AI Article Synopsis
- The study aimed to evaluate how eluxadoline treatment affects health-related quality of life (HRQOL) in patients with irritable bowel syndrome with diarrhea (IBS-D).
- Adult patients were randomly assigned to take eluxadoline or a placebo, with their HRQOL assessed using the IBS-QOL questionnaire over 26 to 52 weeks.
- Results showed significant improvements in HRQOL scores for those on eluxadoline compared to the placebo group, indicating that the treatment is effective for enhancing quality of life for IBS-D patients.
Article Abstract
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.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6373309 | PMC |
| http://dx.doi.org/10.1007/s11136-018-2008-z | DOI Listing |
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