On-demand therapy with pantoprazole 20 mg as effective long-term management of reflux disease in patients with mild GERD: the ORION trial.

Abstract

AIMS:

To compare safety and efficacy of on-demand pantoprazole 20 mg/40 mg versus placebo in the long-term management of patients with mild gastroesophageal reflux disease (GERD) after heartburn relief.

METHODS:

A total of 634 patients with endoscopically confirmed GERD grade 0/I and heartburn were included. During the acute phase, patients were treated with pantoprazole 20 mg once daily for 4 weeks. Those patients relieved from heartburn entered the long-term phase, and were randomly assigned to either treatment group pantoprazole 20 mg, 40 mg or placebo. Over 6 months, patients took study medication on demand (antacids as rescue medication) and discontinued the drug once symptoms abated.

RESULTS:

After 4 weeks a total of 87.1%/90.0% of patients were free of heartburn (ITT/PP), and entered the subsequent long-term phase. The perceived average daily symptom load (placebo: 3.93, pantoprazole 20 mg: 2.91, pantoprazole 40 mg: 2.71, ITT) and the number of antacid tablets taken (average number, placebo: 0.68, pantoprazole 20 mg: 0.45, pantoprazole 40 mg: 0.33, ITT) were significantly higher in the placebo than in both pantoprazole groups (p<0.0001), with no statistically significant difference between the two pantoprazole groups. The discontinuation rate due to insufficient control of heartburn was significantly lower in both pantoprazole groups compared to placebo (placebo: 10.9, pantoprazole 20 mg: 2.8, pantoprazole 40 mg: 0.9, ITT).

CONCLUSIONS:

Our findings favor on-demand treatment with pantoprazole 20 mg for the long-term management of heartburn in patients with uncomplicated GERD (grade 0/I) with superiority to placebo.

• Authors: T Scholten, C P M Dekkers, K Schütze, T Körner, M Bohuschke, G Gatz
• Journal: Digestion (Digestion) Vol. 72 Issue 2-3 Pg. 76-85 ( 2005) ISSN: 0012-2823 [Print] Switzerland
• PMID: 16113546 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright (c) 2005 S. Karger AG, Basel.

Chemical References

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Antacids
• Anti-Ulcer Agents
• Benzimidazoles
• Sulfoxides
• Pantoprazole
• Omeprazole

Topics

• 2-Pyridinylmethylsulfinylbenzimidazoles
• Antacids (therapeutic use)
• Anti-Ulcer Agents (administration & dosage, therapeutic use)
• Benzimidazoles (administration & dosage, therapeutic use)
• Female
• Gastroesophageal Reflux (drug therapy)
• Humans
• Male
• Middle Aged
• Omeprazole (administration & dosage, analogs & derivatives, therapeutic use)
• Pantoprazole
• Statistics, Nonparametric
• Sulfoxides (administration & dosage, therapeutic use)
• Treatment Outcome