Efficacy of novel β3 -adrenoreceptor agonist vibegron on nocturia in patients with overactive bladder: A post-hoc analysis of a randomized, double-blind, placebo-controlled phase 3 study.

To investigate the efficacy of vibegron on nocturia in patients with overactive bladder.

Among the Japanese overactive bladder patients enrolled in the placebo-controlled, multicenter, randomized, double-blind phase 3 study of vibegron, a total of 669 patients with nocturia (≥1 nocturnal void) were included. Changes from baseline in micturition parameters were compared for vibegron treatment (50 and 100 mg/day) versus placebo. Correlations of hours of undisturbed sleep with the frequency of nocturnal voiding and the volume of the first nocturnal voiding were examined. Demographics and baseline characteristics contributing to reduction in the frequency of nocturnal voiding were also analyzed.

At week 12, the frequency of nocturnal voiding was reduced from baseline by 0.74 and 0.78, respectively, for the vibegron 50 and 100 mg groups; the reductions were significant when compared with the placebo group (P < 0.05 and P < 0.001, respectively). The mean volume of nocturnal voids and the volume of the first nocturnal voiding were significantly greater in the vibegron groups than in the placebo group. The vibegron groups showed significant correlations of hours of undisturbed sleep with the changes in the frequency of nocturnal voiding and in the volume of the first nocturnal voiding. Vibegron treatment, no previous treatment with anticholinergics, ≥12 voids per day and hours of undisturbed sleep <180 min significantly contributed to a reduction in the frequency of nocturnal voiding.

Vibegron is a useful therapeutic option for improving nocturia in patients with overactive bladder.

International journal of urology : official journal of the Japanese Urological Association. 2018 Dec 17 [Epub ahead of print]

Masaki Yoshida, Masayuki Takeda, Momokazu Gotoh, Osamu Yokoyama, Hidehiro Kakizaki, Satoru Takahashi, Naoya Masumori, Shinji Nagai, Keita Hashimoto, Kazuyoshi Minemura

Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Aichi, Japan., Department of Urology, Graduate School of Medical Sciences, University of Yamanashi, Kofu, Yamanashi, Japan., Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Aichi, Japan., Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan., Department of Renal and Urologic Surgery, Asahikawa Medical University, Asahikawa, Japan., Department of Urology, Nihon University School of Medicine, Tokyo, Japan., Department of Urology, School of Medicine, Sapporo Medical University, Sapporo, Hokkaido, Japan., Kyorin Pharmaceutical, Tokyo, Japan.