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Open Access 01-12-2016 | Research article

Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease

Authors: Ekkehard Bayerdörffer, Marc-Andre Bigard, Werner Weiss, Fermín Mearin, Luis Rodrigo, Juan Enrique Dominguez Muñoz, Hennie Grundling, Tore Persson, Lars-Erik Svedberg, Nanna Keeling, Stefan Eklund

Published in: BMC Gastroenterology | Issue 1/2016

Abstract

Background

Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.

Methods

This multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks’ treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.

Results

Of 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference −3.5 % [90 % CI: −7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.

Conclusions

In terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.

Trial registration

ClinicalTrials.gov identifier (NCT number): NCT02670642; Date of registration: December 2015.

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Title: Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease
Authors: Ekkehard Bayerdörffer
Marc-Andre Bigard
Werner Weiss
Fermín Mearin
Luis Rodrigo
Juan Enrique Dominguez Muñoz
Hennie Grundling
Tore Persson
Lars-Erik Svedberg
Nanna Keeling
Stefan Eklund
Publication date: 01-12-2016
Publisher: BioMed Central
Published in: BMC Gastroenterology / Issue 1/2016
Electronic ISSN: 1471-230X
DOI: https://doi.org/10.1186/s12876-016-0448-x

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Abstract

Background

Methods

Results

Conclusions

Trial registration

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