Effect of Empagliflozin on Worsening Heart Failure Events in Patients With Heart Failure and Preserved Ejection Fraction: EMPEROR-Preserved Trial.


Journal

Circulation
ISSN: 1524-4539
Titre abrégé: Circulation
Pays: United States
ID NLM: 0147763

Informations de publication

Date de publication:
19 10 2021
Historique:
pubmed: 31 8 2021
medline: 30 12 2021
entrez: 30 8 2021
Statut: ppublish

Résumé

Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events. We randomly assigned 5988 patients with class II through IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite end points. Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.77 [95% CI, 0.67-0.87]; In patients with heart failure with preserved ejection fraction, empagliflozin produced a meaningful, early, and sustained reduction in the risk and severity of a broad range of inpatient and outpatient worsening heart failure events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.

Sections du résumé

BACKGROUND
Empagliflozin reduces the risk of cardiovascular death or hospitalization for heart failure in patients with heart failure with preserved ejection fraction, but additional data are needed about its effect on inpatient and outpatient heart failure events.
METHODS
We randomly assigned 5988 patients with class II through IV heart failure with an ejection fraction of >40% to double-blind treatment with placebo or empagliflozin (10 mg once daily), in addition to usual therapy, for a median of 26 months. We prospectively collected information on inpatient and outpatient events reflecting worsening heart failure and prespecified their analysis in individual and composite end points.
RESULTS
Empagliflozin reduced the combined risk of cardiovascular death, hospitalization for heart failure, or an emergency or urgent heart failure visit requiring intravenous treatment (432 versus 546 patients [empagliflozin versus placebo, respectively]; hazard ratio, 0.77 [95% CI, 0.67-0.87];
CONCLUSIONS
In patients with heart failure with preserved ejection fraction, empagliflozin produced a meaningful, early, and sustained reduction in the risk and severity of a broad range of inpatient and outpatient worsening heart failure events. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03057977.

Identifiants

pubmed: 34459213
doi: 10.1161/CIRCULATIONAHA.121.056824
pmc: PMC8522627
doi:

Substances chimiques

Benzhydryl Compounds 0
Glucosides 0
Sodium-Glucose Transporter 2 Inhibitors 0
empagliflozin HDC1R2M35U

Banques de données

ClinicalTrials.gov
['NCT03057977']

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

1284-1294

Commentaires et corrections

Type : CommentIn

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Auteurs

Milton Packer (M)

Baylor Heart and Vascular Institute, Baylor University Medical Center, Dallas, TX (M.P.).
Imperial College, London, United Kingdom (M.P.).

Javed Butler (J)

Department of Medicine, University of Mississippi School of Medicine, Jackson (J.B.).

Faiez Zannad (F)

Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France (F.Z., J.P.F.).

Gerasimos Filippatos (G)

National and Kapodistrian University of Athens School of Medicine, Athens University Hospital Attikon, Greece (G.F.).

Joao Pedro Ferreira (JP)

Université de Lorraine, Inserm INI-CRCT, CHRU, Nancy, France (F.Z., J.P.F.).
Cardiovascular Research and Development Center, Department of Surgery and Physiology, Faculty of Medicine of the University of Porto, Portugal (J.P.F.).

Stuart J Pocock (SJ)

Department of Medical Statistics, London School of Hygiene and Tropical Medicine, United Kingdom (S.J.P.).

Peter Carson (P)

Washington DC Veterans Affairs Medical Center (P.C.).

Inder Anand (I)

Department of Cardiology, University of Minnesota, Minneapolis (I.A.).

Wolfram Doehner (W)

Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (W.D., S.D.A.).

Markus Haass (M)

Theresienkrankenhaus and St Hedwig-Klinik, Mannheim, Germany (M.H.).

Michel Komajda (M)

Department of Cardiology, Hospital Saint Joseph, Paris, France (M.K.).

Alan Miller (A)

University of Florida, Jacksonville (A.M.).

Steen Pehrson (S)

Department of Cardiology, University Hospital, Rigshospitalet, Copenhagen, Denmark (S.P.).

John R Teerlink (JR)

Section of Cardiology, San Francisco Veterans Affairs Medical Center and School of Medicine, University of California (J.R.T.).

Sven Schnaidt (S)

Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (S.S., C.Z.).

Cordula Zeller (C)

Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (S.S., C.Z.).

Janet M Schnee (JM)

Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT (J.M.S.).

Stefan D Anker (SD)

Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité Universitätsmedizin, Berlin, Germany (W.D., S.D.A.).

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