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

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Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping. / Miehlke, S; Löbe, S; Madisch, A; Kuhlisch, E; Laass, M; Grossmann, D; Knoth, H; Morgner, A; Labenz, J.

In: ALIMENT PHARM THER, Vol. 33, No. 4, 02.2011, p. 471-6.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Miehlke, S, Löbe, S, Madisch, A, Kuhlisch, E, Laass, M, Grossmann, D, Knoth, H, Morgner, A & Labenz, J 2011, 'Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping', ALIMENT PHARM THER, vol. 33, no. 4, pp. 471-6. https://doi.org/10.1111/j.1365-2036.2010.04544.x

APA

Miehlke, S., Löbe, S., Madisch, A., Kuhlisch, E., Laass, M., Grossmann, D., Knoth, H., Morgner, A., & Labenz, J. (2011). Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping. ALIMENT PHARM THER, 33(4), 471-6. https://doi.org/10.1111/j.1365-2036.2010.04544.x

Vancouver

Miehlke S, Löbe S, Madisch A, Kuhlisch E, Laass M, Grossmann D et al. Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping. ALIMENT PHARM THER. 2011 Feb;33(4):471-6. https://doi.org/10.1111/j.1365-2036.2010.04544.x

Bibtex

@article{c3eab48582724db9a044629e3b2b668c,
title = "Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping",
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.",
keywords = "Adolescent, Adult, Anti-Ulcer Agents, Aryl Hydrocarbon Hydroxylases, Cross-Over Studies, Cytochrome P-450 CYP2C19, Drugs, Generic, Enzyme Inhibitors, Esomeprazole, European Continental Ancestry Group, Female, Gastric Acid, Gastric Acidity Determination, Gastroesophageal Reflux, Humans, Hydrogen-Ion Concentration, Male, Middle Aged, Omeprazole, Statistics as Topic, Young Adult, Journal Article, Randomized Controlled Trial",
author = "S Miehlke and S L{\"o}be and A Madisch and E Kuhlisch and M Laass and D Grossmann and H Knoth and A Morgner and J Labenz",
note = "{\textcopyright} 2010 Blackwell Publishing Ltd.",
year = "2011",
month = feb,
doi = "10.1111/j.1365-2036.2010.04544.x",
language = "English",
volume = "33",
pages = "471--6",
journal = "ALIMENT PHARM THER",
issn = "0269-2813",
publisher = "Wiley-Blackwell",
number = "4",

}

RIS

TY - JOUR

T1 - Intragastric acidity during administration of generic omeprazole or esomeprazole - a randomised, two-way crossover study including CYP2C19 genotyping

AU - Miehlke, S

AU - Löbe, S

AU - Madisch, A

AU - Kuhlisch, E

AU - Laass, M

AU - Grossmann, D

AU - Knoth, H

AU - Morgner, A

AU - Labenz, J

N1 - © 2010 Blackwell Publishing Ltd.

PY - 2011/2

Y1 - 2011/2

N2 - 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.

AB - 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.

KW - Adolescent

KW - Adult

KW - Anti-Ulcer Agents

KW - Aryl Hydrocarbon Hydroxylases

KW - Cross-Over Studies

KW - Cytochrome P-450 CYP2C19

KW - Drugs, Generic

KW - Enzyme Inhibitors

KW - Esomeprazole

KW - European Continental Ancestry Group

KW - Female

KW - Gastric Acid

KW - Gastric Acidity Determination

KW - Gastroesophageal Reflux

KW - Humans

KW - Hydrogen-Ion Concentration

KW - Male

KW - Middle Aged

KW - Omeprazole

KW - Statistics as Topic

KW - Young Adult

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1111/j.1365-2036.2010.04544.x

DO - 10.1111/j.1365-2036.2010.04544.x

M3 - SCORING: Journal article

C2 - 21175704

VL - 33

SP - 471

EP - 476

JO - ALIMENT PHARM THER

JF - ALIMENT PHARM THER

SN - 0269-2813

IS - 4

ER -