Abstract
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.
Highlights
Most patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication
Gastroesophageal reflux disease (GERD) is associated with reflux esophagitis, which can be detected and confirmed by esophageal endoscopy, as many as 70 % of patients with GERD display no such endoscopic findings and are termed as having endoscopy-negative or nonerosive reflux disease (NERD) [4]
Despite the absence of esophagitis, many of these patients experience a significant impairment in their health-related quality of life (HRQoL), similar to that experienced by patients with reflux esophagitis [4,5,6]
Summary
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. It has been shown that continuous maintenance treatment with the PPI esomeprazole (20 mg once daily) provides more effective acid suppression and maintained intragastric pH >4 for a greater period of time than maintenance omeprazole, lansoprazole, pantoprazole or rabeprazole in patients with GERD [10, 11]. We compared the efficacy of on-demand versus continuous esomeprazole maintenance treatment in patients with NERD (who had complete resolution of heartburn symptoms following initial treatment with esomeprazole) in terms of the willingness of patients to continue therapy
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