Vibegron Effective and Safe for Treating Overactive Bladder in Adults, Elderly Population: Presented at AUA

 A once-daily regimen of the oral beta3-adrenoceptor (AR) agonist vibegron is effective in the treatment of overactive bladder, including elderly populations, according to results of the phase 3 EMPOWUR trial, presented at the 2019 Annual Meeting of the American Urological Association (AUA).

"The early onset of action of vibegron was statistically superior to placebo at 2 weeks with the 75 mg dose, with no dose adjustment or titration," remarked lead author David Staskin, MD, Tufts University School of Medicine, Boston, Massachusetts, speaking here at a late-breaker podium session on May 5. "Very good efficacy numbers were evident on the key symptoms of urgency and urinary urge incontinence," he added.

In the EMPOWUR trial, Dr. Staskin and colleagues randomised adults with symptoms of overactive bladder to receive once-daily vibegron 75 mg (n = 526), placebo (n = 520), or extended-release tolterodine 4 mg (n = 417). (The trial was not powered to detect a statistically significant difference between vibegron and tolterodine.)

The arms comprised approximately 85% women.

By week 2 of the 12-week trial, Dr. Staskin and colleagues observed a significant benefit for vibegron versus placebo in the reduction of daily micturations (P< .001). They also noted the superiority of vibegron to placebo at 2 weeks in reducing daily urgency episodes (P< .001).

At week 12, the investigators recorded a significant benefit for vibegron versus placebo in increasing volume voided per micturition (mean difference 21.2 cc [95% CI: 14.3 cc to 28.1 cc]; P< .0001).

Key subpopulations experienced similar benefits for vibegron versus placebo for micturition and episodes of urgent urinary incontinence, including patients aged 65 years and older, and those with a prior history of anticholinergic and/or mirabegron use.

The researchers noted comparable adverse events between the 3 arms, including events of particular concern: hypertension, increased blood pressure, urinary-tract infection, and urinary retention. Both active treatments produced a greater rate of dry mouth (1.7% for vibegron and 6.5% for tolterodine) compared with placebo (0.9%), but this was considered manageable.

"Vibegron is very well tolerated and has a very good safety profile, with few adverse events above 2%," Dr. Staskin concluded. "With the drug class of beta 3 agonists, it is important [to note] that vibegron had adverse-event rates similar to placebo rates for hypertension, urinary-tract infections, and urinary retention."

As part of the 1-year extension trial, an ambulatory blood-pressure study is ongoing to fully evaluate the heart-rate and blood-pressure profile for vibegron. Additionally, a specific study is underway on appropriate medication in men with bladder-outlet obstruction, as males represented a smaller portion of the current study population.

Since this study represents an adequate elderly population -- approximately 40% of patients were over 65 years of age and approximately 12% were over 75 years of age -- the authors feel the data are suitable for further studies of elderly subjects with overactive bladder.

Funding for this study was provided by Urovant Sciences Inc., Irvine, California.

[Presentation title: Late-Breaking Abstract: International Phase 3, Double-Blind, Placebo- and Active (Tolterodine)-Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR.Abstract LBA-02]

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