Uro-3. Duloxetine efficacy in the treatment of various levels of stress urinary incontinence severity.

Purpose Duloxetine, a balanced and potent serotonin and norepinephrine reuptake inhibitor (SNRI), has been shown to be safe and effective for the treatment of women with stress urinary incontinence (SUI). The purpose of this analysis was to determine the relationship between baseline incontinence severity and treatment response to duloxetine. North American women who participated in two randomized clinical trials for SUI receiving duloxetine 40 mg BID (N = 484) or placebo (N = 477) for 12 weeks were included. The subjects were stratified based upon baseline incontinence severity into four groups. The median percent change in incontinence episode frequency (IEF) for placebo and duloxetine was determined within each severity group. IEF was calculated by pooling two weekly patient diaries prior to randomization and three diaries after randomization representing baseline and endpoint, respectively. Duloxetine was superior to placebo independent of the incontinence severity at baseline. Nearly identical median percent reductions in IEF were observed in women receiving duloxetine at all levels of severity. The placebo effect diminished in women with more severe incontinence. These data provide strong evidence for the efficacy of duloxetine for the treatment of women with SUI independent of baseline incontinence severity.

Chaofeng Liu, Suresh Siddhanti, Eric S. Meadows, Ilker Yalcin, Maida Taylor, and David Muram. Lilly Research Laboratories. Indianapolis, IN.