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

Abstract

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.

What are the chances of improvement or cure from overactive bladder? A pooled responder analysis of efficacy and treatment emergent adverse events following treatment with fesoterodine

“…This is similar to the results of an observational, open‐label surveillance flexible‐dosing study of OAB treatment with the antimuscarinic darifenacin, where age had a small negative impact on treatment efficacy 33 . In the trials of flexibly dosed fesoterodine, which prospectively recruited older people, the majority of patients escalated their dose to 8 mg to achieve the greatest efficacy, and factors associated with dose escalation have been reported 34–36 . The observation of a slightly reduced effect with age may well be due to increased severity of disease, not adjusted for in this analysis.…”

“… 33 In the trials of flexibly dosed fesoterodine, which prospectively recruited older people, the majority of patients escalated their dose to 8 mg to achieve the greatest efficacy, and factors associated with dose escalation have been reported. 34 , 35 , 36 The observation of a slightly reduced effect with age may well be due to increased severity of disease, not adjusted for in this analysis. This explanation certainly fits with the greater propensity for older adults to up‐titrate to achieve optimal efficacy.…”

Systematic literature review of clinical trials evaluating pharmacotherapy for overactive bladder in elderly patients: An assessment of trial quality

“…While only eight RCTs were found that evaluated OAB treatment explicitly in the elderly, 17 additional papers reported results, from all‐age RCTs, of elderly as post‐hoc analyses. Those post‐hoc analyses were conducted by either pooling the data of elderly subjects from several RCTs involving adults of all ages, or using the data of elderly subjects from single RCTs (subgroup analyses) . However, the results from single or pooled subgroup analyses have important limitations, and do not substitute for trials of explicitly elderly patients.…”

“…Those post-hoc analyses were conducted by either pooling the data of elderly subjects from several RCTs involving adults of all ages, [32][33][34][35][36][37][38][39][40][41][42][43] or using the data of elderly subjects from single RCTs (subgroup analyses). [44][45][46][47][48] However, the results from single or pooled subgroup analyses have important limitations, 49,50 and do not substitute for trials of explicitly elderly patients. A limitation of any SLR is the possible omission of relevant papers that were not identified based on the search strategy.…”

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

“…No change in mean MMSE score was observed from baseline to week 12 in either treatment group. A post-hoc analysis of the data from the double-blind phase found that a higher body mass index, male sex, and less improvement in urgency episodes/24 h and patient perception of bladder condition at week 4 were significantly associated with dose escalation 78 . During open-label treatment with fesoterodine, improvements in OAB symptoms and HRQL were maintained for patients who received double-blind fesoterodine, whereas patients treated with double-blind placebo followed by open-label fesoterodine achieved similar improvements in efficacy endpoints at week 24 77 .…”