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| |  Darifenacin Increases Dry Days and Improves Quality of Life in Patients With “Wet” OAB: Presented at ICS By Jill Stein SAN FRANCISCO -- October 2, 2009 -- Darifenacin-treated patients with “wet” overactive bladder (OAB) are significantly more likely to achieve >=3 consecutive dry days than placebo-treated patients, researchers announced here at the 39th Annual Meeting of the International Continence Society (ICS). Results also revealed that the improvement in consecutive dry days was associated with improved quality of life (QOL). Diane Newman, RNC, MSN, Penn Center for Continence and Pelvic Health, Philadelphia, Pennsylvania, and colleagues conducted a pooled analysis to examine darifenacin’s effects on the number of dry days and health-related QOL. The researchers used efficacy and safety data from three 12-week phase 3 studies with fixed doses of darifenacin. Results were presented on October 1. Each study consisted of a 2-week treatment-free or placebo run-in period and then 12 weeks of placebo or fixed doses of darifenacin 7.5 or 15 mg once daily. The study comprised 1,053 patients aged >=18 years who had OAB symptoms for at least 6 months. Moderately severe/severe OAB was defined as >=14 incontinence episodes per week, and mild OAB was defined as <14 incontinence episodes per week. After 12 weeks of treatment, significantly more patients on darifenacin had >=3 consecutive dry days, as determined by electronic bladder diaries, than patients on placebo (darifenacin 7.5 mg 49% vs 35.2%; darifenacin 15 mg 56.3% vs 39.8%; P < .001), regardless of baseline OAB severity. An analysis of combined data for all doses demonstrated that 52.6% of the darifenacin cohort achieved >=3 consecutive dry days versus 39.8% of the placebo cohort (P < .001). The median decrease in incontinence episodes and the number of incontinence episodes requiring a change in clothing/pads was significantly greater in patients with >=3 consecutive dry days. A statistically significantly greater improvement in health-related QOL, demonstrated by improvement in King’s Health Questionnaire domain scores, was seen with darifenacin treatment compared with placebo (P < .03). Also, significantly more participants receiving darifenacin had reductions of at least 3, 5, or 10 incontinence episodes per week compared with placebo (P <= .001). Common adverse effects were mild in the darifenacin-treated groups and prompted few discontinuations. Overall, the study found that darifenacin treatment is associated with an increase in the number of patients with wet OAB who achieved >=3 consecutive dry days, Newman said, and this resulted in improved health-related QOL. Funding for this study was provided by Procter & Gamble Pharmaceuticals, Novartis Pharmaceuticals Corporation, and CTI Clinical Trial & Consulting Services. [Presentation title: Impact of ‘Dry Days’ on Quality of Life in Patients with ‘Wet’ Overactive Bladder: Results of a Pooled Analysis of Three Phase III Studies With Darifenacin. Abstract 56]
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