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Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy
BACKGROUND: A substantial proportion of patients with gastro‐oesophageal reflux disease (GERD) have only a partial response to proton pump inhibitor (PPI) therapy. Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying. AIM: To evaluate the effect of reve...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024018/ https://www.ncbi.nlm.nih.gov/pubmed/25693609 http://dx.doi.org/10.1111/apt.13115 |
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author | Shaheen, N. J. Adler, J. Dedrie, S. Johnson, D. Malfertheiner, P. Miner, P. Meulemans, A. Poole, L. Tack, J. Thielemans, L. Troy, S. Vakil, N. Zerbib, F. Ruth, M. |
author_facet | Shaheen, N. J. Adler, J. Dedrie, S. Johnson, D. Malfertheiner, P. Miner, P. Meulemans, A. Poole, L. Tack, J. Thielemans, L. Troy, S. Vakil, N. Zerbib, F. Ruth, M. |
author_sort | Shaheen, N. J. |
collection | PubMed |
description | BACKGROUND: A substantial proportion of patients with gastro‐oesophageal reflux disease (GERD) have only a partial response to proton pump inhibitor (PPI) therapy. Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying. AIM: To evaluate the effect of revexepride, a novel prokinetic 5‐hydroxytryptamine type 4 (5‐HT (4)) receptor agonist, compared with placebo, in patients with GERD who have a partial response to PPIs. METHODS: A phase 2b, double‐blind, parallel‐group study was conducted, in which patients were randomised to one of three revexepride treatment groups (0.1, 0.5 and 2.0 mg three times daily) or placebo (1:1:1:1 ratio). Daily e‐diary data captured patients' symptoms over an 8‐week treatment period. The primary efficacy outcome was the weekly percentage of regurgitation‐free days in the second half of the study (weeks 5–8). RESULTS: In total, 480 patients were randomised and 477 received treatment (mean age 47.9 years; 61% women). The mean percentage of regurgitation‐free days increased from baseline (range, 15.0–18.8%) to week 8 (62.3–70.5%) in all four study arms; however, there were no statistically significant differences in this change between placebo and the three treatment arms. No dose‐dependent relationship in treatment effect was observed for any of the study endpoints. The incidence of treatment‐emergent adverse events (TEAEs) was revexepride dose‐dependent. Only one serious TEAE occurred and none resulted in death. CONCLUSIONS: Revexepride was no more effective than placebo in controlling regurgitation in patients with GERD symptoms partially responsive to PPIs. Revexepride was well tolerated. ClinicalTrials.gov Identifier: NCT01472939. |
format | Online Article Text |
id | pubmed-5024018 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-50240182016-09-23 Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy Shaheen, N. J. Adler, J. Dedrie, S. Johnson, D. Malfertheiner, P. Miner, P. Meulemans, A. Poole, L. Tack, J. Thielemans, L. Troy, S. Vakil, N. Zerbib, F. Ruth, M. Aliment Pharmacol Ther Randomised Clinical Trials BACKGROUND: A substantial proportion of patients with gastro‐oesophageal reflux disease (GERD) have only a partial response to proton pump inhibitor (PPI) therapy. Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying. AIM: To evaluate the effect of revexepride, a novel prokinetic 5‐hydroxytryptamine type 4 (5‐HT (4)) receptor agonist, compared with placebo, in patients with GERD who have a partial response to PPIs. METHODS: A phase 2b, double‐blind, parallel‐group study was conducted, in which patients were randomised to one of three revexepride treatment groups (0.1, 0.5 and 2.0 mg three times daily) or placebo (1:1:1:1 ratio). Daily e‐diary data captured patients' symptoms over an 8‐week treatment period. The primary efficacy outcome was the weekly percentage of regurgitation‐free days in the second half of the study (weeks 5–8). RESULTS: In total, 480 patients were randomised and 477 received treatment (mean age 47.9 years; 61% women). The mean percentage of regurgitation‐free days increased from baseline (range, 15.0–18.8%) to week 8 (62.3–70.5%) in all four study arms; however, there were no statistically significant differences in this change between placebo and the three treatment arms. No dose‐dependent relationship in treatment effect was observed for any of the study endpoints. The incidence of treatment‐emergent adverse events (TEAEs) was revexepride dose‐dependent. Only one serious TEAE occurred and none resulted in death. CONCLUSIONS: Revexepride was no more effective than placebo in controlling regurgitation in patients with GERD symptoms partially responsive to PPIs. Revexepride was well tolerated. ClinicalTrials.gov Identifier: NCT01472939. John Wiley and Sons Inc. 2015-02-19 2015-04 /pmc/articles/PMC5024018/ /pubmed/25693609 http://dx.doi.org/10.1111/apt.13115 Text en © 2015 Shire Development LLC. Alimentary Pharmacology & Therapeutics published by John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Randomised Clinical Trials Shaheen, N. J. Adler, J. Dedrie, S. Johnson, D. Malfertheiner, P. Miner, P. Meulemans, A. Poole, L. Tack, J. Thielemans, L. Troy, S. Vakil, N. Zerbib, F. Ruth, M. Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title | Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title_full | Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title_fullStr | Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title_full_unstemmed | Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title_short | Randomised clinical trial: the 5‐HT4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite PPI therapy |
title_sort | randomised clinical trial: the 5‐ht4 agonist revexepride in patients with gastro‐oesophageal reflux disease who have persistent symptoms despite ppi therapy |
topic | Randomised Clinical Trials |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024018/ https://www.ncbi.nlm.nih.gov/pubmed/25693609 http://dx.doi.org/10.1111/apt.13115 |
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