title: A Randomized Controlled Study of Finerenone vs. Eplerenone in Japanese Patients With Worsening Chronic Heart Failure and Diabetes and/or Chronic Kidney Disease.
abstract: 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.
  
  
  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).
authors.affiliation: Cardiology and Intensive Care Unit, Nippon Medical School, Musashi Kosugi Hospital.
authors.forename: Naoki
authors.initials: N
authors.lastname: Sato
authors.forename: Masayoshi
authors.initials: M
authors.lastname: Ajioka
authors.forename: Takahisa
authors.initials: T
authors.lastname: Yamada
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kato
authors.forename: Masafumi
authors.initials: M
authors.lastname: Myoishi
authors.forename: Takashi
authors.initials: T
authors.lastname: Yamada
authors.forename: So-Young
authors.initials: SY
authors.lastname: Kim
authors.forename: Christina
authors.initials: C
authors.lastname: Nowack
authors.forename: Peter
authors.initials: P
authors.lastname: Kolkhof
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Shiga
mesh_terms: D000328:Adult; D002908:Chronic Disease; D003920:Diabetes Mellitus; D004311:Double-Blind Method; D000077545:Eplerenone; D006333:Heart Failure / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D006947:Hyperkalemia / Q000139:chemically induced; D007564:Japan; D009287:Naphthyridines / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D020097:Natriuretic Peptide, Brain / Q000097:blood; D061214:Patient Safety; D010446:Peptide Fragments / Q000097:blood; D051436:Renal Insufficiency, Chronic / Q000150:complications / Q000188:drug therapy*; D013148:Spironolactone / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D009287:Naphthyridines; D010446:Peptide Fragments; C576501:finerenone; C109794:pro-brain natriuretic peptide (1-76); D020097:Natriuretic Peptide, Brain; D013148:Spironolactone; D000077545:Eplerenone