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Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women.
Gastroenterology 2016; 150(2):358-66.e8G

Abstract

BACKGROUND & AIMS

Previous studies have indicated that serotonin-3-receptor antagonists might have a sex-specific effect in patients with irritable bowel syndrome with diarrhea (IBS-D). Alosetron has been approved for the treatment of only women, and ramosetron has been approved for the treatment for only men. We performed a randomized, placebo-controlled, phase 3 study to determine whether ramosetron reduces symptoms of IBS-D in women.

METHODS

We performed a prospective study of 576 female outpatients with IBS-D (according to the Rome III criteria), from February 2013 through February 2014, at 70 academic Gastroenterology Departments in Japan. After a 1-week baseline period, subjects received either 2.5 μg ramosetron (n = 292) or placebo (n = 284) once daily for 12 weeks. Primary end points were the monthly rates of response for relief from overall IBS symptoms and increased stool consistency at the last evaluation point. Quality of life (QOL) also was quantified.

RESULTS

A significantly higher proportion of patients given ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8-56.6) than patients given placebo (32.0%; 95% CI, 26.7-37.8)--a difference of 18.6% (95% CI, 10.7-26.5; P < .001). The relative risk was 1.58 (95% CI, 1.29-1.94) and the number needed to treat was 6 (95% CI, 4-10). A significantly higher proportion of patients in the ramosetron group reported increased stool consistency (40.8%; 95% CI, 35.1%-46.6%) than in the placebo group (24.3%; 95% CI, 19.4%-29.7%)--a difference of 16.5% (95% CI, 8.9%-24.0%; P < .001). Patients receiving ramosetron had significant reductions in abdominal pain and discomfort (P = .001) and greater improvement in QOL (P = .002) compared with placebo. Ramosetron induced constipation in 11.0% of patients.

CONCLUSIONS

In a randomized, placebo-controlled study of 576 women with IBS-D, 2.5 μg ramosetron per day reduced symptoms and increased stool consistency and QOL. Clinicaltrials.gov no: NCT01870895.

Authors+Show Affiliations

Department of Behavioral Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan. Electronic address: sfukudo@med.tohoku.ac.jp.Department of Gastroenterology, Faculty of Medicine, Shimane University, Izumo, Japan.Department of General Medicine, Asahikawa Medical University, Asahikawa, Japan.Japan-Asia Planning and Administration, Medical and Development, Astellas Pharma, Inc, Tokyo, Japan.Japan-Asia Clinical Development 2, Astellas Pharma, Inc, Tokyo, Japan.Japan-Asia Data Science, Astellas Pharma, Inc, Tokyo, Japan.Development Project Management, Astellas Pharma, Inc, Tokyo, Japan.Department of Gastroenterology, Kawasaki Medical School, Kurashiki, Japan.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26551550

Citation

Fukudo, Shin, et al. "Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women." Gastroenterology, vol. 150, no. 2, 2016, pp. 358-66.e8.
Fukudo S, Kinoshita Y, Okumura T, et al. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016;150(2):358-66.e8.
Fukudo, S., Kinoshita, Y., Okumura, T., Ida, M., Akiho, H., Nakashima, Y., ... Haruma, K. (2016). Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology, 150(2), pp. 358-66.e8. doi:10.1053/j.gastro.2015.10.047.
Fukudo S, et al. Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. Gastroenterology. 2016;150(2):358-66.e8. PubMed PMID: 26551550.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women. AU - Fukudo,Shin, AU - Kinoshita,Yoshikazu, AU - Okumura,Toshikatsu, AU - Ida,Motoko, AU - Akiho,Hiraku, AU - Nakashima,Yoshihiro, AU - Nishida,Akito, AU - Haruma,Ken, Y1 - 2015/11/06/ PY - 2015/03/10/received PY - 2015/10/22/revised PY - 2015/10/25/accepted PY - 2015/11/10/entrez PY - 2015/11/10/pubmed PY - 2016/6/4/medline KW - 5-HT KW - 5-Hydroxytryptamine-3–Receptor Antagonist KW - Abdominal Pain KW - Discomfort SP - 358 EP - 66.e8 JF - Gastroenterology JO - Gastroenterology VL - 150 IS - 2 N2 - BACKGROUND & AIMS: Previous studies have indicated that serotonin-3-receptor antagonists might have a sex-specific effect in patients with irritable bowel syndrome with diarrhea (IBS-D). Alosetron has been approved for the treatment of only women, and ramosetron has been approved for the treatment for only men. We performed a randomized, placebo-controlled, phase 3 study to determine whether ramosetron reduces symptoms of IBS-D in women. METHODS: We performed a prospective study of 576 female outpatients with IBS-D (according to the Rome III criteria), from February 2013 through February 2014, at 70 academic Gastroenterology Departments in Japan. After a 1-week baseline period, subjects received either 2.5 μg ramosetron (n = 292) or placebo (n = 284) once daily for 12 weeks. Primary end points were the monthly rates of response for relief from overall IBS symptoms and increased stool consistency at the last evaluation point. Quality of life (QOL) also was quantified. RESULTS: A significantly higher proportion of patients given ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8-56.6) than patients given placebo (32.0%; 95% CI, 26.7-37.8)--a difference of 18.6% (95% CI, 10.7-26.5; P < .001). The relative risk was 1.58 (95% CI, 1.29-1.94) and the number needed to treat was 6 (95% CI, 4-10). A significantly higher proportion of patients in the ramosetron group reported increased stool consistency (40.8%; 95% CI, 35.1%-46.6%) than in the placebo group (24.3%; 95% CI, 19.4%-29.7%)--a difference of 16.5% (95% CI, 8.9%-24.0%; P < .001). Patients receiving ramosetron had significant reductions in abdominal pain and discomfort (P = .001) and greater improvement in QOL (P = .002) compared with placebo. Ramosetron induced constipation in 11.0% of patients. CONCLUSIONS: In a randomized, placebo-controlled study of 576 women with IBS-D, 2.5 μg ramosetron per day reduced symptoms and increased stool consistency and QOL. Clinicaltrials.gov no: NCT01870895. SN - 1528-0012 UR - https://www.unboundmedicine.com/medline/citation/26551550/Ramosetron_Reduces_Symptoms_of_Irritable_Bowel_Syndrome_With_Diarrhea_and_Improves_Quality_of_Life_in_Women_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5085(15)01584-X DB - PRIME DP - Unbound Medicine ER -