Effect of Intravenous Esomeprazole 40 mg and Pantoprazole 40 mg on Intragastric pH in Healthy SubjectsA prospective, open, randomised, two-way cross-over comparative study
21 December 2011 (online)
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.) esomepra-zole 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®) 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 1 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 esome-prazole 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 intra-gastric 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 1 and during the 24-h period of day 1 and day 3 of dosing.