# More on Lotronex



## Guest (Apr 3, 2001)

Am J Gastroenterol 2001 Mar;96(3):803-11 Tolerability and safety of alosetron during long-term administration in female and male irritable bowel syndrome patients.Wolfe SG, Chey WY, Washington MK, Harding J, Heath AT, McSorley DJ, Dukes GE, Hunt CMGastroenterology Clinical Development, Glaxo Wellcome, Research Triangle Park, North Carolina, USA.OBJECTIVES: Alosetron (Lotronex) is a new therapeutic agent for irritable bowel syndrome (IBS) in women with diarrhea-predominant IBS. This multicenter randomized, double-blind, placebo-controlled study assessed the safety and tolerability of alosetron during long-term (< or = 12 months) treatment. METHODS: A total of 859 subjects (637 female and 222 male) with IBS were enrolled from 130 sites in the United States and were randomized 3:1 to receive 1 mg alosetron or placebo b.i.d. for 48 wk; of the subjects, 649 (76%) were randomized to the alosetron group and 212 (24%) to the placebo group. Of the original group, 850 subjects received at least one dose of alosetron (n = 640) or placebo (n = 210). RESULTS: In all, 59% of the subjects completed the study. Safety data were similar in treatment groups and within age, sex, racial origin, and hormone use. Adverse events were reported by 83% (530/640) and 76% (159/210) of subjects in the alosetron and placebo groups, respectively, (p < 0.05) and were similar with the exception of constipation; 32% of subjects receiving alosetron reported constipation, compared to 5% in the placebo group (p < 0.001). Most reports (72%) of constipation were of mild or moderate severity, and 66% of subjects with constipation had single episode of 8 days median duration. Constipation occurred a median of 13 days after initiating treatment and resolved spontaneously, with laxative, or after a brief interruption of therapy. Of the subjects, 4% (11/210) in the alosetron and 5% (28/ 640) in the placebo group experienced serious adverse events. Two deaths occurred in subjects with pre-existing cardiovascular risk factors; neither death was attributed to the study drug. CONCLUSIONS: Alosetron 1 mg b.i.d. for 12 months was well tolerated. Constipation is the most frequent adverse event, with a higher incidence of transient constipation in alosetron-treated patients, typically occurring in the first month of treatment.


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## Jeffrey Roberts (Apr 15, 1987)

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH GASTROINTESTINAL DRUGS ADVISORY COMMITTEE NDA 21-107, LOTRONEX (ALOSETRON) Glaxo Wellcome Tuesday, June 27, 2000 8:30 a.m. Marriott Washington Center 9751 Washington Boulevard Gaithersburg, MarylandTranscript: http://www.fda.gov/ohrms/dockets/ac/00/tra...ipts/3627t2.rtf


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