Vibegron Significantly Reduces Urgency Urinary Incontinence in Overactive Bladder

Table of Content

Introduction

The prevalence of urgency urinary incontinence (UUI) is significant across the world. One study has reported a cure rate of 49% in patients after 1 year of treatment with anticholinergics, emphasizing on the need for a more effective drug. Vibegron is a novel, potent β-3 adrenoreceptor agonist with an excellent pharmacological activity. A phase 3 study demonstrated excellent efficacy and safety of vibegron in Japanese cohort with overactive bladder (OAB).

Aim

This post-hoc analysis evaluated the efficacy of vibegron on UUI in patients with OAB.

Patient Profile

  • UUI episodes >0/day
  • Patients were classified into 2 subgroups
    • Mild-moderate having >0 to <3 UUI episodes per day
    • Severe having >3 UUI episodes per day

Method

Study Design

Post-hoc analysis of phase 3 trial.

Treatment Strategy

  • The mild-moderate and severe UUI groups received vibegron 50 mg/day (n=329), vibegron 100 mg/day (n=327) or placebo (n=333) for 12 weeks

Endpoints

  • Changes from baseline at week 12 in the following parameters
    • Number of UUI episodes/d
    • Number of urgency episodes/d
    • Voided volume/micturition
  • Diary-rate rate comprising of % of patients who became UUI-free
  • Response rate (% of patients with score 1 or 2 evaluated by Patient Global Impression)

Results

  • A total of 989 patients were included in this post-hoc analysis
  • Patients having mild-moderate UUI were 273, 281 and 277 in the vibegron 50 mg, 100 mg and placebo groups respectively
  • Patients having severe UUI were 56, 46 and 56 in the vibegron 50 mg, 100 mg and placebo groups respectively
  • Significant changes in the numbers of UUI episodes at week 12 were seen in both vibegron groups as compared to placebo
  • Changes in UUI episodes at week 12 in vibegron 50 mg, 100 mg and placebo groups were -1.35, -1.47 and -1.08 in all patients, -1.04, -1.13 and -0.89 in the mild-moderate UUI subgroup and -2.95, -3.28 and -2.10 in the severe UUI subgroup
  • Change in the number of urgency episodes /d was significant in vibegron 100 mg group vs placebo in all patients as well as the 2 subgroups
  • In the vibegron 50 mg group, significant changes were observed in all patients and the mild-moderate UUI subgroup
  • Changes in voided volume/micturition was significantly greater in vibegron 50 mg and 100 mg groups vs placebo in all patients and both the subgroups
  • The vibegron active dose groups reported greater diary-rate rates as compared to placebo in all patients and mild-moderate UUI subgroup
  • The vibegron groups demonstrated higher response rates as compared to placebo in all patients and both severity subgroups
  • Multivariate logistic analysis revealed vibegron administration, OAB duration <37 months, mean number of micturitions/d at baseline <12 and mean number of UUI episodes/d at baseline <3 as significant factors associated with the normalization of UUI

Conclusion

  • Treatment with vibegron was associated with a significant reduction in the number of urgency urinary incontinence (UUI) episodes/d and significant increase in voided volume/micturition in patients with overactive bladder, including those with severe UUI, with response rate of more than 50%
  • Vibegron could be a useful therapeutic option in OAB patients with UUI.

BJU Int. 2020 Jan 28. Doi: 0.1111/bju.15020.