AIM: To assess the effect of timing of rebeprazole (RB) 20 mg/d administration on oesophageal acid exposure and nocturnal gastric acid breakthrough (NGAB) in patients with GERD. METHODS:20 GERD patients received two 7-day treatments of RB in the morning (a.m.) or in the evening (p.m.) hours. The regimens were randomized in a double-blind fashion and separated by a 7-day washout period. The tablets were taken 30 min before standardized meals. A combined (oesophageal & gastric) 24-hour pH monitoring was performed before and on day 7 of each treatment. RESULTS:Total oesophageal acid exposure was normalized in 10/14 (71.4%) patients with RB p.m. and in 6/15 (42.8%) with RB a.m. RB p.m. significantly decreased the nocturnal supine oesophageal acid exposure vs. RB a.m., 0.2% vs. 3.4%. The mean NGAB duration was significantly shortened with RB a.m. and p.m. vs. the baseline recording, 4.1+/-1.8 and 3.4+/-1.5 hours vs. 7.8+/-1.7 hours. CONCLUSIONS:Rabeprazole significantly reduced the NGAB duration and significantly increased the mean nocturnal gastric pH; RB p.m. normalized more effectively the total oesophageal exposure than RB-a.m.; RB p.m. provided significantly better control of nocturnal supine gastro-oesophageal reflux than a.m. dosing. These data suggest that administration of a PPI before the evening meal maximizes acid control and would be the preferred dosing schedule in GERD patients, particularly those with nocturnal symptoms.
RCT Entities:
AIM: To assess the effect of timing of rebeprazole (RB) 20 mg/d administration on oesophageal acid exposure and nocturnal gastric acid breakthrough (NGAB) in patients with GERD. METHODS: 20 GERDpatients received two 7-day treatments of RB in the morning (a.m.) or in the evening (p.m.) hours. The regimens were randomized in a double-blind fashion and separated by a 7-day washout period. The tablets were taken 30 min before standardized meals. A combined (oesophageal & gastric) 24-hour pH monitoring was performed before and on day 7 of each treatment. RESULTS: Total oesophageal acid exposure was normalized in 10/14 (71.4%) patients with RB p.m. and in 6/15 (42.8%) with RB a.m. RB p.m. significantly decreased the nocturnal supine oesophageal acid exposure vs. RB a.m., 0.2% vs. 3.4%. The mean NGAB duration was significantly shortened with RB a.m. and p.m. vs. the baseline recording, 4.1+/-1.8 and 3.4+/-1.5 hours vs. 7.8+/-1.7 hours. CONCLUSIONS:Rabeprazole significantly reduced the NGAB duration and significantly increased the mean nocturnal gastric pH; RB p.m. normalized more effectively the total oesophageal exposure than RB-a.m.; RB p.m. provided significantly better control of nocturnal supine gastro-oesophageal reflux than a.m. dosing. These data suggest that administration of a PPI before the evening meal maximizes acid control and would be the preferred dosing schedule in GERDpatients, particularly those with nocturnal symptoms.
Authors: Bimal K Malhotra; Penelope H Crownover; Robert LaBadie; Paul Glue; Scott A MacDiarmid Journal: Eur J Clin Pharmacol Date: 2009-11-14 Impact factor: 2.953