ONE-YEAR PROPHYLACTIC EFFICACY AND SAFETY OF PANTOPRAZOLE IN CONTROLLING GASTROESOPHAGEAL REFLUX SYMPTOMS IN PATIENTS WITH HEALED REFLUX ESOPHAGITIS

Background: Pantoprazole is a benzimidazole derivative which selective ly inhibits the proton pump H+, K+-ATPase necessary for the final step in gastric acid secretion. Aim: To investigate the tolerability and t he prophylactic effect of pantoprazole 40 mg once daily on relapse in patients whose reflux oesophagitis had been healed. Methods: The safet y of pantoprazole 40 mg once daily was assessed in an open 1-year tria l on 222 patients whose reflux oesophagitis had been healed with omepr azole or pantoprazole. Relapse was defined as endoscopically-confirmed reflux oesophagitis (at least Grade I), with endoscopies being perfor med for patients experiencing 3 consecutive days of disease-specific s ymptoms. Results: Kaplan-Meier survival analysis at 6 and 12 months ga ve estimated treatment failure rates of 2% and 6% from confirmed relap ses (per-protocol), and of 9% and 30% for a worst-case group (all with drawals counted as failures). The only population shift in laboratory variables was a doubling of the median serum gastrin level over the fi rst 6 months; thereafter it stabilized. Fifty-four (24%) patients expe rienced adverse events; 15 of these withdrew. Serious adverse events w ere reported for 12 patients. Conclusions: Pantoprazole appears to be highly effective and to have a good safety profile for long-term proph ylaxis of reflux oesophagitis.