Rioprostil in the short-term treatment of duodenal ulcer: a multicentre double-blind trial vs. cimetidine

The efficacy and safety of the new prostaglandin E1 (PGE1) synthetic analogue, rioprostil, 300 micrograms b.d. and cimetidine, 400 mg b.d., on duodenal ulcer healing are compared in an international, multicentre, double-blind study. A total of 257 patients have entered the study; 243 are considered eligible for efficacy analysis and 207 for safety analysis. After 4 and 6 weeks of treatment, the endoscopic healing rates do not significantly differ between the two groups, being 55% and 83% respectively with rioprostil vs. 60% and 78% respectively with cimetidine. The major adverse effect attributable to rioprostil is diarrhoea, which was documented in 11% of patients compared with 1% of patients taking cimetidine. However, central nervous system complaints are twice as frequent in the cimetidine group. Monitoring of clinical laboratory tests show no significant abnormalities when compared with the baseline values during the administration of either drug. This study documents that rioprostil, at the dosage of 300 micrograms b.d., is as effective and safe as cimetidine in the short-term therapy of duodenal ulcer.