NIZATIDINE 150 MG AT NIGHT IN THE PROPHYLAXIS OF GASTRIC-ULCER RELAPSE - A 12-MONTH PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTER STUDY VERSUS PLACEBO

bstract: Objective: To evaluate the safety and efficacy of nizatidine 150 mg as a maintenance therapy for gastric ulcer. Design: A 1-year prospective, multicentre, randomized, double-blind study versus placebo. All patients were examined every 3 months with endoscopy, clinical check-ups and blood tests. Setting: Outpatients followed-up by 22 endoscopic units in north-eastern Italy. Patients: Adult patients with an endoscopically documented healed gastric ulcer, obtained within 8 weeks by nizatidine 300 mg. Two hundred and forty-one patients entered the study: 123 treated with nizatidine 150 mg, 118 with placebo; one was excluded. Thirty-eight patients withdrew during follow-up, 202 concluded the study. Main outcome measures: Age, gender, height, weight, family history of ulcer disease, smoking habit, alcohol consumption, length of gastric ulcer history, previous ulcer treatment, number of ulcers, ulcer size and location, current drug therapy and common laboratory tests were taken into account. Results: Nizatidine proved significantly better than placebo in preventing gastric ulcer relapse, i.e. remission rate was 94 versus 79%, 81 versus 68%, 79 versus 640/o and 77 versus 52% after 3, 6, 9 and 12 months, respectively (P = 0.001). Antacid consumption, symptoms, compliance and adverse events were comparable in both groups; cigarette smoking was the major relapse risk factor in both treatment groups. Conclusion: Long-term nizatidine 150 mg per day proved safe and effective in containing gastric ulcer relapse compared with placebo: smoking habit is the most important risk factor in gastric ulcer relapse.