Efficacy and safety of rioprostil, 300 micrograms b.d., in the treatment of duodenal ulcer: a double-blind, controlled multicentre clinical study vs. ranitidine.
This study is undertaken to evaluate the efficacy and safety of rioprostil, 300 micrograms, compared with ranitidine, 150 mg, when given twice daily for 4-6 weeks to patients with active, uncomplicated duodenal ulcer. The effects of each drug on ulcer healing are evaluated by endoscopy. Of a total of 355 patients who have entered this study, 319 are statistically evaluated for efficacy; 162 receive rioprostil and 157 receive ranitidine. After 4 weeks of treatment, 63% of the patients receiving rioprostil are endoscopically healed, compared with 72% of those receiving ranitidine. After 6 weeks of treatment, the cumulative healing rates are 86% and 93.5% respectively; this difference is statistically significant. Diarrhoea is the main adverse event, but is generally mild and self-limiting. These results indicate that rioprostil, 300 micrograms b.d., is a safe and effective treatment for duodenal ulcer, but is slightly less effective than ranitidine, 150 mg b.d.
Coremans
G
G
Department of Internal Medicine, University of Leuven, U.Z. Gasthuisberg, Belgium.
Vantrappen
G
G
Businger
J A
JA
Demol
P
P
D000328:Adult; D000368:Aged; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011458:Prostaglandins E / Q000008:administration & dosage / Q000627:therapeutic use*; D011465:Prostaglandins, Synthetic / Q000627:therapeutic use; D016032:Randomized Controlled Trials as Topic; D011899:Ranitidine / Q000008:administration & dosage / Q000627:therapeutic use*; D016630:Rioprostil
D000897:Anti-Ulcer Agents; D011458:Prostaglandins E; D011465:Prostaglandins, Synthetic; D016630:Rioprostil; D011899:Ranitidine