Roxatidine acetate as maintenance treatment for patients with peptic ulcer disease. The European Cooperative Roxatidine Study Group.

The efficacy and safety of 75 mg of roxatidine acetate at night as maintenance treatment for chronic peptic ulcer disease was investigated in two double-blind randomized placebo-controlled multicenter studies. A total of 725 patients with endoscopic demonstration of a healed ulcer were recruited; 420 patients were enrolled by 28 centers in the duodenal ulcer study and 305 patients were enrolled by 24 centers in the gastric ulcer study. The duration of treatment in each study was 12 months. The primary efficacy endpoint was ulcer relapse, confirmed on scheduled endoscopy at two, four, six, nine, and 12 months or as necessitated clinically. The total ulcer recurrence rate was significantly lower in patients on active treatment: 35% and 32% of patients with a previously healed duodenal or gastric ulcer relapsed within 12 months while on roxatidine acetate, compared with 66% and 71% of patients in each study on placebo (life-table analysis, P = 0.0001). Both active and placebo treatments were well tolerated. There was no evidence of any clinically significant drug-related laboratory abnormalities, electrocardiographic changes, or changes in vital signs with either treatment. It is concluded that 75 mg of roxatidine acetate at night is a safe and effective maintenance treatment to sustain remission in patients with peptic ulcers.