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Intragastric acidity during administration of generic omeprazole or esomeprazole – a randomised, two‐way crossover study including CYP2C19 genotyping
Author(s) -
Miehlke S.,
Löbe S.,
Madisch A.,
Kuhlisch E.,
Laass M.,
Großmann D.,
Knoth H.,
Morgner A.,
Labenz J.
Publication year - 2011
Publication title -
alimentary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.308
H-Index - 177
eISSN - 1365-2036
pISSN - 0269-2813
DOI - 10.1111/j.1365-2036.2010.04544.x
Subject(s) - esomeprazole , omeprazole , cyp2c19 , medicine , crossover study , gastroenterology , proton pump inhibitor , helicobacter pylori , pharmacology , placebo , alternative medicine , cytochrome p450 , pathology , metabolism
Summary 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.