Alimentary pharmacology & therapeutics · 2012
Control of intra-oesophageal pH in patients with Barrett's oesophagus on omeprazole-sodium bicarbonate therapy.
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Gerson L B, Mitra S, Bleker W F, Yeung P
Аннотация
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.
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.