Pantoprazole maintenance therapy prevents relapse of erosive oesophagitis.

Author(s): Metz DC, Bochenek WJ, Pantoprazole US GERD Study Group

Affiliation(s): Division of Gastroenterology, University of Pennsylvania Health System, 3400 Spruce Street, 3 Dulles, Philadelphia, PA 19104-4283, USA. david.metz@uphs.upenn.edu

Publication date & source: 2003-01, Aliment Pharmacol Ther., 17(1):155-64.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

OBJECTIVES: To compare the safety and efficacy of pantoprazole with ranitidine for the maintenance of endoscopically documented healed (grade 0 or 1) erosive oesophagitis. METHODS: Patients (371) were randomly assigned to receive pantoprazole 10, 20 or 40 mg or ranitidine 150 mg. Endoscopies were performed after 1, 3, 6 and 12 months or when symptoms suggesting relapse (grade = 2) developed. Gastric biopsies were obtained at baseline and on at least one postbaseline visit. Symptom-free days and Gelusil use were assessed. RESULTS: Pantoprazole was significantly (P < 0.001) more effective in maintaining erosive oesophagitis healing. After 12 months, 33%, 40%, 68% and 82% of patients remained healed for the ranitidine and pantoprazole 10, 20 and 40 mg groups, respectively. Daytime and night-time heartburn were eliminated in > 90% of days for the pantoprazole 40 mg group. Gelusil use was significantly lower with pantoprazole 20 and 40 mg than with ranitidine (P < 0.02) during the first 9 months. CONCLUSIONS: Twelve months of maintenance therapy with pantoprazole (10-40 mg once daily) was superior to ranitidine (150 mg twice daily) in maintaining erosive oesophagitis healing. Pantoprazole 40 mg provided the most consistent efficacy and was well tolerated.