enprostil and Diarrhea

One hundred twenty-seven patients with endoscopically diagnosed active duodenal, pyloric, or prepyloric ulcers participated in this multicenter, double-blind, randomized, controlled trial comparing placebo with enprostil 35 micrograms twice daily for up to four weeks. Cumulative endoscopic healing for the enprostil and placebo treatment groups, respectively, was 25% (15 of 59) and 12% (7 of 60) at two weeks (P = 0.060) and 59% (34 of 58) and 33% (19 of 57) at four weeks (P = 0.005). Excluding prepyloric ulcers, cumulative healing for the enprostil and placebo groups, respectively, was 22% (9 of 41) and 7% (3 of 44) at two weeks (P = 0.104) and 56% (23 of 41) and 24% (10 of 42) at four weeks (P = 0.002). A greater percentage of prepyloric ulcers healed on enprostil than placebo, but the difference was not significant. Mean antacid use in both groups was identical, averaging only two or less tablets per day in each group throughout the study. Daytime pain was relieved more quickly in the enprostil group, while median time to relief of nighttime pain was essentially identical in both groups. The most common side effect in the enprostil treatment group, diarrhea, was mostly mild to moderate in intensity and was generally self-limiting, requiring no specific therapy; no patient withdrew because of this complaint. Other symptoms and laboratory profiles were similar in the two groups. These results indicate that enprostil 35 micrograms taken twice daily for four weeks is effective and safe for the treatment of prepyloric, pyloric channel, and duodenal ulcers.

Topics: Adult; Aged; Aged, 80 and over; Clinical Trials as Topic; Diarrhea; Double-Blind Method; Drug Administration Schedule; Duodenal Ulcer; Enprostil; Esophagoscopy; Female; Gastroscopy; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E, Synthetic; Pylorus; Random Allocation; Smoking; Stomach Ulcer

One hundred and forty two patients with duodenal ulcer who after a short term study had relief of pain and healed ulcers proved endoscopically were allocated at random to double blind maintenance treatment with enprostil (a synthetic dehydroprostaglandin E2) 35 micrograms or ranitidine 150 mg at bedtime for up to 12 months. Patients were monitored every third month and examined by endoscopy at three, six, and 12 months, or more often if warranted. The cumulative relapse rates in the enprostil group at three, six, and 12 months were 37% (25/67), 56% (37/66), and 62% (41/66), respectively. The corresponding rates in the ranitidine group were 8% (6/71), 19% (13/69), and 29% (20/69). These differences were highly significant and further enhanced by life table analysis adjusting for withdrawals and by an "intention to treat" analysis in which absence of proof of non-recurrence was counted as failure, more patients in the enprostil group having been withdrawn because of adverse events or recorded as non-compliant with the protocol. Enprostil 35 micrograms at bedtime cannot be recommended for preventing relapse of duodenal ulcer. Furthermore, the results challenge the clinical relevance of using so called "cytoprotection" for preventing recurrence.

Topics: Adult; Aged; Antacids; Diarrhea; Double-Blind Method; Duodenal Ulcer; Enprostil; Female; Humans; Male; Middle Aged; Prostaglandins E, Synthetic; Random Allocation; Ranitidine; Recurrence; Smoking

Topics: Alprostadil; Animals; Cats; Diarrhea; Dinoprostone; Dogs; Enprostil; Ethanol; Female; Gastric Acid; Gastric Mucosa; Gastritis; Guinea Pigs; Histamine; Indomethacin; Misoprostol; Muscle, Smooth; Myometrium; Prostaglandins E, Synthetic; Rats; Receptors, Prostaglandin; Uterine Contraction