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Empagliflozin in patients post myocardial infarction rationale and design of the EMPACT-MI trial - 02/09/22

Doi : 10.1016/j.ahj.2022.05.010 
Josephine Harrington, MD a, b, Jacob A. Udell, MD c, W. Schuyler Jones, MD a, b, Stefan D. Anker, MD PhD d, e, Deepak L. Bhatt, MD MPH f, Mark C. Petrie, MD g, Ola Vedin, MD h, Mikhail Sumin, MD i, Isabella Zwiener, PhD j, Adrian F. Hernandez, MD a, b, Javed Butler, MD MPH MBA k, l,
a Duke University Department of Medicine, Division of Cardiology, Durham North Carolina 
b Duke Clinical Research Institute, Durham North Carolina 
c Women's College Hospital and Peter Munk Cardiac Centre, Toronto General Hospital, all at University of Toronto, Toronto, Canada 
d Department of Cardiology (CVK); and Berlin Institute of Health Center for Regenerative Therapies (BCRT); German Centre for Cardiovascular Research (DZHK) partner site Berlin; Charité Universitätsmedizin Berlin, Germany 
e Institutes of Heart Disease, Wroclaw Medical University, Wroclaw, Poland 
f Brigham and Women's Hospital Heart and Vascular Center, Harvard Medical School, Boston, MA 
g British Heart Foundation Glasgow Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom 
h Boehringer Ingelheim AB, Stockholm, Sweden 
i Boehringer Ingelheim International GmbH, Ingelheim, Germany 
j Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany 
k Baylor Scott and White Research Institute, Dallas TX 
l Department of Medicine, University of Mississippi, Jackson, MS 

Reprint requests: Javed Butler, MD MPH MBA, Baylor Scott and White Research Institute, 3434 Live Oak St Ste 501, Dallas TX 75204.Baylor Scott and White Research Institute3434 Live Oak St Ste 501DallasTX75204

Riassunto

Background

Patients with acute myocardial infarction (MI) are at risk for developing heart failure (HF) and subsequently are at an increased risk of mortality. Sodium-glucose cotransporter-2 inhibitors have been proven to improve outcomes in patients with HF with reduced ejection fraction, and, in the case of empagliflozin, in HF with preserved ejection fraction even without diabetes, but their efficacy and safety in the post-MI population has not yet been evaluated.

Methods

The EMPACT-MI trial will evaluate the safety and efficacy of empagliflozin compared with placebo in patients hospitalized for MI with or at high risk of new onset HF, in addition to standard care. EMPACT-MI is a streamlined, multinational, randomized, double-blind, placebo-controlled trial randomizing 5,000 participants at approximately 480 centers in 22 countries. Eligible patients presenting with spontaneous MI must have new signs or symptoms of pulmonary congestion requiring treatment or new left ventricular dysfunction (LVEF<45%), and at least 1 additional risk factor for development of future HF. Eligible and consenting patients are randomized to empagliflozin 10mg or placebo daily in addition to standard of care within 14 days of hospital admission for MI. The primary composite end point is time to first hospitalization for HF or all-cause mortality.

Conclusions

EMPACT-MI will inform clinical practice regarding the role of empagliflozin in patients after an MI with high-risk for the development of future HF and mortality.

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Abbreviations : ACEi, ARNI, ACS, ACS-HF, CV, DMC, HF, HHF, LVEF, LVSD, MI, SGLT2i, T2DM


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Vol 253

P. 86-98 - Novembre 2022 Ritorno al numero
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