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Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome.
Am J Gastroenterol 2004; 99(11):2195-203AJ

Abstract

OBJECTIVES

To assess long-term safety and efficacy of alosetron in women with severe, chronic diarrhea-predominant IBS and in a subset having more frequent urgency (i.e., bowel urgency at least 10 of 14 days during screening).

METHODS

Randomized patients received either alosetron 1 mg (n = 351) or placebo (n = 363) twice daily during a 48-wk, double-blind study. The primary endpoint was the 48-wk average rate of adequate relief of IBS pain and discomfort. Secondary endpoints included 48-wk average satisfactory control rates of urgency, stool frequency, stool consistency, and bloating. Other efficacy endpoints were average monthly adequate relief and urgency control rates and impact of provided rescue medication.

RESULTS

Alosetron-treated patients had significantly greater 48-wk average adequate relief (p= 0.01) and urgency control (p < 0.001) rates, regardless of rescue medication use, compared with placebo. Results in subjects with more frequent urgency were more robust than those in the overall population (p= 0.005). In weeks without rescue medication use, satisfactory control rates for stool frequency and stool consistency were significantly greater in alosetron-treated patients than placebo. Alosetron-treated patients had significantly greater adequate relief than placebo-treated patients (p < 0.05) in 9 of 12 months and significantly greater urgency control (p < 0.001) in all months. Adequate relief and urgency control were maintained throughout the treatment. Adverse events and serious adverse events were similar between treatment groups, except for constipation. Neither ischemic colitis nor serious events related to bowel motor dysfunction was reported.

CONCLUSIONS

Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency.

Authors+Show Affiliations

University of Michigan Medical Center, Ann Arbor, Michigan, USA.

Pub Type(s)

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

Language

eng

PubMed ID

15555002

Citation

Chey, William D., et al. "Long-term Safety and Efficacy of Alosetron in Women With Severe Diarrhea-predominant Irritable Bowel Syndrome." The American Journal of Gastroenterology, vol. 99, no. 11, 2004, pp. 2195-203.
Chey WD, Chey WY, Heath AT, et al. Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. Am J Gastroenterol. 2004;99(11):2195-203.
Chey, W. D., Chey, W. Y., Heath, A. T., Dukes, G. E., Carter, E. G., Northcutt, A., & Ameen, V. Z. (2004). Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. The American Journal of Gastroenterology, 99(11), pp. 2195-203.
Chey WD, et al. Long-term Safety and Efficacy of Alosetron in Women With Severe Diarrhea-predominant Irritable Bowel Syndrome. Am J Gastroenterol. 2004;99(11):2195-203. PubMed PMID: 15555002.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome. AU - Chey,William D, AU - Chey,William Y, AU - Heath,Amy T, AU - Dukes,George E, AU - Carter,Eric G, AU - Northcutt,Allison, AU - Ameen,Vanessa Z, PY - 2004/11/24/pubmed PY - 2004/12/16/medline PY - 2004/11/24/entrez SP - 2195 EP - 203 JF - The American journal of gastroenterology JO - Am. J. Gastroenterol. VL - 99 IS - 11 N2 - OBJECTIVES: To assess long-term safety and efficacy of alosetron in women with severe, chronic diarrhea-predominant IBS and in a subset having more frequent urgency (i.e., bowel urgency at least 10 of 14 days during screening). METHODS: Randomized patients received either alosetron 1 mg (n = 351) or placebo (n = 363) twice daily during a 48-wk, double-blind study. The primary endpoint was the 48-wk average rate of adequate relief of IBS pain and discomfort. Secondary endpoints included 48-wk average satisfactory control rates of urgency, stool frequency, stool consistency, and bloating. Other efficacy endpoints were average monthly adequate relief and urgency control rates and impact of provided rescue medication. RESULTS: Alosetron-treated patients had significantly greater 48-wk average adequate relief (p= 0.01) and urgency control (p < 0.001) rates, regardless of rescue medication use, compared with placebo. Results in subjects with more frequent urgency were more robust than those in the overall population (p= 0.005). In weeks without rescue medication use, satisfactory control rates for stool frequency and stool consistency were significantly greater in alosetron-treated patients than placebo. Alosetron-treated patients had significantly greater adequate relief than placebo-treated patients (p < 0.05) in 9 of 12 months and significantly greater urgency control (p < 0.001) in all months. Adequate relief and urgency control were maintained throughout the treatment. Adverse events and serious adverse events were similar between treatment groups, except for constipation. Neither ischemic colitis nor serious events related to bowel motor dysfunction was reported. CONCLUSIONS: Long-term use of alosetron is effective and well-tolerated in women with chronic, diarrhea-predominant IBS, including those with more frequent urgency. SN - 0002-9270 UR - https://www.unboundmedicine.com/medline/citation/15555002/Long_term_safety_and_efficacy_of_alosetron_in_women_with_severe_diarrhea_predominant_irritable_bowel_syndrome_ L2 - http://Insights.ovid.com/pubmed?pmid=15555002 DB - PRIME DP - Unbound Medicine ER -