[Clinical utility of long-term administration of trapidil (MDR-1865) in the treatment of diabetic retinopathy].
In order to investigate the usefulness of prolonged administration of trapidil in the treatment of diabetic retinopathy, a follow-up study was carried out after the end of a placebo-controlled, double-blind study of the drug in case of the trapidil-treated group who continued to be treated with 300 mg/day of trapidil (Rocornal) (TT group) and those of the placebo group who were not given any treatment after the end of the study (PP group). The TT group was significantly superior or tended to be superior to the PP group in improvement of hard exudates, retinal hemorrhages and soft exudates, and also in improvement of capillary microaneurysms on fluorescein fundus angiography. In the course of diabetic retinopathy by the global evaluation of findings in individual cases, the TT group was significantly superior or tended to be superior to the PP group. Photocoagulation was performed on 20 (28%) of 72 eyes of the PP group and 13 (19%) of 68 eyes of the TT group, with the mean interval to photocoagulation being 7.2 months for the PP group and 14.0 months for the TT group. There was a significant difference between the 2 groups in terms of the interval to photocoagulation. Randomized fundus photographic evaluation of the findings by the central evaluation committee showed that the TT group was significantly superior or tended to be superior in improving retinal hemorrhages, soft exudates and leakage of fluorescein dye, and was also significantly superior or tended to be superior in relation to the course of the retinopathy, which was consistent with the evaluation by the attending ophthalmologists.(ABSTRACT TRUNCATED AT 250 WORDS)
Department of Ophthalmology, School of Medicine, University of the Ryukyus, Japan.
M
M
Fukuda
H
H
Yoshimoto
M
M
Nakashima
D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003930:Diabetic Retinopathy / Q000188:drug therapy* / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011743:Pyrimidines / Q000008:administration & dosage*; D014192:Trapidil / Q000008:administration & dosage* / Q000627:therapeutic use
D011743:Pyrimidines; D014192:Trapidil