학술논문
Efficacy and Safety of Early Initiation of Eplerenone Treatment in Patients with Acute Heart Failure (EARLIER trial): a multicentre, randomized, double-blind, placebo-controlled trial
Document Type
Clinical report
Author
Asakura, Masanori; Ito, Shin; Yamada, Takahisa; Saito, Yoshihiko; Kimura, Kazuo; Yamashina, Akira; Hirayama, Atsushi; Kobayashi, Youichi; Hanatani, Akihisa; Tsujimoto, Mitsuru; Yasuda, Satoshi; Abe, Yukio; Higashino, Yorihiko; Tamaki, Yodo; Sugino, Hiroshi; Niinuma, Hiroyuki; Okuhara, Yoshitaka; Koitabashi, Toshimi; Momomura, Shin-Ichi; Asai, Kuniya; Nomura, Akihiro; Kawai, Hiroya; Satoh, Yasuhiro; Yoshikawa, Tsutomu; Hirata, Ken-Ichi; Yokoi, Yoshiaki; Tanaka, Jun; Shibata, Yoshisato; Maejima, Yasuhiro; Tamaki, Shunsuke; Kawata, Hiroyuki; Iwahashi, Noriaki; Kobayashi, Masatake; Higuchi, Yoshiharu; Kada, Akiko; Yamamoto, Haruko; Kitakaze, Masafumi
Source
European Heart Journal: Cardiovascular Pharmacotherapy. March 2022, Vol. 8 Issue 2, p108, 10 p.
Subject
Language
English
ISSN
2055-6837
Abstract
Introduction The incidences of acute heart failure (AHF), as well as chronic heart failure (HF), have been steadily increasing because of various social and biological factors, including the ageing of [...]
Aims A mineralocorticoid receptor antagonist (MRA) is effective in patients with chronic heart failure; however, the effects of the early initiation of an MRA in patients with acute heart failure (AHF) have not been elucidated. Methods and results In this multicentre, randomized, double-blind, placebo-controlled, parallel-group study, we focused on the safety and effectiveness of the treatment with eplerenone, a selective MRA in 300 patients with AHF, that is, 149 in the eplerenone group and 151 in the placebo group in 27 Japanese institutions. The key inclusion criteria were (i) patients aged 20years or older and (ii) those with left ventricular ejection fraction of [less than or equal to]40%. The primary outcome was a composite of cardiac death or first re-hospitalization due to cardiovascular disease within 6 months. The mean age of the participants was 66.8 years, 27.3% were women, and the median levels of brain natriuretic peptide were 376.0pg/mL. The incidences of the primary outcome were 19.5% in the eplerenone group and 17.2% in the placebo group [hazard ratio (HR): 1.09, 95% confidence interval (CI): 0.642-1.855]. In prespecified secondary outcomes, HR for the composite endpoint, cardiovascular death, or first re-hospitalization due to heart failure within 6 months was 0.55 (95% CI: 0.213-1.434). The safety profile for eplerenone was as expected. Conclusion The early initiation of eplerenone in patients with AHF could safely be utilized. The reduction of the incidence of a composite of cardiovascular death or first re-hospitalization for cardiovascular diseases by eplerenone is inconclusive because of inadequate power. Keywords Mineralocorticoid receptor antagonist * Acute heart failure * Eplerenone
Aims A mineralocorticoid receptor antagonist (MRA) is effective in patients with chronic heart failure; however, the effects of the early initiation of an MRA in patients with acute heart failure (AHF) have not been elucidated. Methods and results In this multicentre, randomized, double-blind, placebo-controlled, parallel-group study, we focused on the safety and effectiveness of the treatment with eplerenone, a selective MRA in 300 patients with AHF, that is, 149 in the eplerenone group and 151 in the placebo group in 27 Japanese institutions. The key inclusion criteria were (i) patients aged 20years or older and (ii) those with left ventricular ejection fraction of [less than or equal to]40%. The primary outcome was a composite of cardiac death or first re-hospitalization due to cardiovascular disease within 6 months. The mean age of the participants was 66.8 years, 27.3% were women, and the median levels of brain natriuretic peptide were 376.0pg/mL. The incidences of the primary outcome were 19.5% in the eplerenone group and 17.2% in the placebo group [hazard ratio (HR): 1.09, 95% confidence interval (CI): 0.642-1.855]. In prespecified secondary outcomes, HR for the composite endpoint, cardiovascular death, or first re-hospitalization due to heart failure within 6 months was 0.55 (95% CI: 0.213-1.434). The safety profile for eplerenone was as expected. Conclusion The early initiation of eplerenone in patients with AHF could safely be utilized. The reduction of the incidence of a composite of cardiovascular death or first re-hospitalization for cardiovascular diseases by eplerenone is inconclusive because of inadequate power. Keywords Mineralocorticoid receptor antagonist * Acute heart failure * Eplerenone