Efficacy and safety of rioprostil, 300 micrograms b.d., in the treatment of gastric ulcer: a comparison vs. ranitidine, 150 mg b.d., in a randomized multicentre study.

The aim of this study is a double-blind evaluation of the efficacy and safety of rioprostil, 300 micrograms, compared with ranitidine, 150 mg, when given twice a day for 4 or 8 weeks in patients with active, uncomplicated gastric ulcer disease. A total of 194 patients are entered into the study, of which 182 are statistically evaluated for efficacy. Eighty-seven receive rioprostil and 95 receive ranitidine. All patients receive two oral doses of study medication daily. After 4 weeks' treatment, 47.1% of the patients receiving rioprostil are endoscopically healed compared with 53.7% of those receiving ranitidine. After 8 weeks' treatment, the cumulative cure rates are 76.2% and 80.9% respectively. Side effects occur in 26% of the patients receiving rioprostil and in 15% of the patients receiving ranitidine. Gastrointestinal side effects are most common. Changes in stool consistency (i.e. soft stools or mild diarrhoea) are the most reported symptoms in patients receiving rioprostil. These effects are generally self-limiting. Three patients on rioprostil and one patient on ranitidine discontinue treatment due to side effects. No clinically significant changes in biochemical variables occur in either group throughout the treatment period. Rioprostil, 300 micrograms b.d., is a safe and effective treatment for gastric ulcer disease. Healing rates and alleviation of pain are comparable for both treatment groups. The change in stool consistency with rioprostil is of only minor clinical importance, that is, it occurs on about 2% of treatment days.