Double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of eplerenone in Japanese patients with chronic heart failure (J-EMPHASIS-HF)

J-EMPHASIS-HF Study Group

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Background: The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of <1 for the hazard ratio. Methods and Results: HFrEF patients with NYHA functional class II–IV and an EF ≤35% received eplerenone (n=111) or placebo (n=110) on top of standard therapy for at least 12 months. The primary endpoint was a composite of death from cardiovascular causes or hospitalization for HF. The primary endpoint occurred in 29.7% of patients in the eplerenone group vs. 32.7% in the placebo group [hazard ratio=0.85 (95% CI: 0.53–1.36)]. Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone. A total of 17 patients (15.3%) in the eplerenone group and 10 patients (9.1%) in the placebo group died. Adverse events, including hyperkalemia, were similar between the groups. Conclusions: Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study.

Original languageEnglish
Pages (from-to)148-158
Number of pages11
JournalCirculation Journal
Volume82
Issue number1
DOIs
Publication statusPublished - Jan 1 2018

Fingerprint

Hospitalization
Randomized Controlled Trials
Heart Failure
Placebos
Safety
Survival
eplerenone
Mineralocorticoid Receptor Antagonists
Hyperkalemia
Cause of Death
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of eplerenone in Japanese patients with chronic heart failure (J-EMPHASIS-HF). / J-EMPHASIS-HF Study Group.

In: Circulation Journal, Vol. 82, No. 1, 01.01.2018, p. 148-158.

Research output: Contribution to journalArticle

@article{7294b9e27f924c3d879675dc8055440a,
title = "Double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of eplerenone in Japanese patients with chronic heart failure (J-EMPHASIS-HF)",
abstract = "Background: The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of <1 for the hazard ratio. Methods and Results: HFrEF patients with NYHA functional class II–IV and an EF ≤35{\%} received eplerenone (n=111) or placebo (n=110) on top of standard therapy for at least 12 months. The primary endpoint was a composite of death from cardiovascular causes or hospitalization for HF. The primary endpoint occurred in 29.7{\%} of patients in the eplerenone group vs. 32.7{\%} in the placebo group [hazard ratio=0.85 (95{\%} CI: 0.53–1.36)]. Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone. A total of 17 patients (15.3{\%}) in the eplerenone group and 10 patients (9.1{\%}) in the placebo group died. Adverse events, including hyperkalemia, were similar between the groups. Conclusions: Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study.",
author = "{J-EMPHASIS-HF Study Group} and Hiroyuki Tsutsui and Hiroshi Ito and Masafumi Kitakaze and Issei Komuro and Toyoaki Murohara and Tohru Izumi and Kenji Sunagawa and Yoshio Yasumura and Masafumi Yano and Kazuhiro Yamamoto and Tsutomu Yoshikawa and Takayoshi Tsutamoto and Junwei Zhang and Akifumi Okayama and Yoshihiko Ichikawa and Kazuhiro Kanmuri and Masunori Matsuzaki",
year = "2018",
month = "1",
day = "1",
doi = "10.1253/circj.CJ-17-0323",
language = "English",
volume = "82",
pages = "148--158",
journal = "Circulation Journal",
issn = "1346-9843",
publisher = "Japanese Circulation Society",
number = "1",

}

TY - JOUR

T1 - Double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of eplerenone in Japanese patients with chronic heart failure (J-EMPHASIS-HF)

AU - J-EMPHASIS-HF Study Group

AU - Tsutsui, Hiroyuki

AU - Ito, Hiroshi

AU - Kitakaze, Masafumi

AU - Komuro, Issei

AU - Murohara, Toyoaki

AU - Izumi, Tohru

AU - Sunagawa, Kenji

AU - Yasumura, Yoshio

AU - Yano, Masafumi

AU - Yamamoto, Kazuhiro

AU - Yoshikawa, Tsutomu

AU - Tsutamoto, Takayoshi

AU - Zhang, Junwei

AU - Okayama, Akifumi

AU - Ichikawa, Yoshihiko

AU - Kanmuri, Kazuhiro

AU - Matsuzaki, Masunori

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Background: The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of <1 for the hazard ratio. Methods and Results: HFrEF patients with NYHA functional class II–IV and an EF ≤35% received eplerenone (n=111) or placebo (n=110) on top of standard therapy for at least 12 months. The primary endpoint was a composite of death from cardiovascular causes or hospitalization for HF. The primary endpoint occurred in 29.7% of patients in the eplerenone group vs. 32.7% in the placebo group [hazard ratio=0.85 (95% CI: 0.53–1.36)]. Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone. A total of 17 patients (15.3%) in the eplerenone group and 10 patients (9.1%) in the placebo group died. Adverse events, including hyperkalemia, were similar between the groups. Conclusions: Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study.

AB - Background: The mineralocorticoid receptor antagonist eplerenone improved clinical outcomes among patients with heart failure with reduced ejection faction (HFrEF) in the EMPHASIS-HF (Eplerenone in Mild Patients Hospitalization And SurvIval Study in Heart Failure) study. However, similar efficacy and safety have not been established in Japanese patients. We evaluated the efficacy and safety of eplerenone in patients with HFrEF in a multicenter, randomized, double-blind placebo-controlled outcome study (ClinicalTrials.gov Identifier: NCT01115855). The aim of the study was to evaluate efficacy predefined as consistency of the primary endpoint with that of EMPHASIS-HF at a point estimate of <1 for the hazard ratio. Methods and Results: HFrEF patients with NYHA functional class II–IV and an EF ≤35% received eplerenone (n=111) or placebo (n=110) on top of standard therapy for at least 12 months. The primary endpoint was a composite of death from cardiovascular causes or hospitalization for HF. The primary endpoint occurred in 29.7% of patients in the eplerenone group vs. 32.7% in the placebo group [hazard ratio=0.85 (95% CI: 0.53–1.36)]. Hospitalization for any cause and changes in plasma BNP and LVEF were favorable with eplerenone. A total of 17 patients (15.3%) in the eplerenone group and 10 patients (9.1%) in the placebo group died. Adverse events, including hyperkalemia, were similar between the groups. Conclusions: Eplerenone was well-tolerated in Japanese patients with HFrEF and showed results consistent with those reported in the EMPHASIS-HF study.

UR - http://www.scopus.com/inward/record.url?scp=85039710230&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85039710230&partnerID=8YFLogxK

U2 - 10.1253/circj.CJ-17-0323

DO - 10.1253/circj.CJ-17-0323

M3 - Article

C2 - 28824029

AN - SCOPUS:85039710230

VL - 82

SP - 148

EP - 158

JO - Circulation Journal

JF - Circulation Journal

SN - 1346-9843

IS - 1

ER -