Skip to main content

Lund University Publications

LUND UNIVERSITY LIBRARIES

Rationale and design of the DAPA-MI trial : Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction

James, Stefan ; Erlinge, David LU orcid ; Storey, Robert F. ; McGuire, Darren K. ; de Belder, Mark ; Björkgren, Ida ; Johansson, Peter A. ; Langkilde, Anna Maria ; Ridderstråle, Wilhelm and Parvaresh Rizi, Ehsan , et al. (2023) In American Heart Journal 266. p.188-197
Abstract

Background: Therapies that could further prevent the development of heart failure (HF) and other cardiovascular and metabolic events in patients with recent myocardial infarction (MI) represent a large and unmet medical need. Methods: DAPA-MI is a multicenter, parallel-group, registry-based, randomized, double-blind, placebo-controlled phase 3 trial in patients without known diabetes or established HF, presenting with MI and impaired left ventricular systolic function or Q-wave MI. The trial evaluated the effect of dapagliflozin 10 mg vs placebo, given once daily in addition to standard of care therapy, on death, hospitalization for HF (HHF), and other cardiometabolic outcomes. The primary objective of the trial was to determine, using... (More)

Background: Therapies that could further prevent the development of heart failure (HF) and other cardiovascular and metabolic events in patients with recent myocardial infarction (MI) represent a large and unmet medical need. Methods: DAPA-MI is a multicenter, parallel-group, registry-based, randomized, double-blind, placebo-controlled phase 3 trial in patients without known diabetes or established HF, presenting with MI and impaired left ventricular systolic function or Q-wave MI. The trial evaluated the effect of dapagliflozin 10 mg vs placebo, given once daily in addition to standard of care therapy, on death, hospitalization for HF (HHF), and other cardiometabolic outcomes. The primary objective of the trial was to determine, using the win-ratio method, if dapagliflozin is superior to placebo by comparing the hierarchical composite outcome of death, HHF, nonfatal MI, atrial fibrillation/flutter, new onset of type 2 diabetes mellitus, HF symptoms as measured by New York Heart Association Functional Classification at last visit, and body weight decrease ≥5% at last visit. Assuming a true win-ratio of 1.20 between dapagliflozin and placebo, 4,000 patients provide a statistical power of 80% for the test of the primary composite outcome. A registry-based randomized controlled trial framework allowed for recruitment, randomization, blinding, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries (in Sweden and the UK) integrated with the trial database. Conclusions: The trial explores opportunities to improve further the outcome of patients with impaired LV function after MI. The innovative trial design of DAPA-MI, incorporating national clinical registry data, has facilitated efficient patient recruitment as well as outcome ascertainment. Trial registration: ClinicalTrials.gov Identifier NCT04564742.

(Less)
Please use this url to cite or link to this publication:
author
; ; ; ; ; ; ; ; and , et al. (More)
; ; ; ; ; ; ; ; ; ; and (Less)
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
American Heart Journal
volume
266
pages
10 pages
publisher
Mosby-Elsevier
external identifiers
  • pmid:37648579
  • scopus:85177186373
ISSN
0002-8703
DOI
10.1016/j.ahj.2023.08.008
language
English
LU publication?
yes
id
4aad4289-0c67-4361-b0fb-2d061bccc750
date added to LUP
2023-12-18 14:59:19
date last changed
2024-04-17 03:10:56
@article{4aad4289-0c67-4361-b0fb-2d061bccc750,
  abstract     = {{<p>Background: Therapies that could further prevent the development of heart failure (HF) and other cardiovascular and metabolic events in patients with recent myocardial infarction (MI) represent a large and unmet medical need. Methods: DAPA-MI is a multicenter, parallel-group, registry-based, randomized, double-blind, placebo-controlled phase 3 trial in patients without known diabetes or established HF, presenting with MI and impaired left ventricular systolic function or Q-wave MI. The trial evaluated the effect of dapagliflozin 10 mg vs placebo, given once daily in addition to standard of care therapy, on death, hospitalization for HF (HHF), and other cardiometabolic outcomes. The primary objective of the trial was to determine, using the win-ratio method, if dapagliflozin is superior to placebo by comparing the hierarchical composite outcome of death, HHF, nonfatal MI, atrial fibrillation/flutter, new onset of type 2 diabetes mellitus, HF symptoms as measured by New York Heart Association Functional Classification at last visit, and body weight decrease ≥5% at last visit. Assuming a true win-ratio of 1.20 between dapagliflozin and placebo, 4,000 patients provide a statistical power of 80% for the test of the primary composite outcome. A registry-based randomized controlled trial framework allowed for recruitment, randomization, blinding, and pragmatic data collection of baseline demographics, medications, and clinical outcomes using existing national clinical registries (in Sweden and the UK) integrated with the trial database. Conclusions: The trial explores opportunities to improve further the outcome of patients with impaired LV function after MI. The innovative trial design of DAPA-MI, incorporating national clinical registry data, has facilitated efficient patient recruitment as well as outcome ascertainment. Trial registration: ClinicalTrials.gov Identifier NCT04564742.</p>}},
  author       = {{James, Stefan and Erlinge, David and Storey, Robert F. and McGuire, Darren K. and de Belder, Mark and Björkgren, Ida and Johansson, Peter A. and Langkilde, Anna Maria and Ridderstråle, Wilhelm and Parvaresh Rizi, Ehsan and Deanfield, John and Oldgren, Jonas}},
  issn         = {{0002-8703}},
  language     = {{eng}},
  pages        = {{188--197}},
  publisher    = {{Mosby-Elsevier}},
  series       = {{American Heart Journal}},
  title        = {{Rationale and design of the DAPA-MI trial : Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction}},
  url          = {{http://dx.doi.org/10.1016/j.ahj.2023.08.008}},
  doi          = {{10.1016/j.ahj.2023.08.008}},
  volume       = {{266}},
  year         = {{2023}},
}