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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

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Tack, Jan Zerbib, Frank Blondeau, Kathleen des Varannes, Stanislas Bruley Piessevaux, Hubert [UCL] Ruth, Magnus

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.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès restreint
Publication date 2015
Language Anglais
Journal information "Neurogastroenterology and Motility" - Vol. 27, no. 2, p. 258-268 (2015)
Peer reviewed yes
Publisher Wiley-Blackwell Publishing Ltd. ((United Kingdom) Oxford)
issn 1350-1925
e-issn 1365-2982
Publication status Publié
Affiliations UCL - (SLuc) Service d'hépato-gastro-entérologie
UCL - SSS/IREC/GAEN - Pôle d'Hépato-gastro-entérologie
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Bibliographic reference Tack, Jan ; Zerbib, Frank ; Blondeau, Kathleen ; des Varannes, Stanislas Bruley ; Piessevaux, Hubert ; et. al. Randomized clinical trial: Effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment. In: Neurogastroenterology and Motility, Vol. 27, no. 2, p. 258-268 (2015)
Permanent URL http://hdl.handle.net/2078.1/164364