An Evaluation of Arbaprostil at Multiple Doses for the Treatment of Acute Duodenal Ulcer: A Randomized Double Blind Placebo-Controlled International Trial

Euler, A. R.; Krawiec, J.; Odes, H.; Gilat, T.; Garcia, L.; Rachmilewitz, D.; Gabryelewicz, A.; Gibinski, K.; Bass, D.; Barbara, L.; Porro, G. Bianchi; Lazzaroni, M.; Kirchmayer, S.; Nago-Nago, A.; Popiela, T.; Kulig, J.; Roca, M.; Hagenmuller, F.; Bergemann, W.; Schryver, M.
February 1990
American Journal of Gastroenterology;Feb1990, Vol. 85 Issue 2, p145
Academic Journal
Six hundred and thirty patients were enrolled in a randomized double-blind placebo-controlled trial evaluating two arbaprostil dosages (25 µg and 50 µg) qid for 4 wk for the treatment of acute duodonal ulcers. The healing rates in the placebo, 25-µg, and 50-µg 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-µg, and 50-µg treatment groups, respectively. Severe diarrhea occurred in 1% of those patients who received the 50-µg 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.


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