Once-daily omeprazole/sodium bicarbonate heals severe refractory reflux esophagitis with morning or nighttime dosing.
BACKGROUND
Morning dose or twice-daily proton pump inhibitor (PPI) use is often prescribed to heal severe reflux esophagitis.


OBJECTIVE
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.
Department of Otolaryngology, Mayo Clinic, 200 First St., SW, Rochester, MN, 55905, USA, orbelo.diana@mayo.edu.
Diana M
DM
Orbelo
Felicity T
FT
Enders
Yvonne
Y
Romero
Dawn L
DL
Francis
Sami R
SR
Achem
Tushar S
TS
Dabade
Michael D
MD
Crowell
Debra M
DM
Geno
Ramona S
RS
DeJesus
Vikneswaran
V
Namasivayam
Steven C
SC
Adamson
Amindra S
AS
Arora
Andrew J
AJ
Majka
Jeffrey A
JA
Alexander
Joseph A
JA
Murray
Matthew
M
Lohse
Nancy N
NN
Diehl
Mary
M
Fredericksen
Kee Wook
KW
Jung
Margaret S
MS
Houston
Angela E
AE
O'Neil
David A
DA
Katzka
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001471:Barrett Esophagus / Q000453:epidemiology; D015897:Comorbidity; D004338:Drug Combinations; D016145:Endoscopy, Digestive System; D016099:Endoscopy, Gastrointestinal; D004942:Esophagitis, Peptic / Q000188:drug therapy* / Q000453:epidemiology; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009092:Mucous Membrane / Q000473:pathology; D009853:Omeprazole / Q000008:administration & dosage*; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D017693:Sodium Bicarbonate / Q000008:administration & dosage*
D004338:Drug Combinations; D054328:Proton Pump Inhibitors; C494109:omeprazole, sodium bicarbonate drug combination; D017693:Sodium Bicarbonate; D009853:Omeprazole