TY - JOUR
T1 - Randomized clinical trial: effect of the 5-HT4 receptor agonist revexepride on reflux parameters in patients with persistent reflux symptoms despite PPI treatment
AU - Tack, J.
AU - Zerbib, F.
AU - Blondeau, K.
AU - des Varannes, S. B.
AU - Piessevaux, H.
AU - Borovicka, J.
AU - Mion, F.
AU - Fox, M.
AU - Bredenoord, A. J.
AU - Louis, H.
AU - Dedrie, S.
AU - Hoppenbrouwers, M.
AU - Meulemans, A.
AU - Rykx, A.
AU - Thielemans, L.
AU - Ruth, M.
PY - 2015
Y1 - 2015
N2 - BackgroundApproximately, 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. MethodsThis 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 ( identifier: NCT01370863). Patients were randomized to either revexepride (0.5mg, three times daily) or matching placebo for 4weeks. Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires. Key ResultsIn 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 & InferencesNo clear differences were seen in reflux parameters between the placebo and revexepride groups
AB - BackgroundApproximately, 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. MethodsThis 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 ( identifier: NCT01370863). Patients were randomized to either revexepride (0.5mg, three times daily) or matching placebo for 4weeks. Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires. Key ResultsIn 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 & InferencesNo clear differences were seen in reflux parameters between the placebo and revexepride groups
U2 - https://doi.org/10.1111/nmo.12484
DO - https://doi.org/10.1111/nmo.12484
M3 - Article
C2 - 25530111
SN - 1350-1925
VL - 27
SP - 258
EP - 268
JO - Neurogastroenterology and Motility
JF - Neurogastroenterology and Motility
IS - 2
ER -