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Duloxetine (Yentreve) Significantly Improves Stress Urinary Incontinence: Presented at ICS

By Jill Stein

PARIS, FRANCE -- August 26, 2004 -- Treatment with duloxetine (Yentreve) significantly improves symptoms in women who have at least one daily episode of stress urinary incontinence.

Investigators reported the findings in a poster session here on August 26^th at the Joint Meeting of the International Continence Society and the International UroGynecologial Association.

Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor that increases rhabdosphincter contractility via the stimulation of pudendal motor neuron alpha-1 adrenergic and 5-hydrotryptamine-2 receptors.

Richard Bump, MD, Senior Medical Advisor for duloxetine, Lilly Research Laboratories, Indianapolis, Indiana, presented the results of a post-hoc analysis of the integrated database from one phase II and three phase III randomized controlled trials.

The researchers analysed data on a total of 1913 women aged 22 to 83 years diagnosed with predominant stress urinary incontinence. Overall, 858 women were treated with duloxetine 40 mg twice daily, and 955 received placebo.

In the post-hoc analysis, stress urinary incontinence was diagnosed using a clinical algorithm that is 90.2% predictive for urodynamic stress incontinence.

Outcome was evaluated over 12 weeks using incontinence episode frequency (IEF) from diaries completed by patients and scores on the Validated Incontinence Quality of Life (I-QOL) questionnaire.

Women were divided into four groups depending on the severity of their incontinence at baseline: less than 7 episodes/week, 7 to 13 episodes/week, 14 to 20 episodes/week, and 21 or more episodes/week.

The researchers found that the placebo response in the least severe group was high and enhanced compared with the more severe groups, a finding that is in line with previously reported effects.

Duloxetine showed a median percent decrease in incontinence of at least 50% in all four groups; however, this was not superior to the placebo response in the lease severe subgroup. The separation of duloxetine response from placebo response in the other subgroups ranged between 21.6% and 32.8%.

The data support the significant and clinically important efficacy of duloxetine in women with stress urinary incontinence with one or more daily episodes of incontinence, according to the researchers. In addition, they were not able to demonstrate significant improvement in women with very mild incontinence who had high baseline IQOL scores.

Although it is difficult to demonstrate a significant impact of treatment in patients with very mild disease, these patients should have the least damaged continence mechanism and should therefore be best able to respond to duloxetine, they conclude.

The study was sponsored by Eli Lilly and Boehringer Ingelheim.


[Abstract title: "The Effect of Baseline Severity on the Efficacy of Duloxetine in the Treatment of Women With Stress Urinary Incontinence." Abstract 275]

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