Overactive bladder treatment safe, effective in extension study
Results from the EMPOWUR extension study presented at the virtual International Continence Society Annual Meeting showed that vibegron, a beta-3 adrenergic agonist taken daily, could help treat patients with overactive bladder.
“A large segment of the [overactive bladder (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,” David Staskin, MD, principal investigator of the EMPOWUR study and associate professor of urology at Tufts University School of Medicine in Massachusetts, said in a press release issued by the manufacturer. “This situation leads to OAB being overlooked and undertreated and highlights the need for therapeutic options to improve quality of life.”
Staskin and colleagues conducted a long-term extension study of the phase 3 EMPOWER study to further evaluate the efficacy and safety of vibegron (Urovant Science) compared with tolterodine. The extended study added 40 weeks to the initial 12-week study for a total patient exposure of 52 weeks.
The researchers determined that among the 143 patients who received 75 mg of vibegron, 61% experienced a 75% or greater reduction in urgent urinary incontinence, and 40.8% experienced a 100% reduction in these symptoms at week 52.
Staskin and colleagues also found that 71.1% of patients treated with vibegron had a 50% or greater reduction in incontinence episodes from baseline to the end of the extension study.
During this time, the researchers found that vibegron demonstrated numerically larger improvements from the baseline in quality of life scores measured by a questionnaire, which included coping, concern, sleep, social interactions and health-related quality of life compared with tolterodine.
According to the researchers, vibegron at 75 mg daily had similar safety profiles in both the 40-week extension and the initial 12-week study.
The researchers reported that 62.6% of those who received vibegron and 54.3% of those who received tolterodine experienced adverse effects, with 1.5% of those who received vibegron and 3.4% of those who received tolterodine discontinuing the study due to these effects.
“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,” Staskin said in the press release.