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Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine.
Neurogastroenterol Motil 2011; 23(12):1098-104NM

Abstract

BACKGROUND

The 5-HT(3) receptor antagonists are known to be effective for the treatment of diarrhea-predominant irritable bowel syndrome (IBS), but not widely used yet. The aim of this study was to compare the efficacy and safety of ramosetron, a 5-HT(3) receptor antagonist, and mebeverine in male patients with IBS with diarrhea (IBS-D).

METHODS

This study was performed in a multicenter, randomized, open-label design. Data of 343 male patients with IBS-D who were randomized to either a 4-week treatment of ramosetron 5μg once daily or a 4-week treatment of mebeverine 135 mg three times daily were analyzed by the intent-to-treat analysis. The primary efficacy parameter was the proportion of patients with adequate relief of IBS symptoms at the last week of treatment. The secondary endpoints were changes in each symptom score and the safety profiles.

KEY RESULTS

The responder rates for global IBS symptoms, abdominal pain/discomfort and abnormal bowel habits in the ramosetron and mebeverine groups significantly increased during the treatment period. The severity scores of abdominal pain/discomfort and urgency, the stool form score, and the stool frequency in both treatment arms were significantly reduced, compared with the baselines. There were no significant differences in the responder rates (37%vs 38% on ITT analysis) and adverse event profiles between the ramosetron and mebeverine groups. Neither severe constipation nor ischemic colitis was reported by ramosetron-treated patients.

CONCLUSIONS & INFERENCES

Ramosetron 5μg once daily is as effective as mebeverine three times daily in male patients with IBS-D.

Authors+Show Affiliations

Department of Gastroenterology, Ajou University School of Medicine, Suwon, Korea.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

21920001

Citation

Lee, K J., et al. "Efficacy of Ramosetron in the Treatment of Male Patients With Irritable Bowel Syndrome With Diarrhea: a Multicenter, Randomized Clinical Trial, Compared With Mebeverine." Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society, vol. 23, no. 12, 2011, pp. 1098-104.
Lee KJ, Kim NY, Kwon JK, et al. Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine. Neurogastroenterol Motil. 2011;23(12):1098-104.
Lee, K. J., Kim, N. Y., Kwon, J. K., Huh, K. C., Lee, O. Y., Lee, J. S., ... Rhee, P. L. (2011). Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine. Neurogastroenterology and Motility : the Official Journal of the European Gastrointestinal Motility Society, 23(12), pp. 1098-104. doi:10.1111/j.1365-2982.2011.01771.x.
Lee KJ, et al. Efficacy of Ramosetron in the Treatment of Male Patients With Irritable Bowel Syndrome With Diarrhea: a Multicenter, Randomized Clinical Trial, Compared With Mebeverine. Neurogastroenterol Motil. 2011;23(12):1098-104. PubMed PMID: 21920001.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of ramosetron in the treatment of male patients with irritable bowel syndrome with diarrhea: a multicenter, randomized clinical trial, compared with mebeverine. AU - Lee,K J, AU - Kim,N Y, AU - Kwon,J K, AU - Huh,K C, AU - Lee,O Y, AU - Lee,J S, AU - Choi,S C, AU - Sohn,C I, AU - Myung,S J, AU - Park,H J, AU - Choi,M K, AU - Bak,Y T, AU - Rhee,P L, Y1 - 2011/09/15/ PY - 2011/9/17/entrez PY - 2011/9/17/pubmed PY - 2012/4/17/medline SP - 1098 EP - 104 JF - Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society JO - Neurogastroenterol. Motil. VL - 23 IS - 12 N2 - BACKGROUND: The 5-HT(3) receptor antagonists are known to be effective for the treatment of diarrhea-predominant irritable bowel syndrome (IBS), but not widely used yet. The aim of this study was to compare the efficacy and safety of ramosetron, a 5-HT(3) receptor antagonist, and mebeverine in male patients with IBS with diarrhea (IBS-D). METHODS: This study was performed in a multicenter, randomized, open-label design. Data of 343 male patients with IBS-D who were randomized to either a 4-week treatment of ramosetron 5μg once daily or a 4-week treatment of mebeverine 135 mg three times daily were analyzed by the intent-to-treat analysis. The primary efficacy parameter was the proportion of patients with adequate relief of IBS symptoms at the last week of treatment. The secondary endpoints were changes in each symptom score and the safety profiles. KEY RESULTS: The responder rates for global IBS symptoms, abdominal pain/discomfort and abnormal bowel habits in the ramosetron and mebeverine groups significantly increased during the treatment period. The severity scores of abdominal pain/discomfort and urgency, the stool form score, and the stool frequency in both treatment arms were significantly reduced, compared with the baselines. There were no significant differences in the responder rates (37%vs 38% on ITT analysis) and adverse event profiles between the ramosetron and mebeverine groups. Neither severe constipation nor ischemic colitis was reported by ramosetron-treated patients. CONCLUSIONS & INFERENCES: Ramosetron 5μg once daily is as effective as mebeverine three times daily in male patients with IBS-D. SN - 1365-2982 UR - https://www.unboundmedicine.com/medline/citation/21920001/Efficacy_of_ramosetron_in_the_treatment_of_male_patients_with_irritable_bowel_syndrome_with_diarrhea:_a_multicenter_randomized_clinical_trial_compared_with_mebeverine_ L2 - https://doi.org/10.1111/j.1365-2982.2011.01771.x DB - PRIME DP - Unbound Medicine ER -