Aldose reductase inhibitor ranirestat significantly improves nerve conduction velocity in diabetic polyneuropathy: A randomized double‐blind placebo‐controlled study in Japan

Journal of Diabetes Investigation

the Ranirestat Group¹  Masayuki Baba²  Yutaka Naito³  Nobuo Kohara⁴  Tetsuo Komori⁵  Tomihiro Imai⁶  Kenji Sekiguchi⁷  Tatsuto Hamatani⁸  Yasuyuki Yamaguchi⁸  Jo Satoh⁹ 

[1] ;Department of Neurology Aomori Prefectural Central Hospital Aomori Japan;Department of Neurology Japanese Red Cross Ise Hospital Ise Mie Japan;Department of Neurology Kobe City Medical Center General Hospital Kobe Hyogo Japan;Department of Neurology National Hakone Hospital Kanagawa Japan;Department of Occupational Therapy Sapporo Medical University School of Health Sciences Sapporo Japan;Division of Neurology Kobe University Graduate School of Medicine Kobe Hyogo Japan;Sumitomo Dainippon Pharma Co., Ltd Osaka Japan;Tohoku Medical and Pharmaceutical University Wakabayashi Hospital Sendai Miyagi Japan;

关键词: Diabetic polyneuropathy;    Nerve conduction velocity;    Ranirestat;   

DOI  :  10.1111/jdi.12890

来源: DOAJ

【 摘 要 】

Abstract Aims/Introduction Diabetic polyneuropathy is one of the most frequent diabetic complications, and impairs patients’ quality of life. We evaluated the efficacy and safety of ranirestat (40 mg/day) in patients with diabetic polyneuropathy. Materials and Methods This was a multicenter, placebo‐controlled, randomized double‐blind, parallel‐group, phase III study in which 557 patients were randomly assigned to either the ranirestat or placebo group and assessed for 52 weeks. The co‐primary end‐points were the changes in tibial motor nerve conduction velocity and total modified Toronto Clinical Neuropathy Score as a measure of clinical symptoms. Results There was a significant increase in tibial motor nerve conduction velocity in the ranirestat group compared with the placebo group. The difference between groups in the change at last observation was 0.52 m/s (P = 0.021). Increases in nerve conduction velocity in the ranirestat group were found not only in the tibial motor nerves, but also in the median motor nerves, proximal median sensory nerves and distal median sensory nerves. No significant differences in modified Toronto Clinical Neuropathy Score or safety parameters were found between the two groups. Conclusions Ranirestat (40 mg/day) was well tolerated and improved nerve conduction velocity. Regarding symptoms and signs, no detectable benefits over the placebo were observed in the ranirestat group during the 52 weeks of treatment.

【 授权许可】

Unknown