A randomized controlled study of finerenone versus placebo in Japanese patients with type 2 diabetes mellitus and diabetic nephropathy

• Published in: Journal of diabetes and its complications 2017-04, Vol.31 (4), p.758-765
• Main Authors: Katayama, Shigehiro, Yamada, Daishiro, Nakayama, Mikihiro, Yamada, Takashi, Myoishi, Masafumi, Kato, Masaharu, Nowack, Christina, Kolkhof, Peter, Yamasaki, Yoshimitsu
• Format: Article
• Language: English
• Subjects: Aged; Albuminuria; Albuminuria - etiology; Albuminuria - prevention & control; Biomarkers - blood; Biomarkers - urine; Diabetes; Diabetes Mellitus, Type 2 - complications; Diabetic Nephropathies - blood; Diabetic Nephropathies - drug therapy; Diabetic Nephropathies - physiopathology; Diabetic Nephropathies - urine; Diabetic nephropathy; Disease Progression; Dose-Response Relationship, Drug; Double-Blind Method; Drug dosages; Drug Therapy, Combination - adverse effects; Endocrinology & Metabolism; Female; Finerenone; Follow-Up Studies; Glomerular Filtration Rate - drug effects; Heart failure; Hemodialysis; Humans; Japan; Kidney - drug effects; Kidney - physiopathology; Kidney diseases; Male; Middle Aged; Mineralocorticoid Receptor Antagonists - administration & dosage; Mineralocorticoid Receptor Antagonists - adverse effects; Mineralocorticoid Receptor Antagonists - therapeutic use; MRA; Naphthyridines - administration & dosage; Naphthyridines - adverse effects; Naphthyridines - therapeutic use; Potassium; Renal Insufficiency - complications; Renal Insufficiency - drug therapy; Renal Insufficiency - metabolism; Renal Insufficiency - physiopathology; Renin-Angiotensin System - drug effects; Reproducibility of Results; Rodents; Type 2 diabetes
• ISSN: 1056-8727; 1873-460X
• DOI: 10.1016/j.jdiacomp.2016.11.021

Abstract 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 (1.25–20 mg) 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 (0.025–0.167 mmol/L) compared with the placebo group (− 0.075 mmol/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.