A long-term effect of epalrestat on motor conduction velocity of diabetic patients: ARI-Diabetes Complications Trial (ADCT).

Abstract

In order to study a long-term effect along with adverse action of epalrestat, an aldose reductase inhibitor, a randomized, prospective study was conducted over the period of 3 years at 112 facilities. Six hundred and three diabetic patients with median motor conduction velocity (MCV)>40 m/s, HbA1c<9% were randomly allocated to epalrestat (50 mg/day p.o. ac, t.i.d.) group (E group: n=289, age: 61+/-9.8 y.o.) and a control group (C group: n=305, age: 61+/-9.1 y.o.). MCV was measured once a year for 3 years. MCV (m/s, M+/-S.D.) on baseline, 1 year and 3 years, was 52.0+/-4.5, 52.2+/-4.9, 52.1+/-4.6 in E group and 53.3+/-4.4, 52.4+/-4.2, 52.0+/-4.6 in C group, respectively. After 3 years, difference from the baseline was significant (p<0.0001, E versus C). Among the subjects with HbA1c<7.0%, C group showed marked deterioration of MCV while in E group, there was no significant deterioration (p<0.001). Although, the subjects with pre-proliferative or proliferative retinopathy, there was no difference between E and C groups for 3 years, in subjects with background retinopathy or without retinopathy, deterioration rate of E group was significantly less than that of C group (p<0.0001). Epalrestat was found to prevent deterioration of MCV especially in well-controlled patients without advanced complications. No remarkable side effects serious enough to discontinue the study was observed.

• Authors: Kempei Matsuoka, Nobuo Sakamoto, Yasuo Akanuma, Nigishi Hotta, Motoaki Shichiri, Takayoshi Toyota, Yoshitomo Oka, Ryuzo Kawamori, Yukio Shigeta, ADCT Study Group
• Journal: Diabetes research and clinical practice (Diabetes Res Clin Pract) Vol. 77 Suppl 1 Pg. S263-8 (Sep 2007) ISSN: 0168-8227 [Print] Ireland
• PMID: 17599629 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Enzyme Inhibitors
• Glycated Hemoglobin A
• Thiazolidines
• epalrestat
• Rhodanine
• Aldehyde Reductase

Topics

• Age of Onset
• Aged
• Aldehyde Reductase (antagonists & inhibitors)
• Body Mass Index
• Diabetes Mellitus (physiopathology)
• Diabetes Mellitus, Type 2 (physiopathology)
• Diabetic Neuropathies (physiopathology)
• Enzyme Inhibitors (therapeutic use)
• Female
• Glycated Hemoglobin (analysis, metabolism)
• Humans
• Male
• Middle Aged
• Motor Neurons (drug effects, physiology)
• Neural Conduction (drug effects)
• Prospective Studies
• Rhodanine (analogs & derivatives, therapeutic use)
• Thiazolidines (therapeutic use)