Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

Gilles Montalescot; Bertram Pitt; Esteban Lopez de Sa; Christian Hamm; Marcus Flather; Freek Verheugt; Harry Shi; Eva Turgonyi; Miguel Orri; John B. Vincent; Faiez Zannad; G. Noll; R. Weir; B. O'Neill; M. Bohm; W. Hillis; A. Grieve; J. Rouleau; F. Gerasimos; D. Fitchett; S. Lepage; M. Madan; B. Sussex; G. Tremblay; R. Welsh; G. Wong; M. Hutyra; J. Kettner; P. Ostadal; J. Spinar; J. Vojacek; M. Barboteu; J. Collet; P. Coste; Y. Cottin; D. Ducos; M. Galinier; E. Teiger; G. Zemour; J. Bauersachs; R. Hambrecht; G. Hauf; H. Heuer; H. Mudra; T. Munzel; S. Steiner; R. Strasser; K. Sydow; C. Tschope; R. Wachter; N. Werner; D. Alexopoulos; D. Babalis; V. Pyrgakis; C. Dezsi; G. Lupkovics; P. Polgar; J. Tomcsanyi; J. Herrman; J. ten Berg; J. Gorny; J. Kubica; J. Lewczuk; W. Zmuda; M. Hranai; F. Kovar; R. Margoczy; K. Micko; J. Sumbal; X. Genover; A. Ortiz; F. Sala; G. Garcia; C. Muñoz; J. Rey Blas; F. Soriano; D. Adamson; F. Alamgir; A. Chauhan; G. Lip; T. Martin; G. Mccann; D. Newby; D. Smith

doi:10.1093/eurheartj/ehu164

Journal Articles European Heart Journal Year : 2014

Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

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Gilles Montalescot

Function : Author
PersonId : 757375
ORCID : 0000-0003-0824-6809
IdRef : 035732725

CHU Pitié-Salpêtrière [AP-HP]

Bertram Pitt

Function : Author
PersonId : 775891
ORCID : 0000-0001-5880-275X
IdRef : 129368377

University of Michigan [Ann Arbor]

Esteban Lopez de Sa

Function : Author

Hospital Universitario La Paz

Christian Hamm

Function : Author

Kerckhoff-Klinik

Marcus Flather

Function : Author
PersonId : 910514

Norwich Medical School

Freek Verheugt

Function : Author

Onze Lieve Vrouwe Gasthuis

Harry Shi

Function : Author

Pfizer

Eva Turgonyi

Function : Author

Pfizer Ltd

Miguel Orri

Function : Author

Pfizer Ltd

John B. Vincent

Function : Author

Pfizer

Faiez Zannad

Function : Author
PersonId : 756877
ORCID : 0000-0001-7456-1570

Défaillance Cardiovasculaire Aiguë et Chronique

G. Noll

Function : Author

R. Weir

Function : Author

B. O'Neill

Function : Author

M. Bohm

Function : Author

W. Hillis

Function : Author

A. Grieve

Function : Author

J. Rouleau

Function : Author

F. Gerasimos

Function : Author

D. Fitchett

Function : Author

S. Lepage

Function : Author

Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]

M. Madan

Function : Author

B. Sussex

Function : Author

G. Tremblay

Function : Author

R. Welsh

Function : Author

G. Wong

Function : Author

M. Hutyra

Function : Author

J. Kettner

Function : Author

P. Ostadal

Function : Author

J. Spinar

Function : Author

J. Vojacek

Function : Author

M. Barboteu

Function : Author

LAboratoire de Modélisation Pluridisciplinaire et Simulations

J. Collet

Function : Author

P. Coste

Function : Author

Y. Cottin

Function : Author

CHU Dijon

D. Ducos

Function : Author

M. Galinier

Function : Author

Institut des Maladies Métaboliques et Cardiovasculaires

E. Teiger

Function : Author

G. Zemour

Function : Author

J. Bauersachs

Function : Author

R. Hambrecht

Function : Author

G. Hauf

Function : Author

H. Heuer

Function : Author

H. Mudra

Function : Author

T. Munzel

Function : Author

S. Steiner

Function : Author

R. Strasser

Function : Author

K. Sydow

Function : Author

C. Tschope

Function : Author

R. Wachter

Function : Author

N. Werner

Function : Author

D. Alexopoulos

Function : Author

D. Babalis

Function : Author

V. Pyrgakis

Function : Author

C. Dezsi

Function : Author

G. Lupkovics

Function : Author

P. Polgar

Function : Author

J. Tomcsanyi

Function : Author

J. Herrman

Function : Author

J. ten Berg

Function : Author

J. Gorny

Function : Author

Laboratoire Avancé de Spectroscopie pour les Intéractions la Réactivité et l'Environnement - UMR 8516

J. Kubica

Function : Author

J. Lewczuk

Function : Author

W. Zmuda

Function : Author

M. Hranai

Function : Author

F. Kovar

Function : Author

R. Margoczy

Function : Author

K. Micko

Function : Author

J. Sumbal

Function : Author

X. Genover

Function : Author

A. Ortiz

Function : Author
PersonId : 755443
ORCID : 0000-0002-7212-2061

F. Sala

Function : Author

G. Garcia

Function : Author

Conception, synthèse et vectorisation de biomolécules

C. Muñoz

Function : Author

Departamento de Fisica Teorica C-XI

J. Rey Blas

Function : Author

F. Soriano

Function : Author

D. Adamson

Function : Author

F. Alamgir

Function : Author

A. Chauhan

Function : Author

G. Lip

Function : Author

T. Martin

Function : Author

G. Mccann

Function : Author

D. Newby

Function : Author

D. Smith

Function : Author

Abstract

AIMS: We aimed to assess the impact of eplerenone on cardiovascular (CV) outcomes in STEMI without known heart failure, when initiated within 24 h of symptom onset. METHODS AND RESULTS: In this randomized, placebo-controlled, double-blind trial, we assigned 1012 patients with acute STEMI and without a history of heart failure to receive either eplerenone (25-50 mg once daily) or placebo in addition to standard therapy. The primary endpoint was the composite of CV mortality, re-hospitalization, or, extended initial hospital stay, due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40%, or elevated BNP/NT-proBNP at 1 month or more after randomization. BNP elevation was defined as BNP levels or values above 200 pg/mL or NT-proBNP values above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50-75 years) or above 1800 pg/mL (patients older than 75). After a mean follow-up of 10.5 months, the primary endpoint occurred in 92 patients (18.2%) in the eplerenone group and in 149 patients (29.4%) in the placebo group [adjusted hazard ratio (HR), 0.58; 95% confidence interval (CI), 0.45-0.76; P < 0.0001]. The primary endpoint was driven by a high BNP/NT-proBNP level (adjusted HR, 0.60; 95% CI, 0.45-0.79; P < 0.0003). Adverse event rates were similar in both groups. Serum potassium levels exceeded 5.5 mmol/L in 5.6 vs. 3.2% (P = 0.09) and were below 3.5 mmol/L in 1.4 vs. 5.6% of patients (P = 0.0002), in the eplerenone and placebo groups, respectively. CONCLUSION: The addition of eplerenone during the acute phase of STEMI was safe and well tolerated. It reduced the primary endpoint over a mean 13 months follow-up mostly because of significantly lower BNP/NT-proBNP levels. Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure. CLINICAL TRIAL REGISTRATION: NCT01176968.

Keywords

B-type natriuretic peptide Eplerenone Mineralocorticoid receptor antagonists Myocardial infarction Potassium

Domains

Cardiology and cardiovascular system

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https://hal.univ-lorraine.fr/hal-01738642

Submitted on : Wednesday, October 25, 2023-2:44:20 PM

Last modification on : Tuesday, July 16, 2024-3:14:04 PM

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hal-01738642 , version 1 (25-10-2023)

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HAL Id : hal-01738642 , version 1
DOI : 10.1093/eurheartj/ehu164
PUBMED : 24780614

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Gilles Montalescot, Bertram Pitt, Esteban Lopez de Sa, Christian Hamm, Marcus Flather, et al.. Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study. European Heart Journal, 2014, 35 (34), pp.2295 - 2302. ⟨10.1093/eurheartj/ehu164⟩. ⟨hal-01738642⟩

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Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

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