Effect of intravenous esomeprazole 40 mg and pantoprazole 40 mg on intragastric pH in healthy subjects

Objective: The aim of this study was to compare the effect on intragastric acidity over 24 h on days 1 and 3 following treatment with intravenous (i.v.) esomeprazole 40 mg (CAS for esomeprazole sodium: 161796-78-7) and pantoprazole 40 mg (CAS for pantoprazole sodium: 138786-67-1). Methods: In an open, randomised, two-way cross-over study, 36 healthy volunteers received esomeprazole (Nexium (R)) 40 mg or pantoprazole 40 mg, both administered once daily as an i.v. bolus injection for 3 consecutive days. Continuous 24-h pH recordings were made under standardised conditions at baseline and on days I and 3 of each treatment period. The primary variable was the percentage of time with intragastric pH > 4 during a 24-h period. Results: Time with intragastric pH > 4 was significantly greater with esomeprazole than with pantoprazole during the first 4 h (47.8 % vs. 18.9 %), as well as for the 24-h period of day 1 and day 3 (day 1: 38.8% vs. 23.7%; day 3: 55.0% vs. 35.2%, p < 0.0001 for all times examined). Mean of median intragastric pH with esomeprazole was significantly higher than with pantoprazole during the 24-h period (day 1:3.2 vs. 2.2, p < 0.0001; day 3:4.3 vs. 3.1, P < 0.00001). Conclusion: Esomeprazole administered as a 40 mg i.v. bolus injection provided faster and more effective control of intragastric acidity than a 40 mg i.v. bolus injection of pantoprazole, and also maintained pH > 4 longer both during the first 4 h on day I and during the 24-h period of day I and day 3 of dosing.