title: Effect of Ranirestat on Sensory and Motor Nerve Function in Japanese Patients with Diabetic Polyneuropathy: A Randomized Double-Blind Placebo-Controlled Study.
abstract: We conducted a 26-week oral-administration study of ranirestat (an aldose reductase inhibitor) at a once-daily dose of 20 mg to evaluate its efficacy and safety in Japanese patients with diabetic polyneuropathy (DPN). The primary endpoint was summed change in sensory nerve conduction velocity (NCV) for the bilateral sural and proximal median sensory nerves. The sensory NCV was significantly (P = 0.006) improved by ranirestat. On clinical symptoms evaluated with the use of modified Toronto Clinical Neuropathy Score (mTCNS), obvious efficacy was not found in total score. However, improvement in the sensory test domain of the mTCNS was significant (P = 0.037) in a subgroup of patients diagnosed with neuropathy according to the TCNS severity classification. No clinically significant effects on safety parameters including hepatic and renal functions were observed. Our results indicate that ranirestat is effective on DPN (Japic CTI-121994).
authors.affiliation: NTT-EAST Tohoku Hospital, 2-29-1 Yamato-machi, Wakabayashi-ku, Sendai, Miyagi 984-8560, Japan.
authors.forename: Jo
authors.initials: J
authors.lastname: Satoh
authors.affiliation: Department of Neurology, Kobe City Medical Center General Hospital, 4-6 Minatojima-Nakamachi, Chuo-ku, Kobe, Hyogo 650-0046, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Kohara
authors.affiliation: Division of Neurology, Kobe University Graduate School of Medicine, 7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo 650-0017, Japan.
authors.forename: Kenji
authors.initials: K
authors.lastname: Sekiguchi
authors.affiliation: Sumitomo Dainippon Pharma, Co., Ltd., 6-8 Doshomachi 2-chome, Chuo-ku, Osaka 541-0045, Japan.
authors.forename: Yasuyuki
authors.initials: Y
authors.lastname: Yamaguchi
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000449:Aldehyde Reductase / Q000378:metabolism; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000188:drug therapy; D003929:Diabetic Neuropathies / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007564:Japan; D007677:Kidney Function Tests; D008111:Liver Function Tests; D008297:Male; D008875:Middle Aged; D009046:Motor Neurons / Q000187:drug effects*; D009431:Neural Conduction; D011719:Pyrazines / Q000627:therapeutic use*; D011984:Sensory Receptor Cells / Q000187:drug effects*; D012720:Severity of Illness Index; D013141:Spiro Compounds / Q000627:therapeutic use*; D013696:Temperature
chemical_list: D004791:Enzyme Inhibitors; D011719:Pyrazines; D013141:Spiro Compounds; D000449:Aldehyde Reductase; C115070:ranirestat