title: Dose-escalating study of the pharmacokinetics and tolerability of fesoterodine in children with overactive bladder.
abstract: OBJECTIVE
  To determine the pharmacokinetics, safety and tolerability of fesoterodine, and assess the utility of 3-day bladder diaries (exploratory objective) in pediatric subjects with neurogenic detrusor overactivity or idiopathic overactive bladder (OAB).
  
  
  METHODS
  In this 8-week open-label study, subjects (8-17 years, >25 kg) received fesoterodine 4 mg for 4 weeks, then 8 mg for 4 weeks. Blood samples were obtained at weeks 4 and 8.
  
  
  RESULTS
  Of 21 subjects enrolled, 11 had neurogenic detrusor overactivity and 10 had idiopathic OAB; 1 discontinued (personal reasons). Mean age and weight were 13.2 years and 54.0 kg for boys (n = 12) and 13.1 years and 49.2 kg for girls (n = 9). 5-Hydroxy-methyltolterodine plasma concentrations did not differ by diagnosis and were consistent with predictions based on adult data. Treatment-related adverse events (all mild or moderate) included 1 event each of dry mouth, constipation, dry eyes and blurred vision, and 2 events each of nausea and increased post-void residual volume. Three-day bladder diaries proved feasible.
  
  
  CONCLUSIONS
  Oral administration of fesoterodine in pediatric subjects (>25 kg) with idiopathic OAB or neurogenic detrusor overactivity produced steady-state plasma 5-hydroxy-methyltolterodine exposures similar to those in adults. The doses given were well tolerated.
authors.affiliation: Pfizer Inc, 685 3rd Ave, Mail stop 235/09/31, New York, NY 10017, USA. bimal.k.malhotra@pfizer.com
authors.forename: Bimal
authors.initials: B
authors.lastname: Malhotra
authors.forename: Ahmed
authors.initials: A
authors.lastname: El-Tahtawy
authors.forename: Ellen Q
authors.initials: EQ
authors.lastname: Wang
authors.forename: Amanda
authors.initials: A
authors.lastname: Darekar
authors.forename: Nandini
authors.initials: N
authors.lastname: Cossons
authors.forename: Tim J
authors.initials: TJ
authors.lastname: Crook
authors.forename: David
authors.initials: D
authors.lastname: Scholfield
authors.forename: Pramod
authors.initials: P
authors.lastname: Reddy
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000886:Anthropometry; D001559:Benzhydryl Compounds / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D018727:Muscarinic Antagonists / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D011788:Quality of Life; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000175:diagnosis / Q000188:drug therapy*; D014563:Urodynamics
chemical_list: D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine