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Randomized clinical trial: Effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment

par Tack, Jan;Blondeau, Kathleen;Zerbib, Frank;des Varannes, Stanislas Bruley;Piessevaux, Hubert;Borovicka, J.;Mion, François;Fox, Mark;Bredenoord, Albert Jan;Louis, Hubert ;Dedrie, S.;Hoppenbrouwers, M.;Meulemans, A.;Rykx, An;Thielemans, Leen;Ruth, M.
Référence Neurogastroenterology and motility, 27, 2, page (258-268)
Publication Publié, 2015-02

Article révisé par les pairs

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Résumé :

Background: Approximately, 20-30% of patients with gastro-esophageal reflux disease (GERD) experience persistent symptoms despite treatment with proton pump inhibitors (PPIs). These patients may have underlying dysmotility; therefore, targeting gastric motor dysfunction in addition to acid inhibition may represent a new therapeutic avenue. The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride (a 5-HT4 receptor agonist) in patients with GERD who have persistent symptoms despite treatment with a PPI. Methods: This was a phase II, exploratory, multicenter, randomized, placebo-controlled, double-blind, parallel-group study in patients with GERD who experienced persistent symptoms while taking a stable dose of PPIs (ClinicalTrials.gov identifier: NCT01370863). Patients were randomized to either revexepride (0.5 mg, three times daily) or matching placebo for 4 weeks. Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires. Key Results: In total, 67 patients were enrolled in the study. There were no significant differences between study arms in the number, the mean proximal extent or the bolus clearance times of liquid-containing reflux events. Changes from baseline in the number of heartburn, regurgitation, and other symptom events were minimal for each treatment group and no clear trends were observed. Conclusions & Inferences: No clear differences were seen in reflux parameters between the placebo and revexepride groups. The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride (a 5-HT4 receptor agonist) in patients with GERD who have persistent symptoms despite treatment with a PPI. Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires. No clear differences were seen in reflux parameters between the placebo and revexepride groups.