Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The randomized double-blind reminder study

Montalescot, Gilles, Pitt, Bertram, Lopez de Sa, Esteban, Hamm, Christian W., Flather, Marcus, Verheugt, Freek, Shi, Harry, Turgonyi, Eva, Orri, Miguel, Vincent, John, Zannad, Faiez, Noll, Georg, Weir, Robin, O'Neill, Blair, Böhm, Michael, Hillis, W. Stuart, Grieve, Andrew, Rouleau, Jean-Lucien, Gerasimos, Filippatos, Fitchett, David, Lepage, Serge, Madan, Minakshi, Sussex, Bruce, Tremblay, Gerald, Welsh, Robert, Wong, Graham, Hutyra, Martin, Kettner, Jiri, Ostadal, Petr, Spinar, Jindrich, Vojacek, Jan, Barboteu, Michel, Collet, Jean-Philippe, Coste, Pierre, Cottin, Yves, Ducos, Dominique, Galinier, Michel, Teiger, Emmanuel, Zemour, Gilles, Bauersachs, Johann, Hambrecht, Rainer, Hauf, Gerhard, Heuer, Hubertus, Mudra, Harald, Munzel, Thomas, Steiner, Stephan, Strasser, Ruth, Sydow, Karsten, Tschope, Carsten, Wachter, Rolf, Werner, Nikos, Alexopoulos, Dimitros, Babalis, Dimitrios, Pyrgakis, Vlassios, Dezsi, Csaba, Lupkovics, Geza, Polgar, Peter, Tomcsanyi, Janos, Herrman, J., ten Berg, J. M., Gorny, Jerzy, Kubica, Jacek, Lewczuk, Jerzy, Zmuda, Witold, Hranai, Marian, Kovar, Frantisek, Margoczy, Roman, Micko, Karol, Sumbal, Jaroslav, Genover, Xavier Bosch, Ortiz, Antonio Fernandez, Sala, Migue Fiol, Garcia, Cosme Garcia, Munoz, Carlos Perez, Rey Blas, Juan Ramon, Soriano, Franciso Ridocci, Adamson, Dawn, Alamgir, Farqad, Chauhan, Anoop, Lip, Gregory, Martin, Thomas, McCann, Gerry, Newby, David and Smith, David (2014) Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The randomized double-blind reminder study. European Heart Journal, 35 (34). pp. 2295-2302. ISSN 0195-668X

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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.

Item Type: Article
Uncontrolled Keywords: myocardial infarction,mineralocorticoid receptor antagonists,eplerenone,b-type natriuretic peptide,potassium
Faculty \ School: Faculty of Medicine and Health Sciences > Norwich Medical School
UEA Research Groups: Faculty of Medicine and Health Sciences > Research Groups > Cardiovascular and Metabolic Health
Faculty of Medicine and Health Sciences > Research Groups > Norwich Clinical Trials Unit
Faculty of Medicine and Health Sciences > Research Groups > Public Health and Health Services Research (former - to 2023)
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Depositing User: Pure Connector
Date Deposited: 01 Apr 2016 10:10
Last Modified: 07 Nov 2023 01:49
URI: https://ueaeprints.uea.ac.uk/id/eprint/58029
DOI: 10.1093/eurheartj/ehu164

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