title: A pooled analysis of the efficacy of fesoterodine for the treatment of overactive bladder, and the relationship between safety, co-morbidity and polypharmacy in patients aged 65 years or older.
abstract: overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity.
  
  
  
  data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted.
  
  
  
  of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few.
  
  
  
  fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.
authors.affiliation: Geriatric Medicine, University of Alberta, Alberta, Canada.
authors.forename: Adrian
authors.initials: A
authors.lastname: Wagg
authors.affiliation: Pfizer Europe-Pfizer Global Innovative Pharma Business, Madrid, Spain.
authors.forename: Daniel
authors.initials: D
authors.lastname: Arumi
authors.affiliation: Urology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.
authors.forename: Sender
authors.initials: S
authors.lastname: Herschorn
authors.affiliation: Urology, Hospital Universitario de Getafe, Getafe, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Angulo Cuesta
authors.affiliation: Groupe Hospitalier Diaconess Croix Saint Simon - Urology, Paris, France.
authors.forename: Francois
authors.initials: F
authors.lastname: Haab
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Fady
authors.initials: F
authors.lastname: Ntanios
authors.affiliation: Pfizer European Service Center BVBA, Brussels, Belgium.
authors.forename: Martin
authors.initials: M
authors.lastname: Carlsson
authors.affiliation: Urology, University of Hannover, Hannover, Bavaria, Germany.
authors.forename: Matthias
authors.initials: M
authors.lastname: Oelke
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001559:Benzhydryl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D015897:Comorbidity; D064420:Drug-Related Side Effects and Adverse Reactions / Q000209:etiology; D005260:Female; D006801:Humans; D016018:Least-Squares Analysis; D016015:Logistic Models; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D016017:Odds Ratio; D019338:Polypharmacy; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000187:drug effects* / Q000503:physiopathology; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D014563:Urodynamics / Q000187:drug effects*; D064804:Urological Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; D064804:Urological Agents; C526675:fesoterodine
keywords: fesoterodine; multimorbidity; older people; overactive bladder; polypharmacy