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
| Autor: | Toshimi Koitabashi, Yoshihiko Saito, Hiroyuki Niinuma, Haruko Yamamoto, Takahisa Yamada, Shin-ichi Momomura, Youichi Kobayashi, Hiroya Kawai, Yasuhiro Maejima, Masanori Asakura, Kuniya Asai, Yoshiharu Higuchi, Yoshiaki Yokoi, Mitsuru Tsujimoto, Akihiro Nomura, Atsushi Hirayama, Noriaki Iwahashi, Tsutomu Yoshikawa, Yoshitaka Okuhara, Yoshisato Shibata, study coordinators, Earlier investigators, Masatake Kobayashi, Shunsuke Tamaki, Yukio Abe, Masafumi Kitakaze, Hiroshi Sugino, Kazuo Kimura, Shin Ito, Yasuhiro Satoh, Satoshi Yasuda, Akira Yamashina, Hiroyuki Kawta, Akiko Kada, Jun Tanaka, Ken-ichi Hirata, Yorihiko Higashino, Youdo Tamaki, Akihisa Hanatani |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Placebo-controlled study Spironolactone Ventricular Function Left Mineralocorticoid receptor Internal medicine medicine Humans Pharmacology (medical) Aged Heart Failure Ejection fraction business.industry Hazard ratio Stroke Volume medicine.disease Brain natriuretic peptide Confidence interval Eplerenone Heart failure Cardiology Female Cardiology and Cardiovascular Medicine business medicine.drug |
| Zdroj: | European heart journal. Cardiovascular pharmacotherapy. 8(2) |
| ISSN: | 2055-6845 |
| Popis: | 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 20 years or older and (ii) those with left ventricular ejection fraction of ≤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 376.0 pg/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. |
| Databáze: | OpenAIRE |
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