دورية أكاديمية
Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint
| العنوان: | Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint |
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| المؤلفون: | Brian E. Lacy, Jean Paul Nicandro, Emil Chuang, David L. Earnest |
| المصدر: | Therapeutic Advances in Gastroenterology, Vol 11 (2018) |
| بيانات النشر: | SAGE Publishing, 2018. |
| سنة النشر: | 2018 |
| المجموعة: | LCC:Diseases of the digestive system. Gastroenterology |
| مصطلحات موضوعية: | Diseases of the digestive system. Gastroenterology, RC799-869 |
| الوصف: | Background: Alosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice. Methods: This prospective, open-label, multicenter, observational 12-week study evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline in stool frequency, fecal urgency and fecal incontinence. Results: Enrolled patients ( n = 192) were primarily White (90.6%), with a mean age of 44.5 years. Patient and physician rating of IBS severity was between moderate and severe (85.9% concordance, Spearman coefficient 0.429, p < 0.0001). Alosetron 0.5 mg twice daily (82.8%) was the most common dosing regimen. A total of 152 alosetron-treated patients completed the study. Of 105 fully evaluable patients, 45% met the FDA composite endpoint responder criteria for ⩾50% of the study period. Improvements in all individual symptoms were statistically significant compared with baseline. There were no serious adverse events, cases of colonic ischemia, or complications of constipation. Conclusion: In a clinical practice setting study, alosetron demonstrated treatment success using a rigorous FDA composite endpoint and also improved multiple other IBS symptoms, including fecal urgency and incontinence in women with severe IBS-D [ ClinicalTrials.gov identifier: NCT01257477]. |
| نوع الوثيقة: | article |
| وصف الملف: | electronic resource |
| اللغة: | English |
| تدمد: | 1756-2848 17562848 |
| Relation: | https://doaj.org/toc/1756-2848 |
| DOI: | 10.1177/1756284818771674 |
| URL الوصول: | https://doaj.org/article/ecbfd7e16ae5449da4cd9c89d60b4ece |
| رقم الأكسشن: | edsdoj.bfd7e16ae5449da4cd9c89d60b4ece |
| قاعدة البيانات: | Directory of Open Access Journals |
Full Text Finder | تدمد: | 17562848 |
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| DOI: | 10.1177/1756284818771674 |