Pantoprazole 20 mg is an effective maintenance therapy for patients with gastro-oesophageal reflux disease

Objectives To compare the efficacy of 20 mg with 40 mg pantoprazole in main taining symptomatic and endoscopic remission in patients with gastro-oesoph ageal reflux disease (GORD), Study design Patients (18-84 years old; n = 433) with healed GORD II or III were included in this prospective multi-centre, randomized, parallel, doub le-blind study. Pantoprazole was administered once daily for up to 1 year a s either a 20 mg or 40 mg enteric-coated tablet to 221 and 212 patients, re spectively. Symptoms of GORD were assessed every 3 months. Endoscopy was pe rformed at entry, after 6 and 12 months, or when symptoms of GORD were perc eived on at least three consecutive days. The primary efficacy parameter wa s the time until endoscopically proven relapse of GORD occurred (stage 1 or greater); the secondary parameters included tolerability, safety, and time until symptomatic relapse occurred. Results In the 20 mg treatment group, 87% and 75% of patients were in endos copic remission after 6 and 12 months, respectively; the corresponding rate s in the 40 mg treatment group were 91% and 78%. In both treatment groups, GORD stage I accounted for about 50% of endoscopic relapses. The symptomati c remission rates in the 20 mg group were estimated as 85% and 77% after 6 and 12 months, respectively; the corresponding values in the 40 mg group we re 87% and 76%. No correlation was seen either between the endoscopically p roven relapse and perception of symptoms, or between the severity of the pr e-treatment stage of GORD and the maintenance dose of pantoprazole. Both do ses were well tolerated. Conclusions Both the 20 mg and 40 mg doses of pantoprazole are safe and eff ective in maintaining patients with healed reflux oesophagitis in remission . Moreover, for the majority of patients, the 20 mg dose provides adequate long-term therapeutic efficacy at a minimal drug exposure and lower costs. (C) 2000 Lippincott Williams & Wilkins.