HealthDay News — For men with lower urinary tract symptoms, treatment is associated with a reduced risk for death, according to a study published in the October 1 issue of The Journal of Urology.

Blayne Welk, MD, and J. Andrew McClure, from Western University in London, Ontario, Canada, conducted a secondary analysis of the Medical Treatment of Prostate Symptoms randomized trial of placebo, doxazosin, finasteride, or a combination of doxazosin and finasteride involving 3046 men aged older than 50 years with moderate-to-severe lower urinary tract symptoms. The relationship between the American Urology Association (AUA) Symptom Score and death was examined.

The researchers found that the hazard ratio for death was 0.96 for each 1-point improvement in the AUA Symptom Score. A similar significant reduction in the hazard ratio for death was seen for men who had active treatment, but not for those randomly assigned to the placebo arm. The results were unchanged when men were censored at the time of transurethral prostate resection, after adjustment for potential confounding variables, or with a shorter observation period after the last study visit. With 1-point improvements in the storage and voiding subscales individually, comparable significant reductions in death were seen (hazard ratios, 0.94 and 0.95, respectively).

“We found a small but significant decrease in mortality risk for older men who received medications for treatment of lower urinary tract symptoms,” Welk said in a statement. “The findings suggest that we may need to view urinary symptoms differently, possibly with an emphasis on earlier treatment.”

One author is a consultant for Becton, Dickinson, and Company.

Abstract/Full Text

Editorial (subscription or payment may be required)

A phase 3 study evaluating the efficacy and safety of vibegron in men with overactive bladder (OAB) symptoms receiving pharmacological therapy for benign prostatic hyperplasia (BPH) met its coprimary and all secondary endpoints.  

Vibegron is an oral, small molecule beta-3 adrenergic receptor agonist. The multicenter, randomized, double-blind, URO-901-3005 study (ClinicalTrials.gov Identifier: NCT03902080) included 1105 men with OAB symptoms receiving pharmacological therapy for BPH (eg, alpha blocker monotherapy or alpha blocker in combination with 5 alpha reductase inhibitor). Study participants were randomly assigned to receive vibegron 75mg orally once daily or placebo for 24 weeks. 

Results showed that treatment with vibegron met the coprimary endpoints demonstrating statistically significant reductions from baseline in daily micturitions (-2.04 [SE: 0.109]; P <.0001) and in daily urgency episodes (-2.88 [SE: 0.164]; P <.0001) at week 12 vs placebo (-1.30 [SE: 0.109] and -1.93 [SE: 0.164], respectively). 

Additionally, statistically significant reductions were observed with vibegron in key secondary endpoints vs placebo, including the average number of nocturia episodes per night (-0.88 vs -0.66, respectively; P =.0015); the average number of urge urinary incontinence episodes per day (-2.19 vs -1.39, respectively; P =.0034); and the International Prostate Symptoms Storage score (-3.0 vs -2.1, respectively; P =.0001). 

Vibegron was also associated with a statistically significant increase in the average volume voided per micturition (25.63mL) compared with placebo (10.56mL; P <.0001). No new safety signals were reported in the trial.

Patients who completed the URO-901-3005 were eligible to continue to the open-label URO-901-3006 extension-study (ClinicalTrials.gov Identifier: NCT04103450). Results showed all endpoints were maintained up to 52 weeks.

“We are pleased to share the results of this study, which underscores the promise of one of our key marketed assets beyond its initial approved indication,” said Myrtle Potter, President and Chief Executive Officer of SMPA. “With these positive data, we look forward to exploring the potential of vibegron as an option for men experiencing OAB symptoms and BPH.”

Vibegron is currently marketed under the brand name Gemtesa for the treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.