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Author Topic:   ALOSETRON STUDY! for lynneb and all woman ,this is a must read!!

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posted 05-19-1999 04:21 PM     Click Here to See the Profile for charlie   Click Here to Email charlie     Edit/Delete Message   Reply w/Quote
hi lynneb,and ladys
well you may have seen this already,but if not enjoy,the drug looks like a winner


AR. Northcutt (1), M. Camilleri (2), EA. Mayer (3), DA. Drossman (4), GE. Dukes (1), RSB. Ehsanullah (1), LR. Hamm (1), JP. Harding (1), AT. Heath (1), L. Jacques (1), S. Wolfe (1) S. Kong(l), D. McSorley (1), AW. Mangel (1). Glaxo Wellcome, Research Triangle Park, NC (1), Mayo Foundation, Rochester, MN (2); CURE, UCLA School of medicine, Los Angeles, CA (3); University of north Carolina School of medicine, Chapel Hill, NC (4).

Background: Serotonergic pathways modulate visceral sensory and colonic motor processes which may play a role in the pathogenesis of irritable bowel syndrome (IBS). We, therefore, sought to evaluate the potent and selective 5HT3-receptor antagonists alosetron, in the treatment of non-constipated IBS patients.

Methods: Three hundred and seventy patients with IBS were recruited from 5 countries and randomly assigned in a double-blind fashion to 12 weeks of treatment with one of the following regimens: alosetron 1,2,4,8 mg BID or placebo BID. During the screening, treatment and foflow-up periods, patients reported symptoms of pain and bowel function daily via an electronic touch-tone telephone based system (1). During the treatment period, patients also reported weekly whether they had obtained adequate relief of their IBS-related abdominal pain and discomfort during the previous week. In patients completing the 12-week treatment period, a responder was prospectively defined as a patient who reported adequate relief for at least 6 weeks; otherwise the patient was a non-responder.

Results: The proportion of female responders (reporting adequete relief) with alosetron 1 mg BID (60%) or 2 mg BID (59%) was significantly greater than the proportion of female responders reporting adequate relief with placebo (33%, p<0.05). Alosetron also significantly improved stool urgency, frequency and consistency in females. There was no evidence of improvement over placebo in the proportion of male patients reporting adequate relief of IBS-related pain/discomfort with any dose of alosetron examined. In males treated with alosetron only stool consistency showed improvement over placebo. The only adverse event of note was constipation that was reported by 2O% (1mg BID) to 29% (8mg BID) of patients treated with alosetron.

Conclusion: Alosetron is effective and wel tolerated in relieving abdominal pain and improving stool frequency, consistency an urgency in female IBS patients.

(1) Harding JP et al Use of a novel electronic data collection system in multicenter studies of irritable bowel syndrome, Alimen.Pharm. Ther. 1997;11,6:1073-76

Gastroenterology 1998;114:A812


Posts: 226
Registered: Mar 99

posted 05-19-1999 07:16 PM     Click Here to See the Profile for LynneB   Click Here to Email LynneB     Edit/Delete Message   Reply w/Quote

Well, now let's hope I got the real thing and not the placebo! The worst that can happen, though, is that I won't be able to get it until it is available to the general public. And it seems like it's on it's way.

Does any one with a pharmeceutical background know the timeframe for the FDA to approve a drug once the papers are filed?


(Thank you, Charlie )

[This message has been edited by LynneB (edited 05-19-99).]

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IBS & the Mind-Body/Brain-Gut Connection, by William B. Salt II, MD