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Rationale and desig...
Rationale and design of the DAPA-MI trial : Dapagliflozin in patients without diabetes mellitus with acute myocardial infarction
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- James, Stefan, 1964- (författare)
- Uppsala University,Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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- Erlinge, David (författare)
- Lund University,Lunds universitet,Kardiologi,Sektion II,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Molekylär kardiologi,Forskargrupper vid Lunds universitet,Cardiology,Section II,Department of Clinical Sciences, Lund,Faculty of Medicine,Molecular Cardiology,Lund University Research Groups,Skåne University Hospital
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- Storey, Robert F. (författare)
- Univ Sheffield, Sch Med & Populat Hlth, Div Clin Med, Cardiovasc Res Unit, Sheffield, England.;Royal Hallamshire Hosp, NIHR Sheffield Biomed Res Ctr, Sheffield, England.,University of Sheffield
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- Mcguire, Darren K. (författare)
- Univ Texas SouthWestern Med Ctr Dallas, Dept Internal Med, Div Cardiol, Dallas, TX USA.;Parkland Hlth & Hosp Syst, Div Cardiol, Dallas, TX USA.,University of Texas Southwestern Medical Center
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- de Belder, Mark (författare)
- Lund Univ, Skane Univ Hosp, Dept Cardiol, Clin Sci, Lund, Sweden.
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- Björkgren, Ida (författare)
- Uppsala University,Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)
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- Johansson, Peter A. (författare)
- Parkland Hlth & Hosp Syst, Div Cardiol, Dallas, TX USA.;Natl Inst Cardiovasc Outcomes Res NICOR, NHS Arden & GEM Commissioning Support Unit, Leicester, England.,AstraZeneca, Sweden
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- Langkilde, Anna Maria (författare)
- Natl Inst Cardiovasc Outcomes Res NICOR, NHS Arden & GEM Commissioning Support Unit, Leicester, England.,AstraZeneca, Sweden
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- Ridderstrale, Wilhelm (författare)
- Natl Inst Cardiovasc Outcomes Res NICOR, NHS Arden & GEM Commissioning Support Unit, Leicester, England.,AstraZeneca, Sweden
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- Rizi, Ehsan Parvaresh (författare)
- Natl Inst Cardiovasc Outcomes Res NICOR, NHS Arden & GEM Commissioning Support Unit, Leicester, England.,AstraZeneca, Sweden
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- Deanfield, John (författare)
- AstraZeneca, Late Stage Dev, Cardiovasc Renal & Metab, BioPharmaceut Res & Dev, Gothenburg, Sweden.,University College London
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- Oldgren, Jonas, 1964- (författare)
- Uppsala University,Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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(creator_code:org_t)
- Elsevier, 2023
- 2023
- Engelska.
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Ingår i: American Heart Journal. - : Elsevier. - 0002-8703 .- 1097-6744. ; 266, s. 188-197
- Relaterad länk:
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https://doi.org/10.1...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://lup.lub.lu.s...
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Abstract
Ämnesord
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- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Endokrinologi och diabetes (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Endocrinology and Diabetes (hsv//eng)
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- Av författaren/redakt...
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James, Stefan, 1 ...
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Erlinge, David
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Storey, Robert F ...
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Mcguire, Darren ...
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de Belder, Mark
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Björkgren, Ida
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visa fler...
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Johansson, Peter ...
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Langkilde, Anna ...
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Ridderstrale, Wi ...
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Rizi, Ehsan Parv ...
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Deanfield, John
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Oldgren, Jonas, ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Endokrinologi oc ...
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American Heart J ...
- Av lärosätet
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Uppsala universitet
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Lunds universitet