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• W2921349141 abstract "Purpose: Clinical trials of irritable bowel syndrome (IBS) treatments have historically used a binary ‘adequate relief’ or global symptom improvement as key efficacy endpoints. Recently, the FDA published a draft guidance document proposing that the use of binary adequate relief endpoints may not accurately measure individual symptoms and that comparison of current symptoms to previous time points may introduce important recall bias of symptoms. Weekly adequate relief of global IBS symptoms and bloating binary endpoints and the FDA composite endpoint using daily assessments were evaluated for responsiveness and validity in 2 identically-designed phase 3, double-blind, placebo-controlled trials. Methods: Patients with mild to moderate non-constipation IBS (TARGET 1, n=623; TARGET 2, n=637) were randomized to rifaximin 550 mg TID or placebo for 2 weeks and evaluated for 10 weeks post treatment. Patients responded to questions regarding achieving weekly adequate relief of global IBS symptoms and IBS-related bloating (Yes/No). Patients also rated daily IBS symptom severity for global IBS symptoms, IBS-related bloating, IBS-related abdominal pain using a 7-point scale (0=not at all - 6=a very great deal), stool consistency using a 5-point scale (1=very hard - 5= watery) and urgency. Per FDA draft guidance, abdominal pain and stool consistency weekly responders were patients who reported ≥30% decrease from baseline in abdominal pain and had an average stool consistency score <4. Responsiveness (ability to detect change) was assessed (Wilcoxon rank-sum test) by comparing the change from baseline in each daily question between responder and non-responder. Spearman rank correlation coefficients were calculated to assess the correlations among weekly responders and daily measures of efficacy. Results: For each study and the combined data, the weekly responder (adequate relief of global IBS symptoms, adequate relief of IBS-related bloating, FDA abdominal and stool consistency) endpoints demonstrated responsiveness by consistently correlating with daily symptom severity scores. Responders had significantly greater improvements in all daily symptom severity scores than non-responders at each week during the course of the study (p < 0.0001). Evidence for convergent validity, based on a Spearman's correlation of 0.40 or greater, was observed for weekly responders with daily symptom severity scores. Conclusion: Both the binary weekly adequate relief as well as the newly proposed FDA composite endpoint are valid and responsive. The degree of correlation between these two endpoint is highly significant (p<0.001). Rifaximin demonstrated a statistically significant greater percentage of patient's with relief of IBS symptoms across these endpoints. Disclosure: This research was funded by Salix Pharmaceuticals, Inc., Morrisville NC. Dr Chey: Salix: consultant and speaker's bureau Dr Pimentel: - Consultant for Salix Pharmaceuticals and Prometheus; Grants from Salix Pharmaceuticals; Cedars-Sinai has a licensing agreement with Salix Pharmaceuticals. Dr Lembo: - Salix - consultant Ironwood - consultant Prometheus - consultant Ocera - consultant Astra-Zeneca - consultant Ardelyx - consultant. Dr Brown - Nothing to disclose Drs. Yu, Mareya, Shaw, Bortey and Forbes are employees of Salix pharmaceuticals and hold stock in the company." @default.
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• W2921349141 date "2010-10-01" @default.
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• W2921349141 title "The Responsiveness and Validity of a Binary Weekly Recall Question and the Proposed FDA Composite Endpoint as Measures of Daily Symptom Severity in Non-Constipation Irritable Bowel Syndrome: Results of TARGET 1 and TARGET 2" @default.
• W2921349141 doi "https://doi.org/10.14309/00000434-201010001-01337" @default.
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