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Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis—a 2‐year follow‐up
Author(s) -
Van Rensburg C. J.,
Van Zyl J. H.,
Grundling H. DE K.
Publication year - 1999
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1046/j.1365-2036.1999.00573.x
Subject(s) - medicine , pantoprazole , gastroenterology , omeprazole , proton pump inhibitor , reflux , esophagitis , adverse effect , reflux esophagitis , population , surgery , disease , environmental health
Background : Pantoprazole is a benzimidazole derivative which selectively inhibits the proton pump H + , K + ‐ATPase, necessary for the final step in gastric acid secretion. Aim : To assess safety and efficacy of oral pantoprazole (40 mg o.d.) used as 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 oesophagitis (Savary–Miller classification) were enrolled into a long‐term, multicentre maintenance study. Endoscopy was performed at entry into the study, after 12 and 24 months, or when disease‐specific symptoms occurred on more than three consecutive days. Symptoms were assessed at 3‐monthly intervals. Endoscopically confirmed relapses (at least stage I) were evaluated as treatment failures. Results : Of the 178 adverse events, experienced by 88 (56%) patients (intention‐to‐treat population), 12 (7%) were assessed by the investigators as possibly related to the study medication. Median serum gastrin levels increased 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 after 12 and 24 months were 87% and 76%, respectively (Life‐Table survival analysis, Kaplan–Meier). Conclusion : Pantoprazole 40 mg proved to be safe and efficacious during a 2‐year prophylaxis treatment in patients with healed reflux oesophagitis.