Vibegron: New Therapeutic Option for Improving Nocturia in Overactive Bladder

18 Mar, 19

Introduction

Nocturia affects the quality of life and is often a cause of sleep disruption. It could lead to an increased risk of depression and fractures, as a result of fall. Overactive bladder (OAB) is one of the causes of nocturia. Anticholinergics have been the standard treatment for nocturia associated with OAB. However, low adherence rates owing to inadequate efficacy and adverse effects, necessitate alternative drugs. Vibegron is a novel, potent ?-3 adrenoreceptor agonist with an excellent pharmacological activity. A phase 3 study conducted recently on Japanese men with OAB demonstrated the excellent efficacy and safety profile of vibegron as compared to placebo. A post-hoc analysis on nocturia using the data of this phase 3 trial was conducted.

Aim

To evaluate the efficacy of vibegron in the treatment of nocturia in men with OAB.

Patient Profile

Age >20 years
Persistent OAB symptoms for more than 6 months
- 1 or more nocturnal voiding per night

Method

Study Design

Post-hoc analysis of multicenter, randomized, double-blind, placebo-controlled phase 3 trial.

Treatment Strategy

N=669 OAB patients randomized into 3 groups and followed up for 12 weeks
N = 224 Placebo group
N = 227 received vibegron 50 mg/day
N = 218 received vibegron 100 mg/day

Endpoints

Changes from baseline to week 12 in the following micturition parameters
- Frequency of nocturnal voiding
- Volume per nocturnal void
- Volume of first nocturnal voiding
- HUS defined as length of time between going to bed and waking up for the first time at night to urinate. HUS is important to ensure the quality of sleep. Non rapid eye movement (REM) episodes usually occur in the first 3 hrs of sleep. The first 3 hrs contribute significantly to the quality of sleep
Correlations between changes from baseline to week 12 in the mean HUS and in the frequency of nocturnal voiding as well as in the mean volume of first nocturnal voiding
Demographic and baseline characteristics contributing to reduction in the frequency of nocturnal voiding (decrease in the number of voids >1) was also analyzed

Results

The changes from baseline in micturition parameters are shown in table 1.

Table 1. Comparison of Changes from Baseline to Week 12 in Micturition Parameters

Micturition parameters	Vibegron 50 mg group	Vibegron 100 mg group	Placebo	p value
Mean frequency of nocturnal voiding	-0.74	-0.78	-0.58	0.007 and <0.001 respectively
Mean volume per nocturnal void (ml)	47.85	58.14	19.42	<0.001 for both
Mean volume of first nocturnal voiding (ml)	48.71	71.42	24.80	0.005 and <0.001 respectively
Mean HUS (min)	81.79	90.95	65.08	0.065 and 0.005 respectively

Changes from baseline to week 12 in the mean HUS negatively correlated with the frequency of nocturnal voiding and positively correlated with mean volume of the first nocturnal voiding
Vibegron treatment, no previous treatment with anticholinergics, >12 voids per day and hours of undisturbed sleep <180 min significantly contributed to a decrease in the frequency of nocturnal voiding

Conclusion

Treatment with vibegron was associated with reduction in the frequency of nocturnal voiding, increase in the volume per nocturnal void and volume of first nocturnal voiding in overactive bladder (OAB) patients with >1 voids
The extension of HUS led to improved quality of sleep
Vibegron could be a useful therapeutic option for improving the nocturia in OAB patients

Int J Urol. 2019 Mar;26(3):369-375. Doi: 10.1111/iju.13877.