Treatment of duodenal ulcer with enprostil, a synthetic prostaglandin E2 analogue.
Enprostil is a synthetic prostaglandin E2 analogue developed by Syntex. In a randomized, double-blind trial involving 128 patients with duodenal ulcer disease, four weeks of treatment with enprostil at doses of 70 micrograms twice daily and 35 micrograms twice daily produced healing rates (78 percent and 65 percent, respectively) that were statistically significantly higher than the placebo rate (39 percent; p less than 0.05). In a subgroup of smokers, ulcer healing occurred with statistically significantly greater frequency at both the high dose (70 percent) and the low dose (60 percent) when compared with the rate in the placebo group (32 percent; p less than 0.05). The only clinically important side effect was diarrhea, which was generally mild, self-limited, and of short duration. This study demonstrated that enprostil is highly effective in the treatment of duodenal ulcer and has a favorable safety profile.
D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004381:Duodenal Ulcer / Q000188:drug therapy*; D016620:Enprostil; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011459:Prostaglandins E, Synthetic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011897:Random Allocation; D012907:Smoking; D013997:Time Factors
D011459:Prostaglandins E, Synthetic; D016620:Enprostil