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- Title
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
Röhss, Kerstin; Wilder-Smith, Clive; Bokelund-Singh, Sara; Sagar, Mohamed; Nagy, Péter; Röhss, Kerstin; Nagy, Péter
- Abstract
<bold>Aim: </bold>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).<bold>Methods: </bold>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).<bold>Results: </bold>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).<bold>Conclusions: </bold>At equivalent total daily doses, the MR formulation of esomeprazole provides less 24-h acid control than the conventional formulation dosed twice-daily.
- Subjects
ACIDS; PROTON pump inhibitors; DRUG dosage; GASTROESOPHAGEAL reflux; ESOMEPRAZOLE; DRUG monitoring; DRUG development; CLINICAL trials; COMPARATIVE studies; CONTROLLED release preparations; CROSSOVER trials; GASTRIC acid; RESEARCH methodology; MEDICAL cooperation; RESEARCH; EVALUATION research; RANDOMIZED controlled trials
- Publication
Digestive Diseases & Sciences, 2010, Vol 55, Issue 12, p3423
- ISSN
0163-2116
- Publication type
journal article
- DOI
10.1007/s10620-010-1176-7