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Empagliflozin after Acute Myocardial Infarction.

Javed Butler1, W Schuyler Jones1, Jacob A Udell1

  • 1From Baylor Scott and White Research Institute, Dallas (J. Butler); the Department of Medicine, University of Mississippi, Jackson (J. Butler); the Division of Cardiology, Department of Medicine, Duke University Medical Center (W.S.J., J.H., A.F.H.), and the Duke Clinical Research Institute (R.D.L.) - both in Durham, NC; Women's College Hospital (J.A.U.), the Peter Munk Cardiac Centre, University Health Network, University of Toronto (J.A.U., S.G.G.), and the Division of Cardiology, Department of Medicine, St. Michael's Hospital, Unity Health Toronto (S.G.G.), Toronto, the Canadian VIGOUR Centre, University of Alberta, Edmonton (S.G.G.), and the Section of Cardiology, Max Rady College of Medicine, University of Manitoba, Winnipeg (S.Z.) - all in Canada; the Department of Cardiology, German Heart Center Charité, Berlin Institute of Health Center for Regenerative Therapies, German Center for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin (S.D.A.), Boehringer Ingelheim Pharma (M.M., I.Z.) and Boehringer Ingelheim International (T.G., W.J., M.B., M. Sumin), Ingelheim, the Department of Cardiology and Angiology, Hannover Medical School, Hannover (J. Bauersachs), and the First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim (M.B.) - all in Germany; the School of Cardiovascular and Medical Sciences, British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow, United Kingdom (M.C.P.); the Heart Institute, Hadassah Medical Center, Hebrew University of Jerusalem, Jerusalem (O.A.); Instituto de Neurología (INECO) Neurociencias Oroño, Fundación INECO, Rosario, Argentina (M.C.B.); the Heart Institute, Hospital Universitari Germans Trias i Pujol, and the Department of Medicine, Universitat Autònomoa de Barcelona, Barcelona (A.B.-G.), and Son Espases University Hospital, Health Research Institute of the Balearic Islands, University of the Balearic Islands, Palma de Mallorca (X.R.) - all in Spain; the Department of Cardiology, First Medical Center of Chinese People's Liberation Army General Hospital, Beijing (Y.C.), and the Department of Cardiology, Zhongshan Hospital, Fudan University, and the Shanghai Institute of Cardiovascular Diseases, National Clinical Research Center for Interventional Medicine, Shanghai (J.G.) - both in China; the Department of Cardiology, Medanta, Gurgaon, India (V.K.C.); the Faculty of Medicine and Health, University of Sydney, Sydney (G.F.); the Department of Cardiology, National Cardiology Hospital, Sofia, Bulgaria (N.G.); Tokai University School of Medicine, Isehara, Japan (S.G.); the Division of Cardiology, Harvard Medical School and Massachusetts General Hospital, Boston (J.L.J.); Chonnam National University Hospital and Medical School, Gwangju, South Korea (M.H.J.); Volgograd State Medical University, Volgograd, Russia (Y.L.); Heart and Vascular Center, Semmelweis University, Budapest, Hungary (B.M.); the Division of Cardiovascular Medicine, Department of Medicine, State University of New York at Stony Brook, Stony Brook (P.B.P.), and Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York (D.L.B.) - both in New York; the Ukrainian Institute of Cardiology M.D. Strazhesko, National Academy of Medical Sciences, Kyiv, Ukraine (A.P.); Collegium Medicum-Faculty of Medicine, WSB University, Dąbrowa Górnicza (T.G.), and the Institute for Heart Diseases Medical University (P.P.) and Jan Mikulicz-Radecki University Clinical Hospital (J.S.), Wrocław - all in Poland; the Department of Cardiology, Herlev and Gentofte University Hospital, Copenhagen (M. Schou); the Department of Cardiovascular Diseases, University Clinical Center Belgrade, Belgrade, Serbia (D.S.); Université Paris-Cité, French Alliance for Cardiovascular Trials, INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.); the Department of Cardiology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands (P.M.); and University and Emergency Hospital of Bucharest, Bucharest, Romania (D.V.).

The New England Journal of Medicine
|April 8, 2024
PubMed
Summary

Empagliflozin did not significantly reduce hospitalizations for heart failure or death in patients post-acute myocardial infarction. This study investigated empagliflozin

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Area of Science:

  • Cardiology
  • Pharmacology
  • Clinical Trials

Background:

  • Empagliflozin is known to benefit patients with heart failure, type 2 diabetes, and chronic kidney disease.
  • The efficacy and safety of empagliflozin in acute myocardial infarction (AMI) patients remain unestablished.
  • Patients hospitalized for AMI are at risk for developing heart failure.

Purpose of the Study:

  • To evaluate the effect of empagliflozin on cardiovascular outcomes in patients following acute myocardial infarction.
  • To assess the composite endpoint of hospitalization for heart failure or all-cause death in this high-risk population.

Main Methods:

  • A double-blind, randomized, placebo-controlled trial (EMPACT-MI) involving 6522 patients.
  • Patients received either 10 mg empagliflozin or placebo daily, in addition to standard care, within 14 days of AMI hospitalization.
  • Primary endpoint assessed was time to first hospitalization for heart failure or death from any cause.

Main Results:

  • The composite primary endpoint occurred in 8.2% of the empagliflozin group and 9.1% of the placebo group (HR, 0.90; 95% CI, 0.76 to 1.06).
  • A trend towards reduced hospitalization for heart failure was observed (HR, 0.77; 95% CI, 0.60 to 0.98), but did not reach statistical significance.
  • Adverse events were comparable between groups and consistent with empagliflozin's known safety profile.

Conclusions:

  • Empagliflozin did not significantly reduce the risk of hospitalization for heart failure or death in patients at increased risk after acute myocardial infarction.
  • Further research may be needed to identify specific subgroups who might benefit from empagliflozin post-AMI.
  • The safety profile of empagliflozin was confirmed in this patient population.