Comparison of enprostil and cimetidine in active duodenal ulcer disease: Summary of pooled European studies

Abstract

Data were combined for statistical analysis from four European trials comparing enprostil (35 micrograms twice daily) with cimetidine (400 mg twice daily) in the treatment of duodenal ulcer, using a double-blind, randomized design with endoscopic control. A total of 369 patients entered the trials, of whom 348 were eligible for the efficacy analyses and 362 for the safety analyses. Patients were allowed antacids as needed. The pooled cumulative healing rates at two, four, and six weeks were 40, 75, and 84 percent, respectively, for enprostil and 42, 77, and 87 percent, respectively, for cimetidine. There were no significant differences between treatments. Healing rates in both groups were reduced in smokers, in those with larger ulcers at baseline, and in those who reported a higher consumption of alcohol. Age, however, had no effect on healing rates. Digestive system complaints were reported more frequently in the enprostil group, whereas central nervous system complaints were more than twice as frequent in the cimetidine group.