Vibegron is effective for overactive bladder in men with BPH

The drug vibegron led to improvements in overactive bladder symptoms and overall quality of life in men undergoing treatment for benign prostatic hyperplasia, according to results of a phase 3 trial presented May 6, 2024 at American Urological Association (AUA) 2024 Annual Meeting in San Antonio, Texas, and data published in Journal of Urology.

“Vibegron was associated with significant reductions in daily urination and urgency episodes, as well as our secondary endpoints,” David R. Staskin, MD, associate professor of urology at Tufts University School of Medicine, told attendees from Boston. “Symptoms actually improved compared to placebo from week 2.”

Vibegron is a selective beta-3 adrenergic receptor agonist approved in 2020 by the US Food and Drug Administration for the treatment of overactive bladder.

However, treating overactive bladder symptoms in patients undergoing treatment for benign prostatic hyperplasia is more complex because the benign prostatic hyperplasia itself can contribute to overactive bladder symptoms, said Kara Watts, MD, professor urology associate at Montefiore Einstein in New York City, who was not. involved in the new research.

“Management of overactive bladder in this setting may also require treatment of benign prostatic hyperplasia, but a discussion of the relationship between benign hyperplasia and overactive bladder symptoms is important,” Watts said. Medscape Medical News. “Beyond consideration of treatment for benign prostatic hyperplasia, which may be in the form of medications or surgery to reduce the size of the prostate, treatment of overactive bladder may include behavioral modifications,” such as avoiding irritants of the bladder, scheduled urination, managing constipation, and nocturnal fluid restriction,” as well as “medications, percutaneous tibial nerve stimulation, and sometimes more invasive options.”

Vibegron “represents a very attractive and effective pharmacologic management option for overactive bladder,” both in patients with and without BPH, Watts said. “It has a favorable side effect profile compared to other oral agents that may be prescribed for overactive bladder, such as anticholinergics, and also has the added benefit of a much lower risk of urinary retention compared to most of other oral agents”.

Among 1104 men aged at least 45 who were being treated for benign prostatic hyperplasia and had symptoms of overactive bladder, 538 received 75 mg of vibegron and 542 received a placebo. Men in the vibegron group showed 2.04 fewer mean daily voidings at 12 weeks and 2.2 fewer at 24 weeks compared with 1.3 fewer at 12 and 24 weeks for men in the placebo group (p <.0001), according to the researchers.

The drug also reduced the urge to urinate. Mean daily urge episodes were 2.88 fewer at 12 weeks and 3.07 fewer at 24 weeks in the vibegron group compared with 1.93 and 2.17 fewer, respectively, in the placebo group (p <.0001).

In side effects, those taking vibegron experienced 0.22 fewer episodes of nocturia (p = 0.002), 0.8 fewer episodes of urge incontinence (p = 0.003), a difference of 0.9 points in improvement in the International Prostate Symptom Score (p <.0001), and about 15 ml more void volume (p <.0001) compared with those who received placebo, the researchers reported.

“The clinical significance of these findings is that vibegron represents an effective pharmacologic option for the management of overactive bladder in the setting of concomitant benign prostatic hyperplasia, which is a broader context than its original bladder-only approval hyperactive,” Watts said.

Data from 969 patients on the Overactive Bladder Quality of Life Questionnaire found that the symptom bother score was 6.2 points better for men in the vibegron group than those who took a placebo (p <.0001) at 12 weeks. Similarly, the total health-related quality of life score was 4.3 points better in the vibegron group (p <.0001). Measures of worry, coping, and sleep also improved significantly in men taking vibegron and remained significant at 24 weeks (p <.0001).

Rates of adverse events were similar in the vibegron (45%) and placebo (39%) groups. The most common adverse event was hypertension, which occurred in 9% of the vibegron group and 8.3% of men in the placebo group.

The research was funded by Sumitomo Pharma America, Inc., which makes vibegron. Staskin is a consultant for Astellas, AzuraBio, Sumitomo Pharma America, Inc. and UroCure; he is a professor at Astellas and Sumitomo; and has other interests in UroCure, AzuraBio and Quillitin Pharma. Three co-authors are employees of Sumitomo; one is a Sumitomo investigator and another has consulted for Hologic, received research funding from Allergan/AbbVie and Uromedica, and participated in clinical trials on behalf of Sumitomo. Watts reported no relevant financial conflicts of interest.

Tara Haelle is a freelance science journalist based in Dallas.