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

• Published in: Digestive diseases and sciences Vol. 60; no. 1; pp. 146 - 162
• Main Authors: 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.
• Format: Journal Article
• Language: English
• Published: Boston Springer US 01.01.2015; Springer; Springer Nature B.V
• Subjects: Adult; Aged; Aged, 80 and over; Barrett Esophagus - epidemiology; Biochemistry; Carbonates; Clopidogrel; Comorbidity; Drug Combinations; Endoscopy, Digestive System; Endoscopy, Gastrointestinal; Esophagitis; Esophagitis, Peptic - drug therapy; Esophagitis, Peptic - epidemiology; Female; Gastroenterology; Gastroesophageal reflux; Hepatology; Humans; Intention to Treat Analysis; Male; Medicine; Medicine & Public Health; Middle Aged; Mucous Membrane - pathology; Omeprazole - administration & dosage; Oncology; Original Article; Pneumoviridae; Prospective Studies; Proton Pump Inhibitors - administration & dosage; Sodium Bicarbonate - administration & dosage; Transplant Surgery; Esophagitis; Barrett’s esophagus; Prospective randomized controlled trial; Gastroesophageal reflux disease
• ISSN: 0163-2116; 1573-2568
• DOI: 10.1007/s10620-013-3017-y

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. 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.