RETRACTED: 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, HbAlc < 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 HbAlc < 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.