A long-term effect of epalrestat on motor conduction velocity of diabetic patients: ARI-Diabetes Complications Trial (ADCT).
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.
Matsuoka
Kempei
K
Saiseikai Shibuya Satellite Clinic, 3-2-3 Shibuya, Tokyo 105-0002, Japan.
Sakamoto
Nobuo
N
Akanuma
Yasuo
Y
Hotta
Nigishi
N
Shichiri
Motoaki
M
Toyota
Takayoshi
T
Oka
Yoshitomo
Y
Kawamori
Ryuzo
R
Shigeta
Yukio
Y
D017668:Age of Onset; D000368:Aged; D000449:Aldehyde Reductase / Q000037:antagonists & inhibitors; D015992:Body Mass Index; D003920:Diabetes Mellitus / Q000503:physiopathology*; D003924:Diabetes Mellitus, Type 2 / Q000503:physiopathology; D003929:Diabetic Neuropathies / Q000503:physiopathology*; D004791:Enzyme Inhibitors / Q000627:therapeutic use*; D005260:Female; D006442:Glycated Hemoglobin / Q000032:analysis / Q000378:metabolism; D006801:Humans; D008297:Male; D008875:Middle Aged; D009046:Motor Neurons / Q000187:drug effects / Q000502:physiology*; D009431:Neural Conduction / Q000187:drug effects*; D011446:Prospective Studies; D012236:Rhodanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D053778:Thiazolidines / Q000627:therapeutic use*
D000449:Aldehyde Reductase; D004791:Enzyme Inhibitors; D006442:Glycated Hemoglobin; D012236:Rhodanine; D053778:Thiazolidines; C038131:epalrestat