rioprostil and Duodenal-Ulcer

Anti-ulcer prostaglandins (PG)--misoprostol, enprostil and rioprostil--have been given to more than 5000 patients in short-term studies on gastric and duodenal ulcer. Analysis of these studies shows the drugs to be safe. Their side effects appear to be dose-dependent and mainly restricted to the gastrointestinal system, the major syndromes being diarrhoea and abdominal pain. The clinical relevance of PG-related unwanted effects, though in average exceeding that of H2-blockers, seems to be sufficiently low. In terms of safety efficacy, however, they appear inferior to H2-antagonists, so their routine use in preference to the latter compounds is still premature.

Topics: Alprostadil; Anti-Ulcer Agents; Clinical Trials as Topic; Duodenal Ulcer; Enprostil; Humans; Misoprostol; Prostaglandins E; Prostaglandins E, Synthetic; Rioprostil; Stomach Ulcer

One hundred and ninety duodenal ulcer patients who had relief of pain and endoscopically proven ulcer healing after a short treatment period are allocated at random to double-blind maintenance treatment with a synthetic dehydroprostaglandin-E1, rioprostil, 300 micrograms, or ranitidine, 150 mg, at bedtime for 6 months. Patients are monitored every two months and examined by endoscopy after six months of treatment, or more often if warranted. The cumulative relapse rate in the rioprostil group at six months is 32% (25/78) vs. 28% (20/72) in the ranitidine group. This difference is not significant. The percentage of side effects observed is 17% in the rioprostil group vs. 5% in the ranitidine group, but discontinuation of treatment is observed with the same frequency in the two groups.

Topics: Anti-Ulcer Agents; Double-Blind Method; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Recurrence; Rioprostil

The efficacy of Rioprostil (a new prostaglandin E1 analogue) is compared with that of ranitidine in the recurrence prevention of duodenal ulcer(s). Duration of treatment is 6 months. Ninety-seven patients received rioprostil, 600 micrograms once-daily orally, and 110 patients received ranitidine, 150 mg once-daily orally. On rioprostil, 14.9% of patients showed a relapse after 6 months compared to 10.1% on ranitidine. Diarrhoea occurred in 7 patients on rioprostil and 3 patients on ranitidine. Rioprostil given 600 micrograms daily in the evening is a highly effective treatment for the prevention of duodenal ulcer relapse, the efficacy not being significantly different from ranitidine 150 mg.

Topics: Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Recurrence; Rioprostil

The efficacy of Rioprostil (a new prostaglandin E1 analogue) is compared with ranitidine in the once-a-day treatment in the evening for 4 or 6 weeks of active uncomplicated duodenal ulcer disease. A total of 255 patients are entered in this study; of these 243 have been statistically evaluated. One hundred and twenty (120) patients receive rioprostil 600 micrograms/daily, and 123 patients receive ranitidine 300 mg/daily. After 4 weeks 63.3% of the patients on rioprostil are endoscopically healed, as compared with 69.1% on ranitidine. After 6 weeks the cumulative cure rates are 87.3% and 89.9%, respectively, the difference not being statistically significant. Pain relief is similar for both drugs. Diarrhoea with rioprostil occurs in about 2% of the treatment days and is generally self-limiting.

Topics: Adult; Anti-Ulcer Agents; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Female; Humans; Male; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Rioprostil

The effectiveness of rioprostil, 300 micrograms b.d. is evaluated in evolutive duodenal ulcer in a double-blind study in five French and North African centres. A total of 115 patients are included in the study (57 in the rioprostil group and 58 in the placebo group). After a 4-week treatment period, a significantly higher endoscopic healing rate is observed in the rioprostil group (57%) compared with the placebo group (33%) (p less than 0.01). The mean time with abdominal pain is significantly lower in the rioprostil group (5.6 +/- 4.4 days) compared to the placebo group (12.7 +/- 5 days) (p less than 0.001). Clinical and biological tolerance is excellent. The only side effect is diarrhoea (3.5% in the rioprostil group). In only one case does diarrhoea necessitate cessation of treatment. Rioprostil, 300 micrograms b.d., is thus effective in the treatment of developing duodenal ulcer.

Topics: Anti-Ulcer Agents; Double-Blind Method; Duodenal Ulcer; Humans; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Rioprostil

A total of 156 patients with endoscopically proven duodenal ulcers are randomized in a double-blind, multicentre trial comparing rioprostil, 300 micrograms b.d., with ranitidine, 150 mg b.d. With rioprostil, the cumulative healing rate by endoscopy is 73% at 4 weeks, and 87% at 6 weeks. With ranitidine it is 79% and 92%, respectively. There is no difference in the occurrence of pain after the two types of treatment, and the side effects are comparable in the two groups. These results show that rioprostil is probably as effective and safe as ranitidine in the treatment of duodenal ulcer.

Topics: Adult; Anti-Ulcer Agents; Double-Blind Method; Duodenal Ulcer; Female; Humans; Male; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Rioprostil

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.

Topics: Adult; Aged; Anti-Ulcer Agents; Double-Blind Method; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Rioprostil

A preliminary analysis on a group of 182 patients participating in a large, multicentre trial comparing nocturnal rioprostil, 600 micrograms and ranitidine, 300 mg, is presented. The results are confined to the ulcer healing properties. Healing rates are 61% and 77%, respectively, at 4 weeks, and 86% and 96% at 8 weeks. The advantage of ranitidine reaches statistical significance at 8 weeks (p less than 0.05). About 20% of patients taking rioprostil report loose bowels or diarrhoea, but only two patients withdraw for this problem.

Topics: Anti-Ulcer Agents; Duodenal Ulcer; Humans; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Ranitidine; Rioprostil

When administered as 300 micrograms b.d. or as 600 micrograms once in the evening, the new prostaglandin E1 analogue, rioprostil, is capable of reducing nocturnal H+ activity (1200 h to 0800 h) by 52% and 74%, respectively (p less than 0.01). Diurnal acidity (0900 h to 1800 h), on the other hand, is only reduced by 33% and 15% (not significant). A single evening dose of rioprostil, 600 micrograms, is used successfully on 208 patients suffering from acute duodenal ulcer. After 2 weeks and 4 weeks of treatment, the healing rates are comparable to the high values obtained with ranitidine, 300 mg nocte (rioprostil, 600 micrograms nocte: 54.1% and 84.1%; ranitidine, 300 mg nocte: 54.4% and 89.9%). There are also no significant differences between the groups as regards symptomatic improvement. Severe diarrhoea and abdominal complaints do not occur with rioprostil, 600 micrograms nocte.

Topics: Adult; Anti-Ulcer Agents; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Ranitidine; Rioprostil

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.

Topics: Anti-Ulcer Agents; Cimetidine; Double-Blind Method; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E; Prostaglandins, Synthetic; Randomized Controlled Trials as Topic; Rioprostil; Time Factors

Anti-ulcer prostaglandins (PG)--misoprostol, enprostil and rioprostil--have been given to more than 5000 patients in short-term studies on gastric and duodenal ulcer. Analysis of these studies shows the drugs to be safe. Their side effects appear to be dose-dependent and mainly restricted to the gastrointestinal system, the major syndromes being diarrhoea and abdominal pain. The clinical relevance of PG-related unwanted effects, though in average exceeding that of H2-blockers, seems to be sufficiently low. In terms of safety efficacy, however, they appear inferior to H2-antagonists, so their routine use in preference to the latter compounds is still premature.

Topics: Alprostadil; Anti-Ulcer Agents; Clinical Trials as Topic; Duodenal Ulcer; Enprostil; Humans; Misoprostol; Prostaglandins E; Prostaglandins E, Synthetic; Rioprostil; Stomach Ulcer

Data from a large number of patients (1918) treated with rioprostil, H2-antagonists and placebo, are analysed to examine the safety profile of rioprostil in the treatment of active gastric ulcer or active duodenal ulcer. Rioprostil is administered to 1000 of those patients. Patients who dropped out of the studies and those with adverse drug reactions are classified and compared within different subgroups. The overall dropout rate for rioprostil patients is 8.8%: 2.3% of these because of adverse reactions. The incidence of adverse reactions during rioprostil treatment is 20.9%, with more than 60% of these having gastrointestinal symptoms, mainly appearing in the first week of therapy. Comparisons show a higher incidence of symptoms with rioprostil treatment than with ranitidine treatment because of the gastrointestinal symptoms. Possible differences are found between groups in sex, age, and drug dose. The analysis of laboratory variables does not show clinically important changes as a result of rioprostil treatment.

Topics: Abdominal Pain; Adult; Anti-Ulcer Agents; Diarrhea; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Nausea; Prostaglandins E; Prostaglandins, Synthetic; Rioprostil; Stomach Ulcer

Topics: Cimetidine; Clinical Trials as Topic; Duodenal Ulcer; Female; Humans; Male; Middle Aged; Prostaglandins; Prostaglandins E; Prostaglandins, Synthetic; Recurrence; Rioprostil; Smoking

Topics: Clinical Trials as Topic; Diarrhea; Double-Blind Method; Duodenal Ulcer; Gastric Acid; Humans; Male; Prostaglandins E; Random Allocation; Rioprostil

Topics: Anti-Ulcer Agents; Clinical Trials as Topic; Duodenal Ulcer; Humans; Male; Prostaglandins E; Ranitidine; Rioprostil

Topics: Adult; Alprostadil; Antacids; Anti-Inflammatory Agents, Non-Steroidal; Arthritis, Rheumatoid; Aspirin; Clinical Trials as Topic; Double-Blind Method; Duodenal Ulcer; Gastroscopy; Humans; Indomethacin; Misoprostol; Omeprazole; Prostaglandins E; Ranitidine; Rioprostil; Stomach Ulcer

Topics: Adolescent; Adult; Aged; Anti-Ulcer Agents; Circadian Rhythm; Clinical Trials as Topic; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Gastric Acid; Humans; Male; Middle Aged; Prospective Studies; Prostaglandins E; Random Allocation; Ranitidine; Rioprostil

Hypochlorhydria induced by potent antisecretory drugs is followed by a marked elevation of serum gastrin levels which leads to changes in ECL cell density in rats. "Soft" antiulcer drugs like prostaglandins do not increase gastrin levels. Their use in peptic ulcer disease seems to be mainly limited by a relatively high incidence of diarrhea and abdominal cramps. Rioprostil is a new prostaglandin E1 analogue. We compared the potency and duration of action of rioprosil 600 micrograms nocte with 300 micrograms bid on human gastric secretion in a placebo-controlled double-blind study. We further evaluated the clinical effectiveness of rioprostil 600 micrograms nocte in the acute treatment of duodenal ulcer. Nocturnal gastric acidity (24:00 to 08:00) was inhibited from 54.5 +/- 1.7 mmol H+/L (placebo experiments; n =9) to 26.7 +/- 3.5 mmol H+/L (52%) by rioprostil 300 micrograms bid (p less than 0.05) and to 14.4 +/- 3.8 mmol H+/L (74%) by rioprostil 600 micrograms nocte (p less than 0.05). During the daytime (09:00 to 18:00), H+ activity was reduced by 33% and 15% respectively (n.s.). Two hundred and three patients with endoscopically proven duodenal ulcers were randomly allocated to treatment with either rioprostil 600 micrograms nocte or ranitidine 300 mg nocte for 4 weeks in a prospective double-blind study. The two groups were similar. After 2 and 4 weeks treatment respectively, about 55% and 85% of patients healed on rioprostil 600 micrograms nocte and 55% and 90% on ranitidine 300 mg nocte. There were no differences between the treatment groups in ulcer pain relief.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adult; Aged; Circadian Rhythm; Drug Administration Schedule; Duodenal Ulcer; Gastric Juice; Humans; Male; Middle Aged; Prostaglandins E; Ranitidine; Rioprostil; Secretory Rate

The antiulcer activity of BAY P 14551 a thiazolylaminobenzimidazole derivative, was evaluated in different experimental ulcer models and its antiulcer activity was compared to that of different reference drugs. The overall activity of the compound was equal to or more potent than that of reference antiulcer drugs, such as pirenzepine, cimetidine and carbenoxolone, but it was not as potent as rioprostil. The ED50 values (expressed as mumol/kg p.o.) were 68 (confidence limits: 51-91) for indomethacin-induced ulcers, 21 (confidence limits: 13-31) for stress-induced ulcers and 1260 mumol/kg p.o. (confidence limits: 412-3800) for ulcers induced by absolute ethanol. The compound had no activity against cysteamine-induced duodenal ulcers and lost its cytoprotective activity in adrenalectomised rats. Since inhibition of gastric acid secretion was seen, if at all, only with the higher doses, the gastro-protective action of BAY P 1455 seemed not to be due to an antisecretory effect, but more likely to a gastroprotective action as hypothesised for prostaglandins.

Topics: Adrenalectomy; Animals; Anti-Ulcer Agents; Benzimidazoles; Cimetidine; Corticosterone; Cysteamine; Duodenal Ulcer; Ethanol; Female; Gastric Acid; Immersion; In Vitro Techniques; Indomethacin; Male; Pirenzepine; Prostaglandins E; Pylorus; Rats; Rats, Inbred Strains; Rioprostil; Stomach Ulcer; Stress, Psychological; Thiazoles

Topics: Anti-Ulcer Agents; Duodenal Ulcer; Humans; Prostaglandins E; Rioprostil