The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials

Abstract

Objective Vibegron is a new kind of β3‐adrenergic receptor agonist. We performed a systematic review and pooled analysis to assess the efficacy, safety, and tolerability of Vibegron for treating overactive bladder (OAB). Methods MEDLINE, the Cochrane Controlled Trial Register and EMBASE were used to pick out randomized controlled trials (RCTs) of Vibegron in treating OAB. The reference lists of the retrieved articles were also studied. We used RevMan version 5.3.0. to analyze the data. Results Three high‐quality RCTs involving a total of 2120 OAB patients were adopted in the systematic review and pooled analysis. The mean number of micturitions episodes/d (mean difference [MD] = −0.77; 95% confidence interval [CI] = −1.0 to −0.55; P < .00001); the mean number of urgency episodes/d (MD = −0.77; 95% CI = −1.03 to −0.52; P < .00001); mean number of urgency incontinence episodes/d (MD = −0.50; 95% CI = −0.64 to −0.35; P < .00001); mean number of incontinence episodes/d (MD = −0.45; 95% CI = −0.66 to −0.25; P < .0001); and mean volume voided/micturition (MD = 22.22; 95% CI = 17.36 to 27.07, P < .00001) showed that Vibegron was more efficacy in treating OAB than placebo. Dry mouth, drug‐related treatment‐emergent adverse event (TEAE), serious adverse event (SAE), and discontinuations due to adverse event (AE) suggested that Vibegron was well tolerated. Conclusions Our systematic review and pooled analysis demonstrate that Vibegron 75 mg or 100 mg/d statistically significant improved OAB symptoms. The treatment was well‐tolerated, with a favorable safety profile.

Efficacy of mirabegron, a β3‐adrenoreceptor agonist, in Japanese women with overactive bladder and either urgency urinary incontinence or mixed urinary incontinence: Post‐hoc analysis of pooled data from two randomized, placebo‐controlled, double‐blind studies

“…Although vibegron is associated with significant improvements versus placebo in micturition, UUI and maximum voided volume in patients with OAB symptoms with or without incontinence at baseline, there are currently no data in patients with OAB who have MUI. 20,21 As noted previously, incontinence is a particularly bothersome OAB symptom, associated with significant impairment in QOL. 8 In both the UUI and MUI populations, treatment with mirabegron 50 mg resulted in a higher frequency of responders in terms of incontinence normalization rates.…”

“…Vibegron, approved in Japan in 2018, is another selective β 3 ‐adrenergic receptor agonist. Although vibegron is associated with significant improvements versus placebo in micturition, UUI and maximum voided volume in patients with OAB symptoms with or without incontinence at baseline, there are currently no data in patients with OAB who have MUI 20,21 …”

Management of mixed urinary incontinence: IUGA committee opinion

“…This analysis demonstrated improvement in incontinence episodes ( p < 0.001), voided volume ( p = 0.005), and nocturia episodes ( p = 0.03) [ 38 ]. A systematic review on the efficacy of vibegron (β3-adrenoceptor agonist) included 3 RCTs and demonstrated improved urinary frequency, urgency and UUI episodes ( p < 0.0001) [ 37 ].…”

Overactive Bladder: Where We Are and Where We Are Going

“…Recently approved, vibegron is a novel beta-3 agonist that has also shown efficacy in placebo-controlled studies including reduction of micturition episodes and urge incontinence episodes [48,49]. Furthermore, recent RCT data showed no difference in the rates of hypertension between patients on vibegron versus placebo [50].…”