Effects of an aldose reductase inhibitor, epalrestat, on diabetic neuropathy. Clinical benefit and indication for the drug assessed from the results of a placebo-controlled double-blind study.
The clinical efficacy of epalrestat (150 mg/day, 50 mg tid, po; A group), an aldose reductase inhibitor, was evaluated in 196 patients with diabetic neuropathy by a double-blind study using placebo (9 mg/day, 3 mg tid, po; P group) as a control for 12 weeks. The disappearance rates of upper limb spontaneous pain were 42.9% and 12.0% in the A and P groups, respectively, and those of lower limb spontaneous pain 48.6% and 22.6%, thus being significantly higher in the A group (p < 0.05, logrank-test). The motor nerve conduction velocity of the peroneal nerve significantly increased only in the A group (delta 1.6 +/- 0.6 m/sec, p < 0.01, paired t-test), and the extent of increase in that of the median nerve was significantly greater in the A group than in the P group (p < 0.05). Thresholds of vibratory sensation and autonomic nerve function were also significantly improved in the A group (p < 0.05). The data were reanalyzed by dividing patients into two groups according to their HbA1c values. The improvement ratings of subjective symptoms and of nerve function tests for cases with HbA1c > or = 7.5% were both significantly different between the A and P groups, with the improvement rate being higher in the A group, and also higher as compared to the analysis for cases with HbA1c < 7.5%.(ABSTRACT TRUNCATED AT 250 WORDS)
Goto
Y
Y
Tohoku Kousei-Nenkin Hospital, Sendai, Japan.
Hotta
N
N
Shigeta
Y
Y
Sakamoto
N
N
Kikkawa
R
R
D000368:Aged; D000449:Aldehyde Reductase / Q000009:adverse effects / Q000037:antagonists & inhibitors* / Q000494:pharmacology*; D001132:Arm; D001786:Blood Glucose; D003929:Diabetic Neuropathies / Q000097:blood / Q000503:physiopathology; D004311:Double-Blind Method; D004791:Enzyme Inhibitors / Q000009:adverse effects / Q000494:pharmacology; D005260:Female; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009431:Neural Conduction / Q000187:drug effects; D010146:Pain / Q000188:drug therapy; D012236:Rhodanine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology; D012684:Sensory Thresholds / Q000187:drug effects; D053778:Thiazolidines; D014732:Vibration / Q000009:adverse effects
D001786:Blood Glucose; D004791:Enzyme Inhibitors; D053778:Thiazolidines; C038131:epalrestat; D012236:Rhodanine; D000449:Aldehyde Reductase