Long-term safety and efficacy of alosetron in women with severe diarrhea-predominant irritable bowel syndrome

Am J Gastroenterol. 2004 Nov;99(11):2195-203. doi: 10.1111/j.1572-0241.2004.30509.x.


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.

Publication types

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

MeSH terms

  • Abdominal Pain / etiology
  • Carbolines / adverse effects
  • Carbolines / therapeutic use*
  • Chronic Disease
  • Diarrhea / drug therapy*
  • Diarrhea / etiology
  • Double-Blind Method
  • Female
  • Gastrointestinal Agents / adverse effects
  • Gastrointestinal Agents / therapeutic use*
  • Humans
  • Irritable Bowel Syndrome / drug therapy*
  • Middle Aged
  • Patient Satisfaction
  • Serotonin Antagonists / adverse effects
  • Serotonin Antagonists / therapeutic use*


  • Carbolines
  • Gastrointestinal Agents
  • Serotonin Antagonists
  • alosetron