Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing

Orbelo, Diana M.; Enders, Felicity; Romero, Yvonne; Francis, Dawn L.; Achem, Sami R.; Dabade, Tushar S.; Crowell, Michael D.; Geno, Debra M.; DeJesus, Ramona S.; Namasivayam, Vikneswaran; Adamson, Steven C.; Arora, Amindra S.; Majka, Andrew J.; Alexander, Jeffrey A.; Murray, Joseph A.; Lohse, Matthew R.; Diehl, Nancy N.; Fredericksen, Mary; Jung, Kee Wook; Houston, Margaret S.; O'neil, Angela; Katzka, David A.

doi:10.1007/s10620-013-3017-y

Cited by 9 publications

(7 citation statements)

References 27 publications

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“…The IR‐OME formulation evaluated in the present study is known to heal severe reflux esophagitis, improve GERD symptoms such as heartburn (Orbelo et al. ), and has shown promise in mitigating a delayed onset of action (Howden ). The incorporation of sodium bicarbonate in the formulation of IR‐OME provides rapid buffering of gastric acidity thereby protecting the IR drug from inactivation.…”

Section: Discussionmentioning

confidence: 99%

A randomized, crossover pharmacodynamic study of immediate‐release omeprazole/sodium bicarbonate and delayed‐release lansoprazole in healthy adult volunteers

Pratha

McGraw

Tobin³

2016

Pharmacology Res & Perspec

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Proton pump inhibitors (PPIs) effectively block gastric acid secretion and are the treatment of choice for heartburn. PPIs differ, however, in onset of action and bioavailability. In this single‐center, open‐label, three‐way crossover study, onset of action of immediate‐release omeprazole 20 mg/sodium bicarbonate 1100 mg (IR‐OME) and delayed‐release (DR) lansoprazole 15 mg was evaluated in 63 healthy fasting adults. Subjects were randomized to once daily IR‐OME, or DR‐lansoprazole, or no treatment for 7 days. The primary efficacy endpoint was the earliest time where a statistically significant difference was observed between IR‐OME and DR‐lansoprazole in median intragastric pH scores for three consecutive 5‐min intervals on day 7. Secondary endpoints compared effects of active treatments on days 1 and 7 (e.g., time to sustained inhibition, percentage of time with pH >4). A significant difference in median intragastric pH favoring IR‐OME was observed on day 7 starting at the 10‐ to 15‐min interval postdosing (P = 0.024) and sustaining through the 115‐ to 120‐min interval (P = 0.017). On day 1, IR‐OME achieved sustained inhibition of intragastric acidity significantly faster than DR‐lansoprazole. IR‐OME maintained pH >4 significantly longer than DR‐lansoprazole over a 24‐h period (P = 0.007) on day 7. Overall, results of this study demonstrate IR‐OME is safe and well tolerated and that treatment with IR‐OME results in significantly faster onset of action and better gastric acid suppression at steady state than DR‐lansoprazole.

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Section: Discussionmentioning

confidence: 99%

A randomized, crossover pharmacodynamic study of immediate‐release omeprazole/sodium bicarbonate and delayed‐release lansoprazole in healthy adult volunteers

Pratha

McGraw

Tobin³

2016

Pharmacology Res & Perspec

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“…The results of the study revealed that SR baclofen plus omeprazole is more effective than omeprazole alone in the treatment of reflux symptoms (heartburn and regurgitation) ( 31 ). Another study which was conducted to compare the effects of single-dose morning versus nighttime once-daily omeprazole/sodium bicarbonate (Zegerid (®) (IR-OME) in patients with esophagitis and symptoms of gastroesophageal reflux, showed that the reflux esophagitis and GERD symptoms improved after taking IR-OME ( 32 – 33 ). According to the study of Kim et al, poor response to PPI treatment is a result of psychological factors, sleep dysfunction and BMI lower 23kg/m in patients with GERD symptoms ( 34 ).…”

Section: Resultsmentioning

confidence: 99%

Gastrointestinal symptoms associated with gastroesophageal reflux disease, and their relapses after treatment with proton pump inhibitors: A systematic review

et al. 2017

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Gastroesophageal reflux disease (GERD) is a common functional gastrointestinal disorder with significant effects on the quality of life. The burden of GERD is soaring in Asia. Preventing symptom relapse is a therapeutic goal in GERD patients. Since proton pump inhibitors (PPI) are the first-line treatment of GERD, drug failure has become a major problem in the treatment procedure. We reviewed the literature in order to find articles related to comorbidities and symptoms affecting GERD from 1980 to 2015 via PubMed and Google Scholar using keywords such as ‘Gastroesophageal reflux disease’, ‘Gastrointestinal symptoms’ and Boolean operators (such as AND, OR, NOT). Due to the cost of PPI therapy and the high rate of GERD relapse after PPI therapy, demand for continuing this type of treatment is decreasing. Thus, we need to discover new approaches to treat the disease and also investigate the relationship between the treatment of GERD and its comorbidities and symptoms such as functional constipation.

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“…14 Once daily morning or bed time omeprazole/sodium bicarbonate was found effective in improving severe reflux esophagitis and GERD symptoms. 15 In another study by Barrett's oesophagus along with complete control of oesophageal pH during 97% of the 24-h recording periods. 16 Omeprazole-sodium bicarbonate was not found more effective than omeprazole in treatment of GERD however, it showed the more sustained relief and effect in systematic review by Higuera-de-la-Tijera.…”

Section: Discussionmentioning

confidence: 99%

A unique formulation of sodium bicarbonate buffered pantoprazole powder for oral suspension: perspectives from an active controlled cross-over bioequivalence study

2022

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Background: The aim was determining bioequivalence between pantoprazole buffered powder for oral suspension and pantoprazole enteric coated tablets under fasting conditions in healthy volunteers.Methods: In randomized cross-over study, participants were administered a single oral dose of pantoprazole powder as suspension 40 mg (sodium bicarbonate as buffer) or one enteric coated tablet of pantoprazole 40 mg, with 240±2 ml of water as per the randomization schedule in each study period. Blood samples were collected at pre-dose and at 0.33, 0.67, 1, 1.33, 1.67, 2, 2.33, 2.67, 3, 3.33, 3.67, 4, 4.5, 5, 5.5, 6, 7, 8, 9, 10, 12-, 14-, 16- and 24-hours post-dose. Plasma concentration of pantoprazole was determined with LC-MS and various pharmacokinetic parameters like Cmax, AUC0-t, AUC0-inf were compared between test and reference groups.Results: Amongst 41 samples, Cmax (3752.4±1084.6 vs. 3521.7±1099.5 ng/ml) was achieved higher in less Tmax time (1 (0.28) vs. 2.3 (0.83) hrs) with test drug as compared to reference drug. The ratios of geometric least square mean and its 90% confidence interval on log transformed Cmax, AUC0-t and AUC0-inf for pantoprazole fall within the acceptance criteria of 80% to 125%. No adverse events were observed.Conclusions: Pantoprazole powder for oral suspension 40 mg (sodium bicarbonate as buffer) was well tolerated and bioequivalent with pantoprazole enteric coated tablets IP 40 mg in terms of rate and extent of absorption under fasting conditions. At same time, the shift in AUC to the left with reduction in Tmax with the new formulation is suggestive of faster rate of absorption.

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Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing

Abstract: Once-daily IR-OME (taken morning or night) effectively heals severe reflux esophagitis and improves GERD symptoms. Results support the clinical practice recommendation to repeat EGD after 8 weeks PPI therapy in severe esophagitis patients to assure healing and exclude Barrett's esophagus.

Cited by 9 publications

References 27 publications

A randomized, crossover pharmacodynamic study of immediate‐release omeprazole/sodium bicarbonate and delayed‐release lansoprazole in healthy adult volunteers

A randomized, crossover pharmacodynamic study of immediate‐release omeprazole/sodium bicarbonate and delayed‐release lansoprazole in healthy adult volunteers

Gastrointestinal symptoms associated with gastroesophageal reflux disease, and their relapses after treatment with proton pump inhibitors: A systematic review

A unique formulation of sodium bicarbonate buffered pantoprazole powder for oral suspension: perspectives from an active controlled cross-over bioequivalence study

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