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

BMC Gastroenterology

Research Article

Werner Weiss¹  Lars-Erik Svedberg²  Stefan Eklund²  Tore Persson²  Nanna Keeling²  Juan Enrique Dominguez Muñoz³  Ekkehard Bayerdörffer⁴  Hennie Grundling⁵  Fermín Mearin⁶  Luis Rodrigo⁷  Marc-Andre Bigard⁸ 

[1] 4th Medical Department, Hospital Rudolfstiftung, Vienna, Austria;AstraZeneca R&D, Gothenburg, Sweden;Department of Gastroenterology, University Hospital, Santiago de Compostela, Spain;Department of Internal Medicine, Lohr Health Centre, Lohr, Germany;Department of Internal Medicine, Universitas Hospital, Bloemfontein, South Africa;Gastroenterology Service, Centro Médico Teknon, Barcelona, Spain;Gastroenterology Service, Hospital Central de Asturias, Oviedo, Spain;Gastroenterology Unit, University Hospital, Vandoeuvre les Nancy, France;

关键词: Discontinuation;    Esomeprazole;    Gastroesophageal reflux disease;    Heartburn;    Non-erosive reflux disease;    On-demand;   

DOI  :  10.1186/s12876-016-0448-x

 received in 2016-02-09, accepted in 2016-02-25,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundMost 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.MethodsThis 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 %.ResultsOf 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.ConclusionsIn 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 registrationClinicalTrials.gov identifier (NCT number): NCT02670642; Date of registration: December 2015.

【 授权许可】

CC BY   
© Bayerdörffer et al. 2016