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| |  Solifenacin Well Tolerated, Effective for Incontinent and Continent Patients With Overactive Bladder: Presented at AUGS By Charlotte Libov HOLLYWOOD, Fla -- September 28, 2009 -- Solifenacin is effective in treating symptoms of overactive bladder (OAB) in both continent and incontinent patients, as well as in elderly patients, researchers reported here at the 30th Annual Scientific Meeting of the American Urogynecologic Society (AUGS). Two post hoc analyses of the VESIcare Investigation of Bother and Quality of Life in Subjects With OAB (VIBRANT) were reported September 25 by Michael Vardy, MD and Terri-Ann Samuels, MD, both of Mount Sinai School of Medicine, New York, New York. The VIBRANT study was a 12-week, randomised, double-blind study of solifenacin versus placebo in patients with OAB for more than 3 months. The primary outcome was the mean score change from baseline diagnosed through patient outcome reports of bothersome urinary events. In Dr. Vandy’s presentation, researchers looked at the efficacy and tolerability of incontinent and continent patients. In this analysis, 768 patients were treated (safety set). Of the patients, 751 had baseline and >=1 subsequent assessment (full analysis set [FAS]). In the FAS, 545 (73%) patients were incontinent and 205 (27%) were continent at baseline. Patients were asked to evaluate their symptoms based on Patient Perception of Bladder Condition (PPBC; >=3 at baseline) and Benefit, Satisfaction, and Willingness to Continue measure. PPBC scores improved significantly in incontinent patients taking solifenacin versus placebo (P < .0001) and in continent patients (P = .4738). In addition, significantly more solifenacin-treated patients in the incontinent group reported treatment benefit compared with placebo (87% vs 63%), satisfaction (84% vs 58%), and willingness to continue treatment (82% vs 59%). In the continent group, respective percentages for solifenacin versus placebo were 76% vs 66% for benefit, 70% vs 64% for satisfaction, and 71% vs 63% for willingness to continue (P > .32 for all). The most frequent adverse events in incontinent and continent patients were dry mouth and constipation. In a related presentation, Dr. Samuels reported on her team’s analysis, which looked at the effect of solifenacin in younger and older patients. In this study, the 768 patients were divided by age group; 476 were aged younger 65 years, and 292 were aged 65 years and older. Improvement was noted both with solifenacin and placebo, but solifenacin significantly improved urgency, incontinence, and frequency, although not nocturia in both age groups. PPBC scores improved significantly in patients aged <65 years (-1.4 vs -1.0; P < .0001) and those aged >=65 years (-1.5 vs -1.1; P <= .0080). In the group <65 years of age, more patients receiving solifenacin reported treatment benefit (83% vs 64%; P < .0001), satisfaction (78% vs 60%; P < .0001), and willingness to continue treatment (76% vs 62%; P = .0012). In the >=65 year age group, more patients receiving solifenacin reported treatment benefit (85% vs 62%), satisfaction (84% vs 58%), and willingness to continue with treatment (83% vs 56%; P < .0001). Most adverse side effects were mild to moderate, and few patients discontinued use because of them. “Solifenacin is well tolerated in both age groups,” said Dr. Samuels. “This is important because there’s always a concern that in older patients there are side effects, to the main point is that this isn’t an issue, as far as this medication is concerned.” Funding for this study was provided by Astellas Pharma. [Presentation title: Solifenacin Improvements in Overactive Bladder Symptoms, Symptom Bother, and Other Patient-Reported Outcomes Versus Placebo in Patients With and Without Incontinence: Post Hoc Analysis of Data from Vibrant. Paper 66]AND[Presentation title: Solifenacin Significantly Improves Overactive Bladder Symptoms, Symptom Bother, and Other Patient-Reported Outcomes Versus Placebo in Younger and Older Patients: Post Hoc Analysis of Data From VIBRANT. Oral Poster 23]
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