Long‐term safety and efficacy of the novel β₃‐adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study

Abstract

Objectives: To evaluate the long-term safety and efficacy of vibegron 50 mg and 100 mg, a novel b 3 -adrenoreceptor agonist, in Japanese patients with overactive bladder.Methods: This was a 1-year, multicenter, open-label, non-controlled study. After a 1-week observation phase, patients were treated with vibegron for 52 weeks. When the efficacy was insufficient after an 8-week treatment with 50 mg, the dose was increased to 100 mg and maintained for an additional 44 weeks. Results: Among a total of 169 patients receiving one or more doses of vibegron, 118 (69.8%) received vibegron 50 mg for 52 weeks, and the dose was increased to 100 mg in 51 (30.2%) patients. The incidence of drug-related adverse events was 18.1% (21/116) in the vibegron 50 mg group and 11.8% (6/51) in the vibegron 100 mg group. Most frequent drug-related adverse events were dry mouth (3.0%), residual urine volume increased (3.0%), constipation (2.4%) and cystitis (1.8%). Statistically significant changes in overactive bladder symptom variables (daily means of micturitions, urgency episodes, urgency incontinence episodes, incontinence episodes and night-time frequency) from baseline were observed at week 4 and maintained until week 52. The condition of patients who did not respond well to vibegron 50 mg was much improved by increasing the dose to 100 mg. Vibegron improved the quality of life, and the proportion of patients' satisfaction after the treatment with vibegron was high. Conclusions: Long-term (52-week) treatment with vibegron is safe, well-tolerated and effective in patients with overactive bladder.

Relationship between frailty and lower urinary tract symptoms among community‐dwelling adults

“…Lower urinary tract symptoms (LUTS) are among the most common urologic conditions in the older population . As the incidence of LUTS and frailty increases with age, the concept of frailty has been recognized as a key factor in older individuals with LUTS . However, only a few studies have evaluated the influence of frailty on LUTS .…”

Editorial Comment from Dr Chapple to Long‐term safety and efficacy of the novel β3‐adrenoreceptor agonist vibegron in Japanese patients with overactive bladder: A phase III prospective study

“…This interesting manuscript by Yoshida et al . represents the long‐term data on safety and efficacy of a new beta 3 agonist, vibegron 50 mg and 100 mg . This study shows the importance of dose titration, in that 30.2% of patients increased the dose up to 100 mg. An important feature of the data set is the low incidence of side effects which could be attributed to pharmacological action of the drug.…”

The efficacy and safety of Vibegron in treating overactive bladder: A systematic review and pooled analysis of randomized controlled trials

“…This proves that the treatment with vibegron is well tolerated in patients with OAB. Also, Yoshida et al 19 conducted a 1‐year, open‐label, multicenter, noncontrolled study which reported that the incidence of drug‐related AE was 11.8% in Vibegron 100 mg set. As for the incidences of the adverse events, the most common AE were nasopharyngitis, dry mouth, cystitis, and constipation.…”