• Kenji Sekiguchi, Nobuo Kohara, Masayuki Baba, Tetsuo Komori, Yutaka Naito, Tomihiro Imai, Jo Satoh, Yasuyuki Yamaguchi, Tatsuto Hamatani, and Ranirestat Group.
• Division of Neurology, Kobe University Graduate School of Medicine, Kobe, Hyogo, Japan.
• J Diabetes Investig. 2019 Mar 1; 10 (2): 466-474.

Aims/IntroductionDiabetic 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 MethodsThis 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.ResultsThere 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.ConclusionsRanirestat (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.© 2018 The Authors Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

28 keywords...

hide…