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Long-Term Use of Fesoterodine for Overactive Bladder Appears Safe and Effective: Presented at AUGS By Charlotte Libov HOLLYWOOD, Fla -- October 1, 2009 -- The long-term use of fesoterodine in women for the treatment of overactive bladder appears effective and well tolerated over a 24-month period, according to a study presented here at the 30th Annual Scientific Meeting of the American Urogynecologic Society (AUGS). On September 25, Harriette Scarpero, MD, Vanderbilt University Medical Center, Nashville, Tennessee, presented the results of a post hoc analysis of pooled data from subjects enrolled in two 12-week randomised, double-blind, placebo-controlled, phase 3 trials. This report presents the post hoc analysis from two 3-year, open-label, extension studies that followed the 12-week trials. The researchers enrolled 890 subjects, of which 705 (79%) were women in the 2 open-label studies. The mean age was 57.7 years, with 32% of subjects over the age of 65 years. Subjects were started on fesoterodine 8 mg and could reduce the dosage to 4 mg, or re-escalate to a higher dosage. All dose reductions or increases occurred at a scheduled site visit and after discussion with the investigator. Efficacy and health outcomes were prespecified to be captured for the first 2 years. The majority of the women opted for the 8-mg dose. During the trials, 12.2% of the women discontinued the medication due to adverse side effects, including 1.8% with dry mouth and 1.3% with constipation. The King’s Health Questionnaire assessed health-related quality of life, and was based on the proportion of subjects reporting in each of 4 categories (“inadequate,” “moderate,” “good,” and “excellent”). Treatment satisfaction was measured at open-label baseline, 4 months, 1 year, and 2 years on a 4-point scale ranging from 1 (“extremely satisfied”) to 4 (“not satisfied”). At 2 years, 94% of women rated their treatment tolerance as predominantly “good” or “excellent,” and 97% of women reported being at least “satisfied” with treatment. “Excellent tolerability was reported by 95% of the subjects,” Dr. Scarpero said. “All groups improved in urgency episodes and 97% of [those] reported they were at least satisfied. The study showed the medication was well tolerated in the long term. The quality-of-life data looks better as time goes on.” Dr. Scarpero added that 49% of subjects opted to continue into the third year of the study. Funding for the original trial was provided by Pfizer Inc. [Presentation title: Long-Term Safety, Tolerability, Efficacy, and Health Outcomes of High-Dose Fesoterodine in Women With Overactive Bladder. Paper 67] E-mail this page to a friend or colleague! To print, use this version