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A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS.
Am J Gastroenterol 2005; 100(1):115-23AJ

Abstract

BACKGROUND

A randomized, double blind, placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome (IBS).

METHODS

Six hundred and sixty-two men were randomized to treatment with alosetron 0.5, 1.0, 2.0, 4.0 mg, or placebo twice daily for 12 wk, followed by a 4-wk posttreatment period. Adequate relief of IBS pain and discomfort during week 5-12 of the treatment phase was the primary endpoint; secondary endpoints included bowel urgency, stool frequency, and consistency, incomplete evacuation, bloating, and abdominal pain or discomfort.

RESULTS

Subjects ranked urgency and abdominal pain as their most bothersome IBS symptoms. The average rate of adequate relief during week 5-12 was significantly higher in the alosetron 1.0 mg twice-daily group compared to placebo (53%vs 40%, p= 0.04), and all doses of alosetron significantly reduced stool consistency scores (p < 0.001) indicating firmer stools. No significant effects of alosetron were seen with regard to urgency, number of bowel movements, bloating, and incomplete evacuation. Constipation was the most common adverse event and occurred in a dose-related manner among subjects receiving alosetron, 9% (0.5 mg twice daily), 15% (1.0 mg twice daily), 11% (2.0 mg twice daily), and 21% (4.0 mg twice daily). No serious adverse events of constipation were reported. One subject in the 0.5 mg twice-daily group had an episode of rectal bleeding suggestive of a possible diagnosis of ischemic colitis.

CONCLUSIONS

Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS.

Authors+Show Affiliations

Center for Neurovisceral Sciences and Women's Health, UCLA Division of Digestive Diseases, Los Angeles, California, USA.

Pub Type(s)

Clinical Trial
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

15654790

Citation

Chang, Lin, et al. "A Dose-ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men With Diarrhea-predominant IBS." The American Journal of Gastroenterology, vol. 100, no. 1, 2005, pp. 115-23.
Chang L, Ameen VZ, Dukes GE, et al. A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. Am J Gastroenterol. 2005;100(1):115-23.
Chang, L., Ameen, V. Z., Dukes, G. E., McSorley, D. J., Carter, E. G., & Mayer, E. A. (2005). A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. The American Journal of Gastroenterology, 100(1), pp. 115-23.
Chang L, et al. A Dose-ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men With Diarrhea-predominant IBS. Am J Gastroenterol. 2005;100(1):115-23. PubMed PMID: 15654790.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A dose-ranging, phase II study of the efficacy and safety of alosetron in men with diarrhea-predominant IBS. AU - Chang,Lin, AU - Ameen,Vanessa Z, AU - Dukes,George E, AU - McSorley,David J, AU - Carter,Eric G, AU - Mayer,Emeran A, PY - 2005/1/19/pubmed PY - 2005/2/16/medline PY - 2005/1/19/entrez SP - 115 EP - 23 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 100 IS - 1 N2 - BACKGROUND: A randomized, double blind, placebo-controlled dose-ranging study was conducted to assess the efficacy of alosetron in men with diarrhea-predominant irritable bowel syndrome (IBS). METHODS: Six hundred and sixty-two men were randomized to treatment with alosetron 0.5, 1.0, 2.0, 4.0 mg, or placebo twice daily for 12 wk, followed by a 4-wk posttreatment period. Adequate relief of IBS pain and discomfort during week 5-12 of the treatment phase was the primary endpoint; secondary endpoints included bowel urgency, stool frequency, and consistency, incomplete evacuation, bloating, and abdominal pain or discomfort. RESULTS: Subjects ranked urgency and abdominal pain as their most bothersome IBS symptoms. The average rate of adequate relief during week 5-12 was significantly higher in the alosetron 1.0 mg twice-daily group compared to placebo (53%vs 40%, p= 0.04), and all doses of alosetron significantly reduced stool consistency scores (p < 0.001) indicating firmer stools. No significant effects of alosetron were seen with regard to urgency, number of bowel movements, bloating, and incomplete evacuation. Constipation was the most common adverse event and occurred in a dose-related manner among subjects receiving alosetron, 9% (0.5 mg twice daily), 15% (1.0 mg twice daily), 11% (2.0 mg twice daily), and 21% (4.0 mg twice daily). No serious adverse events of constipation were reported. One subject in the 0.5 mg twice-daily group had an episode of rectal bleeding suggestive of a possible diagnosis of ischemic colitis. CONCLUSIONS: Alosetron 1 mg twice daily provided adequate relief of IBS pain and discomfort, and improved stool consistency in men with diarrhea-predominant IBS. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/15654790/A_dose_ranging_phase_II_study_of_the_efficacy_and_safety_of_alosetron_in_men_with_diarrhea_predominant_IBS_ L2 - http://Insights.ovid.com/pubmed?pmid=15654790 DB - PRIME DP - Unbound Medicine ER -