The effects of dose and timing of esomeprazole administration on 24-h, daytime and night-time acid inhibition in healthy volunteers.
BACKGROUND
Symptoms of gastro-oesophageal reflux disease (GERD) may persist despite daily treatment with a proton pump inhibitor (PPI).


OBJECTIVE
To compare the pharmacodynamic effect of various esomeprazole dosage and timing regimens in healthy volunteers.


METHODS
The effect of different esomeprazole dosage regimens [20 mg once daily (od) before breakfast or dinner; 20 mg twice daily (b.d.); 40 mg od before breakfast, dinner or at bedtime; and 40 mg b.d.] on 24-h, daytime and night-time acid inhibition was evaluated in a randomized, seven-way crossover study in healthy volunteers. Each regimen was taken for 5 days.


RESULTS
Over the 24-h period (day 5), esomeprazole 20 mg b.d. was associated with superior acid inhibition vs. all 20 mg and 40 mg od regimens (P < 0.05), but was less effective than esomeprazole 40 mg b.d. (P < 0.05). Dosing with esomeprazole 20 mg or 40 mg od before breakfast gave improved 24-h and daytime acid inhibition vs. the corresponding administration before dinner or at bedtime (all P < 0.05). Night-time acid inhibition was improved when esomeprazole 40 mg od was administered before dinner or at bedtime vs. before-breakfast dosing (P < 0.05).


CONCLUSIONS
Varying the dose and timing of esomeprazole administration may provide acid inhibition appropriate for the symptom pattern of individual patients with GERD.
Wilder-Smith
C
C
Brain-Gut Research Group, Gastroenterology Group Practice, Berne, Switzerland. cws@braingut.com
Röhss
K
K
Bokelund Singh
S
S
Sagar
M
M
Nagy
P
P
D000284:Administration, Oral; D000328:Adult; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000008:administration & dosage*; D005260:Female; D005744:Gastric Acid / Q000378:metabolism*; D005745:Gastric Acidity Determination; D006801:Humans; D008297:Male; D013223:Statistics as Topic; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D000897:Anti-Ulcer Agents; D064098:Esomeprazole