Fesoterodine Treatment Research Articles

Fesoterodine treatment of pediatric patients with neurogenic detrusor overactivity: A 24-week, randomized, open-label, phase 3 study

Neurogenic detrusor overactivity (NDO) can damage the upper urinary tract leading to chronic renal impairment. Antimuscarinic therapy is used to improve urinary incontinence and protect the upper urinary tract in patients with NDO. This study investigated safety and efficacy of fesoterodine, a muscarinic receptor antagonist, in 6‒<18-year-old patients with NDO (NCT01557244). This open-label phase 3 study included 2 pediatric cohorts. Patients in Cohort 1 (bodyweight >25kg) were randomized to fesoterodine 4 or 8mg extended-release tablets or oxybutynin XL tablets administered over the 12-week active comparator-controlled phase. The safety extension phase evaluated fesoterodine 4 and 8mg for a further 12 weeks, with patients in the oxybutynin arm allocated to fesoterodine 4 or 8mg. Patients in Cohort 2 (bodyweight ≤25kg) were randomized to fesoterodine 2 or 4mg extended-release beads-in-capsule (BIC) administered over a 12-week efficacy phase and 12-week safety extension phase. Patients with stable neurologic disease and clinically or urodynamically proven NDO were included. The primary endpoint was change from baseline to Week 12 in maximum cystometric bladder capacity (MCC). Secondary efficacy endpoints included detrusor pressure at maximum bladder capacity, bladder volume at first involuntary detrusor contraction, bladder compliance, and incontinence episodes. Safety endpoints included adverse event incidence, and specific assessments of cognition, behavior and vision. The pharmacokinetics of 5-hydroxymethyl tolterodine (5-HMT; fesoterodine's active metabolite) was determined using population-pharmacokinetic analysis. In Cohort 1 (n=124), fesoterodine 4 and 8mg treatment resulted in significant increases from baseline in the primary endpoint of MCC at Week 12. In Cohort 2 (n=57), fesoterodine 2 and 4mg BIC treatment resulted in improvements in MCC from baseline. Fesoterodine 4 and 8mg and fesoterodine 4mg BIC led to improvements in some secondary efficacy endpoints. The most common treatment-related adverse reactions were gastrointestinal effects, such as dry mouth, which occurred more frequently with oxybutynin than fesoterodine. No detrimental effects on visual accommodation or acuity, or on cognitive function or behavior were observed. These safety and efficacy results are consistent with limited published data on fesoterodine treatment in pediatric populations with overactive bladder or NDO. Study limitations include the lack of placebo control and the small sample size, which limits the ability to make formal efficacy comparisons and detect rare adverse reactions. Fesoterodine has a favorable benefit-risk profile in 6‒<18-year-old patients with NDO and may represent an additional option for pediatric NDO treatment.

A plain language summary of the likelihood of symptom relief for patients taking fesoterodine for overactive bladder.

This is a summary of a study originally published in Neurourology and Urodynamics. Overactive bladder is a medical condition that causes an urgent need to urinate, which can cause accidental urination. Fesoterodine is a medication used to treat overactive bladder. Because we don't know how likely it is that an individual patient will achieve a level of improvement in their overactive bladder symptoms, researchers analyzed results of 6 studies of patients with overactive bladder who were treated with fesoterodine. Although complete resolution of all symptoms was rare with fesoterodine treatment, a resolution of accidental urination was more common, which is the most important treatment goal for many patients. After taking fesoterodine, episodes of accidental urination were more likely to be reduced or completely absent than episodes of an urgent need to urinate. These results can help patients with overactive bladder understand their own chances of treatment success with fesoterodine and can help doctors support their patients on what to expect regarding their specific symptoms and concerns. ▪Toviaz (fesoterodine) is approved to treat the condition that is discussed in this summary. Approval varies from country to country; please check with your local health provider for more details. ▪This summary reports the combined results of 6 studies. The results of individual studies may vary from the combined study results presented here. Individuals should make treatment decisions based on all available evidence. ClinicalTrials.gov NCT number: NCT01302054, NCT01302067, NCT00444925, NCT00611026, NCT00220363, and NCT00138723.

A Prospective Study to Investigate the Effect of Fesoterodine Treatment on Quality of Life, Anxiety, and Depression in Urge-Type Urinary Incontinence.

Urinary incontinence (UI) is a fundamental health problem, can occur at any age but is especially common in older women. Depression and anxiety are also considerable problems for the elderly. UI is one of the geriatric syndromes that are thought to be related to depression and quality of life (QOL). This prospective study was conducted for a period of 2 months from February 2020 to April 2020. Women who applied to the outpatient clinic of geriatrics with UI symptoms were taken into the study. The type of UI was determined by using the 3 Incontinence Questions (3IQ). Only patients with urge incontinence were included in the study. Patients were evaluated for QOL, anxiety, depression, disability, and geriatric syndromes before and after treatment. Data analysis was done by using SPSS version 22. The study population was 42 women; the mean age was 69.7 +/- 4.3 years. QoL, anxiety, and depression symptoms, and ADL were revealed to be improved after treatment. ICIQ-SF, I-QOL, and HADs scores were associated with UI treatment when evaluated with one-way MANOVA (F [4, 79] =3.25, p=0.00, Wilk's Λ=0.859, partial η2=0.14). UI is a common problem in the elderly. Patients usually hesitate to tell this complaint to even doctors. That situation affects their physical and psychological condition negatively. In this study, we reached that anticholinergic treatment (fesoterodine) improved ADL, QoL, and psychological symptoms. Those findings represented us that proper treatment of UI is critical for healthy aging.

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.

AimThis study describes patients with different degrees and combinations of symptom resolution in response to fesoterodine exposure to aid physicians in counselling patients with overactive bladder (OAB) on the likelihood of treatment success.MethodsData came from 12‐week fixed‐dose studies of fesoterodine. The proportions of patients experiencing symptom resolution and change in patient‐reported outcome measures (PROM) at 4, 8, and 12 weeks were calculated. Treatment‐emergent adverse events (TEAE) were reported according to response in urinary urgency episodes (UUE). The relationship between PROM and response was examined.ResultsOut of 6689 patients, 81.6% female, urgency urinary incontinence (UUI) episodes/24 h were more responsive to fesoterodine than UUE; with roughly 50% of patients reporting a 50% reduction and fewer than 10% reporting absence of UUE at 12 weeks compared to approximately 40%–50% reporting absence of UUI. TEAE was numerically lower in patients with greater response. There was a statistically significant relationship between improvement in urinary urgency and associated change in OAB‐q symptom bother scores, r = 0.54, p < 0.001. At Week 4, 64.0%–76.7% of patients who had achieved a significant change in Patient Perception of Bladder Condition (PPBC) had a 50% reduction in UUI. At Week 12 this proportion was between 80% and 87.9%, with those being exposed to fesoterodine treatment reporting response in PPBC at numerically higher rates.ConclusionThese data provide clinicians with information from which they may usefully communicate the likelihood of symptom resolution in response to pharmacotherapy for OAB and answer a key clinical question posed by many care providers. Roughly ⅓ of fesoterodine treated patients reported a 50% reduction urgency and ¾ reported 50% resolution of incontinence at 12 weeks. Total resolution of all symptoms was seldom achieved.

Re: Efficacy and Safety of Fesoterodine Treatment for Overactive Bladder Symptoms in Elderly Women with and without Hypertension.

Re: Efficacy and Safety of Fesoterodine Treatment for Overactive Bladder Symptoms in Elderly Women with and without Hypertension.

Efficacy and safety of fesoterodine treatment for overactive bladder symptoms in elderly women with and without hypertension.

To assess fesoterodine treatment in elderly women with overactive bladder with and without hypertension. Data for 2527 elderly women with overactive bladder symptoms, including urgency urinary incontinence, were pooled from 10 double-blind, placebo-controlled fesoterodine studies. A total of 1523 elderly women (60.3%) had a history of hypertension, and 1004 women (39.7%) had no hypertension history. Overactive bladder symptoms, mean bodyweight and mean body mass index at baseline were significantly higher in women with overactive bladder and hypertension versus those without hypertension (P<0.05). Statistically significant improvements in overactive bladder symptoms at week12 were observed for fesoterodine treatment versus placebo in women with hypertension and those without (P<0.05). The diary-dry rate (no urgency urinary incontinence episodes), the proportion with less than eight micturitions/24h, overactive bladder symptom bother and health-related quality of life were also statistically significantly improved by fesoterodine treatment in both populations. Incidence of treatment-related adverse events with fesoterodine was similar in women with hypertension (39.3%) and without hypertension (44.6%). Dry mouth and constipation were the most common treatment-related adverse events with fesoterodine in women with hypertension (26.2% and 5.2%, respectively) and without hypertension (30.5% and 8.0%). A relationship among the severity of overactive bladder symptoms, hypertension and obesity in elderly women is suggested. Fesoterodine provides significantly greater improvements in overactive bladder symptoms and health-related quality of life versus placebo in women with or without hypertension. Hypertension does not appear to affect the efficacy and safety of fesoterodine in elderly women with overactive bladder symptoms, including urgency urinary incontinence.

A pooled analysis of the efficacy of fesoterodine for the treatment of overactive bladder, and the relationship between safety, co-morbidity and polypharmacy in patients aged 65 years or older.

overactive bladder (OAB) is a common condition in older persons. Antimuscarinic treatment remains the mainstay of treatment of OAB but clinicians have been reluctant to prescribe this to older patients. This study examined efficacy and safety information from patients >65 in fesoterodine trials to reaffirm efficacy and to explore the relationships between treatment emergent adverse events (TEAEs), coexisting medication and co-morbidity. data from 10 double-blind, placebo-controlled studies were analysed. A logistic regression analysis, where TEAE incidence was predicted by treatment, prior antimuscarinic treatment, number of coexisting medications, number of concomitant diseases and all possible combinations of two-way interaction terms with treatment was conducted. of 4,040 patients who participated in trials; fesoterodine treatment was associated with statistically significant reductions in all disease-related and patient-reported outcomes compared to placebo. There was a significant increase in the likelihood of reporting a TEAE in association with the number of coexistent medications (odds ratio (OR) = 1.028, 95% CI: 1.0143-1.044, P < 0.003). The OR of having a TEAE with increase in the number of concomitant diseases was 1.058 (95% CI: 1.044-1.072, P < 0.0001). Central nervous system (CNS) events were few. fesoterodine treatment led to clinically meaningful improvements across all included patient reported outcomes. The number of concomitant conditions had the greatest influence on the likelihood of an adverse event being reported. CNS TEAE were not associated with fesoterodine dose and were low across all categories of concomitant disease and coexisting medication.

Cost effectiveness analysis of fesoterodine compared to mirabegron in first-line therapy setting for overactive bladder with urge urinary incontinence, from the Spanish National Health System perspective

ObjectivesTo evaluate the cost–effectiveness of first-line treatment of Overactive Bladder (OAB) with fesoterodine relative to mirabegron, from the Spanish National Health System (NHS) perspective. MethodsA decision tree model was developed to represent a typical clinical process of 52-week of treatment for an OAB patient with urge urinary incontinence (UUI) initiating first-line therapy with fesoterodine 4mg, including optional titration to 8mg, vs.mirabegron 50mg. Efficacy data were obtained from a Bayesian indirect treatment meta-analysis. Patients with UUI of less than one episode/day were defined as treatment responder and persistence was assessed at weeks 4, 12 and 24. At week 12, non-responders discontinued treatment permanently. Quality-adjusted life years (QALYs) were calculated based on time spent in responder and non-responder states. OAB-related drug and medical care costs including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections and depression) were modeled and expressed in €2015. ResultsAt week 52, the percentage of responders was 20.8% for patients starting on fesoterodine 4mg who optionally titrated to 8mg and 19.4% for patients treated with mirabegron. QALYs were slightly higher with fesoterodine than mirabegron (0.7703 vs. 0.7668, difference=0.0035). Fesoterodine treatment also had slightly higher total costs than mirabegron (3296€ vs. 3217, difference=79€), resulting in a cost of 22,523/QALY€ gained for fesoterodine versus mirabegron. Probabilistic sensitivity analysis confirmed the slight advantage of fesoterodine with a 61.1% probability of being cost-effective at the 30,000€ willingness-to-pay for 1 QALY threshold. ConclusionsGiven the relatively small 1-year cost difference between the two treatments, fesoterodine can be considered a cost-effective option relative to mirabegron for the first-line management of OAB with UUI in Spain.

Delirium following fesoterodine treatment for urgency incontinence in an 89-year old man

We describe the case of an 89-year-old man who developed delirium following the introduction of fesoterodine to treat his urgency incontinence. The patient started experiencing visual hallucinations approximately five days after starting fesoterodine 4 mg once daily. Delirium resolved after fesoterodine was stopped. Despite the apparent safe cognitive profile due to its pharmacodynamic properties, fesoterodine should be used with caution in the elderly, frail population.

Análisis de coste efectividad de fesoterodina comparado con mirabegron en el marco de tratamiento de primera línea para vejiga hiperactiva con incontinencia urinaria de urgencia, desde la perspectiva del Sistema Nacional de Salud español

ObjectivesTo evaluate the cost-effectiveness of first-line treatment of Overactive Bladder (OAB) with fesoterodine relative to mirabegron, from the Spanish National Health System (NHS) perspective. MethodsA decision tree model was developed to represent a typical clinical process of 52-week of treatment for an OAB patient with urge urinary incontinence (UUI) initiating first-line therapy with fesoterodine 4mg, including optional titration to 8mg, vs.mirabegron 50mg. Efficacy data were obtained from a Bayesian indirect treatment meta-analysis. Patients with UUI of less than one episode/day were defined as treatment responder and persistence was assessed at weeks 4, 12 and 24. At week 12, non-responders discontinued treatment permanently. Quality-adjusted life years (QALYs) were calculated based on time spent in responder and non-responder states. OAB-related drug and medical care costs including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections and depression) were modeled and expressed in €2015. ResultsAt week 52, the percentage of responders was 20.8% for patients starting on fesoterodine 4mg who optionally titrated to 8mg and 19.4% for patients treated with mirabegron. QALYs were slightly higher with fesoterodine than mirabegron (0.7703vs. 0.7668, difference=0.0035). Fesoterodine treatment also had slightly higher total costs than mirabegron (3,296€vs. 3,217, difference=79€), resulting in a cost of 22,523/QALY€ gained for fesoterodine versus mirabegron. Probabilistic sensitivity analysis confirmed the slight advantage of fesoterodine with a 61.1% probability of being cost-effective at the 30,000€ willingness-to-pay for 1QALY threshold. ConclusionsGiven the relatively small 1-year cost difference between the two treatments, fesoterodine can be considered a cost-effective option relative to mirabegron for the first-line management of OAB with UUI in Spain.

Dose Pattern Evolution and Therapeutic Benefit in Patients on Solifenacin or Fesoterodine Treatment in Daily Clinical Practice

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.

Economic impact of using fesoterodine for the treatment of overactive bladder with urge urinary incontinence in a vulnerable elderly population in the United States

Objectives:To assess the costs of treating overactive bladder (OAB) with fesoterodine compared to no OAB pharmacotherapy among vulnerable elderly from the US payer perspective.Methods:A decision analytic cost model was developed to estimate the 52-week costs of a cohort of vulnerable elderly with OAB initiating treatment with fesoterodine or no OAB pharmacotherapy. Vulnerable elderly OAB patients were defined as those aged ≥65 years with self-reported urge urinary incontinence (UUI) symptoms for ≥3 months, 2–15 UUI episodes/day, and at risk of deteriorating health by a score of ≥3 on the Vulnerable Elders Survey (VES)-13. Patients were evaluated for fesoterodine treatment response (defined as no UUI episodes) and persistence at weeks 12, 26, and 52. The model included a hypothetical health plan with 100,000 elderly members. A total of 7096 vulnerable elderly subjects were identified as the model target population based on the percentage of vulnerable elderly and annual prevalence of OAB among vulnerable elderly. OAB-related costs included fesoterodine drug acquisition costs, healthcare resource use (inpatient hospitalization, outpatient visits, and physician office visits), and OAB-related co-morbidities (falls/fractures, urinary tract infections, depression, and nursing home admissions). All costs were inflated to 2013 US$ using the medical care component of the consumer price index (CPI).Results:When 7096 vulnerable elderly OAB patients were treated with fesoterodine, US healthcare payers could save $11,463,981 per year, or $1616 per patient vs no OAB pharmacotherapy. Univariate one-way sensitivity analyses supported the robustness of the findings and showed results were most sensitive to changes in fesoterodine efficacy followed by annual costs of inpatient hospitalization.Conclusions:From a US payer perspective, treating vulnerable elderly OAB patients with fesoterodine was cost-saving compared to no OAB pharmacotherapy.

Adherence to fesoterodine in women with overactive bladder in routine clinical practice

ObjectivesTo assess the short-term compliance with fesoterodine treatment and to identify the reasons for lack of adherence and discontinuation in routine clinical practice. The secondary aim was to estimate the patient-reported outcomes. MethodsThis was an observational retrospective, multicenter study conducted in a sample of women with overactive bladder on fesoterodine treatment for at least three months. Adherence to medication was assessed using the Morisky–Green test. Patient-reported outcomes were assessed using the Incontinence Questionnaire Short Form (ICIQ-SF), Overactive Bladder Questionnaire Short Form (OAB-qSF), and Treatment Benefit Scale (TBS). ResultsOne hundred and twenty women with a mean age [standard deviation (SD)] of 62.2 (12.0) years with severe OAB [mean (SD) ICIQ-SF score 13.2 (4.0)] were included. 42.1% of the patients were considered compliant with fesoterodine treatment. The main causes for non-compliance/discontinuation stated by the remaining 57.9% of the patients were adverse events (62.2%) and lack of clinical benefits (20.0%). The illness status as well as the patient-perceived bother occasioned by the OAB symptoms and their impact on the quality of life improved significantly after three months on fesoterodine treatment (p<0.0001). Most of the patients stated that the current state of their urinary problems had greatly improved/improved. ConclusionIn routine clinical practice, a high percentage of patients were adherent to fesoterodine and perceived the benefit that the treatment provided them three months after starting treatment. However, more than half of the study population failed to comply or discontinued the treatment mainly due to intolerance or lack of efficacy.

Adherencia a fesoterodina en mujeres con vejiga hiperactiva en la práctica clínica diaria

ObjectivesTo assess the short-term compliance with fesoterodine treatment and to identify the reasons for lack of adherence and discontinuation in routine clinical practice. The secondary aim was to estimate the patient-reported outcomes. MethodsThis was an observational retrospective, multicenter study conducted in a sample of women with overactive bladder on fesoterodine treatment for at least three months. Adherence to medication was assessed using the Morisky-Green test. Patient-reported outcomes were assessed using the Incontinence Questionnaire Short Form (ICIQ-SF), Overactive Bladder Questionnaire Short Form (OAB-qSF), and Treatment Benefit Scale (TBS). ResultsOne hundred and twenty women with a mean age [standard deviation (SD)] of 62.2 (12.0) years with severe OAB [mean (SD) ICIQ-SF score 13.2 (4.0)] were included. 42.1% of the patients were considered compliant with fesoterodine treatment. The main causes for non-compliance/discontinuation stated by the remaining 57.9% of the patients were adverse events (62.2%) and lack of clinical benefits (20.0%). The illness status as well as the patient-perceived bother occasioned by the OAB symptoms and their impact on the quality of life improved significantly after three months on fesoterodine treatment (p<0.0001). Most of the patients stated that the current state of their urinary problems had greatly improved/ improved. ConclusionIn routine clinical practice, a high percentage of patients were adherent to fesoterodine and perceived the benefit that the treatment provided them three months after starting treatment. However, more than half of the study population failed to comply or discontinued the treatment mainly due to intolerance or lack of efficacy.

An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material.

To compare the effects of additional educational material on treatment satisfaction of overactive bladder (OAB) patients treated with a muscarinic receptor antagonist. In an observational study of OAB patients being treated by their physician with fesoterodine for 4 months (FAKTEN study), sites were randomised to providing standard treatment or additional educational material including the SAGA tool. Patient satisfaction was assessed by three validated patient-reported outcomes including the Treatment Satisfaction Question. Because of premature discontinuation of the study, descriptive statistical analysis was performed. A total of 431 and 342 patients received standard treatment or additional educational material, respectively. At study end, 76.1% [95% CI = 71.3, 80.4] of patients with standard care and 79.6% [95% CI = 74.4, 84.1] with additional SAGA tool were satisfied with treatment (primary end-point). Comparable outcomes with and without the additional educational material were also found in various patient subgroups, at the 1-month time point, and for the other patient-reported outcomes. A notable exception was the subgroup of treatment-naïve patients in which the percentage of satisfied patients was 77.2% vs. 89.5% with standard treatment and additional SAGA tool, respectively (post hoc analysis). In an observational study, most overactive bladder patients were satisfied with fesoterodine treatment. Because of the small sample size, the study does not support or refute the hypothesis that adding the SAGA tool will improve patient satisfaction with treatment. The potential effect of additional educational material in treatment-naïve patients warrants further dedicated studies.

Therapeutic benefit in patients switching tolterodine to other novel antimuscarinic agents

Abstract Objectives To explore in the daily clinical practice setting that antimuscarinic, fesoterodine or solifenacin, provides a greater clinical benefit after changing the prior overactive bladder (OAB) therapy with tolterodine extended release (ER) to other novel antimuscarinic agents. Material and methods A post hoc analysis of data from an observational multicenter, cross-sectional, retrospective study. Adult patients of both sexes, with OAB and OAB-V8 score ≥ 8, who switched to fesoterodine or solifenacin within the 3–4 months before study visit from their prior tolterodine-ER-based therapy due to poor response were included. 92 patients were selected for each treatment group, matched (1:1) according to conditioned probability using the propensity score. Benefit of treatment change perceived by the physician and patient was evaluated by means of the Clinical Global Impression of Improvement subscale (CGI-I) and Treatment Benefit Scale (TBS), respectively. Degree of worry, bother and interference with daily living activities due to urinary symptoms, level of satisfaction, and preference for current treatment were also assessed. Results Fesoterodine provided a significantly greater improvement than solifenacin in terms of therapeutic benefit perceived by the physician according to ICG-I. 96.7% of the patients on fesoterodine treatment vs. 81.6% of the solifenacin group showed a score of improvement in TBS (p Conclusions In daily clinical practice the switch from tolterodine LP to fesoterodine seems to provide greater benefits both from the physician's and the patient's point of view compared with those provided by solifenacin.

Cost Effectiveness of Fesoterodine and Tolterodine for the Treatment of Overactive Bladder with Urge Urinary Incontinence in Spain and Finland

Overactive bladder is a prevalent condition worldwide that is associated with a considerable burden, both on the patient and on society. Our objective was to assess the economic value of fesoterodine compared with tolterodine extended release (ER) for the treatment of overactive bladder (OAB) with urge urinary incontinence (UUI) in Spain and Finland. A decision-tree economic model estimated the 52-week costs and quality-adjusted life-years (QALYs) of OAB/UUI patients initiating treatment with fesoterodine 4 mg/day or tolterodine ER. Individuals were evaluated for treatment response (UUI fewer than one episode/day) and persistence at weeks 4, 12, and 24. Titration from fesoterodine 4 mg/day to 8 mg/day was permitted at week 4. At week 12, non-responders discontinued treatment permanently. Efficacy, discontinuation, and utility data were derived from four clinical trials of fesoterodine. OAB-related costs, including physician visits, laboratory tests, incontinence pads, and comorbidities (fracture, skin infection, urinary tract infections, depression, and nursing home) were also included. A total of 19.5 % and 18.0 % of fesoterodine and tolterodine ER patients remained on treatment until week 52, respectively. QALYs were higher with fesoterodine than tolterodine ER (0.762 vs. 0.760). In Spain, fesoterodine treatment had higher total costs than (generic) tolterodine ER (€6,697 vs. 6,597), resulting in a cost of €15,633/QALY gained. In Finland, fesoterodine was cost saving relative to (non-generic) tolterodine ER (€7,885 vs. 8,024). Sensitivity analysis confirmed that these findings were robust to the expected price decrease for generic tolterodine ER in Finland. Fesoterodine is cost effective or cost saving relative to tolterodine ER for the treatment of OAB with UUI in two European countries. Payers and prescribers should consider a broad scope of costs to make informed cost-conscious choices of antimuscarinic treatment.

Beneficio terapéutico tras cambiar tolterodina por otros nuevos antimuscarínicos

ObjectivesTo explore in the daily clinical practice setting that antimuscarinic, Fesoterodine or Solifenacin, provides a greater clinical benefit after changing their prior Overactive Bladder (OAB) therapy with tolterodine extended-release (ER) to other novel antimuscarinic agents. Material and methodsA post-hoc analysis of data from an observational multicenter, cross-sectional, retrospective study. Adult patients of both sexes, with OAB and OAB-V8 score≥8, who switched to fesoterodine or solifenacin within the 3-4 months before study visit from their prior tolterodine-ER-based therapy due to poor response were included. 92 patients were selected for each treatment group, matched (1:1) according to conditioned probability using the propensity score. Benefit of treatment change perceived by the physician and patient was evaluated by means of the Clinical Global Impression of Improvement subscale (CGI-I) and Treatment Benefit Scale (TBS), respectively. Degree of worry, bother and interference with daily living activities due to urinary symptoms, level of satisfaction, and preference for current treatment were also assessed. ResultsFesoterodine provided a significantly greater improvement than solifenacina in terms of therapeutic benefit perceived by the physician according to ICG-I. 96.7% of the patients on fesoterodine treatment vs. 81.6% of the solifenacin group showed a score of improvement in TBS (P<.05). Fesoterodine was also better rated than solifenacin with regard to satisfaction and preference for the new treatment (93.4 vs. 78.2% P<.05). ConclusionsIn daily clinical practice the switch from tolterodine LP to fesoterodine seems to provide greater benefits both from the physician's and the patient's point of view compared with those provided by solifenacin.

1962 AGE, GENDER AND NOCTURNAL URGENCY SEVERITY PREDICT RESPONSE TO ANTIMUSCARINIC TREATMENT

INTRODUCTION AND OBJECTIVES: Nocturnal urinary urgency significantly impacts quality of life in patients with overactive bladder. To date, only 1 prospective study has demonstrated antimuscarinic efficacy for reducing nocturnal urgency episodes. Data on predictors of positive treatment outcomes would help identify patients who would most likely benefit from antimuscarinic pharmacotherapy. We examined the impact of sex, age and baseline nocturnal urgency on the response to fesoterodine (FESO) in overactive bladder (OAB) subjects with nocturnal urgency. METHODS: Eligible subjects aged 18 years with self-reported OAB symptoms, including nocturnal urgency, were randomized to receive fesoterodine or PBO for 12 wk if they had 2-8 nocturnal urgency episodes/24 h at baseline and a 35% reduction of nocturnal urgency episodes during a 2-week, single-blind PBO run-in. Following 1:1 randomization, FESO 4 mg (n 463) or PBO (n 474) was administered once daily for 4 weeks, followed by optional escalation to 8 mg for the remaining 8 weeks at the discretion of the investigator. For this post-hoc analysis, a logistic regression model was used to assess whether treatment, sex, age and number of baseline nocturnal urgency episodes predicted the likelihood of response, defined as a reduction from baseline of 1 micturition-related nocturnal urgency episodes/24 h at week 12. Missing data were imputed with the last observation carried forward method. RESULTS: Nocturnal urgency episodes were significantly reduced following fesoterodine treatment (P 0.0034; Figure). Women (P 0.0225) were more likely to show a treatment response than men to respond to fesoterodine. Greater number of baseline nocturnal urgency episodes (P 0.0001) was also associated with an increased likelihood of treatment response. Older age (P 0.0123) was associated with a slightly decreased likelihood of treatment response. CONCLUSIONS: Treatment, sex, age, and number of nocturnal urgency episodes at baseline significantly predicted the likelihood of response in subjects with OAB and nocturnal urgency.

Effects of drug cessation after flexible‐dose fesoterodine in patients with overactive bladder

To determine the course of overactive bladder (OAB) symptoms after 4 weeks of no treatment following a 12-week study of the efficacy and safety of flexible-dose fesoterodine in patients with OAB who were enrolled in the UK healthcare system. There are limited data available on the natural time course of OAB symptoms after the cessation of treatment. In the open-label UK Study Assessing Flexible-dose Fesoterodine in Adults trial, patients aged ≥18 years with self-reported OAB symptoms for ≥3 months, a mean of at least eight micturitions per 24 h and three or more urgency episodes per 24 h on a 3-day bladder diary at baseline, and at least moderate bladder-related problems reported on the Patient Perception of Bladder Condition (PPBC) at baseline, were treated with fesoterodine for 12 weeks. All patients received fesoterodine 4 mg once daily for the first 4 weeks, at which time they could choose to increase the dose to 8 mg once daily, based on a discussion of treatment efficacy and tolerability with the investigator, or they could remain on fesoterodine 4 mg for the remaining 8 weeks. The 12-week treatment period was followed by a 4-week follow-up period of no fesoterodine treatment. Patients completed 3-day bladder diaries and the PPBC at baseline, week 4, end of treatment (week 12) and end of the follow-up period (week 16); the King's Health Questionnaire at baseline, end of treatment (week 12) and end of the follow-up period (week 16); and the Benefit, Satisfaction and Willingness to Continue questionnaire at week 12. After 12 weeks of fesoterodine treatment, patients had clinically meaningful improvements in bladder diary variables and King's Health Questionnaire domains; 79% (254/322) of patients reported an improvement on the PPBC. After 4 weeks of no treatment, most patients deteriorated back to week 4 levels or worse on all bladder diary and patient-reported outcomes. Patients who expressed a benefit from fesoterodine treatment, satisfaction with their treatment or a willingness to continue treatment showed greater improvement from baseline to week 12 and greater deterioration from week 12 to week 16 than patients who did not respond positively on the Benefit, Satisfaction and Willingness to Continue questionnaire. Both men and women showed a meaningful deterioration in bladder diary variables and patient-reported outcomes at week 16; baseline symptom severity, age and week 4 dose escalation status did not appear to affect outcome deterioration at week 16. At 4 weeks after fesoterodine was discontinued, patients showed an increase in the frequency of OAB symptoms, an increase in the severity of bladder-related problems and a reduction in health-related quality of life. Many patients with OAB who respond to antimuscarinics may require treatment for more than 12 weeks because symptoms recur as early as 4 weeks after the cessation of therapy.