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Efficacy of novel β 3 ‐adrenoreceptor agonist vibegron on nocturia in patients with overactive bladder: A post‐hoc analysis of a randomized, double‐blind, placebo‐controlled phase 3 study
Author(s) -
Yoshida Masaki,
Takeda Masayuki,
Gotoh Momokazu,
Yokoyama Osamu,
Kakizaki Hidehiro,
Takahashi Satoru,
Masumori Naoya,
Nagai Shinji,
Hashimoto Keita,
Minemura Kazuyoshi
Publication year - 2019
Publication title -
international journal of urology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.172
H-Index - 67
eISSN - 1442-2042
pISSN - 0919-8172
DOI - 10.1111/iju.13877
Subject(s) - nocturia , medicine , overactive bladder , placebo , urination , urology , nocturnal , post hoc analysis , randomized controlled trial , anesthesia , urinary system , alternative medicine , pathology
Objectives To investigate the efficacy of vibegron on nocturia in patients with overactive bladder. Methods 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. Results 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. Conclusions Vibegron is a useful therapeutic option for improving nocturia in patients with overactive bladder.