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

Diana M. Orbelo; Felicity T. Enders; Yvonne Romero; Dawn L. Francis; Sami R. Achem; Tushar S. Dabade; Michael D. Crowell; Debra M. Geno; Ramona S. DeJesus; Vikneswaran Namasivayam; Steven C. Adamson; Amindra S. Arora; Andrew J. Majka; Jeffrey A. Alexander; Joseph A. Murray; Matthew Lohse; Nancy N. Diehl; Mary Fredericksen; Kee Wook Jung; Margaret S. Houston; Angela E. O’Neil; David A. Katzka

doi:10.1007/s10620-013-3017-y

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

Diana M. Orbelo, Felicity T. Enders, Yvonne Romero, Dawn L. Francis, Sami R. Achem, Tushar S. Dabade, Michael D. Crowell, Debra M. Geno, Ramona S. DeJesus, Vikneswaran Namasivayam, Steven C. Adamson, Amindra S. Arora, Andrew J. Majka, Jeffrey A. Alexander, Joseph A. Murray, Matthew Lohse, Nancy N. Diehl, Mary Fredericksen, Kee Wook Jung, Margaret S. HoustonAngela E. O’Neil, David A. Katzka

Research output: Contribution to journal › Article

4 Scopus citations

Abstract

Methods: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.

Results: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19–86), median BMI 29 (range 21–51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett’s esophagus was 14 % with half diagnosed only after treatment.

Conclusions: 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.

Background: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.

Aim: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid^®) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.

Original language	English (US)
Pages (from-to)	146-162
Number of pages	17
Journal	Digestive diseases and sciences
Volume	60
Issue number	1
DOIs	https://doi.org/10.1007/s10620-013-3017-y
State	Published - Jan 1 2014

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Keywords

Barrett’s esophagus
Esophagitis
Gastroesophageal reflux disease
Prospective randomized controlled trial

ASJC Scopus subject areas

Physiology
Gastroenterology

Cite this

Orbelo, D. M., Enders, F. T., Romero, Y., Francis, D. L., Achem, S. R., Dabade, T. S., Crowell, M. D., Geno, D. M., DeJesus, R. S., Namasivayam, V., Adamson, S. C., Arora, A. S., Majka, A. J., Alexander, J. A., Murray, J. A., Lohse, M., Diehl, N. N., Fredericksen, M., Jung, K. W., ... Katzka, D. A. (2014). Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing. Digestive diseases and sciences, 60(1), 146-162. https://doi.org/10.1007/s10620-013-3017-y

Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing. / Orbelo, Diana M.; Enders, Felicity T.; 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; Diehl, Nancy N.; Fredericksen, Mary; Jung, Kee Wook; Houston, Margaret S.; O’Neil, Angela E.; Katzka, David A.

In: Digestive diseases and sciences, Vol. 60, No. 1, 01.01.2014, p. 146-162.

Research output: Contribution to journal › Article

Orbelo, DM, Enders, FT, Romero, Y, Francis, DL, Achem, SR, Dabade, TS, Crowell, MD, Geno, DM, DeJesus, RS, Namasivayam, V, Adamson, SC, Arora, AS, Majka, AJ, Alexander, JA, Murray, JA, Lohse, M, Diehl, NN, Fredericksen, M, Jung, KW, Houston, MS, O’Neil, AE & Katzka, DA 2014, 'Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing', Digestive diseases and sciences, vol. 60, no. 1, pp. 146-162. https://doi.org/10.1007/s10620-013-3017-y

Orbelo, Diana M. ; Enders, Felicity T. ; 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 ; Diehl, Nancy N. ; Fredericksen, Mary ; Jung, Kee Wook ; Houston, Margaret S. ; O’Neil, Angela E. ; Katzka, David A. / Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing. In: Digestive diseases and sciences. 2014 ; Vol. 60, No. 1. pp. 146-162.

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abstract = "Methods: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.Results: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19–86), median BMI 29 (range 21–51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett{\textquoteright}s esophagus was 14 % with half diagnosed only after treatment.Conclusions: 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{\textquoteright}s esophagus.Background: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.Aim: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid{\textregistered}) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.",

keywords = "Barrett{\textquoteright}s esophagus, Esophagitis, Gastroesophageal reflux disease, Prospective randomized controlled trial",

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

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T1 - Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing

AU - Orbelo, Diana M.

AU - Enders, Felicity T.

AU - Romero, Yvonne

AU - Francis, Dawn L.

AU - Achem, Sami R.

AU - Dabade, Tushar S.

AU - Crowell, Michael D.

AU - Geno, Debra M.

AU - DeJesus, Ramona S.

AU - Namasivayam, Vikneswaran

AU - Adamson, Steven C.

AU - Arora, Amindra S.

AU - Majka, Andrew J.

AU - Alexander, Jeffrey A.

AU - Murray, Joseph A.

AU - Lohse, Matthew

AU - Diehl, Nancy N.

AU - Fredericksen, Mary

AU - Jung, Kee Wook

AU - Houston, Margaret S.

AU - O’Neil, Angela E.

AU - Katzka, David A.

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N2 - Methods: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.Results: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19–86), median BMI 29 (range 21–51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett’s esophagus was 14 % with half diagnosed only after treatment.Conclusions: 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.Background: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.Aim: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid®) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.

AB - Methods: Adult outpatients with Los Angeles grade C or D esophagitis were allocated to open-label 40 mg IR-OME once a day for 8 weeks in a prospective, randomized, parallel design, single center study. Esophagogastroduodenoscopy (EGD) and validated self-report symptom questionnaires were completed at baseline and follow-up. Intention-to-treat and per-protocol analyses were performed.Results: Ninety-two of 128 (72 %) eligible subjects participated [64 (70 %) male, mean age 58 (range 19–86), median BMI 29 (range 21–51), 58 C:34 D]. Overall, 81 (88 %) subjects healed [n = 70 (76 %)] or improved [n = 11 (12 %)] erosions. There was no significant difference (morning vs. night) in mucosal healing [81 vs. 71 %, (p = 0.44)] or symptom resolution [heartburn (77 vs. 65 %, p = 0.12), acid regurgitation (82 vs. 73 %, p = 0.28)]. Prevalence of newly identified Barrett’s esophagus was 14 % with half diagnosed only after treatment.Conclusions: 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.Background: Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.Aim: Compare the effect of single dose morning (control arm) versus nighttime (experimental arm) omeprazole/sodium bicarbonate (Zegerid®) (IR-OME) on esophagitis and gastroesophageal reflux symptoms.

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KW - Prospective randomized controlled trial

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10.1007/s10620-013-3017-y