Résumé
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%; por=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.