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The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea
PURPOSE: Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D. METHODS: Adult patients meeting Rom...
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2018
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373309/ https://www.ncbi.nlm.nih.gov/pubmed/30267294 http://dx.doi.org/10.1007/s11136-018-2008-z |
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author | Abel, Jessica L. Carson, Robyn T. Andrae, David A. |
author_facet | Abel, Jessica L. Carson, Robyn T. Andrae, David A. |
author_sort | Abel, Jessica L. |
collection | PubMed |
description | PURPOSE: Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D. METHODS: Adult patients meeting Rome III criteria for IBS-D were randomized to oral eluxadoline (75 mg or 100 mg) or placebo twice daily in two phase III clinical trials for 52 weeks (IBS-3001) and 26 weeks (IBS-3002). The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire assessed disease-specific HRQOL throughout the study. Changes from baseline to Week 26 in IBS-QOL total and subscale scores were analyzed using an analysis of covariance model. Percentages of IBS-QOL responders with ≥ 14- and 20-point changes were evaluated for IBS-QOL total and subscale scores. A longitudinal mixed-effects model was fitted to evaluate mean IBS-QOL total scores. A cumulative distribution function for change from baseline to Week 26 in IBS-QOL total score was plotted. RESULTS: Mean changes from baseline to Week 26 for the IBS-QOL total and all subscale scores were significantly higher for patients treated with eluxadoline (both doses) compared to placebo. A significantly greater proportion of eluxadoline-treated patients were responders compared to placebo. Mean and mixed-effects model estimated mean IBS-QOL total scores were consistently higher for eluxadoline versus placebo over 52 weeks. CONCLUSIONS: Compared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials. |
format | Online Article Text |
id | pubmed-6373309 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | Springer International Publishing |
record_format | MEDLINE/PubMed |
spelling | pubmed-63733092019-03-01 The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea Abel, Jessica L. Carson, Robyn T. Andrae, David A. Qual Life Res Article PURPOSE: Irritable bowel syndrome with diarrhea (IBS-D) significantly impacts health-related quality of life (HRQOL). This post hoc analysis of two phase III trials evaluated the effects of eluxadoline treatment on disease-specific HRQOL among patients with IBS-D. METHODS: Adult patients meeting Rome III criteria for IBS-D were randomized to oral eluxadoline (75 mg or 100 mg) or placebo twice daily in two phase III clinical trials for 52 weeks (IBS-3001) and 26 weeks (IBS-3002). The Irritable Bowel Syndrome Quality of Life (IBS-QOL) questionnaire assessed disease-specific HRQOL throughout the study. Changes from baseline to Week 26 in IBS-QOL total and subscale scores were analyzed using an analysis of covariance model. Percentages of IBS-QOL responders with ≥ 14- and 20-point changes were evaluated for IBS-QOL total and subscale scores. A longitudinal mixed-effects model was fitted to evaluate mean IBS-QOL total scores. A cumulative distribution function for change from baseline to Week 26 in IBS-QOL total score was plotted. RESULTS: Mean changes from baseline to Week 26 for the IBS-QOL total and all subscale scores were significantly higher for patients treated with eluxadoline (both doses) compared to placebo. A significantly greater proportion of eluxadoline-treated patients were responders compared to placebo. Mean and mixed-effects model estimated mean IBS-QOL total scores were consistently higher for eluxadoline versus placebo over 52 weeks. CONCLUSIONS: Compared to placebo, twice-daily eluxadoline treatment significantly improved HRQOL among patients with IBS-D in two phase III trials. Springer International Publishing 2018-09-28 2019 /pmc/articles/PMC6373309/ /pubmed/30267294 http://dx.doi.org/10.1007/s11136-018-2008-z Text en © The Author(s) 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Article Abel, Jessica L. Carson, Robyn T. Andrae, David A. The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title | The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title_full | The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title_fullStr | The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title_full_unstemmed | The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title_short | The impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
title_sort | impact of treatment with eluxadoline on health-related quality of life among adult patients with irritable bowel syndrome with diarrhea |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373309/ https://www.ncbi.nlm.nih.gov/pubmed/30267294 http://dx.doi.org/10.1007/s11136-018-2008-z |
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