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, Jahrgang 33, Nr. 4, 02.2011, S. 471-6.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -