title: Flexible dosing with fesoterodine 4 and 8 mg: a systematic review of data from clinical trials.
abstract: OBJECTIVE
  To systematically review dose-escalation data from flexible-dose studies of fesoterodine and summarise factors associated with dose-escalation decisions.
  
  
  METHODS
  A PubMed search was conducted using the terms (fesoterodine AND flexible dose), with no limits. Articles were included if they contained fesoterodine dose-escalation data for efficacy or safety outcomes or factors associated with dose-escalation decisions.
  
  
  RESULTS
  Of 13 articles identified by the search, 10 articles (six clinical studies) met inclusion criteria. In flexible-dose trials of fesoterodine, 51-63% of subjects initially receiving fesoterodine 4 mg opted for dose escalation to fesoterodine 8 mg. Escalators generally reported significantly more severe overactive bladder (OAB) symptoms, greater OAB symptom bother and worse health-related quality of life at baseline than non-escalators. Escalators demonstrated less treatment benefit with fesoterodine 4 mg than non-escalators. Non-escalators generally had a higher rate of dry mouth and constipation with fesoterodine 4 mg than escalators. The decision to escalate appeared to be determined by the efficacy/tolerability responses; fesoterodine escalators demonstrated a lower sensitivity (less efficacy and fewer adverse events) before their decision to escalate. By study end (8-11 weeks after escalation decision), the efficacy and tolerability profiles were similar in escalators and non-escalators.
  
  
  CONCLUSIONS
  Data from flexible-dose studies provide strong evidence that fesoterodine provides treatment benefit to individual subjects with OAB because of its true dose-response effect. In clinical practice, it can be worthwhile to escalate to fesoterodine 8 mg in individual subjects who require additional efficacy benefit.
authors.affiliation: Department of Urology, Universiteit en Universitair Ziekenhuis Antwerpen, Antwerp, Belgium.
authors.forename: J J
authors.initials: JJ
authors.lastname: Wyndaele
authors.forename: T
authors.initials: T
authors.lastname: Schneider
authors.forename: S
authors.initials: S
authors.lastname: MacDiarmid
authors.forename: D
authors.initials: D
authors.lastname: Scholfield
authors.forename: D
authors.initials: D
authors.lastname: Arumi
mesh_terms: D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000009:adverse effects*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
chemical_list: D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine