Irritable Bowel Syndrome Message Boards | Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

The American Journal of Gastroenterology
Volume 100 Issue 1 Page 115 - January 2005
doi:10.1111/j.1572-0241.2005.40365.x

A Dose-Ranging, Phase II Study of the Efficacy and Safety of Alosetron in Men with Diarrhea-Predominant IBS

Lin Chang, M.D.1, Vanessa Z. Ameen, M.D.1, George E. Dukes, Pharm.D.1, David J. McSorley M.S.1, Eric G. Carter, M.D., Ph.D.1, and Emeran A. Mayer, M.D.1
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 512 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 512 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.

http://www.blackwell-synergy.com/links/doi/10.1111/j.1572-0241.2005.40365.x/abs/

--------------------
Heather is the Administrator of the IBS Message Boards. She is the author of Eating for IBS and The First Year: IBS, and the CEO of Heather's Tummy Care. Join her IBS Newsletter. Meet Heather on Facebook!

Print Remind Me Notify Moderator