Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR

Frankel, Jeffrey; Varano, Susann; Kennelly, Michael; Newman, Diane K.; Rosenberg, Matt T.; Jankowich, Rachael; Shortino, Denise; Mudd, Paul N.; Girman, Cynthia J.

doi:10.1007/s12325-021-01972-8

Cited by 8 publications

(8 citation statements)

References 38 publications

(66 reference statements)

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“…In an analysis of clinical meaningfulness of the EMPOWUR trial, significantly more patients receiving vibegron versus placebo achieved meaningful reductions in efficacy end points (ie, 15% reduction in micturitions, 50% reduction in urgency episodes, and 75% and 90% reduction in UUI episodes), which were associated with patient-perceived improvement. 18 Although slightly higher rates of certain TEAEs, such as headache, occurred more frequently with vibegron than with placebo among women (4.3% vs 2.6%, respectively), the incidence of headache with vibegron versus placebo aligns with the overall safety results of the overall population from the EMPOWUR trial (4.0% vs 2.4%, respectively). 16 In addition, TEAEs of hypertension in women displayed similar rates for vibegron and placebo (1.9% and 1.7%, respectively).…”

Section: N Original Researchmentioning

confidence: 69%

“…The LSMD for vibegron versus placebo was generally comparable in women and the overall population for micturitions (women, −0.5; overall, −0.5), UUI episodes (−0.7; −0.6), and urgency episodes (−0.8; −0.7). In an analysis of clinical meaningfulness of the EMPOWUR trial, significantly more patients receiving vibegron versus placebo achieved meaningful reductions in efficacy end points (ie, ≥15% reduction in micturitions, ≥50% reduction in urgency episodes, and ≥75% and 90% reduction in UUI episodes), which were associated with patient-perceived improvement 18 …”

Section: Discussionmentioning

confidence: 99%

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Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial

Newman

Thomas

Greene

et al. 2022

UROGC

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Importance The international phase 3 EMPOWUR trial demonstrated efficacy and safety of vibegron, a newer b 3 -adrenergic receptor agonist, in adults with overactive bladder (OAB). Women are disproportionately affected by OAB, especially those with bothersome symptoms, such as urge urinary incontinence (UUI). Objective This subgroup analysis from EMPOWUR assessed efficacy and safety of vibegron in women. Study Design In EMPOWUR, patients with OAB were randomized 5:5:4 to 12 weeks of treatment with once-daily vibegron 75 mg, placebo, or tolterodine 4-mg extended release. Efficacy end points included change from baseline at week 12 in mean daily number of micturitions, UUI episodes, and urgency episodes. Safety was assessed through adverse events (AEs). Results Of the patients included in the analysis, 1286 (84.9%) were women (vibegron, n = 463; placebo, n = 459; tolterodine, n = 364). At week 12, women receiving vibegron showed significant reductions (95% confidence intervals of least squares mean differences does not include 0) from baseline versus placebo in mean daily micturitions, UUI episodes, and urgency episodes, with least squares mean differences (95% confidence intervals) of −0.5 (−0.8 to −0.2), −0.7 (−1.0 to −0.4), and −0.8 (−1.3 to −0.4), respectively. Treatment-emergent AE incidence was similar with vibegron (39%) and placebo (35%); the most common AE with incidence higher with vibegron (4.3%) than placebo (2.6%) was headache. Conclusions In this subgroup analysis, women receiving vibegron showed significant reductions in key efficacy end points versus placebo and favorable safety profile, consistent with the overall results from EMPOWUR, suggesting that vibegron is efficacious and safe for the treatment of OAB in this patient population.

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Section: N Original Researchmentioning

confidence: 69%

Section: Discussionmentioning

confidence: 99%

Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial

Newman

Thomas

Greene

et al. 2022

UROGC

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“…Studies using the OAB-q and WPAI:US have shown that patients with OAB experience significantly decreased work productivity and HRQL, as well as impairment in daily activities, with significantly increased HCRU [ 3 , 4 , 35 ]. Vibegron has been shown to significantly improve QoL in patients with OAB in a clinically meaningful manner as reported by patients [ 36 , 37 ]. Improving QoL by mitigating bothersome symptoms of OAB in a real-world setting is a key component of COMPOSUR.…”

Section: Discussionmentioning

confidence: 95%

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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“…However, it is important to note that 24%−45% of patients receiving placebo in this analysis were classified as responders based on the various cut-off criteria. 27 When continuation rates were compared at 1 year with vibegron and mirabegron in a relatively small study with various populations, vibegron appeared superior (83.8% vs. 58.2%). 28 In those with idiopathic OAB (n = 56), it was 80% versus 42% in favor of vibegron.…”

Section: Beta-agonistsmentioning

confidence: 99%

“…In general, adverse event profiles were similar when compared to tolterodine for hypertension, UTI, nasopharyngitis, although dry mouth was better in favor of vibegron (1.8% vs. 5.2%) 26 . Frankel et al, in their study assessed the meaningfulness of these clinical reductions in endpoints using the patient perception of improvement 27 . They were able to demonstrate that significantly more patients treated with vibegron versus placebo achieved meaningful reductions in daytime frequency, urgency, and urge incontinence episodes.…”

Section: Beta‐3 Agonistsmentioning

confidence: 99%

What is the best first choice oral drug therapy for OAB?

Sahai,

Robinson,

Abrams

et al. 2024

Neurourology and Urodynamics

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AimsThe management of overactive bladder (OAB) involves lifestyle changes and conservative measures in the first instance with the use of liquid/dietary advice, weight loss, and bladder training. Thereafter oral pharmacotherapy is instigated in symptomatic patients. Antimuscarinics and beta 3 agonists form the main classes of drug therapy in this field. Views on what is the best first line OAB treatment is changing based on recent evidence and adverse event profiles of these medications.MethodsAt the ICI‐RS meeting 2023, Bristol, UK this topic was discussed and debated as a proposal. The following article summarizes the concepts presented that day as well as the interactive discussion that took place thereafter.ResultsOAB guidelines are moving in many circumstances to an either antimuscarinic or beta 3 agonist approach based on patient factors. Several studies have raised concerns on the long‐term impact of antimuscarinics, in relation to cognition, dementia, cardiovascular events, and mortality all related to antimuscarinic load. Neither antimuscarinics nor beta 3 agonists have good persistence and adherence rates in the medium to long term. Several barriers also exist to prescribing including guidelines recommending utilizing drugs with the lowest acquisition cost and “step therapy.” A newer approach to managing OAB is personalized therapy in view of the many possible etiological factors and phenotypes. These concepts are highlighted in this article.ConclusionsCurrent oral pharmacotherapy in managing OAB is limited by adverse events, adherence and persistence problems. Both antimuscarinics and beta 3 agonists are efficacious but most clinical trials demonstrate significant placebo effects in this field. Personalizing treatment to the individual seems a logical approach to OAB. There is a need for better treatments and further studies are required of existing treatments with high quality longer term outcomes.

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Interpretation of the Meaningfulness of Symptom Reduction with Vibegron in Patients with Overactive Bladder: Analyses from EMPOWUR

Abstract: Introduction:Reductions in bothersome symptoms of overactive bladder (OAB) demonstrate improvement in clinical trials, but patient perception of meaningfulness of such

Cited by 8 publications

References 38 publications

Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial

Efficacy and Safety of Vibegron for the Treatment of Overactive Bladder in Women: A Subgroup Analysis From the Double-Blind, Randomized, Controlled EMPOWUR Trial

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

What is the best first choice oral drug therapy for OAB?

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