A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease

Abstract

on behalf of the ARTS-HF Japan study group Background: Finerenone, a nonsteroidal mineralocorticoid receptor antagonist, was evaluated in Japanese patients with heart failure (HF) with reduced ejection fraction and chronic kidney disease and/or diabetes mellitus.Methods and Results: ARTS-HF Japan was a randomized, double-blind, phase 2b study. Patients (n=72) received oral, once-daily (o.d.) finerenone (2.5, 5, 7.5, 10 or 15 mg, up-titrated to 5, 10, 15, 20, or 20 mg, respectively, on day 30) or eplerenone (25 mg every other day, increased to 25 mg o.d. on day 30, and 50 mg on day 60) for 90 days. The primary endpoint was the proportion of individuals with a decrease of >30% in plasma NT-proBNP at day 90. Safety endpoints included the incidence of hyperkalemia. Decreases in NT-proBNP occurred in 23.1% of patients in the eplerenone group and 15.4%, 23.1%, 45.5%, 27.3% and 45.5% in the 2.5→5 mg, 5→10 mg, 7.5→15 mg, 10→20 mg and 15→20 mg finerenone groups, respectively (all P=NS). Mean changes in serum potassium levels were similar between groups. Conclusions:Because of the small sample size, limited conclusions can be drawn. Considering the results of ARTS-HF and that finerenone was well tolerated in Japanese patients in ARTS-HF Japan, the safety and efficacy of finerenone should be further explored in a large outcomes trial including Japanese patients. (Circ J 2016; 80: 1113 -1122

The use of a novel non-steroidal mineralocorticoid receptor antagonist finerenone for the treatment of chronic heart failure

“…Figure 1 A shows the flow chart of study selection. After removal of duplicates, 126 citations were screened for potential eligibility and 4 articles [ 14 – 17 ] were reviewed in full text. A total of 3 RCTs [ 15 – 17 ] involving 1520 participants were included in this meta-analysis.…”

“…After removal of duplicates, 126 citations were screened for potential eligibility and 4 articles [ 14 – 17 ] were reviewed in full text. A total of 3 RCTs [ 15 – 17 ] involving 1520 participants were included in this meta-analysis. Two studies [ 16 , 17 ] included patients who used eplerenone and were followed up for 3 months.…”

Reappraisal on pharmacological and mechanical treatments of heart failure

“…In EPHESUS, eplerenone reduced hospitalizations and mortality in HFrEF/HEpEF [61], regardless of percutaneous coronary intervention [62]. However, no relevant studies support the hypothesis that eplerenone has a significantly beneficial effect on glucose homeostasis in patients with HFrEF and either glucose intolerance or diabetes [63].Finerenone was well tolerated and induced a 30% or greater decrease in NT-proBNP levels in a similar proportion of patients to eplerenone [64], and finerenone was well tolerated in Japanese patients in ARTS-HF Japan [65].…”

The novel mineralocorticoid receptor antagonist finerenone in diabetic kidney disease: Progress and challenges

“…However, the incidence of clinical composite endpoint was lower in subjects with all finerenone dosages than those with eplerenone, with the highest finerenone 10-20 mg group showing a much lower probability of each event. Mean changes in serum potassium levels were similar between groups [45,47].…”