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

Autor: Bayerdörffer E; Department of Internal Medicine, Lohr Health Centre, Lohr, Germany. bayerdoerffer@gmx.de., Bigard MA; Gastroenterology Unit, University Hospital, Vandoeuvre les Nancy, France., Weiss W; 4th Medical Department, Hospital Rudolfstiftung, Vienna, Austria., Mearin F; Gastroenterology Service, Centro Médico Teknon, Barcelona, Spain., Rodrigo L; Gastroenterology Service, Hospital Central de Asturias, Oviedo, Spain., Dominguez Muñoz JE; Department of Gastroenterology, University Hospital, Santiago de Compostela, Spain., Grundling H; Department of Internal Medicine, Universitas Hospital, Bloemfontein, South Africa., Persson T; AstraZeneca R&D, Gothenburg, Sweden., Svedberg LE; AstraZeneca R&D, Gothenburg, Sweden., Keeling N; AstraZeneca R&D, Gothenburg, Sweden., Eklund S; AstraZeneca R&D, Gothenburg, Sweden.
Jazyk: angličtina
Zdroj: BMC gastroenterology [BMC Gastroenterol] 2016 Apr 14; Vol. 16, pp. 48. Date of Electronic Publication: 2016 Apr 14.
DOI: 10.1186/s12876-016-0448-x
Abstrakt: 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.
Databáze: MEDLINE
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