S J Spechler1, P N Barker, D G Silberg. 1. VA North Texas Healthcare System and the University of Texas Southwestern Medical Center, Dallas, TX 75216, USA. sjspechler@aol.com
Abstract
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 receivedopen-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.
RCT Entities:
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.