Published in:
01-12-2010 | Original Article
Acid Control Cannot Be Improved with a Modified-Release Formulation of a Proton Pump Inhibitor Compared with Twice-Daily Dosing of the Conventional Formulation
Authors:
Kerstin Röhss, Clive Wilder-Smith, Sara Bokelund-Singh, Mohamed Sagar, Péter Nagy
Published in:
Digestive Diseases and Sciences
|
Issue 12/2010
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Abstract
Aim
The aim of this study was to compare acid control with a once-daily (od) modified-release (MR) formulation of esomeprazole vs. the conventional formulation (CF) dosed twice-daily (bid).
Methods
In a randomized, five-way crossover study, 55 healthy volunteers underwent 24-h intragastric pH monitoring after 5-day treatment with MR esomeprazole (40, 60 or 80 mg od) and CF esomeprazole (20 or 40 mg bid).
Results
Modified-release 60 and 80 mg od resulted in a significantly longer time with intragastric pH > 4 than MR 40 mg od (77.1 and 79.0% vs. 66.4%, respectively; both p < 0.05). At equivalent total daily doses, CF 20 mg bid led to a significantly longer time with intragastric pH > 4 than MR 40 mg od (72.3 vs. 66.4%; p < 0.05), and CF 40 mg bid led to a significantly longer time with pH > 4 than MR 80 mg od (85.5 vs. 79.0%; p < 0.05).
Conclusions
At equivalent total daily doses, the MR formulation of esomeprazole provides less 24-h acid control than the conventional formulation dosed twice-daily.