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

International Journal of Urology : Official Journal of the Japanese Urological Association
Masaki YoshidaTakafumi Kurose

Abstract

To evaluate the long-term safety and efficacy of vibegron 50 mg and 100 mg, a novel β3 -adrenoreceptor agonist, in Japanese patients with overactive bladder. 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. 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 ...Continue Reading

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Citations

Oct 24, 2019·Lower Urinary Tract Symptoms·Osamu SomaChikara Ohyama
Oct 1, 2020·Expert Opinion on Pharmacotherapy·Tomasz Rechberger, Andrzej Wróbel
Sep 25, 2020·F1000Research·George AraklitisLinda Cardozo
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May 21, 2020·International Journal of Urology : Official Journal of the Japanese Urological Association·Shuichiro FujinagaMayu Nakagawa
Oct 23, 2020·Current Urology Reports·Cora FogaingLysanne Campeau
Mar 3, 2021·International Journal of Urology : Official Journal of the Japanese Urological Association·Satoru TakahashiTsuyoshi Yoshizawa
Jul 18, 2021·International Journal of Urology : Official Journal of the Japanese Urological Association·Nobutaka ShimizuHirotsugu Uemura
May 30, 2021·International Urology and Nephrology·Fengli Wang, Lujin Li
Oct 6, 2021·International Journal of Urology : Official Journal of the Japanese Urological Association·Katsuya AokiKiyohide Fujimoto

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