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- Title
Aldose reductase inhibitor ranirestat significantly improves nerve conduction velocity in diabetic polyneuropathy: A randomized double‐blind placebo‐controlled study in Japan.
- Authors
Sekiguchi, Kenji; Kohara, Nobuo; Baba, Masayuki; Komori, Tetsuo; Naito, Yutaka; Imai, Tomihiro; Satoh, Jo; Yamaguchi, Yasuyuki; Hamatani, Tatsuto
- 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. This study shows that ranirestat, aldose reductase inhibitor, significantly improves nerve conduction velocity in patients with diabetic polyneuropathy.
- Subjects
JAPAN; REDUCTASE inhibitors; ALDOSE reductase; NEURAL conduction; MEDIAN nerve; TIBIAL nerve; GROUP velocity; POLYNEUROPATHIES
- Publication
Journal of Diabetes Investigation, 2019, Vol 10, Issue 2, p466
- ISSN
2040-1116
- Publication type
Article
- DOI
10.1111/jdi.12890