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Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials
BACKGROUND: Recurring abdominal pain is a characteristic and often unpredictable and debilitating symptom of irritable bowel syndrome with diarrhea (IBS‐D). Measuring the effects of IBS‐D treatments on abdominal pain remains a significant challenge in clinical trials. Here, we aimed to examine the e...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154635/ https://www.ncbi.nlm.nih.gov/pubmed/31984655 http://dx.doi.org/10.1111/nmo.13774 |
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author | Lembo, Anthony J. Covington, Paul S. Dove, Leonard S. Andrae, David A. |
author_facet | Lembo, Anthony J. Covington, Paul S. Dove, Leonard S. Andrae, David A. |
author_sort | Lembo, Anthony J. |
collection | PubMed |
description | BACKGROUND: Recurring abdominal pain is a characteristic and often unpredictable and debilitating symptom of irritable bowel syndrome with diarrhea (IBS‐D). Measuring the effects of IBS‐D treatments on abdominal pain remains a significant challenge in clinical trials. Here, we aimed to examine the effect of eluxadoline through various post hoc analyses. METHODS: Data from two eluxadoline Phase 3 trials were pooled over 26 weeks, comparing eluxadoline 100 mg twice daily to placebo. Worst abdominal pain (WAP) was measured daily on a 0‐10 scale. WAP responder criteria were prospectively defined as a ≥30% improvement in daily WAP score on ≥50% of days. Pairwise, two‐sided Cochran‐Mantel‐Haenszel tests assessed treatment effects. Cumulative distribution functions were used to plot WAP response rates using variations on the response criteria. KEY RESULTS: Of 1615 patients with IBS‐D (66% female, mean age 46 years), 806 received eluxadoline and 809 received placebo; 48.3% and 44.0% were WAP responders (≥30% improvement), respectively (P value not significant). When the response threshold was increased to 50% daily WAP improvement from baseline, a significantly greater percentage of eluxadoline‐treated patients versus placebo‐treated patients were WAP responders (38.7% vs 32.5%, respectively; P = .009). At Week 26, average WAP changes from baseline were −3.4 and −3.0 points, respectively (P = .002). CONCLUSIONS AND INFERENCES: Despite small effect sizes, eluxadoline demonstrated consistent and sustained improvement in WAP compared to placebo across a range of prospective and post hoc analyses. Assessing WAP response across a range of measures is important for fully understanding a treatment's efficacy. |
format | Online Article Text |
id | pubmed-7154635 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-71546352020-04-14 Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials Lembo, Anthony J. Covington, Paul S. Dove, Leonard S. Andrae, David A. Neurogastroenterol Motil Original Articles BACKGROUND: Recurring abdominal pain is a characteristic and often unpredictable and debilitating symptom of irritable bowel syndrome with diarrhea (IBS‐D). Measuring the effects of IBS‐D treatments on abdominal pain remains a significant challenge in clinical trials. Here, we aimed to examine the effect of eluxadoline through various post hoc analyses. METHODS: Data from two eluxadoline Phase 3 trials were pooled over 26 weeks, comparing eluxadoline 100 mg twice daily to placebo. Worst abdominal pain (WAP) was measured daily on a 0‐10 scale. WAP responder criteria were prospectively defined as a ≥30% improvement in daily WAP score on ≥50% of days. Pairwise, two‐sided Cochran‐Mantel‐Haenszel tests assessed treatment effects. Cumulative distribution functions were used to plot WAP response rates using variations on the response criteria. KEY RESULTS: Of 1615 patients with IBS‐D (66% female, mean age 46 years), 806 received eluxadoline and 809 received placebo; 48.3% and 44.0% were WAP responders (≥30% improvement), respectively (P value not significant). When the response threshold was increased to 50% daily WAP improvement from baseline, a significantly greater percentage of eluxadoline‐treated patients versus placebo‐treated patients were WAP responders (38.7% vs 32.5%, respectively; P = .009). At Week 26, average WAP changes from baseline were −3.4 and −3.0 points, respectively (P = .002). CONCLUSIONS AND INFERENCES: Despite small effect sizes, eluxadoline demonstrated consistent and sustained improvement in WAP compared to placebo across a range of prospective and post hoc analyses. Assessing WAP response across a range of measures is important for fully understanding a treatment's efficacy. John Wiley and Sons Inc. 2020-01-27 2020-04 /pmc/articles/PMC7154635/ /pubmed/31984655 http://dx.doi.org/10.1111/nmo.13774 Text en © 2020 The Authors. Neurogastroenterology & Motility published by John Wiley & Sons, Ltd. This is an open access article under the terms of the 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 | Original Articles Lembo, Anthony J. Covington, Paul S. Dove, Leonard S. Andrae, David A. Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title | Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title_full | Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title_fullStr | Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title_full_unstemmed | Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title_short | Effects of treatment with eluxadoline on abdominal pain in patients with IBS‐D: Additional post hoc analyses of Phase 3 trials |
title_sort | effects of treatment with eluxadoline on abdominal pain in patients with ibs‐d: additional post hoc analyses of phase 3 trials |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7154635/ https://www.ncbi.nlm.nih.gov/pubmed/31984655 http://dx.doi.org/10.1111/nmo.13774 |
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