Effect of ramosetron in female patients with irritable bowel syndrome with diarrhea: a phase III long-term study

Journal of Gastroenterology
Shin FukudoKen Haruma

Abstract

The long-term safety of administration of ramosetron in female patients with irritable bowel syndrome with diarrhea (IBS-D) is unknown. The aim of this study was to assess the long-term safety, tolerability, and outcomes with the use of ramosetron in female patients with IBS-D. This was a phase III, open-label, uncontrolled, long-term safety trial of the treatment of female Japanese patients with IBS-D, diagnosed according to the Rome III criteria. A total of 151 patients were given 2.5 μg of ramosetron for 4 weeks, and responders continued the same dose for another 48 weeks. Non-responders at 4 weeks were given 5 μg of ramosetron for 48 weeks. At the end of week 52, 106 patients receiving 2.5 μg and 17 patients receiving 5 μg had completed the study. Safety and efficacy including symptoms and quality of life (QOL) were evaluated. Concerning safety, no serious adverse event related to ramosetron, specifically ischemic colitis, was observed in patients with either dose of ramosetron. However, constipation occurred in 19.7 % of patients given 2.5 μg and 10.5 % of patients given 5 μg of ramosetron. Ramosetron-treated patients showed high rates of global improvement. Stool consistency, abdominal pain and discomfort, and IBS-QOL wer...Continue Reading

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Citations

Apr 3, 2018·Journal of Neurogastroenterology and Motility·Kyung Ho SongUNKNOWN Clinical Practice Guidelines Group Under the Korean Society of Neurogastroenterology and Motility
Jan 24, 2018·Biomedical Papers of the Medical Faculty of the University Palacký, Olomouc, Czechoslovakia·Biljana Radovanovic-DinicValentina Zivkovic
Oct 24, 2018·Journal of Neurogastroenterology and Motility·Young Sun Kim, Nayoung Kim
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Feb 5, 2021·Journal of Gastroenterology·Shin FukudoKazuhiko Koike
Jan 23, 2021·Current Opinion in Endocrinology, Diabetes, and Obesity·Abishek Arokiadoss, H Christian Weber

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