PMID- 28025025
OWN - NLM
STAT- MEDLINE
DCOM- 20180319
LR  - 20210721
IS  - 1873-460X (Electronic)
IS  - 1056-8727 (Linking)
VI  - 31
IP  - 4
DP  - 2017 Apr
TI  - A randomized controlled study of finerenone versus placebo in Japanese patients 
      with type 2 diabetes mellitus and diabetic nephropathy.
PG  - 758-765
LID - S1056-8727(16)30603-1 [pii]
LID - 10.1016/j.jdiacomp.2016.11.021 [doi]
AB  - AIMS: Finerenone (BAY 94-8862) is a novel non-steroidal mineralocorticoid 
      receptor antagonist. The aim of this study was to compare the efficacy and safety 
      of seven once-daily oral doses of finerenone (1.25-20mg) and placebo in 96 
      patients with type 2 diabetes mellitus (T2DM) and diabetic nephropathy (DN) 
      receiving a RAS blocker. METHODS: ARTS-DN Japan was a multicenter, randomized, 
      double-blind, placebo-controlled, phase 2b study. RESULTS: Analysis of the 
      urinary albumin-to-creatinine ratio (UACR) at day 90 relative to baseline 
      indicated a nominally significant effect of finerenone. The UACR at day 90 
      relative to baseline for each finerenone treatment group was numerically reduced 
      compared with placebo. No serious adverse events (AEs) or deaths were reported 
      and no patients experienced treatment-emergent AEs resulting in discontinuation 
      of study drug. Small mean increases in serum potassium level were observed in the 
      finerenone treatment groups (0.025-0.167mmol/L) compared with the placebo group 
      (-0.075mmol/L); no patients developed hyperkalemia. CONCLUSION: When given in 
      addition to a RAS inhibitor, finerenone reduced albuminuria without adverse 
      effects on serum potassium levels or renal function in Japanese patients with 
      T2DM and DN.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Inc. All rights reserved.
FAU - Katayama, Shigehiro
AU  - Katayama S
AD  - Kawagoe Clinic, Saitama Medical University, Saitama, Japan. Electronic address: 
      skataya@saitama-med.ac.jp.
FAU - Yamada, Daishiro
AU  - Yamada D
AD  - Jiyugaoka Yamada Clinic, Hokkaido, Japan.
FAU - Nakayama, Mikihiro
AU  - Nakayama M
AD  - Nakayama Clinic, Aichi, Japan.
FAU - Yamada, Takashi
AU  - Yamada T
AD  - Bayer Yakuhin, Ltd, Osaka, Japan.
FAU - Myoishi, Masafumi
AU  - Myoishi M
AD  - Bayer Yakuhin, Ltd, Osaka, Japan.
FAU - Kato, Masaharu
AU  - Kato M
AD  - Bayer Yakuhin, Ltd, Osaka, Japan.
FAU - Nowack, Christina
AU  - Nowack C
AD  - Global Clinical Development, Bayer Pharma AG, Wuppertal, Germany.
FAU - Kolkhof, Peter
AU  - Kolkhof P
AD  - Heart Diseases Research, Global Drug Discovery, Bayer Pharma AG, Wuppertal, 
      Germany.
FAU - Yamasaki, Yoshimitsu
AU  - Yamasaki Y
AD  - AMC Nishi Umeda Clinic, Osaka, Japan.
CN  - ARTS-DN Japan study group
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20161214
PL  - United States
TA  - J Diabetes Complications
JT  - Journal of diabetes and its complications
JID - 9204583
RN  - 0 (Biomarkers)
RN  - 0 (Mineralocorticoid Receptor Antagonists)
RN  - 0 (Naphthyridines)
RN  - 0 (finerenone)
SB  - IM
CIN - J Diabetes Complications. 2017 Apr;31(4):651-652. PMID: 28153675
MH  - Aged
MH  - Albuminuria/etiology/*prevention & control
MH  - Biomarkers/blood/urine
MH  - Diabetes Mellitus, Type 2/*complications
MH  - Diabetic Nephropathies/blood/*drug therapy/physiopathology/urine
MH  - Disease Progression
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination/adverse effects
MH  - Female
MH  - Follow-Up Studies
MH  - Glomerular Filtration Rate/drug effects
MH  - Humans
MH  - Japan
MH  - Kidney/*drug effects/physiopathology
MH  - Male
MH  - Middle Aged
MH  - Mineralocorticoid Receptor Antagonists/administration & dosage/adverse 
      effects/*therapeutic use
MH  - Naphthyridines/administration & dosage/adverse effects/*therapeutic use
MH  - Renal Insufficiency/complications/*drug therapy/metabolism/physiopathology
MH  - Renin-Angiotensin System/drug effects
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - Albuminuria
OT  - Diabetic nephropathy
OT  - Finerenone
OT  - MRA
OT  - Type 2 diabetes
EDAT- 2016/12/28 06:00
MHDA- 2018/03/20 06:00
CRDT- 2016/12/28 06:00
PHST- 2016/10/05 00:00 [received]
PHST- 2016/11/24 00:00 [revised]
PHST- 2016/11/25 00:00 [accepted]
PHST- 2016/12/28 06:00 [pubmed]
PHST- 2018/03/20 06:00 [medline]
PHST- 2016/12/28 06:00 [entrez]
AID - S1056-8727(16)30603-1 [pii]
AID - 10.1016/j.jdiacomp.2016.11.021 [doi]
PST - ppublish
SO  - J Diabetes Complications. 2017 Apr;31(4):758-765. doi: 
      10.1016/j.jdiacomp.2016.11.021. Epub 2016 Dec 14.