Control of Intra-esophageal pH in Barrett's Esophagus
Control of Intra-esophageal pH in Barrett's Esophagus
Prior studies in the literature demonstrated that patients with BE were more likely to manifest abnormal oesophageal pH profiles on PPI therapy, despite adequate control of reflux symptoms. The presence of persistent pathological supine reflux in these patients was believed to be associated with prolonged exposure of the oesophageal squamous mucosa to acid reflux leading to more severe erosive oesophagitis and formation of columnar metaplasia.
In contrast to the data from prior studies in BE patients on PPI therapy demonstrating abnormal pH profiles in 30–50% of patients, our current study demonstrated adequate control of intra-oesophageal acidity in 97% of patients on Ome-NaBic twice daily and 100% control of supine oesophageal pH. The data were particularly impressive since this is the first study in the medical literature to use Bravo pH monitoring in this patient cohort and collect data for 48-h time periods. The limitations of this study included the small sample size, a cohort of patients with primarily short-segment BE, and the fact that the study relied on comparison of intra-oesophageal pH levels on Ome-NaBic to other PPIs based on historical controls.
Although this is the first study to examine oesophageal pH profiles in BE patients on Ome-NaBic therapy, the prior literature has demonstrated excellent suppression of daytime and nocturnal oesophageal pH on Ome-NaBic in small cohorts of GERD patients who received the drug once daily. In a prospective open-labelled study of patients prescribed Ome-NaBic once daily either in the morning or at bedtime, four of five (80%) of the GERD subjects taking the medication in the morning normalised their oesophageal pH profiles on therapy, and one (100%) subject administered the medication at bedtime demonstrated a normal 24-h oesophageal pH recording period. In a subsequent follow-up of this study, six of seven (86%) subjects prescribed Ome-NaBic in the morning demonstrated normal pH profiles, and three of five (60%) subjects taking the medication at bedtime demonstrated normal pH profiles.
There have not been prior studies examining b.d. dosing of Ome-NaBic on oesophageal pH profiles to date. Table 3 highlights the prior literature with regard to control of intra-oesophageal pH values on PPI therapy in BE patients. Approximately 40–62% of BE patients using PPI therapy q.d.s. or b.d. demonstrated abnormal oesophageal pH profiles. In a 2006 study where esomeprazole was prescribed up to three times daily, this value fell to 16%. However, if we calculate that only 1/15 (7%) of patients in our study demonstrated an abnormal pH profile on Ome-NaBic b.d. therapy, this value remains significantly improved compared to the prior published literature. Larger studies in BE patients are warranted to confirm these encouraging results.
The potential advantages of Ome-NaBic appear to be related to the ability to provide sustained control of intragastric pH at steady state. Prior studies have demonstrated that administration of Ome-NaBic at bedtime was effective for the control of nocturnal oesophageal pH and night-time GERD symptoms. In a randomised, open-label, crossover trial, Ome-NaBic at bedtime offered significantly better control of nocturnal gastric pH compared with once or twice daily delayed-release pantoprazole tablets, in 36 patients with symptomatic nocturnal GERD.
In summary, despite the prior literature demonstrating significant nocturnal gastric acid breakthrough and pathological supine oesophageal pH reflux in patients with BE, we demonstrated that the usage of Ome-NaBic twice daily before breakfast and bedtime resulted in 100% control of 48 h supine intra-oesophageal acid profiles. These results are intriguing given the prior challenges with control of pH values in these patient cohorts. It should be noted that our findings are preliminary due to premature stopping of the study, and that furthermore comparative studies should be encouraged. Future studies are indicated to examine whether or not the usage of Ome-NaBic in patients with BE might be associated with reduction of the risk of progression to dysplasia.
Discussion
Prior studies in the literature demonstrated that patients with BE were more likely to manifest abnormal oesophageal pH profiles on PPI therapy, despite adequate control of reflux symptoms. The presence of persistent pathological supine reflux in these patients was believed to be associated with prolonged exposure of the oesophageal squamous mucosa to acid reflux leading to more severe erosive oesophagitis and formation of columnar metaplasia.
In contrast to the data from prior studies in BE patients on PPI therapy demonstrating abnormal pH profiles in 30–50% of patients, our current study demonstrated adequate control of intra-oesophageal acidity in 97% of patients on Ome-NaBic twice daily and 100% control of supine oesophageal pH. The data were particularly impressive since this is the first study in the medical literature to use Bravo pH monitoring in this patient cohort and collect data for 48-h time periods. The limitations of this study included the small sample size, a cohort of patients with primarily short-segment BE, and the fact that the study relied on comparison of intra-oesophageal pH levels on Ome-NaBic to other PPIs based on historical controls.
Although this is the first study to examine oesophageal pH profiles in BE patients on Ome-NaBic therapy, the prior literature has demonstrated excellent suppression of daytime and nocturnal oesophageal pH on Ome-NaBic in small cohorts of GERD patients who received the drug once daily. In a prospective open-labelled study of patients prescribed Ome-NaBic once daily either in the morning or at bedtime, four of five (80%) of the GERD subjects taking the medication in the morning normalised their oesophageal pH profiles on therapy, and one (100%) subject administered the medication at bedtime demonstrated a normal 24-h oesophageal pH recording period. In a subsequent follow-up of this study, six of seven (86%) subjects prescribed Ome-NaBic in the morning demonstrated normal pH profiles, and three of five (60%) subjects taking the medication at bedtime demonstrated normal pH profiles.
There have not been prior studies examining b.d. dosing of Ome-NaBic on oesophageal pH profiles to date. Table 3 highlights the prior literature with regard to control of intra-oesophageal pH values on PPI therapy in BE patients. Approximately 40–62% of BE patients using PPI therapy q.d.s. or b.d. demonstrated abnormal oesophageal pH profiles. In a 2006 study where esomeprazole was prescribed up to three times daily, this value fell to 16%. However, if we calculate that only 1/15 (7%) of patients in our study demonstrated an abnormal pH profile on Ome-NaBic b.d. therapy, this value remains significantly improved compared to the prior published literature. Larger studies in BE patients are warranted to confirm these encouraging results.
The potential advantages of Ome-NaBic appear to be related to the ability to provide sustained control of intragastric pH at steady state. Prior studies have demonstrated that administration of Ome-NaBic at bedtime was effective for the control of nocturnal oesophageal pH and night-time GERD symptoms. In a randomised, open-label, crossover trial, Ome-NaBic at bedtime offered significantly better control of nocturnal gastric pH compared with once or twice daily delayed-release pantoprazole tablets, in 36 patients with symptomatic nocturnal GERD.
In summary, despite the prior literature demonstrating significant nocturnal gastric acid breakthrough and pathological supine oesophageal pH reflux in patients with BE, we demonstrated that the usage of Ome-NaBic twice daily before breakfast and bedtime resulted in 100% control of 48 h supine intra-oesophageal acid profiles. These results are intriguing given the prior challenges with control of pH values in these patient cohorts. It should be noted that our findings are preliminary due to premature stopping of the study, and that furthermore comparative studies should be encouraged. Future studies are indicated to examine whether or not the usage of Ome-NaBic in patients with BE might be associated with reduction of the risk of progression to dysplasia.
Source...