographic functional and structural parameters over 26 weeks of treatment was evaluated. LVEF, left-ventricular ejection fraction; LVEDV, left-ventricular end-diastolic volume; LVESV, left-ventricular end-systolic volume; NT-proBNP, N-terminal pro-hormone of brain natriuretic peptide.
Figure 1
Figure 1
Patient disposition. *Baseline N-terminal pro-hormone of brain natriuretic peptide and at least one follow-up N-terminal pro-hormone of brain natriuretic peptide measurement at the central laboratory were available.
Figure 2
Figure 2
(A) Percentage decline across all visits in N-terminal pro-hormone of brain natriuretic peptide concentration by treatment group (log-transformed data). (B) Percentage decline at Week 26 as function of N-terminal pro-hormone of brain natriuretic peptide at baseline (empagliflozin group). (C) Percentage decline at Week 26 as function of N-terminal pro-hormone of brain natriuretic peptide at baseline (placebo group).
Figure 3
Figure 3
Changes in echocardiographic parameters by treatment group: (A) left-ventricular ejection fraction, (B) E/e′, (C) left-ventricular end-systolic volume, and (D) left-ventricular end-diastolic volume.
See this image and copyright information in PMC

Comment in

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