Lotronex Clinical Trials and Studies
Lotronex Information
Lotronex Clinical Trials and Studies
Lotronex 1 mg twice daily was studied in two 12-week U.S. multicenter, randomized, double-blind, placebo-controlled trials of identical design (Studies 1 and 2) in non-constipated women with IBS meeting the Rome Criteria1 for at least 6 months. Women with severe pain or a history of severe constipation were excluded. A 2-week run-in period established baseline IBS symptoms.
There were a total of 633 women on Lotronex and 640 on placebo, about two thirds with diarrhea-predominant IBS. Compared with placebo, 10% to 19% more women with diarrhea-predominant IBS who received Lotronex had adequate relief of IBS abdominal pain and discomfort during each month of the study.
Women with Severe Diarrhea-Predominant IBS: Lotronex is indicated only for women with severe diarrhea-predominant IBS. The indication has been narrowed to this group of severely affected patients because serious gastrointestinal adverse events, some fatal, have been reported with the use of Lotronex. The following prospective and retrospective analyses support efficacy of Lotronex in this subset of the population that was studied in clinical trials.
In two 12-week, randomized, double-blind, placebo-controlled clinical trials of women with diarrhea-predominant IBS and bowel urgency on at least 50% of days at entry (Studies 3 and 4), there were a total of 778 women on Lotronex and 515 on placebo. Patients on Lotronex had significant increases over placebo (13% to 16%) in the median percentage of days with urgency control.
Retrospective Analyses: In analyses of patients from Studies 1 and 2 who had diarrhea-predominant IBS and indicated their baseline run-in IBS symptoms were severe at the start of the trial, Lotronex provided greater adequate relief of IBS pain and discomfort than placebo. In further analyses of Studies 1 and 2, 57% of patients had urgency at baseline on 5 or more days per week. In this subset, 32% of patients on Lotronex had urgency no more than 1 day in the last week of the trial, compared to 19% of patients on placebo.
In Studies 3 and 4, 66% of patients had urgency at baseline on 5 or more days per week. In this subset, 50% of patients on Lotronex had urgency no more than 1 day in the last week of the trial, compared to 29% of patients on placebo. Moreover, in the same subset, 12% on LOTRONEX had urgency no more than 2 days per week in any of the 12 weeks on treatment compared to 1% of placebo patients.
Lotronex efficacy in men has not been established.
