
Aldose reductase inhibitor ranirestat significantly improves nerve conduction velocity in diabetic polyneuropathy: A randomized double‐blind placebo‐controlled study in Japan
Author(s) -
Sekiguchi Kenji,
Kohara Nobuo,
Baba Masayuki,
Komori Tetsuo,
Naito Yutaka,
Imai Tomihiro,
Satoh Jo,
Yamaguchi Yasuyuki,
Hamatani Tatsuto
Publication year - 2019
Publication title -
journal of diabetes investigation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.089
H-Index - 50
eISSN - 2040-1124
pISSN - 2040-1116
DOI - 10.1111/jdi.12890
Subject(s) - medicine , nerve conduction velocity , placebo , polyneuropathy , diabetic neuropathy , tibial nerve , diabetes mellitus , randomized controlled trial , anesthesia , median nerve , aldose reductase inhibitor , surgery , endocrinology , aldose reductase , pathology , alternative medicine , stimulation
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.