[Effect of enprostil on the healing and the recurrence of duodenal ulcer. Comparison with ranitidine].

Enprostil, a synthetic prostaglandin E2, has been shown to exert both antisecretory and mucoprotective activity. It is effective in duodenal ulcer healing. OBJECTIVE--This study was performed to compare the frequency and the delay of spontaneous duodenal ulcer relapse during a two-year follow up period after initial healing by enprostil (35 micrograms, twice a day) or ranitidine (300 mg per day). METHODS--This multicentric, double-blind, randomized study included 642 patients (324 in the enprostil group and 318 in the ranitidine group). Patients included in the follow up period were evaluated by an endoscopy at 6 months, one and two years after healing. RESULTS--After a 6 weeks treatment period, healing rate was 85% for ranitidine and 70% for enprostil, respectively (P < 0.001). Adverse effects, especially digestive ones, occurred more often with enprostil than with ranitidine (P < 0.001). After initial healing, there was no significant difference between the 2 groups concerning the cumulative rate of relapse, despite a non significant trend for a milder rate of relapse in the enprostil group (P = 0.08). Twenty-seven % of the patients randomized to treatment (intend-to-treat analysis) in the enprostil group and 29% in the ranitidine group had no ulcer recurrence 6 months after ulcer healing, and respectively 12% and 13% at 2 years (difference not statistically significant). CONCLUSIONS--It is concluded that a) ranitidine is more effective and has less adverse effects than enprostil for duodenal ulcer healing, b) after duodenal ulcer healing by enprostil, there is a non significant trend for a lower rate of relapse than after healing with ranitidine, c) there is the same proportion of patients without ulcer in the 2 groups after 6 months and 2 years.