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| |  Fesoterodine Provides Multiple Benefits in Patients With Overactive Bladder Not Satisfied With Prior Treatment: Presented at ICS By Jill Stein SAN FRANCISCO -- October 3, 2009 -- Fesoterodine, at 4 and 8 mg, significantly improves overactive bladder (OAB) symptoms in patients choosing to remain on the initial 4-mg dose as well as in subjects escalating to the 8-mg dose after 4 weeks, researchers stated here at the 39th Annual Meeting of the International Continence Society (ICS). Jon D. Morrow, MD, Pfizer Inc., New York, New York, presented a post hoc analysis of a 12-week open-label flexible-dose study in patients who were previously dissatisfied with tolterodine or tolterodine extended-release (ER) treatment, on October 2. Flexible dosing of fesoterodine showed significant improvements from baseline in OAB symptoms and multiple patient-reported outcome measures. All participants in the open-label trial were evaluated as a single group irrespective of dose escalation. In the post hoc analysis, the data were stratified according to whether patients opted for dose escalation. Patients received fesoterodine 4 mg once daily for the first 4 weeks of treatment, with an optional dose increase to fesoterodine 8 mg after week 4 based on discussion of efficacy and tolerability between the patient and investigator. Overall, 255(50%) of 513 patients consented to dose escalation to 8 mg. Compared with baseline, all bladder-diary variables including urinary frequency and urge urinary incontinence (UUI) significantly improved after 1, 4, and 12 weeks of treatment with fesoterodine (all P < .0001), regardless of whether patients opted for dose escalation after week 4. On baseline diary, 123 of 256 patients (47%) who did not escalate at week 4 and 131 of 255 patients (51%) who opted for dose escalation at week 4 reported >0 UUI episodes. On the 5-day diary completed before week 4 immediately prior to the dose-escalation decision, 62% of patients who did not escalate and 42% of patients who did escalate reported UUI = 0. At week 12, 68% and 60% of these patients reported UUI = 0, respectively. Patients who did not escalate their dose and patients who opted for dose escalation had similar high rates of treatment satisfaction and similar adverse event rates. Significant improvements in quality of life measures occurred from baseline to weeks 4 and 12 regardless of escalation status. The analysis also showed that improvements occurred in escalators and non-escalators as early as week 1 and also at the 4- and 12-week assessments. Overall, the results demonstrate that fesoterodine 4 and 8 mg provides significant improvements in bladder diary variables and patient-reported measures of bladder-related problems, urgency, symptom bother, and health-related quality of life in patients who were not satisfied with tolterodine therapy. Funding for this study was provided by Pfizer Inc. [Presentation title: Efficacy and Tolerability of Fesoterodine in Subjects Stratified by Dose Escalation in an Open-Label Flexible-Dose Study. Abstract 712]
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