Intragastric acidity during administration of generic omeprazole or esomeprazole - A randomised, two-way crossover study including CYP2C19 genotyping

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • S. Miehlke - , University of Hamburg (Author)
  • S. Löbe - , University Hospital Carl Gustav Carus Dresden, Department of internal Medicine I (Author)
  • A. Madisch - , KRH Hospital Siloah (Author)
  • E. Kuhlisch - , Institute for Medical Informatics and Biometry (Author)
  • M. Laass - , Department of Paediatrics (Author)
  • D. Großmann - , University Hospital Carl Gustav Carus Dresden, Department of internal Medicine I (Author)
  • H. Knoth - , Pharmacy (Author)
  • A. Morgner - , University Hospital Carl Gustav Carus Dresden (Author)
  • J. Labenz - , Diakonie Klinikum Jung-Stilling (Author)

Abstract

Background Generic omeprazole has been approved in many countries for the treatment of acid-related gastrointestinal disorders. However, clinical studies comparing generic to original proton pump inhibitors are limited. Aims To compare the effect of generic omeprazole 20 mg/day with esomeprazole 20 mg/day on intragastric acidity and to investigate the influence of the CYP2C19 metabolizer status. Methods In this randomised, single-blinded, two-way crossover study, 24 healthy Helicobacter pylori-negative subjects, received generic omeprazole (Omep; Hexal AG, Holzkirchen, Germany) 20 mg once daily or esomeprazole 20 mg once daily for five consecutive days. Twenty-four-hour intragastric pH was recorded on day 5 of each treatment. CYP2C19 status was determined by polymerase chain reaction-restriction fragment length polymorphism. Results Over all, there were no statistically significant differences between generic omeprazole and esomeprazole with respect to median intragastric pH (3.5 and 3.9, P = 0.07), the total hours with intragastric pH >4 (10.4 and 11.3, P = 0.29), and during upright (9.6 and 9.1, P = 0.77) or supine (2.2 and 2.2, P = 0.94) position. However, in CYP2C19 rapid metabolizers, esomeprazole was superior to omeprazole, with the percentage of time with intragastric pH >3.0 and pH >3.5 being higher with esomeprazole than with generic omeprazole [Δ = 9% (P = 0.026) and Δ = 8% (P = 0.046), respectively]. Conclusions Overall, generic omeprazole 20 mg appears to provide a similar intragastric acid control when compared with esomeprazole 20 mg. However, esomeprazole might be advantageous in subjects with a rapid CYP2C19 metabolizer status.

Details

Original languageEnglish
Pages (from-to)471-476
Number of pages6
JournalAlimentary Pharmacology and Therapeutics
Volume33
Issue number4
Publication statusPublished - Feb 2011
Peer-reviewedYes

External IDs

PubMed 21175704

Keywords