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

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

SUCRALFATE, RANITIDINE AND NO TREATMENT IN GASTRIC-ULCER MANAGEMENT - A MULTICENTER, PROSPECTIVE, RANDOMIZED, 24-MONTH FOLLOW-UP WITH A STUDY OF RISK-FACTORS OF RELAPSE

This multicenter, prospective, randomized, open, long-term study compares sucralfate (2 g daily) with ranitidine (150 mg daily) and no treatment in gastric ulcer (GU). We report the results of the second year of a scheduled 3-year follow-up, the outcome of the 1 st year has been reported earlier. The 24-month follow-up was completed by 142 patients who were continuously either treated with the drug randomly assigned at the beginning of the study or left untreated (i.e. 32 patients took 150 mg ranitidine at bedtime, 29 took 1 g sucralfate twice daily and 81 were left untreated, 23 of whom came from the ranitidine group, 19 from the sucralfate group and 39 from the untreated group). Seven patients dropped out and 26 subjects relapsed (5 under ranitidine, 4 under sucralfate and 17 untreated cases). Ranitidine versus previous ranitidine, sucralfate versus previous sucralfate and each one versus no treatment showed comparable relapse rates. An additional study, using Cox's models, showed that three variables have a significant correlation with relapse during the 1 st year of follow-up: therapy carried out (p = 0.0025), symptoms (p = 0.0047) and family history of ulcer (p = 0.0392). In conclusion, both ranitidine 150 mg and sucralfate 2 g proved effective in reducing GU relapse as compared with no treatment, an effect which does not seem to persist during the 2nd year of therapy, when the 'no treatment' option may be taken into account

LONG-TERM TREATMENT OF PATIENTS WITH GASTRIC-ULCER - SUCRALFATE VERSUS RANITIDINE VERSUS NO TREATMENT - AN INTERIM-REPORT AT THE END OF YEAR-1 OF A 3-YEAR MULTICENTER, RANDOMIZED STUDY

This multicenter, prospective, randomized, open, long-term study compared the efficacy of sucralfate (1 g twice daily) versus ranitidine (150 mg once daily) versus no therapy in patients with gastric ulcer. The results at the end of the first of a scheduled 3-year follow-up are reported. Two hundred ninety patients with healed GU entered the 3-year, open study. Ninety patients were randomly assigned to receive sucralfate, 105 to receive ranitidine, and 95 to receive no treatment. The three groups proved well matched in terms of standard clinical data. Fifty patients were withdrawn from the study during the first year; a gastric neoplasm was diagnosed in four patients. At months 3, 6, and 12 of therapy, the remission rates were, respectively, 94.8%, 86.2%, and 79.6% with sucralfate; 98.9%, 91.6%, and 82.5% with ranitidine; and 89.3%, 80.7%, and 66.9% with no treatment. Sucralfate was as effective as ranitidine (P = NS), and both drugs produced higher cumulative remission rates than no treatment (P < 0.06 and P < 0.01, respectively). We conclude that 1 g of sucralfate twice daily was as effective as 150 mg of ranitidine once daily in maintaining GU remission for 1 year; both treatments led to a better outcome than no treatment