Long-Term Efficacy and Safety of Vibegron for Overactive Bladder Syndrome in Patients ≥65 Years Old: Analysis From the EMPOWUR Extension Trial

Staskin D1, Frankel J2, Varano S3, Greene H4, Thomas E4

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 297
Overactive Bladder
Scientific Podium Short Oral Session 21
Friday 9th September 2022
12:15 - 12:22
Hall G1
Clinical Trial Detrusor Overactivity Incontinence Urgency Urinary Incontinence Urgency/Frequency
1. Tufts University School of Medicine, 2. Seattle Urology Research Center, 3. Clinical Research Consulting, 4. Urovant Sciences
In-Person
Presenter
Links

Abstract

Hypothesis / aims of study
Overactive bladder (OAB) syndrome prevalence increases with age. Vibegron is a β3-adrenergic agonist approved for adults with OAB. In the phase 3 EMPOWUR extension trial [1], once-daily vibegron 75 mg showed long-term safety and efficacy in patients with OAB, consistent with results of the 12-week study [2]. These post hoc analyses of the extension trial assessed safety and efficacy in patients ≥65 years old.
Study design, materials and methods
Patients completing the EMPOWUR trial could enter the 40-week extension trial (NCT03583372). Patients previously receiving vibegron or tolterodine 4 mg extended release continued active treatment; patients previously receiving placebo were randomly assigned 1:1 to vibegron or tolterodine. The primary outcome was safety, assessed by adverse events (AEs). Key efficacy endpoints were change from EMPOWUR baseline at week 52 in average daily micturitions, urgency urinary incontinence (UUI) episodes, and urgency episodes. Outcomes were assessed in patients ≥65 years old. No formal sample size calculation was performed; it was determined that rolling 500 patients over from the EMPOWUR trial was sufficient to characterize the long-term safety profile of vibegron. The study was approved by an institutional review board, research ethics board, or independent ethics committee prior to study initiation; all patients provided written informed consent.
Results
Of 505 patients receiving ≥1 dose of study drug in the extension (n=273, vibegron; n=232, tolterodine), 235 patients (46.5%) were ≥65 years old, and 60 patients (11.9%) were ≥75 years old. Of the patients ≥65 years old, 71.1% were women, and 75.7% had OAB wet (ie, with incontinence). Of the patients ≥75 years old, 55.0% were women, and 68.3% had OAB wet. After 40‒52 weeks of treatment, the rate of treatment-related AEs was similar between vibegron (33.3%) and tolterodine (25.5%) (Table 1). The most commonly occurring AEs were hypertension (10.9% with vibegron vs 9.4% with tolterodine), urinary tract infection (7.8% vs 12.3%, respectively), and headache (7.0% vs 4.7%, respectively). Patients who received 52 weeks of active treatment showed improvement in least squares mean change from baseline at week 52 in average daily number of micturitions (vibegron, −2.3; tolterodine, −1.7), UUI episodes (−1.8; −1.2, respectively), and urgency episodes (−3.3; −2.4, respectively) (Table 2). Safety and efficacy outcomes were generally similar in patients ≥75 years old.
Interpretation of results
In this subgroup analysis of the EMPOWUR extension trial, once-daily vibegron 75 mg was associated with sustained reductions from baseline in micturitions, UUI episodes, and urgency episodes and was safe in older adults (≥65 years) with OAB.
Concluding message
The safety and efficacy of vibegron in older adults was consistent with that observed in the overall population of the EMPOWUR extension trial. These results suggest that vibegron is similarly safe and effective for symptoms of OAB in adult patients.
Figure 1 Table 1
Figure 2 Table 2
References
  1. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. J Urol. 2021;205(5):1421-1429.
  2. Staskin D, Frankel J, Varano S, Shortino D, Jankowich R, Mudd PN, Jr. J Urol. 2020;204(2):316-324.
Disclosures
Funding Urovant Sciences Clinical Trial Yes Registration Number ClinicalTrials.gov, NCT03583372 RCT Yes Subjects Human Ethics Committee The study was approved by an institutional review board or independent ethics committee at each of the 107 study sites Helsinki Yes Informed Consent Yes
Citation

Continence 2S2 (2022) 100363
DOI: 10.1016/j.cont.2022.100363

15/10/2024 07:38:48