학술논문
Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study
Document Type
Academic Journal
Author
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; OʼNeill, 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; Münzel, Thomas; Steiner, Stephan; Strasser, Ruth; Sydow, Karsten; Tschöpe, 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, Miguel Fiol; Garcia, Cosme Garcia; Muñoz, Carlos Perez; Rey Blas, Juan Ramon; Soriano, Franciso Ridocci; Adamson, Dawn; Alamgir, Farqad; Chauhan, Anoop; Lip, Gregory; Martin, Thomas; McCann, Gerry; Newby, David; Smith, David
Source
European Heart Journal. Sep 07, 2014 35(34):2295-2302
Subject
Language
English
ISSN
0195-668X
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.