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Residents’ Podcast: Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe UUI related to OAB

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Part of the BURST/BJUI Podcast Series

Nikita Bhatt is a Specialist Trainee in Urology in the East of England Deanery and a BURST Committee member @BURSTUrology

Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

Masaki Yoshida*, Masayuki Takeda†, Momokazu Gotoh‡, Osamu Yokoyama§, Hidehiro Kakizaki, Satoru Takahashi**, Naoya Masumori††, Shinji Nagai‡‡ and Kazuyoshi Minemura‡‡

*Department of Urology, National Centre for Geriatrics and Gerontology, Obu, †Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan, ‡Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, §Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan, **Department of Urology, Nihon University School of Medicine, Tokyo, ††Department of Urology, Sapporo Medical University School of Medicine, Sapporo, and ‡‡Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan

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Abstract

Objective

To evaluate the efficacy of a novel and selective β3‐adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). Follow us visaliaweddingstyle for more details .

Patients and Methods

A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI‐free (‘diary‐dry’ rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.

Results

Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, 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. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary‐dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.

Conclusions

Vibegron, a novel β3‐adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

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Article of the week: Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe UUI related to OAB: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

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Every week, the Editor-in-Chief selects an Article of the Week from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to this post, there is an editorial written by a prominent member of the urological community and a video produced by the authors. Please use the comment buttons below to join the conversation.

If you only have time to read one article this week, we recommend this one. 

Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

 

Masaki Yoshida*, Masayuki Takeda†, Momokazu Gotoh‡, Osamu Yokoyama§, Hidehiro Kakizaki, Satoru Takahashi**, Naoya Masumori††, Shinji Nagai‡‡ and Kazuyoshi Minemura‡‡

*Department of Urology, National Centre for Geriatrics and Gerontology, Obu, †Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan, ‡Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, §Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan, **Department of Urology, Nihon University School of Medicine, Tokyo, ††Department of Urology, Sapporo Medical University School of Medicine, Sapporo, and ‡‡Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan

Read the full article

Abstract

Objective

To evaluate the efficacy of a novel and selective β3‐adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).

Patients and Methods

A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI‐free (‘diary‐dry’ rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.

Diary‐dry rate. UUI, urgency urinary incontinence. Data are presented as mean (95% CI). Chi‐squared test, *P < 0.05, **P < 0.001 vs placebo. PBO, placebo group; V 100, vibegron 100 mg group; V 50, vibegron 50 mg group; Wk, week(s).

Results

Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, 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. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary‐dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.

Conclusions

Vibegron, a novel β3‐adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

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Video: Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder

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Efficacy of vibegron, a novel β3‐adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo‐controlled, double‐blind, comparative phase 3 study

Abstract

Objective

To evaluate the efficacy of a novel and selective β3‐adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB).

Patients and Methods

A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI‐free (‘diary‐dry’ rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated.

Results

Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, 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. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary‐dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI.

Conclusions

Vibegron, a novel β3‐adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.

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Article of the Month – Guidelines of the Guidelines: Urinary Incontinence in Women

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Every month, the Editor-in-Chief selects an Article of the Month from the current issue of BJUI. The abstract is reproduced below and you can click on the button to read the full article, which is freely available to all readers for at least 30 days from the time of this post.

In addition to the article itself, there is an editorial prepared by a prominent member of the urological community and a video by the authors; we invite you to use the comment tools at the bottom of each post to join the conversation. 

If you only have time to read one article this month, we recommend this one. 

Guidelines of the Guidelines: Urinary Incontinence in Women

Rachael D. Sussman*, Raveen Syan† and Benjamin M. Brucker‡
*Department of Urology, MedStar Georgetown University Hospital, Washington, DC, †Department of Urology, Stanford School of Medicine, Stanford, CA, and ‡Department of Urology, New York University Medical Center, New York, NY, USA

Read the full article

Introduction

Urinary incontinence (UI) is a common disease, with prevalence rates as high as 44–57% in middle‐aged and post‐menopausal women. Those with UI may experience physical, functional, and psychological limitations and diminished quality of life (QoL) at home and at work. The financial burden of UI care is significant, with an estimated direct cost of $19.5 billion (American dollars) in the USA alone.

UI can be classified into a number of different categories, with stress UI (SUI) and urgency UI (UUI) being the most common. Many professional organisations have created guidelines to help clinicians navigate the diagnosis and evaluation of UI, as well as the treatments including conservative, pharmacological, and surgical. The methodologies upon which most guidelines are based are similar, starting with systematic reviews and grading of available literature. Organisations then make recommendations with different definitions and strengths. Guidelines are not exhaustive, but rather serve as a practical review of evidence‐based management of ‘index patients’.

The present ‘Guideline of guidelines,’ updated from a 2016 publication, reviews various international guidelines that have been updated at different time intervals and provides an updated summary of the important similarities and differences on the management of UI in women.

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