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Clinical trial: intragastric acid control in patients who have Barrett’s oesophagus—comparison of once- and twice-daily regimens of esomeprazole and lansoprazole
Article first published online: 29 APR 2009
DOI: 10.1111/j.1365-2036.2009.04032.x
Published 2009. This article is a US Government work and is in the public domain in the USA
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How to Cite
SPECHLER, S. J., BARKER, P. N. and SILBERG, D. G. (2009), Clinical trial: intragastric acid control in patients who have Barrett’s oesophagus—comparison of once- and twice-daily regimens of esomeprazole and lansoprazole. Alimentary Pharmacology & Therapeutics, 30: 138–145. doi: 10.1111/j.1365-2036.2009.04032.x
Publication History
- Issue published online: 26 JUN 2009
- Article first published online: 29 APR 2009
- Publication data Submitted 4 February 2009 First decision 1 March 2009 Resubmitted 27 April 2009 Accepted 28 April 2009 Epub Accepted Article 29 April 2009
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Summary
Background Gastric acid control is important for treatment of gastro-oesophageal reflux disease associated with Barrett’s oesophagus. Substantial indirect evidence suggests that gastric acid control may have a chemopreventive role in Barrett’s oesophagus.
Aim To compare the pharmacodynamic efficacy of esomeprazole and lansoprazole at two dosages for intragastric pH control with Barrett’s oesophagus.
Methods Patients with Barrett’s oesophagus received open-label consecutive treatment (a 15-day period of once-daily dosing followed by a 10-day period of twice-daily dosing) with esomeprazole (40-mg capsules) and lansoprazole (30-mg capsules) in random order with no washouts. Twenty-four-hour intragastric pH was recorded on the last day of each dosing period. The primary end point was the percentage of time with intragastric pH > 4.0.
Results In the per-protocol once- (n = 46) and twice-daily (n = 41) analyses, the percentage of time with intragastric pH > 4.0 was significantly (P < 0.0001) longer after once- (67.1%) or twice-daily (81.2%) esomeprazole than after once- (50.8%) or twice-daily (64.3%) lansoprazole. The proportion of patients with intragastric pH > 4.0 for >12 h was significantly higher for esomeprazole than lansoprazole with once- (P = 0.004) and twice-daily (P = 0.016) dosing.
Conclusion Esomeprazole 40 mg is significantly more effective than lansoprazole 30 mg in controlling intragastric pH with Barrett’s oesophagus.