Efficacy of three different dosages of esomeprazole in the long-term management of reflux disease: a prospective, randomized study, using the wireless Bravo pH system.
OBJECTIVE
Gastroesophageal reflux disease (GERD) is a chronic condition that usually requires long-term maintenance therapy with proton-pump inhibitors (PPIs). In clinical practice, patients receive PPIs at the lowest dose to control symptoms. However, it is not known whether this approach adequately controls acidic esophageal reflux. We sought to investigate the efficacy of three different dosages of esomeprazole in patients receiving maintenance therapy for GERD, using the Bravo pH system.


METHODS
Patients with a previous history of erosive esophagitis A or B (LA classification) that was healed at the time of enrollment or endoscopy-negative reflux disease (ENRD), documented with an abnormal pH study, were randomized to receive maintenance therapy with esomeprazole 40 mg twice daily (group A), once daily (group B), or every other day (group C). Intraesophageal pH was monitored for two consecutive days using the Bravo wireless system, 30 days after randomization. The parameters subjected to analysis were percent of total time pH<4 and the De Meester score.


RESULTS
The pH results from 73 patients (group A=24, group B=24, group C=25 patients) were subjected to final analysis. On the first day of the study, the mean (+/-s.d.) percent of total time pH <4 and the De Meester score were group A: 0.9(1.2) and 4.1(4.0); group B: 1.5(1.6) and 7.0(6.9); group C: 1.3(1.0) and 6.0(3.3), respectively (P=0.262 and 0.134, respectively). On the second day of the study, the corresponding values were group A: 0.7(1.0) and 3.9(5.9); group B: 1.5(1.8) and 6.4(6.6); group C: 7.0(4.4) and 29.4(19.4), respectively. The difference was statistically significant (P<0.0001 and <0.0001, respectively). Further analysis showed that patients not receiving PPI had a significantly higher mean percent of total time pH<4 and De Meester score as compared with patients on PPI once or twice daily (P<0.001 and <0.001 respectively).


CONCLUSIONS
The administration of esomeprazole 40 mg every other day does not control acidic esophageal reflux on the day off PPI. Esomeprazole 40 mg once daily effectively controls reflux of acid in patients with history of mild esophagitis or ENRD, whereas doubling the dose does not seem to confer any further advantage.
Vasiliadis
Konstantinos V
KV
Department of Gastroenterology, Athens Naval Hospital, Athens, Greece. vasileiadisk@yahoo.gr
Viazis
Nikos
N
Vlachogiannakos
Jiannis
J
Sgouros
Spiros N
SN
Stefanidis
Gerasimos
G
Archimandritis
Athanasios
A
Karamanolis
Dimitrios G
DG
D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000008:administration & dosage*; D050782:Esophageal pH Monitoring / Q000295:instrumentation*; D005260:Female; D005764:Gastroesophageal Reflux / Q000188:drug therapy* / Q000209:etiology / Q000473:pathology; D016481:Helicobacter Infections / Q000150:complications / Q000175:diagnosis / Q000628:therapy; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
D054328:Proton Pump Inhibitors; D064098:Esomeprazole