Duloxetine Safe, Effective in Stress Urinary Incontinence

Laurie Barclay, MD

September 12, 2003

Sept. 12, 2003 — Duloxetine is safe and effective for treating women with stress urinary incontinence (SUI), according to the results of a phase III, double-blind, placebo-controlled trial published in the October issue of the Journal of Urology.

"These data are important for physicians and sufferers as there are currently no pharmaceutical options for the millions of women affected by SUI," lead author Roger Dmochowski, MD, from Vanderbilt University in Nashville, Tennesee, says in a news release. "A pharmaceutical option would be a welcomed choice."

By blocking the reuptake of serotonin and norepinephrine in the spinal cord, duloxetine is thought to increase contraction of the urethral sphincter. The U.S. Food and Drug Administration recently issued an approvable letter for duloxetine for SUI.

This multicenter study performed in the U.S. and Canada enrolled 683 women aged 22 to 84 years with prominent symptoms of SUI and at least seven episodes of incontinence per week for at least three months. After a two-week placebo lead-in period, subjects were randomized to receive placebo or 40 mg duloxetine twice daily for 12 weeks.

Compared with the placebo group, the duloxetine group fared better in terms of number of weekly incontinence episodes, decrease in weekly incontinence episode frequency (50% vs. 27%; P < .001), increase in voiding interval (20 vs. 2 minutes; P < .001), and improvements in scores on a validated incontinence quality-of-life survey ( P < .001). On the Patient Global Impression of Improvement (PGI-I) Scale, improvements were noted in 62.0% of women treated with duloxetine and in 39.6% of women receiving placebo. Duloxetine treatment response was not affected by incontinence severity at baseline.

Adverse events led to withdrawal from the study in 4% of patients in the placebo group and in 24% of patients in the duloxetine group ( P < .001). Nausea was the most common reason for withdrawal and the most common adverse effect, but it tended to be mild to moderate and to resolve within one to four weeks.

"These phase 3 data are consistent with phase 2 data and they provide further support for duloxetine as a pharmacological agent for the treatment of women with SUI," the authors write. "Clearly improvements due to duloxetine must be weighed against a considerable discontinuation rate due to early side effects."

Eli Lilly supported this study and has financial arrangements with its authors, some of whom also have financial arrangements with other pharmaceutical companies.

J Urol. 2003;170:1259-1263

Reviewed by Gary D. Vogin, MD

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