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

Schneider, Tim; Arumí, Daniel; Crook, Tim; Sun, Franklin; Michel, Martin C.

doi:10.1111/ijcp.12450

Cited by 8 publications

(9 citation statements)

References 36 publications

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“…As a result, CYP3A inhibitors may be needed to ensure tolterodine metabolism to 5‐HMT for OAB treatment . Comparative studies performed during clinical administration have demonstrated a satisfactory response to fesoterodine compared to tolterodine . Such competence of fesoterodine compared with other muscarinic drugs has led us to focus on its synthetic strategy.…”

Section: Introductionmentioning

confidence: 99%

Formal Synthesis of Fesoterodine by Acid‐Facilitated Aromatic Alkylation

Lee

Shabbir

Jeong

et al. 2015

Bulletin Korean Chem Soc

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The competitive muscarinic receptor antagonist fesoterodine is a congener of tolterodine and has better efficiency compared to tolterodine. In this study, we present an efficient synthesis of the fesoterodine intermediate 3-(3-diisopropylamino-1-phenylpropyl)-4-hydroxybenzaldehyde from ethyl benzoylacetate by Friedel-Crafts alkylation in the presence of an acid as a key reaction step. The synthesis is carried out by the reduction of the ketoester to a 1,3-diol, diisopropylamine substitution, and Friedel-Crafts alkylation, followed by reduction and chiral resolution.

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Section: Introductionmentioning

confidence: 99%

Formal Synthesis of Fesoterodine by Acid‐Facilitated Aromatic Alkylation

Lee

Shabbir

Jeong

et al. 2015

Bulletin Korean Chem Soc

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“…To evaluate patient perception of efficacy and overall treatment satisfaction, COMPOSUR uses the OAB-q-SF questionnaire, assessing system bother and HRQL, which has also been used in a previous real-world study [ 25 ]. Although treatment satisfaction is sometimes assessed with the single-question Treatment Satisfaction Visual Analog Scale [ 25 , 26 ], COMPOSUR uses the OAB-SAT-q to measure patient satisfaction with treatment, enabling greater assessment of not only satisfaction but also side effects, convenience, and preference. COMPOSUR will monitor patients over a 12-month period, with patient visits occurring slightly more frequently than a previous 12-month-long real-world study [ 25 ]; however, frequency of study visits is representative of usual practice for treating providers.…”

Section: Discussionmentioning

confidence: 99%

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder

et al. 2023

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Background Overactive bladder (OAB) is defined as urinary urgency accompanied by frequency and nocturia, with or without urge urinary incontinence (UUI). Vibegron, a selective β3-adrenergic receptor agonist approved in the US in December 2020, demonstrated efficacy in reducing symptoms of OAB and was safe and well tolerated in the 12-week EMPOWUR trial and its 40-week, double-blind extension trial. The goal of the COMPOSUR study is to evaluate vibegron in a real-world setting to assess patient treatment satisfaction, tolerability, safety, duration of treatment, and persistence. Methods This is a 12-month, prospective, observational, real-world study, with an optional 12-month extension to 24 months, in the US assessing adults ≥ 18 years old starting a new course of vibegron. Patients must be previously diagnosed with OAB with or without UUI, symptomatic for ≥ 3 months before enrollment, and receive prior treatment with an anticholinergic, with mirabegron, or with a combination of an anticholinergic and mirabegron. Enrollment is performed by the investigator following exclusion and inclusion criteria guided by US product labeling, reinforcing a real-world approach. Patients complete the OAB Satisfaction with Treatment Questionnaire (OAB-SAT-q) monthly and the OAB Questionnaire short form (OAB-q-SF) and Work Productivity and Activity Impairment Questionnaire (WPAI:US) at baseline and monthly for 12 months. Patients are followed up via phone call, in-person visits, or telehealth (ie, virtual) visits. The primary endpoint is patient treatment satisfaction as determined by the OAB-SAT-q satisfaction domain score. Secondary endpoints include percent positive responses to individual OAB-SAT-q questions, additional OAB-SAT-q domain scores, and safety. Exploratory endpoints include adherence and persistence. Discussion OAB leads to a significant decrease in quality of life, as well as impairment of work activities and productivity. Persistence with OAB treatments can be challenging, often due to lack of efficacy and adverse effects. COMPOSUR is the first study to provide long-term, prospective, pragmatic treatment data for vibegron in the US and the resultant effect on quality of life among patients with OAB in a real-world clinical setting. Trial registration ClinicalTrials.gov identifier: NCT05067478; registered: October 5, 2021.

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“…Various OAB treatments improve PROM such as PPBC at the group level, and the present NIS confirm this. While such improvements are routinely observed to occur concomitant with improvements of diary-based OAB symptoms in randomized controlled trials and NIS, 3,[14][15][16][17][18][19][20][21][22] other than the original validation study 8 apparently only one previous study (all based on tolterodine) has explored relationships between PPBC and OAB symptoms at the single-patient level and was limited to analysis of baseline values. 3 The present analyses confirm those findings and extends them to treatmentassociated improvements.…”

Section: Discussionmentioning

confidence: 99%

“…However, the PPBC is an ordinal variable, which should be reported as medians or distributions and analyzed by nonparametric tests. While this has been done in the original validation studies, 8 few other studies in the field have followed that example 3,15,18 . Despite being scientifically unsound, many studies have reported PPBC as means, for instance, 19,21,22 which ignores that PPBC is an ordinal variable.…”

Section: Discussionmentioning

confidence: 99%

Associations between the Patient Perception of Bladder Condition score and overactive bladder syndrome symptoms at baseline and upon treatment

Schönburg

Murgas

Fornara

et al. 2022

Neurourology and Urodynamics

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Background: Patient-reported outcomes such as the Patient Perception of Bladder Condition (PPBC) score are frequently used to characterize overactive bladder syndrome (OAB) patients and their treatment outcomes. However, little information is available on the relationship of such scores to OAB symptoms at the individual patient level. Methods: We have performed a post hoc analysis of two large noninterventional studies (n = 1345 and 745) in which patients received propiverine extended release (30 or 45 mg/day) for 12 weeks to determine the strength of nonparametric correlations between PPBC and OAB symptoms at baseline, after treatment and with treatment-associated changes thereof. Results: PPBC was not correlated with age but with episode frequencies of urgency, incontinence, micturitions, and nocturia, but the strength of correlations was only moderate (Spearman rank correlation coefficient 0.2045−0.3553). Similarly moderate correlations were observed after treatment and when changes in PPBC were compared to those of OAB symptoms, although these correlations were somewhat stronger.Conclusions: PPBC is only moderately correlated to OAB symptoms indicating that it characterizes patients beyond what is captured by their symptoms.

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

Cited by 8 publications

References 36 publications

Formal Synthesis of Fesoterodine by Acid‐Facilitated Aromatic Alkylation

Formal Synthesis of Fesoterodine by Acid‐Facilitated Aromatic Alkylation

Study design of a phase 4, real-world study (COMPOSUR) to evaluate vibegron in patients with overactive bladder

Associations between the Patient Perception of Bladder Condition score and overactive bladder syndrome symptoms at baseline and upon treatment

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