Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint

Therapeutic Advances in Gastroenterology
Brian E LacyDavid L Earnest

Abstract

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. 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. 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...Continue Reading

References

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Citations

Nov 20, 2019·Expert Opinion on Drug Safety·Icilio Cavero, Henry H Holzgrefe
Dec 11, 2019·Minerva gastroenterologica e dietologica·Imke MasuyJan Tack
Nov 7, 2018·Current Gastroenterology Reports·Hans Törnblom, Douglas A Drossman
Jun 17, 2020·World Journal of Gastroenterology : WJG·Qi-Yun XiaoGui-Jun Fei
Oct 22, 2019·Therapeutic Advances in Gastroenterology·David J Cangemi, Brian E Lacy
Jul 29, 2020·Gastroenterology Clinics of North America·Lauren Stemboroski, Ron Schey
Jul 27, 2021·Gastroenterology Clinics of North America·Gregory S Sayuk
Jul 27, 2021·Gastroenterology Clinics of North America·Hans Törnblom, Douglas A Drossman
Aug 8, 2021·Journal of Clinical Medicine·Mónica GrosEva Latorre
Sep 15, 2021·Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society·Vikram RanganAnthony Lembo

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Clinical Trials Mentioned

NCT01257477

Software Mentioned

SAS

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