arbaprostil and Acute-Disease

Six hundred and thirty patients were enrolled in a randomized double-blind placebo-controlled trial evaluating two arbaprostil dosages (25 micrograms and 50 micrograms) qid for 4 wk for the treatment of acute duodenal ulcers. The healing rates in the placebo, 25-micrograms, and 50-micrograms treatment groups were 39%, 51%, and 60%, respectively. Smoking was found to adversely affect the healing rates in all the treatment groups. Pain severity was less with either arbaprostil treatment. The only side effect found was diarrhea: 10%, 14%, and 32% in the placebo, 25-micrograms, and 50-micrograms treatment groups, respectively. Severe diarrhea occurred in 1% of those patients who received the 50-micrograms dosage regimen, but in none of the other two groups. Arbaprostil at these two dosage levels, when given for 4 wk, appears to be a safe and efficacious agent for the treatment of acute duodenal ulcers.

Topics: Acute Disease; Arbaprostil; Capsules; Double-Blind Method; Duodenal Ulcer; Duodenoscopy; Female; Humans; Male; Multicenter Studies as Topic; Placebos; Prostaglandins E, Synthetic; Randomized Controlled Trials as Topic; Time Factors; Wound Healing

A randomized, double-blind, placebo-controlled, multiclinic trial evaluated arbaprostil [15(R)-15 methyl prostaglandin E2] for the treatment of acute gastric ulcer, achieving an overall enrollment of 124 patients (of which 113 were considered evaluable). This 6-wk trial used an arbaprostil dose of 10 micrograms q.i.d., which has little gastric acid antisecretory activity. Endoscopies were performed after 21 and 42 days of treatment, at which times the arbaprostil and placebo healing rates, respectively, were 6/59 (10.2%) and 4/53 (7.6%) on day 21 and 25/59 (42.4%) and 16/50 (32.0%) on day 42. No significant differences between the treatment groups were found for pain relief, antacid consumption, and mucosal healing. This trial documents that a 10-micrograms dose of arbaprostil (which may be considered cytoprotective because of its small effect on gastric acid secretion), although safe and associated with no side effects, is not efficacious in healing acute gastric ulcers.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Arbaprostil; Clinical Trials as Topic; Double-Blind Method; Female; Gastric Mucosa; Humans; Male; Middle Aged; Multicenter Studies as Topic; Prostaglandins E, Synthetic; Random Allocation; Stomach Ulcer

Twenty outpatients with an endoscopic diagnosis of gastric ulcer were evaluated for 6 wk in a randomized, double-blind trial comparing 15(R)-15-methyl prostaglandin E2 (Arbacet) (10 micrograms, 0.5 h before each meal and at bedtime) with placebo. Endoscopy was performed at 3 wk and 6 wk during the study period. Five of nine patients (56%) taking Arbacet and seven of 11 patients (64%) in the placebo group had complete healing of their gastric ulcer. Healing occurred in four patients from the Arbacet group and three patients in the placebo group at 3 wk. A cytoprotective dose of Arbacet (40 micrograms daily) is not significantly better than placebo in healing gastric ulcers.

Topics: Acute Disease; Arbaprostil; Clinical Trials as Topic; Double-Blind Method; Female; Gastroscopy; Humans; Male; Middle Aged; Placebos; Prostaglandins E, Synthetic; Random Allocation; Stomach Ulcer