Pilot study of on-demand therapy with pantoprazole 20mg for long-term treatment in patients with mild gastro-oesophageal reflux disease

• Published in: Clinical drug investigation Vol. 25; no. 10; pp. 633 - 642
• Main Authors: Scholten, Theo, Pustlauk, Uwe, Sander, Peter, Bohuschke, Martina, Gatz, Gudrun
• Format: Journal Article
• Language: English
• Published: New Zealand Wolters Kluwer Health, Inc 01.01.2005
• ISSN: 1173-2563; 1179-1918
• DOI: 10.2165/00044011-200525100-00002

Few clinical studies have demonstrated the efficacy of proton pump inhibitors (PPIs) as on-demand therapy for the long-term management of patients with mild gastro-oesophageal reflux disease (GORD). On-demand therapy with pantoprazole 20mg may offer an effective strategy for the management of mild GORD. Patients with mild GORD grade 0 or 1 and heartburn of at least moderate intensity at the start of the study were treated with pantoprazole 20mg once daily for 28 days (n = 254). Patients with no heartburn during the final 3 days of the acute treatment phase entered the long-term treatment phase and took pantoprazole 20mg on demand for 6 months. Antacids were provided as rescue medication during this phase. The primary endpoint was the percentage of patients unwilling to continue the study because of insufficient control of symptoms. In addition, the intensities and the relapse rates for heartburn, acid eructation and epigastric pain were determined. At the end of the acute treatment phase, 234 of 254 patients (92.1%) were free from heartburn and entered the long-term treatment phase (intention-to-treat [ITT]). The time until study discontinuation because of inadequate control of heartburn during the on-demand treatment phase ranged from 9 to 147 days. In the ITT population, only 2.8% of patients were unwilling to continue the study because of insufficient heartburn control. Relapse rates were 4.3% for heartburn, 2.3% for acid eructation and 1.0% for epigastric pain. After 6 months of on-demand treatment, 82% of patients stated that improvements in their symptoms were maintained. For symptom control during the on-demand phase, patients took one tablet of pantoprazole 20mg every 2.3 days. Additionally, patients took one magaldrate tablet every 2.4 days. Results of this pilot study show that on-demand therapy with pantoprazole 20mg appears to be an effective treatment strategy for the long-term treatment of mild GORD. Treatment acceptance by patients was high.