Vibegron improves quality of life (QoL) and incontinence with good long-term tolerability in patients with overactive bladder (OAB) and symptoms of urge urinary incontinence (UUI), investigators reported at ICS 2020 Online, the virtual meeting of the International Continence Society.
Patients with OAB often experience poor sleep, fatigue, difficulty with daily activities, and other decrements in quality of life.
“A large segment of the OAB population suffers in silence because they are embarrassed, afraid, or unaware that there are treatments, including medications that could address their problems with bladder control,” said EMPOWUR principal investigator David Staskin, MD, of St. Elizabeth’s Medical Center and Tufts University School of Medicine in Boston, Massachusetts, according to a press release. “This situation leads to OAB being overlooked and undertreated, and highlights the need for therapeutic options to improve quality of life.”
Vibegron is a once-daily, beta-3 adrenergic agonist under FDA investigation for the treatment of OAB.
In the EMPOWUR trial and extension study, 61% of 143 vibegron-treated patients had a 75% or greater reduction and 40.8% had a 100% reduction in UUI symptoms at week 52. In addition, 71.1% experienced at least a 50% decline in total incontinence episodes from baseline.
Importantly, vibegron (75 mg once daily) also improved all QoL subscale scores on the Overactive Bladder Questionnaire Long Form (OAB-qLF) — including coping (27.1 vs 22.1), concern (26.7 vs 22.4), sleep (22.1 vs 21.4), social interaction (17.2 vs 13.3), health-related QoL (24.0 vs 20.3), and symptom bother (-29.1 vs -25.3) — compared with the antimuscarinic tolterodine.
No new safety signals were detected. Adverse events (AEs) occurred in 62.6% (171 of 273) of vibegron and 54.3% (126 of 232) of tolterodine patients. Four (1.5%) vibegron and 8 (3.4%) tolterodine patients discontinued their study medication due to an AE. These results were consistent with those in the original trial. Key AEs (greater than 5%) were hypertension (8.8% and 8.6%), urinary tract infection (6.6% and 7.3%), and headache (5.5% and 3.9%) for vibegron and tolterodine, respectively. One death (due to arteriosclerotic cardiovascular disease, judged not related to study drug by investigators or
sponsor) occurred in the vibegron group.
“The EMPOWUR 40-week extension study demonstrated how vibegron, if approved by the FDA, has the potential to offer a lasting solution for adult patients with OAB to manage urinary frequency and urinary incontinence associated with the urgent need to go to the bathroom,” Dr Staskin said.
Disclosure: This clinical trial was supported by Urovant Sciences. Please see the original reference for a full list of authors’ disclosures.
Urovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension Study [press release]. Urovant Sciences; November 19, 2020.
Staskin D, Frankel J, Varano S, et al. Once-daily vibegron 75 mg for overactive bladder (OAB): Double-blind 52-week results from an extension study of the international phase 3 trial (EMPOWUR). J Urol.
Staskin D, et al. Once-daily vibegron 75 mg improves quality-of-life and incontinence efficacy endpoints in patients with overactive bladder: double-blind 52-week results from an extension study of the EMPOWUR international phase 3 trial. Presented at: ICS 2020 Online, November 19-22, 2020. Abstract 440.