Treatment effects of empagliflozin in hospitalized heart failure patients across the range of left ventricular ejection fraction - Results from the EMPULSE trial.

Acute heart failure Left ventricular ejection fraction SGLT2 inhibitor

Journal

European journal of heart failure
ISSN: 1879-0844
Titre abrégé: Eur J Heart Fail
Pays: England
ID NLM: 100887595

Informations de publication

Date de publication:
04 Apr 2024
Historique:
revised: 23 02 2024
received: 21 10 2023
accepted: 12 03 2024
medline: 4 4 2024
pubmed: 4 4 2024
entrez: 4 4 2024
Statut: aheadofprint

Résumé

The EMPULSE (EMPagliflozin in patients hospitalised with acUte heart faiLure who have been StabilizEd) trial showed that, compared to placebo, the sodium-glucose cotransporter 2 inhibitor empagliflozin (10 mg/day) improved clinical outcomes of patients hospitalized for acute heart failure (HF). We investigated whether efficacy and safety of empagliflozin were consistent across the spectrum of left ventricular ejection fraction (LVEF). A total of 530 patients hospitalized for acute de novo or decompensated HF were included irrespective of LVEF. For the present analysis, patients were classified as HF with reduced (HFrEF, LVEF ≤40%), mildly reduced (HFmrEF, LVEF 41-49%) or preserved (HFpEF, LVEF ≥50%) ejection fraction at baseline. The primary endpoint was a hierarchical outcome of death, worsening HF events (HFE) and quality of life over 90 days, assessed by the win ratio. Secondary endpoints included individual components of the primary endpoint and safety. Out of 523 patients with baseline data, 354 (67.7%) had HFrEF, 54 (10.3%) had HFmrEF and 115 (22.0%) had HFpEF. The clinical benefit (hierarchical composite of all-cause death, HFE and Kansas City Cardiomyopathy Questionnaire total symptom score) of empagliflozin at 90 days compared to placebo was consistent across LVEF categories (≤40%: win ratio 1.35 [95% confidence interval 1.04, 1.75]; 41-49%: win ratio 1.25 [0.66, 2.37)] and ≥50%: win ratio 1.40 [0.87, 2.23], p The clinical benefit of empagliflozin proved consistent across LVEF categories in the EMPULSE trial. These results support early in-hospital initiation of empagliflozin regardless of LVEF.

Identifiants

pubmed: 38572654
doi: 10.1002/ejhf.3218
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.

Références

Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, et al. 2022 AHA/ACC/HFSA Guideline for the management of heart failure: A report of the American College of Cardiology/American Heart Association Joint Committee on clinical Practice Guidelines. Circulation 2022;145:e895–e1032. https://doi.org/10.1161/CIR.0000000000001063
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Böhm M, et al.; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: Developed by the Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). With the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail 2022;24:4–131. https://doi.org/10.1002/ejhf.2333
McMurray JJV, Packer M, Desai AS, Gong J, Lefkowitz MP, Rizkala AR, et al.; PARADIGM‐HF Investigators and Committees. Angiotensin‐neprilysin inhibition versus enalapril in heart failure. N Engl J Med 2014;371:993–1004. https://doi.org/10.1056/NEJMoa1409077
Solomon SD, McMurray JJV, Anand IS, Ge J, Lam CSP, Maggioni AP, et al.; PARAGON‐HF Investigators and Committees. Angiotensin‐neprilysin inhibition in heart failure with preserved ejection fraction. N Engl J Med 2019;381:1609–1620. https://doi.org/10.1056/NEJMoa1908655
McMurray JJV, Östergren J, Swedberg K, Granger CB, Held P, Michelson EL, et al.; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and reduced left‐ventricular systolic function taking angiotensin‐converting‐enzyme inhibitors: The CHARM‐Added trial. Lancet 2003;362:767–771. https://doi.org/10.1016/S0140‐6736(03)14283‐3
Massie BM, Carson PE, McMurray JJ, Komajda M, McKelvie R, Zile MR, et al.; I‐PRESERVE Investigators. Irbesartan in patients with heart failure and preserved ejection fraction. N Engl J Med 2008;359:2456–2467. https://doi.org/10.1056/NEJMoa0805450
Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, et al.; TOPCAT Investigators. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med 2014;370:1383–1392. https://doi.org/10.1056/NEJMoa1313731
Yusuf S, Pfeffer MA, Swedberg K, Granger CB, Held P, McMurray JJV, et al.; CHARM Investigators and Committees. Effects of candesartan in patients with chronic heart failure and preserved left‐ventricular ejection fraction: The CHARM‐Preserved trial. Lancet 2003;362:777–781. https://doi.org/10.1016/S0140‐6736(03)14285‐7
Jhund PS, Kondo T, Butt JH, Docherty KF, Claggett BL, Desai AS, et al. Dapagliflozin across the range of ejection fraction in patients with heart failure: A patient‐level, pooled meta‐analysis of DAPA‐HF and DELIVER. Nat Med 2022;28:1956–1964. https://doi.org/10.1038/s41591‐022‐01971‐4
Butler J, Packer M, Filippatos G, Ferreira JP, Zeller C, Schnee J, et al. Effect of empagliflozin in patients with heart failure across the spectrum of left ventricular ejection fraction. Eur Heart J 2022;43:416–426. https://doi.org/10.1093/eurheartj/ehab798
Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, et al.; SOLOIST‐WHF Trial Investigators. Sotagliflozin in patients with diabetes and recent worsening heart failure. N Engl J Med 2021;384:117–128. https://doi.org/10.1056/NEJMoa2030183
Vaduganathan M, Docherty KF, Claggett BL, Jhund PS, de Boer RA, Hernandez AF, et al. SGLT2 inhibitors in patients with heart failure: A comprehensive meta‐analysis of five randomised controlled trials. Lancet 2022;400:757–767. https://doi.org/10.1016/S0140‐6736(22)01429‐5
Voors AA, Angermann CE, Teerlink JR, Collins SP, Kosiborod M, Biegus J, et al. The SGLT2 inhibitor empagliflozin in patients hospitalized for acute heart failure: A multinational randomized trial. Nat Med 2022;28:568–574. https://doi.org/10.1038/s41591‐021‐01659‐1
Tromp J, Ponikowski P, Salsali A, Angermann CE, Biegus J, Blatchford J, et al. Sodium‐glucose co‐transporter 2 inhibition in patients hospitalized for acute decompensated heart failure: Rationale for and design of the EMPULSE trial. Eur J Heart Fail 2021;23:826–834. https://doi.org/10.1002/ejhf.2137
Kosiborod MN, Angermann CE, Collins SP, Teerlink JR, Ponikowski P, Biegus J, et al. Effects of empagliflozin on symptoms, physical limitations, and quality of life in patients hospitalized for acute heart failure: Results from the EMPULSE trial. Circulation 2022;146:279–288. https://doi.org/10.1161/CIRCULATIONAHA.122.059725
Shen L, Jhund PS, Docherty KF, Vaduganathan M, Petrie MC, Desai AS, et al. Accelerated and personalized therapy for heart failure with reduced ejection fraction. Eur Heart J 2022;43:2573–2587. https://doi.org/10.1093/eurheartj/ehac210
Tromp J, Voors AA. Heart failure medication: Moving from evidence generation to implementation. Eur Heart J 2022;43:2588–2590. https://doi.org/10.1093/eurheartj/ehac272
Mebazaa A, Davison B, Chioncel O, Cohen‐Solal A, Diaz R, Filippatos G, et al. Safety, tolerability and efficacy of up‐titration of guideline‐directed medical therapies for acute heart failure (STRONG‐HF): A multinational, open‐label, randomised, trial. Lancet 2022;400:1938–1952. https://doi.org/10.1016/S0140‐6736(22)02076‐1

Auteurs

Jasper Tromp (J)

Saw Swee Hock School of Public Health, National University of Singapore & the National University Health System, Singapore, Singapore.
Duke-NUS Medical School, Singapore, Singapore.

Mikhail N Kosiborod (MN)

Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.
George Institute for Global Health, Sydney, NSW, Australia.
University of New South Wales, Sydney, NSW, Australia.

Christiane E Angermann (CE)

Comprehensive Heart Failure Centre and Department of Medicine I (Cardiology), University and University Hospital of Würzburg, Würzburg, Germany.

Sean P Collins (SP)

Department of Emergency Medicine, Vanderbilt University Medical Center and Geriatric Research and Education Clinical Care, Tennessee Valley Healthcare Facility VA Medical Center, Nashville, TN, USA.

John R Teerlink (JR)

Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California San Francisco, San Francisco, CA, USA.

Piotr Ponikowski (P)

Institute of Heart Diseases, Medical University, Wroclaw, Poland.

Jan Biegus (J)

Institute of Heart Diseases, Medical University, Wroclaw, Poland.

João Pedro Ferreira (JP)

Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Porto, Portugal.

Michael E Nassif (ME)

Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
School of Medicine, University of Missouri-Kansas City, Kansas City, MO, USA.

Mitchell A Psotka (MA)

Inova Heart and Vascular Institute, Falls Church, VA, USA.

Martina Brueckmann (M)

Boehringer Ingelheim International GmbH, Ingelheim, Germany.
First Department of Medicine, Faculty of Medicine Mannheim, University of Heidelberg, Mannheim, Germany.

Jonathan P Blatchford (JP)

Elderbrook Solutions GmbH on behalf of Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.

Dominik Steubl (D)

Boehringer Ingelheim International, Ingelheim, Germany.
Department of Nephrology, Klinikum rechts der Isar, Faculty of Medicine, Technical University, Munich, Germany.

Adriaan A Voors (AA)

University of Groningen Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.

Classifications MeSH