A trial to evaluate the effect of the sodium–glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF)

on behalf of the DAPA-HF Committees and Investigators

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: Sodium–glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown. Design and methods: The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF) is an international, multicentre, parallel group, randomized, double-blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2 . The trial is event-driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes. A total of 4744 patients have been randomized. Conclusions: DAPA-HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.

Original languageEnglish (US)
Pages (from-to)665-675
Number of pages11
JournalEuropean Journal of Heart Failure
Volume21
Issue number5
DOIs
StatePublished - May 1 2019

Fingerprint

Symporters
Stroke Volume
Heart Failure
Morbidity
Mortality
Hospitalization
2-(3-(4-ethoxybenzyl)-4-chlorophenyl)-6-hydroxymethyltetrahydro-2H-pyran-3,4,5-triol
Brain Natriuretic Peptide
Glomerular Filtration Rate
Double-Blind Method
Type 2 Diabetes Mellitus
Primary Health Care
Cardiovascular Diseases
Placebos

Keywords

  • Clinical trial
  • Heart failure
  • Sodium–glucose co-transporter 2 inhibitor
  • Type 2 diabetes mellitus

PubMed: MeSH publication types

  • Journal Article

Cite this

@article{f3b0183c774346f48fbb26e1041475bc,
title = "A trial to evaluate the effect of the sodium–glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF)",
abstract = "Background: Sodium–glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown. Design and methods: The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF) is an international, multicentre, parallel group, randomized, double-blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40{\%}, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2 . The trial is event-driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes. A total of 4744 patients have been randomized. Conclusions: DAPA-HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.",
keywords = "Clinical trial, Heart failure, Sodium–glucose co-transporter 2 inhibitor, Type 2 diabetes mellitus",
author = "{on behalf of the DAPA-HF Committees and Investigators} and McMurray, {John J.V.} and DeMets, {David L.} and Inzucchi, {Silvio E.} and Lars K{\o}ber and Kosiborod, {Mikhail N.} and Langkilde, {Anna M.} and Martinez, {Felipe A.} and Olof Bengtsson and Piotr Ponikowski and Sabatine, {Marc S.} and Mikaela Sj{\"o}strand and Solomon, {Scott D.} and McMurray, {John J.V.} and DeMets, {David L.} and Inzucchi, {Silvio E.} and Lars K{\o}ber and Kosiborod, {Mikhail N.} and Langkilde, {Anna Maria} and Martinez, {Felipe A.} and Piotr Ponikowski and Sabatine, {Marc S.} and Mikaela Sj{\"o}strand and Solomon, {Scott D.} and Mirta Diez and Jose Nicolau and Tzvetana Katova and Eileen O'Meara and Jonathan Howlett and Subodh Verma and Junbo Ge and Jan Belohlavek and Morten Schou and Michael B{\"o}hm and Bela Merkely and Vijay Chopra and Masafumi Kitakaze and {de Boer}, {Rudolf A.} and Jaroslaw Drozdz and Sergey Tereshchenko and Andrej Dukat and Charlotta Ljungman and Chiang, {Chern En} and Mark Petrie and Akshay Desai and Inder Anand and Pham, {Vinh Nguyen} and Pfeffer, {Marc A.} and Stuart Pocock and Karl Swedberg and Rouleau, {Jean L.}",
year = "2019",
month = "5",
day = "1",
doi = "10.1002/ejhf.1432",
language = "English (US)",
volume = "21",
pages = "665--675",
journal = "European Journal of Heart Failure",
issn = "1388-9842",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - A trial to evaluate the effect of the sodium–glucose co-transporter 2 inhibitor dapagliflozin on morbidity and mortality in patients with heart failure and reduced left ventricular ejection fraction (DAPA-HF)

AU - on behalf of the DAPA-HF Committees and Investigators

AU - McMurray, John J.V.

AU - DeMets, David L.

AU - Inzucchi, Silvio E.

AU - Køber, Lars

AU - Kosiborod, Mikhail N.

AU - Langkilde, Anna M.

AU - Martinez, Felipe A.

AU - Bengtsson, Olof

AU - Ponikowski, Piotr

AU - Sabatine, Marc S.

AU - Sjöstrand, Mikaela

AU - Solomon, Scott D.

AU - McMurray, John J.V.

AU - DeMets, David L.

AU - Inzucchi, Silvio E.

AU - Køber, Lars

AU - Kosiborod, Mikhail N.

AU - Langkilde, Anna Maria

AU - Martinez, Felipe A.

AU - Ponikowski, Piotr

AU - Sabatine, Marc S.

AU - Sjöstrand, Mikaela

AU - Solomon, Scott D.

AU - Diez, Mirta

AU - Nicolau, Jose

AU - Katova, Tzvetana

AU - O'Meara, Eileen

AU - Howlett, Jonathan

AU - Verma, Subodh

AU - Ge, Junbo

AU - Belohlavek, Jan

AU - Schou, Morten

AU - Böhm, Michael

AU - Merkely, Bela

AU - Chopra, Vijay

AU - Kitakaze, Masafumi

AU - de Boer, Rudolf A.

AU - Drozdz, Jaroslaw

AU - Tereshchenko, Sergey

AU - Dukat, Andrej

AU - Ljungman, Charlotta

AU - Chiang, Chern En

AU - Petrie, Mark

AU - Desai, Akshay

AU - Anand, Inder

AU - Pham, Vinh Nguyen

AU - Pfeffer, Marc A.

AU - Pocock, Stuart

AU - Swedberg, Karl

AU - Rouleau, Jean L.

PY - 2019/5/1

Y1 - 2019/5/1

N2 - Background: Sodium–glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown. Design and methods: The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF) is an international, multicentre, parallel group, randomized, double-blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2 . The trial is event-driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes. A total of 4744 patients have been randomized. Conclusions: DAPA-HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.

AB - Background: Sodium–glucose co-transporter 2 (SGLT2) inhibitors have been shown to reduce the risk of incident heart failure hospitalization in individuals with type 2 diabetes who have, or are at high risk of, cardiovascular disease. Most patients in these trials did not have heart failure at baseline and the effect of SGLT2 inhibitors on outcomes in individuals with established heart failure (with or without diabetes) is unknown. Design and methods: The Dapagliflozin And Prevention of Adverse-outcomes in Heart Failure trial (DAPA-HF) is an international, multicentre, parallel group, randomized, double-blind, study in patients with chronic heart failure, evaluating the effect of dapagliflozin 10 mg, compared with placebo, given once daily, in addition to standard care, on the primary composite outcome of a worsening heart failure event (hospitalization or equivalent event, i.e. an urgent heart failure visit) or cardiovascular death. Patients with and without diabetes are eligible and must have a left ventricular ejection fraction ≤ 40%, a moderately elevated N-terminal pro B-type natriuretic peptide level, and an estimated glomerular filtration rate ≥ 30 mL/min/1.73 m 2 . The trial is event-driven, with a target of 844 primary outcomes. Secondary outcomes include the composite of total heart failure hospitalizations (including repeat episodes), and cardiovascular death and patient-reported outcomes. A total of 4744 patients have been randomized. Conclusions: DAPA-HF will determine the efficacy and safety of the SGLT2 inhibitor dapagliflozin, added to conventional therapy, in a broad spectrum of patients with heart failure and reduced ejection fraction.

KW - Clinical trial

KW - Heart failure

KW - Sodium–glucose co-transporter 2 inhibitor

KW - Type 2 diabetes mellitus

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U2 - 10.1002/ejhf.1432

DO - 10.1002/ejhf.1432

M3 - Article

C2 - 30895697

AN - SCOPUS:85063211855

VL - 21

SP - 665

EP - 675

JO - European Journal of Heart Failure

JF - European Journal of Heart Failure

SN - 1388-9842

IS - 5

ER -