Intravenous Esomeprazole 40mg is Effective for the Control of Intragastric Acid Levels Whether Given as a 3-Minute Injection or a 30-Minute Infusion.
BACKGROUND
An intravenous (IV) formulation of esomeprazole has been developed as an alternative to oral administration. To meet the needs of different clinical situations it would be preferable if an IV dose could be administered as either an injection or an infusion, while producing similar effects.


OBJECTIVE
To compare the effects of IV esomeprazole 40mg given as a 3-minute injection or a 30-minute infusion on intragastric pH during single and repeated once-daily dosing in healthy subjects.


METHODS
In this single-centre, double-blind, double-dummy, randomised, two- way crossover study, subjects were randomised to receive either a 3-minute IV injection or a 30-minute IV infusion of esomeprazole 40mg. Both regimens were given once daily for 10 days. After a washout period of at least 13 days, subjects were crossed over to the other treatment. Intragastric pH monitoring was performed on days 1 and 10. Blood samples were also taken throughout days 1 and 10.


RESULTS
Data were available from 41 subjects. Time with intragastric pH >4 was 3.1h/24h at baseline, increasing to almost 8h in association with IV esomeprazole injection or infusion on day 1, and to >13h on day 10. Geometric mean time with pH >4/24h ratios (injection/infusion) were 0.99 on day 1 and 1.03 on day 10. Mean esomeprazole AUC values were approximately 15% higher with the injection than the infusion, but 90% CI limits for geometric mean AUC ratios ranged from 1.07 to 1.23, indicating bioequivalence.


CONCLUSIONS
IV esomeprazole 40mg provides similarly potent acid control whether administered by injection or infusion.
Wilder-Smith
Clive
C
Brain-Gut Research Group, Berne, Switzerland.
Röhss
Kerstin
K
Bondarov
Patrik
P
Hassan-Alin
Mohammed
M
Lundin
Christina
C
Niazi
Mohammad
M
Nilsson-Pieschl
Catharina
C
Ahlbom
Henrik
H