Control of intra-oesophageal pH in patients with Barrett's oesophagus on omeprazole-sodium bicarbonate therapy

Abstract

Background Approximately 30-40% of patients with Barrett's oesophagus (BE) patients manifest abnormal oesophageal pH profiles despite proton pump inhibitor (PPI) therapy. Aim To determine control of oesophageal reflux using Bravo pH monitoring in patients BE on omeprazole-sodium bicarbonate oral suspension powder (Ome-NaBic) 40 mg twice daily. Methods Initial pH monitoring off PPI for 1 week was performed. All patients underwent repeat pH testing on Ome-NaBic administered before breakfast and at bedtime after 21-28 days of therapy depending upon the prior PPI therapy. The goal was to enroll 30 subjects, however, the trial was terminated prematurely when the sponsor lost financing due to a change in business strategy. Results A total of 88 patients responded to the study invitation, 27 patients signed informed consent, and 21 patients underwent pH testing of PPI. A total of 15 patients completed the protocol (13 men, 2 women). Demographic information for patients completing at least one Bravo study included a mean (±s.d.) age 62 ± 9 years; body mass index 31 ± 8 kg/m 2 (range 23-48); mean BE length of 2.6 ± 2 cm; 9 (43%) patients with long segment BE. All (100%) patients demonstrated normalisation of supine pH on both days of Ome-NaBic therapy. One patient (6%) demonstrated abnormal upright reflux on the second day of monitoring on Ome-NaBic therapy; all the other patients demonstrated normal pH scores on therapy. Conclusions Administration of twice daily Ome-NaBic demonstrated control of nocturnal oesophageal reflux in 100% of patients with Barrett's oesophagus, and complete control of oesophageal pH during 97% of the 24-h recording periods. © 2012 Blackwell Publishing Ltd.