The Experts below are selected from a list of 1122 Experts worldwide ranked by ideXlab platform

Zhonghong Guan - One of the best experts on this subject based on the ideXlab platform.

  • add on Fesoterodine for residual storage symptoms suggestive of overactive bladder in men receiving α blocker treatment for lower urinary tract symptoms
    BJUI, 2012
    Co-Authors: Steven A. Kaplan, Franklin Sun, Jason Gong, Claus G Roehrborn, Zhonghong Guan
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men. Flexible-dose Fesoterodine as an add-on treatment significantly improved urinary frequency and symptom bother, but not urgency episodes (primary endpoint), versus add-on placebo and was well tolerated in men with persistent overactive bladder symptoms despite receiving α-blocker. OBJECTIVE •  To evaluate flexible-dose Fesoterodine vs placebo in men with persistent overactive bladder (OAB) symptoms despite receiving α-blocker treatment SUBJECTS AND METHODS •  This was a double-blind, 12-week, flexible-dose trial. •  Men with persistent storage symptoms (≥8 micturitions and ≥3 urgency episodes per 24 h) after receiving an α-blocker for ≥6 weeks were randomized to add-on Fesoterodine 4 mg or placebo, with optional dose escalation to 8 mg at week 4 and reduction back to 4 mg at week 8 (or matching placebo adjustments). •  Subjects completed 3-day diaries, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12. RESULTS •  A total of 943 men were randomized and received at least one dose of study treatment (Fesoterodine, n= 471; placebo, n= 472). •  Among these, 251 (53%) in the Fesoterodine group and 300 (64%) in the placebo group requested dose escalation at week 4 and 35 (7%) and 15 (3%) requested dose reduction at week 8. Changes from baseline to week 12 in urgency episodes (primary endpoint) in the Fesoterodine (−3.2) and placebo (−2.9) groups were not significantly different (P= 0.196), but improvements in micturitions (P= 0.009) and OAB-q symptom bother score (P= 0.007) were significantly greater with Fesoterodine. •  At week 4, significantly greater improvements in micturitions (P= 0.006), severe urgency episodes (P= 0.006), IPSS storage score (P= 0.022), OAB-q symptom bother score (P= 0.004), and OAB-q health-related quality of life (P= 0.041), but not urgency episodes (P= 0.062), were observed with add-on Fesoterodine. •  Dry mouth (Fesoterodine, 21%; placebo, 6%) and constipation (Fesoterodine, 6%; placebo, 2%) were the most common adverse events. Dysuria and urinary retention were reported by 3% and 2% of subjects, respectively, in the Fesoterodine add-on group vs 1% and <1% of subjects, respectively in the placebo add-on group. One subject in each group had acute urinary retention requiring catheterization. CONCLUSIONS •  Flexible-dose Fesoterodine was well tolerated as an add-on treatment in men with persistent storage symptoms. •  Changes in urgency episodes at week 12 (primary endpoint) and many secondary endpoints were not significantly different between Fesoterodine and placebo add-on treatment; however, improvements in frequency and symptom bother were significantly greater with Fesoterodine. •  These data suggest that there remains a limited understanding of the optimal evaluation and treatment of men with LUTS.

  • Long-Term Safety, Tolerability and Efficacy of Fesoterodine in Subjects with Overactive Bladder Symptoms Stratified by Age
    Drugs & Aging, 2012
    Co-Authors: Peter K Sand, Zhonghong Guan, Martin Carlsson, John Heesakkers, Stephen R. Kraus, Sandra Berriman
    Abstract:

    Background: Previous work has demonstrated the efficacy and safety of Fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term Fesoterodine treatment in different age groups has not been assessed. Objective: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with Fesoterodine 8 mg in subjects with OAB syndrome. Methods: This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with Fesoterodine were included. Subjects were initiated on Fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. Results: A total of 890 subjects were treated (age

  • Long-term safety, tolerability and efficacy of Fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies.
    Drugs & Aging, 2012
    Co-Authors: Peter K Sand, Zhonghong Guan, Martin Carlsson, John Heesakkers, Stephen R. Kraus, Sandra Berriman
    Abstract:

    Background: Previous work has demonstrated the efficacy and safety of Fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term Fesoterodine treatment in different age groups has not been assessed.

  • effects of voluntary dose escalation in a placebo controlled flexible dose trial of Fesoterodine in subjects with overactive bladder
    Neurourology and Urodynamics, 2011
    Co-Authors: David R Staskin, Zhonghong Guan, Franklin Sun, Jon D Morrow, Martin C. Michel, Vik Khullar, Roger R Dmochowski
    Abstract:

    Aims To characterize the response to Fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study. Methods Subjects were randomized to Fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non-escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes. Results Sixty-three per cent of 438 subjects randomized to Fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, Fesoterodine escalators had significantly more micturitions and urgency episodes than Fesoterodine non-escalators (P   0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point. Conclusion A rapid and robust response to Fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to Fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg Fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose. Neurourol. Urodynam. Neurourol. Urodynam. 30: 1480–1485, 2011. © 2011 Wiley Periodicals, Inc.

  • Add-on Fesoterodine for residual storage symptoms suggestive of overactive bladder in men receiving α-blocker treatment for lower urinary tract symptoms.
    BJU International, 2011
    Co-Authors: Steven A. Kaplan, Franklin Sun, Jason Gong, Claus G Roehrborn, Zhonghong Guan
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b What's known on the subject? and What does the study add? Male lower urinary tract symptoms are often attributed to bladder outlet obstruction secondary to benign prostatic hyperplasia and treated with drugs targeting the prostate. However, many men with storage lower urinary tract symptoms may not respond adequately to these agents. Antimuscarinics, with or without an α-blocker, may be effective for the treatment of the storage symptoms of overactive bladder in some men. Flexible-dose Fesoterodine as an add-on treatment significantly improved urinary frequency and symptom bother, but not urgency episodes (primary endpoint), versus add-on placebo and was well tolerated in men with persistent overactive bladder symptoms despite receiving α-blocker. OBJECTIVE •  To evaluate flexible-dose Fesoterodine vs placebo in men with persistent overactive bladder (OAB) symptoms despite receiving α-blocker treatment SUBJECTS AND METHODS •  This was a double-blind, 12-week, flexible-dose trial. •  Men with persistent storage symptoms (≥8 micturitions and ≥3 urgency episodes per 24 h) after receiving an α-blocker for ≥6 weeks were randomized to add-on Fesoterodine 4 mg or placebo, with optional dose escalation to 8 mg at week 4 and reduction back to 4 mg at week 8 (or matching placebo adjustments). •  Subjects completed 3-day diaries, International Prostate Symptom Score (IPSS), Overactive Bladder Questionnaire (OAB-q), Patient Perception of Bladder Condition (PPBC), and Urgency Perception Scale (UPS) at baseline and weeks 4 and 12. RESULTS •  A total of 943 men were randomized and received at least one dose of study treatment (Fesoterodine, n= 471; placebo, n= 472). •  Among these, 251 (53%) in the Fesoterodine group and 300 (64%) in the placebo group requested dose escalation at week 4 and 35 (7%) and 15 (3%) requested dose reduction at week 8. Changes from baseline to week 12 in urgency episodes (primary endpoint) in the Fesoterodine (−3.2) and placebo (−2.9) groups were not significantly different (P= 0.196), but improvements in micturitions (P= 0.009) and OAB-q symptom bother score (P= 0.007) were significantly greater with Fesoterodine. •  At week 4, significantly greater improvements in micturitions (P= 0.006), severe urgency episodes (P= 0.006), IPSS storage score (P= 0.022), OAB-q symptom bother score (P= 0.004), and OAB-q health-related quality of life (P= 0.041), but not urgency episodes (P= 0.062), were observed with add-on Fesoterodine. •  Dry mouth (Fesoterodine, 21%; placebo, 6%) and constipation (Fesoterodine, 6%; placebo, 2%) were the most common adverse events. Dysuria and urinary retention were reported by 3% and 2% of subjects, respectively, in the Fesoterodine add-on group vs 1% and

Daniel Arumi - One of the best experts on this subject based on the ideXlab platform.

  • do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2019
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P < 0.001). Dry mouth and constipation rates were higher with Fesoterodine 8 mg. CONCLUSIONS Dose-escalator patients had a significantly greater UUI response with Fesoterodine 8 mg versus 4 mg. Given the potential for adverse events, Fesoterodine 4 mg is recommended to start; however, patients with UUI and identified predictors may benefit from initial treatment with Fesoterodine 8 mg or rapid dose escalation.

  • Do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2018
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P 

  • Dose Pattern Evolution and Therapeutic Benefit in Patients on Solifenacin or Fesoterodine Treatment in Daily Clinical Practice
    Open Journal of Urology, 2016
    Co-Authors: Jose Maria Garcia-mediero, Daniel Arumi, Francisco Sanchez-ballester, Isabel Lizarraga
    Abstract:

    Aim: To explore in daily clinical practice the evolution in time of the Fesoterodine and solifenacin dose pattern and assess the therapeutic benefit provided by the highest dose of these anti-muscarinics. Patients and Methods: This was a post-hoc analysis of data from an observational, cross-sectional, retrospective and multicenter study. Adult patients diagnosed with over active bladder (OAB) who initiated Fesoterodine or solifenacin treatment were included. Data on the prescribed treatment and dose, change of dose, reasons for switching and treatment benefit were recorded. Results: A total of 828 subjects were analyzed (262 receiving solifenacin and 566 Fesoterodine). Most subjects were women with a mean time since diagnosis of more than one year and aged around 60 years old. The majority of patients initiated the OAB treatment with the lowest available dose (64% Fesoterodine vs. 77% solifenacin). At the follow-up visit 54% of the Fesoterodine group and 66% of the solifenacin opted for dose escalation. At the study visit, 70.1% Fesoterodine vs. 43.3% solifenacin remained on the highest dose. A significantly greater proportion of subjects receiving Fesoterodine 8 mg, reported higher improvement in terms of both patient-reported-treatment benefit and clinical global impression compared with solifenacin 10 mg (p < 0.05). Conclusion: In routine clinical practice more than half of the patients opted for the higher dose and remained on it over time, suggesting a desire for greater efficacy. Fesoterodine 8 mg seems to provide greater benefits from the physician’s and the patient’s point of view compared with those provided by solifenacin 10 mg.

  • Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review.
    Current Medical Research and Opinion, 2015
    Co-Authors: Christopher R. Chapple, Matthias Oelke, David Scholfield, Steven A. Kaplan, Daniel Arumi, Adrian Wagg
    Abstract:

    AbstractObjective:To summarize published evidence on the pharmacology, efficacy, and safety of Fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles.Methods:A systematic review of published articles on Fesoterodine was conducted via a PubMed search. Articles were identified using the search term Fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral Fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively.Results:Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of Fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of Fesoterodine 8 mg versus Fesoterodine 4 mg and tolterodine extended release 4 mg in treat...

  • Review of the Efficacy and Safety of Fesoterodine for Treating Overactive Bladder and Urgency Urinary Incontinence in Elderly Patients
    Drugs & Aging, 2015
    Co-Authors: Adrian Wagg, Matthias Oelke, David Scholfield, Javier C. Angulo, Daniel Arumi
    Abstract:

    Overactive bladder (OAB) is a common condition, with prevalence rates increasing with advancing age. Symptoms of OAB, including urgency urinary incontinence (UUI), are associated with various co-morbidities in elderly individuals (e.g., falls and fractures, functional impairment, and depression). The current mainstay of pharmacological therapy for OAB is antimuscarinic agents. Until recently, few studies had specifically evaluated the efficacy and safety of antimuscarinics in the treatment of OAB symptoms in elderly patients. This review summarises available evidence from the medical literature on the efficacy and safety of Fesoterodine in elderly patients with OAB symptoms, including UUI. The data from unique placebo-controlled Fesoterodine trials of elderly and vulnerable elderly patients, together with age-stratified data from post hoc analyses of Fesoterodine trials, demonstrate that treatment with Fesoterodine 4 or 8 mg results in statistically and clinically significant improvements in OAB symptoms and patient-reported outcomes in many elderly patients. The data indicate that the efficacy of Fesoterodine in elderly patients is comparable with that in younger patients. Fesoterodine is generally well tolerated in elderly and vulnerable elderly patients, with low rates of urinary retention and little evidence of central nervous system events or impaired cognition. The data support a favourable benefit-to-risk ratio for Fesoterodine in elderly and medically complex vulnerable elderly patients with OAB.

Peter K Sand - One of the best experts on this subject based on the ideXlab platform.

  • Long-Term Safety, Tolerability and Efficacy of Fesoterodine in Subjects with Overactive Bladder Symptoms Stratified by Age
    Drugs & Aging, 2012
    Co-Authors: Peter K Sand, Zhonghong Guan, Martin Carlsson, John Heesakkers, Stephen R. Kraus, Sandra Berriman
    Abstract:

    Background: Previous work has demonstrated the efficacy and safety of Fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term Fesoterodine treatment in different age groups has not been assessed. Objective: The aim was to determine the impact of age on the safety, tolerability and efficacy of long-term treatment with Fesoterodine 8 mg in subjects with OAB syndrome. Methods: This was a pooled analysis of two identically designed open-label extensions of 12-week, randomized, double-blind, placebo-controlled studies. The setting was urology and general practice offices. Subjects who participated in the 12-week, double-blind studies and opted to continue long-term, open-label treatment with Fesoterodine were included. Subjects were initiated on Fesoterodine 8 mg/day at open-label baseline. After 1 month, subjects could elect dose reduction to 4 mg/day and subsequent re-escalation to 8 mg; each was permitted once annually. Maximal duration of open-label treatment ranged from 24 to 36 months. Discontinuations, subject-reported treatment tolerance, and efficacy (3-day diaries) were assessed at open-label baseline and months 1, 4, 8, 12 and 24. Results: A total of 890 subjects were treated (age

  • Long-term safety, tolerability and efficacy of Fesoterodine in subjects with overactive bladder symptoms stratified by age: pooled analysis of two open-label extension studies.
    Drugs & Aging, 2012
    Co-Authors: Peter K Sand, Zhonghong Guan, Martin Carlsson, John Heesakkers, Stephen R. Kraus, Sandra Berriman
    Abstract:

    Background: Previous work has demonstrated the efficacy and safety of Fesoterodine in older and younger subjects with overactive bladder (OAB) symptoms. The effect of long-term Fesoterodine treatment in different age groups has not been assessed.

  • Fesoterodine in patients with overactive bladder syndrome can the severity of baseline urgency urinary incontinence predict dosing requirement
    BJUI, 2010
    Co-Authors: Linda Cardozo, Joseph T. Wang, Zhonghong Guan, Vik Khullar, Peter K Sand
    Abstract:

    Study Type – Therapy (RCT) Level of Evidence 1b OBJECTIVES To determine whether baseline urgency urinary incontinence (UUI) episodes predict the need for increased doses of Fesoterodine in patients with overactive bladder (OAB), as clinicians would benefit from data that help to predict which patients require higher doses of antimuscarinics to manage UUI episodes. PATIENTS AND METHODS In this pooled analysis of data from two double-blind, placebo-controlled trials, patients were randomized to placebo or Fesoterodine 4 or 8 mg for 12 weeks and stratified into tertiles (>0–<2, 2–<4, or ≥4) according to the number of UUI episodes/24 h as recorded in 3-day bladder diaries at baseline. The change in mean UUI episodes/24 h from baseline to end of study was assessed using analysis of covariance. RESULTS In a post hoc analysis of data from two clinical trials, there were significant reductions from baseline in UUI episodes for Fesoterodine 4 and 8 mg vs placebo in patients (n) with >0–<2 (422), 2–<4 (424) and ≥4 (481) UUI episodes at baseline (all P < 0.01). In patients with 2–<4 and ≥4 UUI episodes at baseline, Fesoterodine 8 mg gave significantly greater mean reductions (−1.92 and −4.17, respectively) vs Fesoterodine 4 mg (−1.43 and −3.31) (P < 0.05). The most common adverse events were dry mouth (placebo, 8%; Fesoterodine 4 mg, 19%; and 8 mg, 35%) and constipation (placebo, 2%; Fesoterodine 4 mg, 5%; and 8 mg, 6%). CONCLUSION Fesoterodine 4 and 8 mg significantly reduced UUI episodes vs placebo; this effect appeared to be greater with Fesoterodine 8 mg in patients with ≥2 UUI episodes/24 h at baseline. Fesoterodine was well tolerated, although higher doses increased the incidence of adverse events. These findings might aid the clinical identification of patients with OAB who would most benefit from increasing the dose of Fesoterodine from 4 to 8 mg.

  • Efficacy and tolerability of Fesoterodine in women with overactive bladder
    International Urogynecology Journal, 2009
    Co-Authors: Peter K Sand, Jon D Morrow, Dana Creanga, Tamara Bavendam, Victor W. Nitti
    Abstract:

    Introduction and hypothesis We assessed Fesoterodine efficacy and tolerability in women with overactive bladder (OAB). Methods This post hoc analysis of pooled data from two clinical trials included 1,548 women with OAB randomized to placebo, Fesoterodine 4 or 8 mg, or tolterodine extended release (ER) 4 mg (in 1 trial) for 12 weeks. Subjects completed 3-day bladder diaries at baseline and weeks 2 and 12 and rated Treatment Response at weeks 2 and 12. Results By weeks 2 and 12, all active-treatment groups showed significant improvements in all five bladder diary variables assessed and greater Treatment Response rates vs placebo. Fesoterodine 8 mg was significantly more efficacious than Fesoterodine 4 mg and tolterodine ER in improving urgency urinary incontinence episodes and continent days per week. The most common adverse events were dry mouth and constipation, which were predominately mild or moderate. Conclusions Fesoterodine is efficacious and well tolerated in women with OAB.

Steven A. Kaplan - One of the best experts on this subject based on the ideXlab platform.

  • do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2019
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P < 0.001). Dry mouth and constipation rates were higher with Fesoterodine 8 mg. CONCLUSIONS Dose-escalator patients had a significantly greater UUI response with Fesoterodine 8 mg versus 4 mg. Given the potential for adverse events, Fesoterodine 4 mg is recommended to start; however, patients with UUI and identified predictors may benefit from initial treatment with Fesoterodine 8 mg or rapid dose escalation.

  • Do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2018
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P 

  • Fesoterodine clinical efficacy and safety for the treatment of overactive bladder in relation to patient profiles: a systematic review.
    Current Medical Research and Opinion, 2015
    Co-Authors: Christopher R. Chapple, Matthias Oelke, David Scholfield, Steven A. Kaplan, Daniel Arumi, Adrian Wagg
    Abstract:

    AbstractObjective:To summarize published evidence on the pharmacology, efficacy, and safety of Fesoterodine for the treatment of overactive bladder (OAB) symptoms in relation to patient clinical and demographic profiles.Methods:A systematic review of published articles on Fesoterodine was conducted via a PubMed search. Articles were identified using the search term Fesoterodine, with limits of human species and abstract available. Review and meta-analysis articles, validation studies, articles focused on treatment compliance/adherence, meeting abstracts, and articles not focused on oral Fesoterodine administration in human subjects were excluded. Data from retained articles were summarized descriptively.Results:Of 137 articles identified, 61 (15 articles on the pharmacology and 46 articles on the efficacy and/or safety of Fesoterodine) met inclusion criteria. Superiority trials demonstrated the additional efficacy of Fesoterodine 8 mg versus Fesoterodine 4 mg and tolterodine extended release 4 mg in treat...

  • A pilot study of the use of Fesoterodine in the management of men with refractory overactive bladder symptoms after surgery for bladder outlet obstruction
    Urological Science, 2015
    Co-Authors: Bilal Chughtai, Melissa A. Laudano, Claire Dunphy, Richard K. Lee, Steven A. Kaplan
    Abstract:

    Abstract Objective To assess the efficacy of long-acting Fesoterodine on persistent lower urinary tract symptoms in men who have had previous surgical treatment for bladder outlet obstruction (BOO). Materials and methods Seventeen patients with overactive bladder (OAB) secondary to BOO, persisting for 3 months after the obstruction was surgically relieved, were treated with Fesoterodine. Follow up was performed at 2 months, 3 months, and 7 months. The primary endpoint was change in the International Prostate Symptom Score (IPSS). The secondary endpoints were change in the maximum flow rate (Qmax) and postvoid residual (PVR). Results Patients receiving Fesoterodine demonstrated trends for improvement in mean nocturia episodes (3.2–2.6, p  = 0.065), IPSS irritative subscore (6.2–2.0, p  = 0.066), and quality of life score (4.2–3.5, p  = 0.067) over 7 months of follow up. There was also a reduction in the mean IPSS score which was not significant over time (18.8–15.1, p  = 0.183). There was no significant change observed in Qmax or PVR. Six patients (33%) had significant side effects and did not complete the study. Conclusion Patients with persistent OAB symptoms after surgical treatment of BOO displayed possible reductions in the IPSS, IPSS irritative subscore, and mean number of nocturia events after 7 months of follow up, as well as trends for an increased quality of life when treated with Fesoterodine. Larger trials are needed to help characterize the utility of Fesoterodine in the treatment of persistent lower urinary tract symptoms after surgical treatment of benign prostatic hyperplasia.

  • efficacy and safety of Fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine er
    International Journal of Clinical Practice, 2014
    Co-Authors: Steven A. Kaplan, Sender Herschorn, Laurence Whelan, David Scholfield, Daniel Arumi, Martin Carlsson, Linda Cardozo, Lars Grenabo, T J Crook, Fady Ntanios
    Abstract:

    Summary Aims To assess Fesoterodine 8 mg efficacy over time and vs. placebo in subjects with overactive bladder (OAB) who responded suboptimally to tolterodine extended release (ER) 4 mg. Methods In a 12-week, double-blind trial, subjects with self-reported OAB symptoms for ≥ 6 months, mean of ≥ 8 micturitions and ≥ 2 to < 15 urgency urinary incontinence (UUI) episodes/24 h, and suboptimal response to tolterodine ER 4 mg (defined as ≤ 50% reduction in UUI episodes during 2-week run-in) were randomised to Fesoterodine (4 mg for 1 week, 8 mg for 11 weeks) or placebo once daily. Change from baseline to week 12 in UUI episodes (primary end-point) was analysed in step-wise fashion: first, baseline vs. week 12 for Fesoterodine; if significant, then change from baseline to week 12 for Fesoterodine vs. placebo. Results By week 12, subjects receiving Fesoterodine 8 mg had significantly greater improvement from baseline vs. placebo in UUI episodes, urgency episodes and scores on the Patient Perception of Bladder Control, Urgency Perception Scale and OAB Questionnaire Symptom Bother and Health-Related Quality of Life scales and domains (all p < 0.05). 50% and 70% UUI responder rates were also significantly higher with Fesoterodine 8 mg vs. placebo at week 12 (p < 0.05). Dry mouth (placebo, 4%, 12/301; Fesoterodine, 16.6%, 51/308) and constipation (placebo, 1.3%, 4/301; Fesoterodine, 3.9%, 12/308) were the most frequent adverse events. Conclusions Subjects who responded suboptimally to tolterodine ER 4 mg showed significant improvements in UUI and other OAB symptoms and patient-reported outcomes, with good tolerability, during treatment with Fesoterodine 8 mg vs. placebo.

Martin Carlsson - One of the best experts on this subject based on the ideXlab platform.

  • do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2019
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P < 0.001). Dry mouth and constipation rates were higher with Fesoterodine 8 mg. CONCLUSIONS Dose-escalator patients had a significantly greater UUI response with Fesoterodine 8 mg versus 4 mg. Given the potential for adverse events, Fesoterodine 4 mg is recommended to start; however, patients with UUI and identified predictors may benefit from initial treatment with Fesoterodine 8 mg or rapid dose escalation.

  • Do patient characteristics predict which patients with overactive bladder benefit from a higher Fesoterodine dose
    International Urogynecology Journal, 2018
    Co-Authors: Howard B Goldman, Matthias Oelke, Erin Mangan, Steven A. Kaplan, Daniel Arumi, Tekeya Kitta, David Russell, Martin Carlsson, Fady Ntanios
    Abstract:

    INTRODUCTION AND HYPOTHESIS We sought to determine whether baseline characteristics predict which overactive bladder (OAB) patients benefit from Fesoterodine 8 mg versus 4 mg. METHODS In double-blind, placebo-controlled, flexible-dose trials, baseline characteristics of OAB patients with ≥ 1 urgency urinary incontinence (UUI) episodes/24 h who escalated from Fesoterodine 4 mg to 8 mg were evaluated. Possible dose-escalation predictors (age; sex; previous antimuscarinic use; UUI, micturitions, and urgency episodes/24 h; race; body mass index; time to dose escalation; OAB duration) were compared in escalators versus non-escalators. Patients from fixed-dose trials with dose-escalator characteristics were identified (matched dose-escalator sample) to assess changes from baseline with Fesoterodine 4 mg, 8 mg, and placebo. RESULTS In flexible-dose trials, significant predictors of Fesoterodine dose escalation were younger age (≤ 65.8 years), greater number of baseline micturitions (≥ 13.1) and urgency episodes/24 h (≥ 10.9), greater OAB duration (≥ 9.1 years), and more frequent previous antimuscarinic use (58.3%), but not baseline UUI episodes/24 h. In the matched dose-escalator sample (Fesoterodine 4 mg: n = 215; 8 mg: n = 198; placebo: n = 217), change from baseline in UUI episodes significantly improved with Fesoterodine 8 mg versus 4 mg (P = 0.043) and with both doses versus placebo (P 

  • Fesoterodine for the Treatment of Nocturnal Urgency in Patients with Overactive Bladder Syndrome: An Analysis of Responders and Nonresponders
    Journal of Urology, 2017
    Co-Authors: Johnathan A. Khusid, Martin Carlsson, Jeffrey P. Weiss, E.k. Mangan
    Abstract:

    Purpose: A recent study demonstrated improvement in nocturnal urgency in patients with overactive bladder when treated with Fesoterodine. In the current study we aimed to determine which bladder diary parameters predict the response to Fesoterodine in these patients.Materials and Methods: Patients with nocturnal urgency completed a 2-week, single-blind placebo run-in followed by 1:1 double-blind randomization to 12 weeks of Fesoterodine or placebo. We analyzed bladder diary parameter changes from baseline to week 12, including the actual number of night voids (total number of nocturia episodes), maximum voided volume, nocturnal bladder capacity, Nocturnal Bladder Capacity Index (NBCi) (actual number of night voids – nocturnal urine volume/maximum voided volume – 1), nocturnal urine volume, the nocturia index (nocturnal urine volume/maximum voided volume) and the nocturnal polyuria index (nocturnal urine volume/24-hour volume). Additionally, we analyzed OAB-q (Overactive Bladder Questionnaire) changes.Resu...

  • efficacy and safety of Fesoterodine 8 mg in subjects with overactive bladder after a suboptimal response to tolterodine er
    International Journal of Clinical Practice, 2014
    Co-Authors: Steven A. Kaplan, Sender Herschorn, Laurence Whelan, David Scholfield, Daniel Arumi, Martin Carlsson, Linda Cardozo, Lars Grenabo, T J Crook, Fady Ntanios
    Abstract:

    Summary Aims To assess Fesoterodine 8 mg efficacy over time and vs. placebo in subjects with overactive bladder (OAB) who responded suboptimally to tolterodine extended release (ER) 4 mg. Methods In a 12-week, double-blind trial, subjects with self-reported OAB symptoms for ≥ 6 months, mean of ≥ 8 micturitions and ≥ 2 to < 15 urgency urinary incontinence (UUI) episodes/24 h, and suboptimal response to tolterodine ER 4 mg (defined as ≤ 50% reduction in UUI episodes during 2-week run-in) were randomised to Fesoterodine (4 mg for 1 week, 8 mg for 11 weeks) or placebo once daily. Change from baseline to week 12 in UUI episodes (primary end-point) was analysed in step-wise fashion: first, baseline vs. week 12 for Fesoterodine; if significant, then change from baseline to week 12 for Fesoterodine vs. placebo. Results By week 12, subjects receiving Fesoterodine 8 mg had significantly greater improvement from baseline vs. placebo in UUI episodes, urgency episodes and scores on the Patient Perception of Bladder Control, Urgency Perception Scale and OAB Questionnaire Symptom Bother and Health-Related Quality of Life scales and domains (all p < 0.05). 50% and 70% UUI responder rates were also significantly higher with Fesoterodine 8 mg vs. placebo at week 12 (p < 0.05). Dry mouth (placebo, 4%, 12/301; Fesoterodine, 16.6%, 51/308) and constipation (placebo, 1.3%, 4/301; Fesoterodine, 3.9%, 12/308) were the most frequent adverse events. Conclusions Subjects who responded suboptimally to tolterodine ER 4 mg showed significant improvements in UUI and other OAB symptoms and patient-reported outcomes, with good tolerability, during treatment with Fesoterodine 8 mg vs. placebo.

  • sustained improvement in patient reported outcomes during long term Fesoterodine treatment for overactive bladder symptoms pooled analysis of two open label extension studies
    BJUI, 2012
    Co-Authors: Con Kelleher, Roger R Dmochowski, Zoe Kopp, Sandra Berriman, Martin Carlsson
    Abstract:

    Study Type – Outcomes (cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Short-term (12-week) trials have demonstrated that subjects with OAB who receive treatment with Fesoterodine 4- and 8-mg, either in fixed-dose or flexible-dose regimens, show significant improvements in measures of HRQL and other patient-reported outcomes. The results of this long-term, open-label study show that treatment with Fesoterodine for up to 24 months resulted in sustained improvement in measures of HRQL and severity of bladder-related problems in subjects with OAB symptoms. Throughout the study, a high percentage of subjects reported satisfaction with Fesoterodine treatment. The results were similar in men and women and across age groups (<45 years; 45–64 years; 65–74; ≥75 years). Long term treatment with Fesoterodine is beneficial to patients with overactive bladder. OBJECTIVES •  To evaluate the effects of long-term Fesoterodine treatment on health-related quality of life (HRQL) and treatment satisfaction in subjects with overactive bladder (OAB) symptoms. •  To determine the impact of gender and age on these effects. PATIENTS AND METHODS •  This is a post hoc analysis of data pooled from identically designed open-label extensions of two randomized, double-blind, 12-week Fesoterodine studies. •  Initial treatment was once-daily Fesoterodine 8 mg; subjects had the opportunity to receive open-label Fesoterodine for ≥24 months. •  After 1 month, subjects could elect dose reduction to 4 mg and subsequent re-escalation to 8 mg; dose reduction and re-escalation were each allowed once annually. •  Changes in scores on the King's Health Questionnaire (KHQ), International Consultation on Incontinence Questionnaire–Short Form (ICIQ-SF) and a Likert scale evaluating severity of bladder-related problems were assessed at open-label baseline and months 12 and 24; treatment satisfaction was assessed at open-label baseline and at months 4, 12 and 24. RESULTS •  A total of 864 enrolled subjects were included (men, n= 182; women, n= 682; aged <45 years, n= 134; 45–64 years, n= 432; 65–74 years, n= 204; ≥75 years, n= 94); most subjects (77%) who continued treatment maintained the 8-mg dose. •  Among subjects in the overall population, there were significant improvements in all KHQ domains, ICIQ-SF scores, and bladder-related problems at open-label baseline vs double-blind baseline (P < 0.05); additional significant improvements were observed at months 12 and 24 vs open-label baseline in all outcomes (P < 0.05) except for the KHQ General Health Perception domain. •  When data were stratified by gender or age, significant improvements at open-label baseline vs double-blind baseline were further significantly enhanced or sustained at months 12 and 24 for most KHQ domains, and for ICIQ-SF scores and bladder-related problems for all groups. Women had significantly greater improvements than men in the KHQ Emotion (P= 0.0173) and Severity/Coping (P= 0.0112) domains and ICIQ-SF scores (P= 0.0276) during open-label treatment. Subjects aged <45 years had significantly greater improvement in the Personal Relationships domain compared with those aged 45–64 years (P= 0.0357) and in the Sleep/Energy domain compared with all other groups (all P < 0.02). •  Treatment satisfaction was high (≥92%) throughout open-label treatment regardless of gender or age. CONCLUSIONS •  Long-term Fesoterodine treatment was associated with sustained improvement in measures of health-related quality of life and bladder-related problems and with high treatment satisfaction in subjects with overactive bladder symptoms. •  Effects of gender and age were minimal.