Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis - a 2-year follow-up

Background: Pantoprazole is a benzimidazole derivative which selectively in hibits the proton pump H+, K+-ATPase, necessary for the final step in gastr ic acid secretion, Aim: To assess safety and efficacy of oral pantoprazole (40 mg o.d,) used a s a prophylaxis against relapse in patients with healed reflux oesophagitis during an open-label, 2-year study. Methods: Outpatients (n = 157) with healed stage II or III reflux oesophagi tis (Savary-Miller classification) were enrolled into a long-term, multicen tre maintenance study, Endoscopy was performed at entry into the study, aft er 12 and 24 months, or when disease-specific symptoms occurred on more tha n three consecutive days. Symptoms were assessed at 3-monthly intervals. En doscopically confirmed relapses (at least stage I) were evaluated as treatm ent failures, Results: Of the 178 adverse events, experienced by 88 (56%) patients (inten tion-to-treat population), 12 (7%) were assessed by the investigators as po ssibly related to the study medication, Median serum gastrin levels increas ed from a baseline of 46 ng/L to 90 ng/L, reaching a plateau after 9 months , For the intention-to-treat population the endoscopic remission rates afte r 12 and 24 months were 87% and 76%, respectively (Life-Table survival anal ysis, Kaplan-Meier). Conclusion: Pantoprazole 40 mg proved to be safe and efficacious during a 2 -year prophylaxis treatment in patients with healed reflux oesophagitis.