1352 Fesoterodine Is Effective and Well Tolerated in Vulnerable Elderly Subjects With Urgency Incontinence: A Double-Blind, Placebo-Controlled Study

Long‐term safety, tolerability and efficacy of flexible‐dose fesoterodine in elderly patients with overactive bladder: Open‐label extension of the SOFIA trial

“…This study extends previous observations of the safety, tolerability, and efficacy of fesoterodine in elderly patients, as this is the first study prospectively designed to assess antimuscarinic treatment in elderly patients for longer than 12 weeks. Additionally, the proportion of patients who were aged >75 years was higher than in previous studies.…”

“…Dry mouth and constipation were the most frequently observed AEs, and occurred in the DB placebo/OL fesoterodine group at rates similar to those in the DB fesoterodine/OL fesoterodine group during the double‐blind phase of the SOFIA study (33.9% and 8.9%, respectively) . Although the types and rates of AEs observed most frequently (dry mouth, constipation, and urinary tract infection) were similar to those seen in other studies of fesoterodine in the elderly the rates of dry mouth and constipation were lower in patients treated with fesoterodine over the entire 24 weeks. This may suggest that tolerance to these AEs developed, that the option to adjust the dose mitigated the expression of these bothersome AEs, and/or that attrition of patients with these AEs occurred during the double‐blind phase.…”

“…The lack of effect on UUI episodes is consistent with the data from the doubleblind phase of the SOFIA study and is likely due to the lower rate of UUI episodes at baseline than in previous studies of fesoterodine in elderly patients. 10,18,19 This study extends previous observations of the safety, tolerability, and efficacy of fesoterodine in elderly patients, 10,11,[18][19][20] as this is the first study prospectively designed to assess antimuscarinic treatment in elderly patients for longer than 12 weeks. Additionally, the proportion of patients who were aged >75 years was higher than in previous studies.…”

Factors associated with dose escalation of fesoterodine for treatment of overactive bladder in people >65 years of age: A post hoc analysis of data from the SOFIA study

“…3 OAB is responsible for considerable disease burden in older people, both in terms of restrictions on quality of life and social functioning, and health care resource use. Whereas older people were often neglected in treatment trials in this area, they have recently been the subject of considerable interest with the recent publication of several studies in community-dwelling and more at risk older people focusing on antimuscarinic efficacy, safety, and cognitive safety, [4][5][6][7][8] partially redressing the concerns about the paucity of data in older people highlighted by the International Consultation on Incontinence. 9 Once treated, even though adherence in the overall patient population for these medications is low, older people appear to be more persistent with their antimuscarinic treatment 10 although these data are conflicting.…”

Fesoterodine fumarate and the oxybutynin ring for the treatment of urinary incontinence in women

“…Most recently there have been several studies performed looking at the safety and efficacy of fesoterodine in medically complex vulnerable elderly patients with urgency UI [36,47,48]. These studies all report that fesoterodine is safe and efficacious in this group of patients.…”