Comparison of morning and evening administration of rabeprazole for gastro-oesophageal reflux and nocturnal gastric acid breakthrough in patients with reflux disease: a double-blind, cross-over study.

Author(s): Pehlivanov ND, Olyaee M, Sarosiek I, McCallum RW

Affiliation(s): Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA. ndpehliv@utmb.edu

Publication date & source: 2003-11-01, Aliment Pharmacol Ther., 18(9):883-90.

Publication type: Clinical Trial; Randomized Controlled Trial

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.