@article{1aa963de58654483abc0aff6365db433,
title = "Once-Daily Omeprazole/Sodium Bicarbonate Heals Severe Refractory Reflux Esophagitis with Morning or Nighttime Dosing",
abstract = "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.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.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.",
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.}",
note = "Funding Information: This study was funded in part by an Investigator-Initiated Research Award from Santarus, Inc., IRB # 07-008503. Santarus Inc. provided study medications [omeprazole/sodium bicarbonate (Zegerid) and Gelusil{\texttrademark}] at no charge. No assistance for manuscript preparation was received from Santarus, Inc. Unpaid academicians voluntarily wrote this paper. All data analysis was undertaken by Felicity T. Enders, Diana M. Orbelo, Nancy N. Diehl, Debra M. Geno, Yvonne Romero, David A. Katzka, Dawn L. Francis, Michael D. Crowell, Sami R. Achem, Ramona DeJesus, Vikneswaran Namasivayam, Steven C. Adamson, Amindra S. Arora, Andrew J. Majka, Jeffrey A. Alexander, Joseph A. Murray, Kee Wook Jung, Margaret S. Houston and Angela O{\textquoteright}Neil, all of whom are or were Mayo Clinic employees at the time. Santarus Inc. provided salary support to FTE, NND, and DMG for data analysis, and DMG and MF for data collection. The Santarus study sponsors, William F. Bleker, M.D., Philip Yeung, Pharm.D., Gregg Checani, M.D., and E. David Ballard, M.D., participated in study design but did not participate in data collection, analysis or interpretation, and did not participate in drafting the manuscript or in the decision to publish the results of this trial. Study sponsors were permitted to review the manuscript prior to its submission for publication. Yvonne Romero has received research funding from Aptalis, AstraZeneca, Meritage Pharma and Takeda, has served as an ad hoc consultant for Kala, and receives royalties from the licensed use of the Mayo Dysphagia Questionnaire—30 day. Dawn L. Francis has received research funding from AstraZeneca, and receives royalties from the licensed use of the Mayo Dysphagia Questionnaire—30 day. Jeffrey A. Alexander has received research funding from Aptalis and Merck, serves as a consultant and has stock holdings of Meritage Pharma and receives royalties from the licensed use of the Mayo Dysphagia Questionnaire—30 day. Joseph A. Murray has an ownership interest with Torax Medical Inc. and Vysera Biomedical, and receives royalties from the licensed use of the Mayo Dysphagia Questionnaire—30 day. Felicity T. Enders, Michael D. Crowell, Debra M. Geno, Matthew Lohse, Nancy N. Diehl, and Mary Fredericksen receive royalties from the licensed use of the Mayo Dysphagia Questionnaire—30 day. {\textregistered} Funding Information: We thank Lori R. Anderson for help typing and submitting the manuscript; Kaiser Lim, M.D., Prasad Iyer, M.D., Adil A. Abdalla, M.B.B.S. and Judith McElhiney, M.D., for help recruiting subjects; Rayna M. Grothe, M.D., Joanna M. Peloquin, M.D., Shabana F. Pasha, M.D., and Darlene E. Graner, CCC-SLP, for help conceptualizing the study design; and Michael D. Van Norstrand, M.D., Ph.D., for editorial assistance. The project was supported in part by the Miles and Shirley Fiterman Center for Digestive Diseases at Mayo Clinic, Rochester, Minnesota. Yvonne Romero, M.D., was supported in part by a grant from the National Institutes of Health (NIDDK 02956) and the Robert Wood Johnson Foundation Harold Amos Medical Faculty Development Program. Publisher Copyright: {\textcopyright} 2014, Springer Science+Business Media New York.",
year = "2014",
month = jan,
doi = "10.1007/s10620-013-3017-y",
language = "English (US)",
volume = "60",
pages = "146--162",
journal = "Digestive Diseases and Sciences",
issn = "0163-2116",
publisher = "Springer New York",
number = "1",
}