Efficacy and Safety of Rioprostil, 300 μg b.d., in the Treatment of Duodenal Ulcer: A Double-Blind, Controlled Multicentre Clinical Study vs. Ranitidine

Abstract

Coremans G, Vantrappen G, Businger JA, Demol P, Coinvestigators. Efficacy and safety of rioprostil, 300 μg b.d., in the treatment of duodenal ulcer; a double-blind, controlled multicentre clinical study vs. ranitidine. Scand J Gastroenterol 1989, 24(suppl 164), 198-206

This study is undertaken to evaluate the efficacy and safety of rioprostil, 300 μg, 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 μg b.d., is a safe and effective treatment for duodenal ulcer, but is slightly less effective than ranitidine, 150mg b.d.

Key Words:

• Duodenal ulcer
• Ranitidine
• rioprostil