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KMID : 0358320060470050527
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Korean Journal of Urology
2006 Volume.47 No. 5 p.527 ~ p.535
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Duloxetine versus Placebo for the Treatment of Korean Women with Stress Predominant Urinary Incontinence
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Mah Sang-Yol
Lee Kyu-Sung
Choo Myoung-Soo
Seo Ju-Tae
Lee Jeong-Zoo
Park Won-Hee
Kim Joon-Chul
Lee Seung-Yun
Zhao Yan Daniel
Julie Beyrer
Meghan Wulster-Radcliffe
Louise Levine
Lars Viktrup
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Abstract
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Purpose: To compare duloxetine with placebo for the treatment of Korean women with stress urinary incontinence(SUI).
Materials and Methods: This was a phase 3, double-blind, stratified, randomized, parallel, placebo-controlled, multi-center study investigating efficacy and safety of a of duloxetine compared with placebo in the treatment of SUI. After a 2-week no-drug screening period, women ages 29-69 were randomly assigned to placebo(n=60) or duloxetine(n=61) as 40mg twice daily for 8 weeks followed by a 2 week no-drug period. Women were seen at 4-week intervals. The primary efficacy variable was percent change in incontinence episodes frequency(IEF)/week. Secondary variables included percent change in, changes in Incontinence Quality of Life(I-QoL) total and 3 sub-scale scores, and Patient Global Impression of Improvement(PGI-I) ratings. Safety was evaluated by treatment emergent adverse events(TEAE), discontinuations due to adverse events, vital signs measurements, and clinical laboratory tests.
Results: There were statistically significant improvements with duloxetine compared with placebo in IEF(duloxetine baseline 16.4IEF/wk, endpoint 7.7IEF/wk, median percent reduction=50.0% vs placebo baseline 13.3IEF/ wk, endpoint 8.8IEF/wk, median percent reduction=37.1%, p=0.033), and avoidance and limiting behavior subscale(p=0.006) in I-QoL. TEAEs were reported significantly more often in the duloxetine group compared with the placebo group(82.0% vs 31.7%; p＜0.001); common AEs(≥5% in duloxetine-treated subjects and p＜0.05) were nausea, dizziness, anorexia, fatigue, lethargy, abdominal discomfort, and constipation. Discontinuation rates because of AEs were 34.4% for duloxetine and 8.3% for placebo.
Conclusions: These data provide evidence for the safety and efficacy of duloxetine for the treatment for Korean women with SUI. (Korean J Urol 2006;47:527-535)
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KEYWORD
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Urinary incontinence, stress, Duloxetine
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