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Comparison of mirabegron and vibegron for clinical efficacy and safety in female patients with overactive bladder: a multicenter prospective randomized crossover trial

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A Letter to the Editor to this article was published on 13 May 2024

Abstract

Purpose

To compare the efficacy and safety of mirabegron and vibegron in female OAB patients.

Methods

We conducted a multicenter, prospective, randomized crossover study of female patients with OAB. The patients were assigned to Group MV (mirabegron for 8 weeks, followed by vibegron for 8 weeks) or group VM (vibegron for 8 weeks, followed by mirabegron for 8 weeks). The primary endpoint was the change in OABSS from baseline, and the secondary endpoint was the change in FVC parameters. After completion of the study, each patient was asked which drug was preferable.

Results

A total of 83 patients were enrolled (40 and 43 in groups MV and VM, respectively). At 8th and 16th week, 33 and 29 in Group MV and 34 and 27 in Group VM continued to receive the treatment. The change in PVR was not significantly different between treatment with mirabegron and vibegron. The changes in OABSS, nighttime frequency, mean, and maximum voided volume were similar between mirabegron and vibegron. The mean change in the daytime frequency was greater in the vibegron than in the mirabegron. Of the 56 patients, 15 (27%) and 30 (53%) preferred mirabegron and vibegron, respectively. The remaining 11 patients (20%) showed no preference. The change in the urgency incontinence score during vibegron was better in patients who preferred vibegron to mirabegron.

Conclusion

The efficacies of mirabegron and vibegron in female patients was similar. The patients’ preference for vibegron could depend on the efficacy of vibegron for urgency incontinence.

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Data availability

The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations

AE:

Adverse event

CYP:

Cytochrome P450

FAS:

Full analysis set

FVC:

Frequency-volume charts

LMMs:

Linear mixed-effects models

OAB:

Overactive bladder

OABSS:

Overactive bladder symptom score

PPS:

Per-protocol set

PVR:

Post-void residual

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Acknowledgements

We wish to thank Ayumi Shintani, Department of Medical Statistics, Osaka City University School of Medicine, and Graduate School of Medicine, for their advice on statistical analysis.

Funding

None.

Author information

Authors and Affiliations

  1. Department of Renal and Urologic Surgery, Asahikawa Medical University, 2-1-1-1 Midorigaoka Higashi, Asahikawa, 078-8510, Japan

    Naoki Wada, Noriyuki Abe, Kotona Miyauchi, Shin Kobayashi, Miyu Ohtani, Ryoken Tsunekawa, Masaya Nagabuchi, Shun Morishita & Hidehiro Kakizaki

  2. Nagayama Renal and Urology Clinic, Asahikawa, Japan

    Mitsuhiro Mizunaga

  3. Department of Urology, Kitasaito Hospital, Asahikawa, Japan

    Teppei Ohyama & Satoshi Yamaguchi

  4. Department of Urology, Hokushinkai Megumino Hospital, Eniwa, Japan

    Hiromichi Iuchi

  5. Department of Urology, Fukagawa City Hospital, Fukagawa, Japan

    Tsuyoshi Noda & Yuji Saga

  6. Department of Urology, Asahikawa Rehabilitation Hospital, Asahikawa, Japan

    Tadasu Motoya & Norihiro Kawakami

  7. Nishihara Nephro-Urology Clinic, Rumoi, Japan

    Masayuki Nishihara

  8. Department of Urology, Furano Kyokai Hospital, Furano, Japan

    Atsushi Numata

Authors
  1. Naoki Wada
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  2. Mitsuhiro Mizunaga
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  3. Noriyuki Abe
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  4. Kotona Miyauchi
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  5. Shin Kobayashi
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  7. Ryoken Tsunekawa
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  8. Masaya Nagabuchi
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  10. Teppei Ohyama
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  11. Satoshi Yamaguchi
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  12. Hiromichi Iuchi
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  13. Tsuyoshi Noda
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  14. Yuji Saga
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  15. Tadasu Motoya
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  16. Norihiro Kawakami
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  17. Masayuki Nishihara
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  18. Atsushi Numata
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  19. Hidehiro Kakizaki
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Contributions

NW contributed to protocol/project development, NA, KM, SK, MO, RT, MN, SM, TO, HI, TN, TM, and MN to the data collection, NW SY, YS, NK, and AN to the data analysis, NW to the drafting the manuscript, HK to the critical revision of the manuscript for scientific and factual content, NW to the statistical analysis, and HK to the supervision.

Corresponding author

Correspondence to Naoki Wada.

Ethics declarations

Conflict of interest

Naoki Wada received speaker honorarium from Astellas Pharma Inc. Hidehiro Kakizaki received speaker honorarium from Astella Pharma Inc., Kyorin and Kissei. The other authors declare that they have no conflicts of interest to disclose.

Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. The ethics committee of Asahikawa Medical University approved the study protocol (approval number:18174).

Informed consent

Informed consent was obtained from all individual participants included in the study before enrollment. This study was registered at https://center.umin.ac.jp as UMIN000034720.

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Wada, N., Mizunaga, M., Abe, N. et al. Comparison of mirabegron and vibegron for clinical efficacy and safety in female patients with overactive bladder: a multicenter prospective randomized crossover trial. World J Urol 42, 113 (2024). https://doi.org/10.1007/s00345-024-04799-4

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