Comparative safety and efficacy of enprostil and cimetidine in patients with duodenal ulcer

Abstract

In an open study, the efficacy and safety of 35-μg enprostil BID and 400-mg cimetidine BID were compared in 51 patients with duodenal or prepyloric ulcers. Except for antacids to relieve pain, no anti-ulcer drugs were allowed. Patients were evaluated at baseline and at weeks 2, 4, and 6 with clinical history, laboratory analysis, and/or endoscopy. The healing rates, pain incidence, and overall therapeutic response of the two groups were similar. Healing rates differed between smokers and nonsmokers, older and younger patients, and those with initially small and large ulcers, but only in the early weeks and only when the data from patients in both groups were pooled. Daytime and nighttime pain relief were equal in both the enprostil- and cimetidine-treatment groups. Use of supplemental antacids for pain relief was low and of little clinical significance in ulcer healing. By the end of the study, 82% in the enprostil group and 85% in the cimetidine group were healed. Most adverse events reported were mild and in the enprostil group primarily included gastrointestinal disturbances such as changes in bowel habits toward less consistent and/or more frequent stools and gastrointestinal pain (8% for each). Headache and somnolence were the most frequent adverse events in the cimetidine group. Differences between the treatment groups were insignificant. Enprostil and cimetidine were found to be equally effective and safe for the treatment of duodenal and prepyloric ulcers.