A randomized trial of sorbinil, an aldose reductase inhibitor, in diabetic retinopathy. Sorbinil Retinopathy Trial Research Group.
A total of 497 patients aged 18 to 56 years with insulin-dependent diabetes mellitus for 1 to 15 years were randomly assigned to take oral sorbinil or placebo and followed up for a median of 41 months. The percentage of patients whose retinopathy severity grade at maximum follow-up had worsened by two or more levels was not significantly different between the two treatment groups (28% in the sorbinil group and 32% in the placebo group, P = .344). The number of microaneurysms increased at a slightly slower rate in the sorbinil group than in the placebo group, with statistically significant differences at 21 (P = .046) and 30 (P = .039) months but not at the maximum follow-up (P = .156). About 7% of the patients assigned sorbinil developed a hypersensitivity reaction in the first 3 months. On the basis of these results, it is unlikely that sorbinil administered at a dosage of 250 mg daily for 3 years has a clinically important effect on the course of retinopathy in adults with insulin-dependent diabetes of moderate duration. Our data are consistent, however, with a slightly slower progression rate in the microaneurysm count among patients assigned to take sorbinil, a finding of uncertain clinical importance.
D000293:Adolescent; D000328:Adult; D000449:Aldehyde Reductase / Q000037:antagonists & inhibitors*; D000783:Aneurysm / Q000188:drug therapy; D016009:Chi-Square Distribution; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000201:enzymology; D004361:Drug Tolerance; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D048289:Imidazolidines; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012171:Retinal Vessels / Q000187:drug effects; D013401:Sugar Alcohol Dehydrogenases / Q000037:antagonists & inhibitors*
D007093:Imidazoles; D048289:Imidazolidines; D013401:Sugar Alcohol Dehydrogenases; D000449:Aldehyde Reductase; C026411:sorbinil