Safety and efficacy of pantoprazole 40 mg daily as relapse prophylaxis in patients with healed reflux oesophagitis - A 2-year follow-up
Date
1999
Authors
Van Rensburg C.J.
Honiball P.J.
Van Zyl J.H.
De Grundling H.K.
Eloff F.P.
Spies S.K.
Simjee A.E.
Theron I.
Fischer R.
Louw J.A.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
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.
Description
Keywords
gastrin, pantoprazole, adult, aged, article, clinical trial, diarrhea, drug efficacy, drug safety, female, follow up, gastrin blood level, gastrointestinal endoscopy, human, influenza, major clinical study, male, multicenter study, oral drug administration, priority journal, reflux esophagitis, relapse, remission, stomach acid secretion, symptom, upper respiratory tract infection, 2-Pyridinylmethylsulfinylbenzimidazoles, Adolescent, Adult, Aged, Aged, 80 and over, Anti-Ulcer Agents, Benzimidazoles, Enzyme Inhibitors, Esophagitis, Peptic, Female, Follow-Up Studies, H(+)-K(+)-Exchanging ATPase, Humans, Life Tables, Male, Middle Aged, Omeprazole, Recurrence, Sulfoxides, Time Factors
Citation
Alimentary Pharmacology and Therapeutics
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