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Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure

James, Stefan ; Erlinge, David LU orcid ; Storey, Robert F. ; McGuire, Darren K. ; de Belder, Mark ; Eriksson, Niclas ; Andersen, Kasper LU orcid ; Austin, David ; Arefalk, Gabriel and Carrick, David , et al. (2024) In NEJM Evidence 3(2).
Abstract

BACKGROUND In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. METHODS In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last... (More)

BACKGROUND In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. METHODS In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method. The key secondary outcome was the same hierarchical composite excluding the body weight component. RESULTS We enrolled 4017 patients of whom 2019 were assigned to dapagliflozin and 1998 to placebo. The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval [CI], 1.20 to 1.50; P<0.001). The win ratio outcome, which was adopted in a change of analysis during trial performance because of low event accrual, was mainly driven by the added cardiometabolic outcomes. The composite of time to cardiovascular death/hospitalization for heart failure occurred in 50/2019 (2.5%) patients assigned to dapagliflozin and 52/1998 (2.6%) patients assigned to placebo (hazard ratio, 0.95; 95% CI, 0.64 to 1.40). The rates of other cardiovascular events were low, with differences between the groups not reaching nominal statistical significance. No safety concerns were identified. CONCLUSIONS In patients with acute MI as noted above, after approximately 1 year of treatment with dapagliflozin there were significant benefits with regard to improvement in cardiometabolic outcomes but no impact on the composite of cardiovascular death or hospitalization for heart failure compared with placebo.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
NEJM Evidence
volume
3
issue
2
publisher
Massachusetts Medical Society
external identifiers
  • scopus:105024703086
ISSN
2766-5526
DOI
10.1056/EVIDoa2300286
language
English
LU publication?
yes
additional info
Publisher Copyright: Copyright © 2024 Massachusetts Medical Society All rights reserved.
id
f33329f8-3cf0-43d3-82ea-4f180ba5cdce
date added to LUP
2026-03-06 13:16:14
date last changed
2026-03-07 03:14:42
@article{f33329f8-3cf0-43d3-82ea-4f180ba5cdce,
  abstract     = {{<p>BACKGROUND In patients with acute myocardial infarction (MI), therapies that could further reduce the risk of adverse cardiovascular and metabolic outcomes are needed. METHODS In this international registry-based, randomized, double-blind trial, patients without prior diabetes or chronic heart failure, presenting with acute MI and impaired left ventricular systolic function, were randomly assigned 10 mg of dapagliflozin or placebo, given once daily. The primary outcome was the hierarchical composite of death, hospitalization for heart failure, nonfatal MI, atrial fibrillation/flutter, type 2 diabetes mellitus, New York Heart Association Functional Classification at the last visit, and body weight decrease of 5% or greater at the last visit using the win ratio analysis method. The key secondary outcome was the same hierarchical composite excluding the body weight component. RESULTS We enrolled 4017 patients of whom 2019 were assigned to dapagliflozin and 1998 to placebo. The analysis of the primary hierarchical composite outcome resulted in significantly more wins for dapagliflozin than for placebo (win ratio, 1.34; 95% confidence interval [CI], 1.20 to 1.50; P&lt;0.001). The win ratio outcome, which was adopted in a change of analysis during trial performance because of low event accrual, was mainly driven by the added cardiometabolic outcomes. The composite of time to cardiovascular death/hospitalization for heart failure occurred in 50/2019 (2.5%) patients assigned to dapagliflozin and 52/1998 (2.6%) patients assigned to placebo (hazard ratio, 0.95; 95% CI, 0.64 to 1.40). The rates of other cardiovascular events were low, with differences between the groups not reaching nominal statistical significance. No safety concerns were identified. CONCLUSIONS In patients with acute MI as noted above, after approximately 1 year of treatment with dapagliflozin there were significant benefits with regard to improvement in cardiometabolic outcomes but no impact on the composite of cardiovascular death or hospitalization for heart failure compared with placebo.</p>}},
  author       = {{James, Stefan and Erlinge, David and Storey, Robert F. and McGuire, Darren K. and de Belder, Mark and Eriksson, Niclas and Andersen, Kasper and Austin, David and Arefalk, Gabriel and Carrick, David and Hofmann, Robin and Hoole, Stephen P. and Jones, Daniel A. and Lee, Kelvin and Tygesen, Hans and Johansson, Peter A. and Langkilde, Anna Maria and Ridderstråle, Wilhelm and Rizi, Ehsan Parvaresh and Deanfield, John and Oldgren, Jonas}},
  issn         = {{2766-5526}},
  language     = {{eng}},
  number       = {{2}},
  publisher    = {{Massachusetts Medical Society}},
  series       = {{NEJM Evidence}},
  title        = {{Dapagliflozin in Myocardial Infarction without Diabetes or Heart Failure}},
  url          = {{http://dx.doi.org/10.1056/EVIDoa2300286}},
  doi          = {{10.1056/EVIDoa2300286}},
  volume       = {{3}},
  year         = {{2024}},
}