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Clinical Trial
. 2019 Mar;26(3):369-375.
doi: 10.1111/iju.13877. Epub 2018 Dec 17.

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

Masaki Yoshida  1 , Masayuki Takeda  2 , Momokazu Gotoh  3 , Osamu Yokoyama  4 , Hidehiro Kakizaki  5 , Satoru Takahashi  6 , Naoya Masumori  7 , Shinji Nagai  8 , Keita Hashimoto  8 , Kazuyoshi Minemura  8
Affiliations
Clinical Trial

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

Masaki Yoshida et al. Int J Urol. 2019 Mar.

Abstract

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.

Keywords: hours of undisturbed sleep; nocturia; overactive bladder; vibegron; β3-adrenoreceptor agonist.

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Conflict of interest statement

Masaki Yoshida has received consultancy fees from Kyorin; grants from Astellas; and speaker fees from Kyorin, Kissei, Astellas, Daiichi‐Sankyo, Ono and Pfizer. Masayuki Takeda has received consultancy fees from Kyorin; grants from Astellas, Asahi‐Kasei Pharma, GSK, Nippon Shinyaku, Takeda and Pfizer; and speaker fees from Kyorin, Kissei, Astellas, Daiichi‐Sankyo, Nippon Shinyaku, Ono and Pfizer. Momokazu Gotoh has received consultancy fees from Kyorin, Medtronics Japan and Taiho; grants from Kyorin, Kissei, Asahi‐Kasei Pharma, Astellas, Chugai, Daiichi‐Sankyo, Nippon Shinyaku, Novartis, Ono, Pfizer, Sanofi‐Aventis, Taiho and Takeda; and speaker fees from Kyorin, Kissei, Asahi‐Kasei Pharma, Astellas, AstraZeneca, Daiichi‐Sankyo, Hisamitsu, Nippon Shinyaku, Ono, Pfizer, Sanofi‐Aventis and Takeda. Osamu Yokoyama has received consultancy fees from Kyorin, Astellas, GSK, Pfizer and Taiho; grants from Kissei, Astellas, Nippon Shinyaku, Ono, Pfizer and Taiho; and speaker fees from Kissei, Astellas, Nippon Shinyaku and Pfizer. Hidehiro Kakizaki has received consultancy fees from Kyorin, Astellas and Taiho; grants from Kissei, Astellas, Daiichi‐Sankyo, Nippon Shinyaku, Taiho and Takeda; and speaker fees from Kyorin, Kissei, Astellas, Nippon Shinyaku and Pfizer. Satoru Takahashi has received consultancy fees from Kyorin; grants from Astellas and Nippon Shinyaku; and speaker fees from Kyorin, Kissei, Astellas, Nippon Shinyaku and Pfizer. Naoya Masumori has received consultancy fees from Kyorin; research grants from Astellas, Daiichi‐Sankyo, MSD, Ono and Taiho; and received lecture fees from Kyorin, Kissei, Janssen, Nippon Shinyaku, Takeda and Vorpal Technologies. Shinji Nagai, Keita Hashimoto and Kazuyoshi Minemura are employees of Kyorin.

Figures

Figure 1
Figure 1
Change in frequency of nocturnal voiding per 24 h. Blue, red and green bars show the placebo, vibegron 50 mg and vibegron 100 mg groups, respectively. *P < 0.05; **P < 0.001.
Figure 2
Figure 2
Change in volume per nocturnal void. Blue, red and green bars show the placebo, vibegron 50 mg and vibegron 100 mg groups, respectively. **P < 0.001.
Figure 3
Figure 3
Change in volume of the first nocturnal voiding. Blue, red and green bars show the placebo, vibegron 50 mg and vibegron 100 mg groups, respectively. *P < 0.05; **P < 0.001.
Figure 4
Figure 4
Change in HUS. Blue, red and green bars show placebo, vibegron 50 mg and vibegron 100 mg groups, respectively. *P < 0.05.
Figure 5
Figure 5
Correlations of changes in HUS with change in the frequency of nocturnal voiding and in the volume of the first nocturnal voiding. †Spearman's rank correlation coefficient.
Figure 6
Figure 6
Odds ratios of demographic and baseline characteristics associated with a reduction in the frequency of nocturnal voiding. Circles show odds ratio and the bars show 95% CIs.
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References

    1. Abrams P, Cardozo L, Fall M et al Standardisation Sub‐Committee of the International Continence Society. The standardization of terminology of lower urinary tract function: report from the Standardization Sub‐committee of the International Continence Society. Urology 2003; 61: 37–49. - PubMed
    1. Homma Y, Yamaguchi O, Hayashi K; Neurogenic Bladder Society Committee . An epidemiological survey of overactive bladder symptoms in Japan. BJU Int. 2005; 96: 1314–8. - PubMed
    1. Irwin DE, Milsom I, Hunskaar S et al Population‐based survey of urinary incontinence, overactive bladder, and other lower urinary tract symtoms in five countries: results of the EPIC study. Eur. Urol. 2006; 50: 1306–14. - PubMed
    1. Stewart WF, Van Rooyen JB, Cundiff GW et al Prevalence and burden of overactive bladder in the United States. World J. Urol. 2003; 20: 327–36. - PubMed
    1. Yu HJ, Chen FY, Huang PC, Chen TH, Chie WC, Liu CY. Impact of nocturia on symptom‐specific quality of life among community‐dwelling adults aged 40 years and older. Urology 2006; 67: 713–8. - PubMed

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