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Circ J. 2017 Dec 25;82(1):148-158. doi: 10.1253/circj.CJ-17-0323. Epub 2017 Aug 19.

Double-Blind, Randomized, Placebo-Controlled Trial Evaluating the Efficacy and Safety of Eplerenone in Japanese Patients With Chronic Heart Failure (J-EMPHASIS-HF).

Author information

1
Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kyushu University.
2
Department of Cardiovascular Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
3
Department of Clinical Medicine and Development, National Cerebral and Cardiovascular Research Center.
4
Department of Cardiovascular Medicine, the University of Tokyo Graduate School of Medicine.
5
Department of Cardiology, Nagoya University Graduate School of Medicine.
6
Kitasato University.
7
Niigata Minami Hospital.
8
Center for Disruptive Cardiovascular Medicine, Kyushu University.
9
Cardiovascular Division, Osaka Police Hospital.
10
Division of Cardiology, Department of Medicine and Clinical Science, Yamaguchi University Graduate School of Medicine.
11
Department of Molecular Medicine and Therapeutics, Faculty of Medicine, Tottori University.
12
Department of Cardiology, Sakakibara Heart Institute.
13
Cardiovascular Medicine, Toyosato Hospital.
14
Clinical Research, Development Japan, Pfizer Japan.
15
Clinical Statistics, Development Japan, Pfizer Japan.
16
St. Hill Hospital.
17
Yamaguchi University.

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.

KEYWORDS:

Clinical trial; Eplerenone; Heart failure; Japanese; Mineralocorticoid receptor antagonist

PMID:
28824029
DOI:
10.1253/circj.CJ-17-0323
[Indexed for MEDLINE]
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