Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers
Article first published online: 22 JAN 2007
Alimentary Pharmacology & Therapeutics
Volume 25, Issue 4, pages 501–510, February 2007
How to Cite
NORRIS, V., BAISLEY, K., DUNN, K., WARRINGTON, S. and MOROCUTTI, A. (2007), Combined analysis of three crossover clinical pharmacology studies of effects of rabeprazole and esomeprazole on 24-h intragastric pH in healthy volunteers. Alimentary Pharmacology & Therapeutics, 25: 501–510. doi: 10.1111/j.1365-2036.2006.03221.x
- Issue published online: 22 JAN 2007
- Article first published online: 22 JAN 2007
- Publication data Submitted 24 February 2006 First decision 11 March 2006 Resubmitted 21 October 2006 Resubmitted 27 November 2006 Accepted 27 November 2006
To compare antisecretory effects of rabeprazole and esomeprazole after single and repeat dosing in Helicobacter pylori-negative healthy volunteers.
Results were pooled from three smaller, open, crossover, randomized studies to obtain data from 80 subjects. The studies compared: (a) 5 days’ dosing of 20 mg rabeprazole and esomeprazole (n = 24); (b) single doses of rabeprazole 20 mg and esomeprazole 40 mg (n = 27) and (c) 5 days’ dosing of rabeprazole 10 mg and esomeprazole 20 mg (n = 29). Washout periods were ≥14 days. Intragastric pH was recorded continuously for 24 h on days 0, 1 and 5.
Single doses of rabeprazole 20 mg maintained 24-h intragastric pH >4 for longer than esomeprazole 20 mg (45% vs. 32%; P < 0.001); rabeprazole 20 mg and esomeprazole 40 mg were equivalent in their effects. After 5 days’ dosing, rabeprazole 20 mg maintained pH >4 for longer than esomeprazole 20 mg (62% vs. 56%; P = 0.046); the reverse was true for esomeprazole 20 mg vs. rabeprazole 10 mg (56% vs. 48%; P = 0.035). In general, intragastric pH AUC during 0–5 h after dosing was higher after esomeprazole than rabeprazole, whereas the reverse was true during the night.
The order of effects on 24-h pH was: rabeprazole 10 mg ≤ esomeprazole 20 mg < rabeprazole 20 mg = esomeprazole 40 mg. Esomeprazole acts faster, whereas rabeprazole's effect lasts longer.