rioprostil and Duodenitis

The protective effect of rioprostil against gastroduodenal mucosal lesions induced by indomethacin is investigated in a double-blind controlled trial on 36 healthy adult volunteers, divided into three groups. All the volunteers are treated with indomethacin, 50 mg t.d.s. during a period of 5 days. The first group is treated with placebo, the second with rioprostil, 300 micrograms, and the third with rioprostil, 600 micrograms. Endoscopies are performed before and after treatment. Blood samples for high performance liquid chromatography determination of indomethacin plasma concentrations are taken on the 6th day, before the last dose of indomethacin is administered, and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12 and 24 h after the last dose of indomethacin. It is found that in both doses rioprostil exerts a protective effect against indomethacin-induced lesions, reducing the appearance rate of erosions from 67% to 17% statistically significant in the 600 micrograms group. The bioavailability of indomethacin in the three groups does not differ significantly.

Topics: Adult; Anti-Ulcer Agents; Double-Blind Method; Duodenitis; Gastritis; Humans; Indomethacin; Male; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Rioprostil

Thirty outpatients with erosions of the duodenal bulb unrelated to peptic ulcer were randomly allocated to an 8-week treatment regimen with either rioprostil, 200 micrograms b.d., or with sucralfate, 1 g t.i.d. At endoscopic control complete disappearance of duodenal erosions was found in 57.2% of rioprostil-treated patients and in 64.3% of patients treated with sucralfate. The difference was not statistically significant. The two drugs were shown to be significantly and equally effective in inducing relief of dyspeptic symptoms. No intestinal side effects were observed during treatment with rioprostil.

Topics: Adult; Aged; Anti-Ulcer Agents; Duodenitis; Female; Humans; Male; Middle Aged; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Rioprostil; Sucralfate

In a randomized, double-blind, placebo-controlled, prospective trial, the activity of rioprostil, a new prostaglandin E1 alcohol analogue, on non-steroidal anti-inflammatory drug-induced gastroduodenal mucosal lesions is studied in 30 patients with rheumatic diseases. Both treatment regimens, rioprostil, 150 micrograms t.i.d., and rioprostil, 200 micrograms b.i.d., for a period of 12 weeks, significantly reduce the rate of mucosal lesions in all patients when compared to placebo. Furthermore, rioprostil achieves a reduction in gastrointestinal symptoms without enhancement of joint disease activity, and significantly reduces antacid intake. Therapy is safe and well tolerated by all patients. It can be concluded from this study that prostaglandins could play an important part in the prevention and treatment of gastrointestinal damage due to NSAIDs.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Anti-Ulcer Agents; Arthritis, Rheumatoid; Double-Blind Method; Duodenitis; Female; Gastritis; Humans; Male; Middle Aged; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Rioprostil