HOMEPRODUCTSCOMPANYCONTACTFAQResearchDictionaryPharmaSign Up FREE or Login

Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.

AbstractBACKGROUND:
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.
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.
AuthorsDiana 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
JournalDigestive diseases and sciences (Dig Dis Sci) Vol. 60 Issue 1 Pg. 146-62 (Jan 2015) ISSN: 1573-2568 [Electronic] United States
PMID24448652 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Drug Combinations
  • Proton Pump Inhibitors
  • omeprazole, sodium bicarbonate drug combination
  • Sodium Bicarbonate
  • Omeprazole
Topics
  • Adult
  • Aged
  • Aged, 80 and over
  • Barrett Esophagus (epidemiology)
  • Comorbidity
  • Drug Combinations
  • Endoscopy, Digestive System
  • Endoscopy, Gastrointestinal
  • Esophagitis, Peptic (drug therapy, epidemiology)
  • Female
  • Humans
  • Intention to Treat Analysis
  • Male
  • Middle Aged
  • Mucous Membrane (pathology)
  • Omeprazole (administration & dosage)
  • Prospective Studies
  • Proton Pump Inhibitors (administration & dosage)
  • Sodium Bicarbonate (administration & dosage)

Join CureHunter, for free Research Interface BASIC access!

Take advantage of free CureHunter research engine access to explore the best drug and treatment options for any disease. Find out why thousands of doctors, pharma researchers and patient activists around the world use CureHunter every day.
Realize the full power of the drug-disease research graph!


Choose Username:
Email:
Password:
Verify Password:
Enter Code Shown: