title: Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease.
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.
  
  
  BACKGROUND
  ClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.
authors.affiliation: Department of Internal Medicine, Lohr Health Centre, Lohr, Germany. bayerdoerffer@gmx.de.
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Bayerdörffer
authors.affiliation: Gastroenterology Unit, University Hospital, Vandoeuvre les Nancy, France.
authors.forename: Marc-Andre
authors.initials: MA
authors.lastname: Bigard
authors.affiliation: 4th Medical Department, Hospital Rudolfstiftung, Vienna, Austria.
authors.forename: Werner
authors.initials: W
authors.lastname: Weiss
authors.affiliation: Gastroenterology Service, Centro Médico Teknon, Barcelona, Spain.
authors.forename: Fermín
authors.initials: F
authors.lastname: Mearin
authors.affiliation: Gastroenterology Service, Hospital Central de Asturias, Oviedo, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Rodrigo
authors.affiliation: Department of Gastroenterology, University Hospital, Santiago de Compostela, Spain.
authors.forename: Juan Enrique
authors.initials: JE
authors.lastname: Dominguez Muñoz
authors.affiliation: Department of Internal Medicine, Universitas Hospital, Bloemfontein, South Africa.
authors.forename: Hennie
authors.initials: H
authors.lastname: Grundling
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Tore
authors.initials: T
authors.lastname: Persson
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Lars-Erik
authors.initials: LE
authors.lastname: Svedberg
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Nanna
authors.initials: N
authors.lastname: Keeling
authors.affiliation: AstraZeneca R&D, Gothenburg, Sweden.
authors.forename: Stefan
authors.initials: S
authors.lastname: Eklund
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D064098:Esomeprazole / Q000008:administration & dosage*; D004942:Esophagitis, Peptic / Q000209:etiology; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006356:Heartburn / Q000188:drug therapy*; D006801:Humans; D060046:Maintenance Chemotherapy; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole
keywords: Discontinuation; Esomeprazole; Gastroesophageal reflux disease; Heartburn; Non-erosive reflux disease; On-demand