Long-term, open-label trial: safety and efficacy of continuous maintenance treatment with pantoprazole for up to 15 years in severe acid-peptic disease.

Abstract

BACKGROUND:

To date, the safety and tolerability of proton pump inhibitors (PPIs) have been demonstrated in studies of up to 10 years.

AIM:

To report on the tolerability, safety and efficacy of up to 15 years' continuous treatment with pantoprazole in patients with severe acid-peptic disease.

METHODS:

Following healing of endoscopically confirmed peptic ulcer or reflux oesophagitis during 4-12 weeks' treatment with pantoprazole (40-80 mg/day), adult patients received open-label maintenance treatment with pantoprazole (40-160 mg/day) for up to 15 years in a single centre combined study (10-year initial study; 5-year extension study). Safety assessments were carried out using endoscopy, clinical examination, clinical laboratory investigations, serum gastrin determination, gastric mucosal histology and mucosal endocrine cell quantification.

RESULTS:

The safety set comprised 142 patients. At 12 weeks, healing rates were 95.8%. During long-term treatment, mean fasting gastrin levels rose from baseline to moderate levels throughout the study. Mean enterochromaffin-like cell density showed a moderate initial increase during the first 3 years, remaining stable thereafter. These changes were not associated with any clinically relevant changes of the gastric mucosa. Patients with successful Helicobacter pylori eradication showed long-term regression of antral and corpus gastritis during continued pantoprazole treatment.

CONCLUSIONS:

Daily pantoprazole maintenance therapy for up to 15 years for severe acid-peptic disease is effective and well tolerated, with no identified safety concerns. The longest study to date, these data provide reassuring evidence for the long-term safety of pantoprazole.

• Authors: G Brunner, C Athmann, A Schneider
• Journal: Alimentary pharmacology & therapeutics (Aliment Pharmacol Ther) Vol. 36 Issue 1 Pg. 37-47 (Jul 2012) ISSN: 1365-2036 [Electronic] England
• PMID: 22531114 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © 2012 Blackwell Publishing Ltd.

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Proton Pump Inhibitors
• Pantoprazole

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles (adverse effects, therapeutic use)
• Adult
• Esophagitis, Peptic (drug therapy)
• Female
• Gastric Mucosa (drug effects)
• Helicobacter Infections (drug therapy)
• Helicobacter pylori (isolation & purification)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Pantoprazole
• Peptic Ulcer (drug therapy)
• Proton Pump Inhibitors (adverse effects, therapeutic use)
• Severity of Illness Index
• Time Factors
• Treatment Outcome