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Data Shows Trospium Chloride Does Not Affect Sleep Patterns

March 4, 2005

Indevus Pharmaceuticals has announced that a new study published in the January edition of British Journal of Urology demonstrates that trospium chloride, the active ingredient in Sanctura, marketed in the U.S. as a first-line therapy for overactive bladder (OAB), had no effect on the sleep patterns of older subjects (aged 51 to 65 years).

Other currently marketed anticholinergic OAB treatments tested in this study were oxybutynin and tolterodine. Although OAB can occur in people of all ages, the incidence in older adults is higher. The data in this study were gathered from 24 healthy volunteers. The participants underwent four two-night periods of study in a sleep laboratory, with the study periods separated by a 12-day "washout" period. They were randomly assigned to receive one of the three medications or placebo. The duration of rapid-eye movement (REM) sleep, as a percentage of total sleep time, was selected as the primary outcome measure of the study.

Results showed that the proportion of the night spent in REM sleep after treatment with trospium chloride was not significantly different from placebo. In contrast, REM sleep was decreased by 14 percent after treatment with oxybutynin, compared with placebo, and by 15 percent after treatment with tolterodine compared with placebo.