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Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study

  1. P. O. Katz1,
  2. D. O. Castell2,
  3. Y. Chen3,
  4. T. Andersson3,
  5. M. B. Sostek3

Article first published online: 21 JUL 2004

DOI: 10.1111/j.1365-2036.2004.02079.x

Issue

Alimentary Pharmacology & Therapeutics

Alimentary Pharmacology & Therapeutics

Volume 20, Issue 4, pages 399–406, August 2004

Additional Information

How to Cite

Katz, P. O., Castell, D. O., Chen, Y., Andersson, T. and Sostek, M. B. (2004), Intragastric acid suppression and pharmacokinetics of twice-daily esomeprazole: a randomized, three-way crossover study. Alimentary Pharmacology & Therapeutics, 20: 399–406. doi: 10.1111/j.1365-2036.2004.02079.x

Author Information

  1. 1

    Division of Gastroenterology and Nutrition, Albert Einstein Medical Center, Philadelphia, PA

  2. 2

    Department of Gastroenterology and Hepatology, Medical University of South Carolina, Charleston, SC

  3. 3

    Clinical Science, AstraZeneca LP, Wilmington, DE, USA

*Dr P. O. Katz, Klein Building, Suite 331, 5501 Old York Road, Philadelphia, PA 19141, USA. E-mail: pkatz19512@aol.com

Publication History

  1. Issue published online: 21 JUL 2004
  2. Article first published online: 21 JUL 2004
  3. Accepted for publication 21 May 2004

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Summary

Background : Patients with refractory gastro-oesophageal reflux disease, extra-oesophageal reflux symptoms, Barrett's oesophagus, or Zollinger–Ellison syndrome may require greater acid suppression than that obtained with once-daily esomeprazole.

Aim : To assess gastric acid suppression (determined by intragastric pH) and pharmacokinetics of twice-daily vs. once-daily esomeprazole.

Methods : In a randomized, double-blind, three-way crossover study, healthy subjects received esomeprazole 40 mg once daily, 20 mg twice daily, or 40 mg twice daily for five consecutive days. Twenty-four-hour continuous ambulatory intragastric pH was recorded on day 5.

Results : Esomeprazole 40 mg twice daily provided a mean of 19.2 h with intragastric pH > 4.0 (80.1% of a 24-h time period; 95% confidence interval 74.5–85.7%) vs. 14.2 h with 40 mg once daily (59.2%; 95% CI 53.7–64.7%) and 17.5 h with 20 mg twice daily (73.0%; 95% confidence interval 67.4–78.5%) in 25 subjects. Intragastric pH was maintained >4.0 for a similar percentage of time during active and sleeping periods for all doses.

Conclusions : Esomeprazole 40 mg twice daily provides significantly greater acid suppression (number of hours in a 24-h period with pH > 4.0) than once-daily dosing and may be a reasonable consideration for patients requiring greater acid suppression for acid-related disease.

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