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Aliment. Pharmacol. Ther. · Jul 2009
Randomized Controlled Trial Multicenter Study Comparative StudyClinical trial: intragastric acid control in patients who have Barrett's oesophagus--comparison of once- and twice-daily regimens of esomeprazole and lansoprazole.
- S J Spechler, P N Barker, and D G Silberg.
- VA North Texas Healthcare System and the University of Texas Southwestern Medical Center, Dallas, TX 75216, USA. sjspechler@aol.com
- Aliment. Pharmacol. Ther. 2009 Jul 1; 30 (2): 138-45.
BackgroundGastric 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.AimTo compare the pharmacodynamic efficacy of esomeprazole and lansoprazole at two dosages for intragastric pH control with Barrett's oesophagus.MethodsPatients 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.ResultsIn 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.ConclusionEsomeprazole 40 mg is significantly more effective than lansoprazole 30 mg in controlling intragastric pH with Barrett's oesophagus.
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