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.
OBJECTIVE
To investigate factors which may influence dose escalation of antimuscarinics for overactive bladder (OAB) in older patients and how dose escalation affects treatment efficacy.


METHODS
A post hoc analysis of data from the 12-week randomized, placebo controlled phase of the SOFIA study investigating treatment with fesoterodine in older people with OAB. Predictors and outcomes in patients aged ≥65 years with OAB who did or did not choose to escalate from fesoterodine 4 to 8 mg before the first dose-escalation choice point (week 4) and at the end of the study (week 12) were assessed.


RESULTS
Variables which significantly increased likelihood of dose escalation were, at baseline, body mass index (OR: 1.06, 95% CI 1.01, 1.12; P = 0.0222), and male gender (OR: 2.06, 95% CI 1.28, 3.32; P = 0.0028) and at week 4, change from baseline in urgency episodes (OR: 1.12, 95% CI 1.05, 1.20; P = 0.0008), patient perception of bladder control (PPBC) (OR: 1.44, 95% CI 1.12, 1.84; P = 0.004). At week 12, dose escalation was associated with slightly reduced treatment outcomes compared to week 4 non-escalators.


CONCLUSIONS
No baseline disease related factor associated with dose escalation was identified. Magnitude of change in urgency episodes and reduction in PPBC at 4 weeks were associated with dose escalation. These data may be of use to healthcare providers as they allow judgement to be made in individual patients, allowing treatment decisions to be made. At end of treatment, improvements in efficacy and quality of life were achieved in both escalators and non-escalators.
University of Alberta, Edmonton, Alberta, Canada.
Adrian
A
Wagg
Pfizer Ltd, Walton Oaks, United Kingdom.
Amanda
A
Darekar
Pfizer Europe, Madrid, Spain.
Daniel
D
Arumi
St Mary's Hospital, Imperial College, London, United Kingdom.
Vik
V
Khullar
Hannover Medical School, Hannover, Germany.
Matthias
http://orcid.org/0000-0002-2960-9931
M
Oelke
D000368:Aged; D001559:Benzhydryl Compounds / Q000008:administration & dosage*; D015992:Body Mass Index; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D018727:Muscarinic Antagonists / Q000008:administration & dosage*; D012737:Sex Factors; D016896:Treatment Outcome; D053201:Urinary Bladder, Overactive / Q000188:drug therapy*
D001559:Benzhydryl Compounds; D018727:Muscarinic Antagonists; C526675:fesoterodine
elderly; fesoterodine; health services; overactive bladder