복압성 요실금이 있는 한국 여성의 치료에 있어서 둘록세틴과 위약의 비교
Duloxetine versus Placebo for the Treatment of Korean Women with Stress Predominant Urinary Incontinence
마상열, 이규성, 주명수, 서주태, 이정주, 박원희, 김준철, 이승윤, Zhao Yan Daniel, Julie Beyrer, Meghan Wulster-Radcliffe, Louise Levine, Lars Viktrup,
소속 상세정보
마상열 ( Mah Sang-Yol )
영동세브란스병원 비뇨기과
이규성 ( Lee Kyu-Sung )
삼성의료원 비뇨기과
주명수 ( Choo Myoung-Soo )
서울아산병원 비뇨기과
서주태 ( Seo Ju-Tae )
삼성제일병원 비뇨기과
이정주 ( Lee Jeong-Zoo )
부산대학교병원 비뇨기과
박원희 ( Park Won-Hee )
인하대학교병원 비뇨기과
김준철 ( Kim Joon-Chul )
강남성모병원 비뇨기과
이승윤 ( Lee Seung-Yun )
Lilly Korea
( Zhao Yan Daniel )
Indianapolis Lilly Research Laboratories
( Julie Beyrer )
Indianapolis Lilly Research Laboratories
( Meghan Wulster-Radcliffe )
Indianapolis Lilly Research Laboratories
( Louise Levine )
Indianapolis Lilly Research Laboratories
( Lars Viktrup )
Indianapolis Lilly Research Laboratories
KMID : 0358320060470050527
Abstract
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)
키워드
Urinary incontinence;stress; Duloxetine
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