Rabeprazole is superior to ranitidine in the management of active duodenalulcer disease: Results of a double-blind, randomized North American study

OBJECTIVE: The primary purpose of this study was to compare the efficacy an d tolerability of rabeprazole versus ranitidine in the treatment of patient s with active duodenal ulcer disease. METHODS:This multicenter, double-blind, randomized, parallel-group study en rolled 376 patients. Patients were randomly assigned to receive rabeprazole 20 mg administered once daily in the morning (q.a.m.) with matching raniti dine placebo twice daily (b.i.d.) (n = 188), or ranitidine 150 mg b.i.d. wi th matching rabeprazole placebo q.a.m. (n = 188). Three visits were schedul ed: wk 0 (baseline; days -3 to -1), wk 2 (day 15 +/- 3 days), and wk 3 (day 29 +/- 3 days). The primary efficacy response variable was defined as comp lete regeneration of the mucose at the site of all ulcers identified during the study. Secondary efficacy variables included patients' ratings of freq uency and severity of ulcer pain, frequency of antacid use, and improvement of overall physical well-being. Tolerability was evaluated with analyses o f adverse events, laboratory evaluations, fasting serum gastrin levels, vit al signs, body weight, and electrocardiograms. RESULTS: Up to 4 wk of treatment with rabeprazole 20 mg q.a.m. produced sig nificantly greater healing rates, compared to treatment with ranitidine150 mg b.i.d. (83% vs 73%; p = 0.017). Significant differences between treatmen t groups were also observed for secondary efficacy indices. At wk 2, rabepr azole was more likely than ranitidine to produce complete resolution of duo denal ulcer pain (39% vs 25%; p = 0.006), improvement in duodenal ulcer nig httime pain severity (76% vs 65%; p = 0.044), and improvement in overall we ll-being (55% vs 41%; p = 0.009). At wk 4, the proportion of patients with normalization of overall wellbeing was significantly higher in the rabepraz ole group than in the ranitidine group (45% vs 29%; p = 0.003). Rabeprazole was safe and well tolerated in this study. CONCLUSIONS: In patients with active duodenal ulcer disease, rabeprazole 20 mg g.a.m, is superior to ranitidine 150 mg b.i.d. in healing, resolving ul cer pain frequency, improving nighttime pain severity, and improving overal l wellbeing. Rabeprazole is an effective and well-tolerated alternative tre atment for patients with active duodenal ulcer disease. (C) 2000 by Am. Cel l. of Gastroenterology.