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

Abstract

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.

• Authors: J Tack, F Zerbib, K Blondeau, S B des Varannes, H Piessevaux, J Borovicka, F Mion, M Fox, A J Bredenoord, H Louis, S Dedrie, M Hoppenbrouwers, A Meulemans, A Rykx, L Thielemans, M Ruth
• Journal: Neurogastroenterology and motility (Neurogastroenterol Motil) Vol. 27 Issue 2 Pg. 258-68 (Feb 2015) ISSN: 1365-2982 [Electronic] England
• PMID: 25530111 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons Ltd.

Chemical References

• Benzofurans
• Proton Pump Inhibitors
• Serotonin 5-HT4 Receptor Agonists
• revexepride

Topics

• Adolescent
• Adult
• Aged
• Benzofurans (adverse effects, therapeutic use)
• Double-Blind Method
• Esophageal pH Monitoring
• Female
• Gastroesophageal Reflux (complications, drug therapy)
• Humans
• Male
• Middle Aged
• Proton Pump Inhibitors (therapeutic use)
• Serotonin 5-HT4 Receptor Agonists (adverse effects, therapeutic use)
• Treatment Outcome
• Young Adult