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

Abstract

Fesoterodine was well tolerated and improvements in OAB symptoms and quality of life measures were not diminished with longer-term treatment of patients aged ≥65 years.

Is benign prostatic obstruction surgery indicated for improving overactive bladder symptoms in men with lower urinary tract symptoms?

“…Furthermore, even after endoscopy and urodynamics including pressure-flow studies, some cases remain equivocal regarding obstruction. In these cases, pharmacological treatment may be initiated based on antimuscarinics if the postvoid residual is low and if the patient accepts the risk of urinary retention (estimated as low as 0.9% in men with OAB [16]). …”

Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review

“…The SOFIA (Study of Fesoterodine In an Aged population) trial had a 12 week, randomized, double-blind, placebo-controlled phase, followed by a 12 week, openlabel phase in elderly (aged !65 years) patients (47% men) with OAB symptoms for !3 months, including !8 micturitions/24 h and !3 urgency episodes/24 h, and a Mini-Mental State Examination (MMSE) score of !20 76,77 . During double-blind treatment, patients received fesoterodine 4 mg or placebo once daily, with age ( 75 or 475 years) and dose time (morning or evening) stratification, and had the option to increase to fesoterodine 8 mg at weeks 4 and 8 based on treatment response and tolerability; patients who increased the dose at week 4 could decrease at week 8.…”

Treatment of Overactive Bladder in Elderly Patients: Clinical Considerations

“…49 Good efficacy and tolerability 50 tolterodine lower rates of adverse events than oxybutynin 52 Fesoterodine Unique drug having studies specifically designed for elderly patients. 58 Proven efficacy in older people, but limited extent of effect or safety concerns 61 solifenacin…”

“…58 During the double-blind treatment, patients received fesoterodine 4 mg or placebo once daily, with stratification according to age (75 or 75 years) and dosing time (morning or evening), and they had the option to increase the dosage to fesoterodine 8 mg. At week 12, fesoterodine significantly improved urgency episodes/24 hours and health-related QoL (HRQoL) versus placebo regardless of age group or dosing time. The most common adverse events reported were dry mouth (fesoterodine, 34%; placebo, 5%) and constipation (fesoterodine, 9%; placebo, 3%).…”

“…Flexible-dose fesoterodine was generally well tolerated in both elderly and very elderly (aged  75 years) patients with OAB symptoms. 58 A double-blind, four-way crossover study performed by Kay et al assessed the effects of fesoterodine on cognitive function in 20 healthy older adults aged 65-85 years with an MMSE score of 26 at baseline. 59 Each subject received the following dosage: fesoterodine 4 mg for six days with placebo on day 6; fesoterodine 4 mg for three days followed by fesoterodine 8 mg for three days with placebo on day 6; placebo for six days; and placebo for six days with alprazolam 1 mg on day 6, with a three-to-six-day washout period between treatments.…”