Effect of intravenous esomeprazole 40 mg and pantoprazole 40 mg on intragastric pH in healthy subjects. A prospective, open, randomised, two-way cross-over comparative study

Arzneimittelforschung. 2007;57(10):654-8.

Abstract

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) 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 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 1 and during the 24-h period of day 1 and day 3 of dosing.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • 2-Pyridinylmethylsulfinylbenzimidazoles / administration & dosage
  • 2-Pyridinylmethylsulfinylbenzimidazoles / adverse effects
  • 2-Pyridinylmethylsulfinylbenzimidazoles / therapeutic use*
  • Adolescent
  • Adult
  • Analysis of Variance
  • Anti-Ulcer Agents / administration & dosage
  • Anti-Ulcer Agents / therapeutic use*
  • Cross-Over Studies
  • Electrodes
  • Esomeprazole / administration & dosage
  • Esomeprazole / adverse effects
  • Esomeprazole / therapeutic use*
  • Female
  • Gastric Acidity Determination
  • Gastric Mucosa / metabolism*
  • Humans
  • Hydrogen-Ion Concentration
  • Injections, Intravenous
  • Male
  • Middle Aged
  • Pantoprazole
  • Prospective Studies
  • Stomach / drug effects

Substances

  • 2-Pyridinylmethylsulfinylbenzimidazoles
  • Anti-Ulcer Agents
  • Pantoprazole
  • Esomeprazole