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Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia

  • Benign Prostatic Hyperplasia (K McVary, Section Editor)
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Abstract

Purpose of Review

To review the efficacy and safety of mirabegron in men with overactive bladder (OAB) and benign prostatic hyperplasia (BPH).

Recent Findings

Numerous studies have shown mirabegron to be efficacious and safe in treating symptoms of OAB. More recent studies evaluating the use of mirabegron in men with OAB and BPH have also shown the medication to be effective with few adverse side effects when used as monotherapy or in combination therapy.

Summary

Mirabegron is an effective and safe treatment for men with OAB and BPH.

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References

Papers of particular interest, published recently, have been highlighted as: • Of importance •• Of major importance

  1. D’Ancona C, Haylen B, Oelke M, Abranches-Monteiro L, Arnold E, Goldman H, et al. The International Continence Society (ICS) report on the terminology for adult male lower urinary tract and pelvic floor symptoms and dysfunction. Neurourol Urodyn. 2019;38:433–77. https://doi.org/10.1002/nau.23897.

    Article  PubMed  Google Scholar 

  2. Irwin DE, Milsom I, Hunskaar S, Reilly K, Kopp ZS, Herschorn S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006;50:1306–14.

    Article  Google Scholar 

  3. Irwin DE, Milsom I, Kopp ZS, Abrams P, Artibani W, Herschorn S. Prevalence, severity, and symptom bother of lower urinary tract symptoms among men in the EPIC study: impact of overactive bladder. Eur Urol. 2009;56:14–20. https://doi.org/10.1016/j.eururo.2009.02.026.

    Article  PubMed  Google Scholar 

  4. Agarwal A, Eryuzlu LN, Cartwright R, Thorlund K, Tammela TL, Guyatt GH, et al. What is the most bothersome lower urinary tract symptom? Individual- and population-level perspectives for both men and women. Eur Urol. 2014;65:1211–7. https://doi.org/10.1016/j.eururo.2014.01.019.

    Article  PubMed  PubMed Central  Google Scholar 

  5. Irwin DE, Kopp ZS, Agatep B, Milsom I, Abrams P. Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJU Int. 2011;108:1132–8. https://doi.org/10.1111/j.1464-410X.2010.09993.x.

    Article  PubMed  Google Scholar 

  6. Gibson W, Wagg A. Incontinence in the elderly, ‘normal’ ageing, or unaddressed pathology? Nat Rev Urol. 2017;14:440–8. https://doi.org/10.1038/nrurol.2017.53.

    Article  PubMed  Google Scholar 

  7. Egan KB. The epidemiology of benign prostatic hyperplasia associated with lower urinary tract symptoms: prevalence and incident rates. Urol Clin North Am. 2016;43:289–97. https://doi.org/10.1016/j.ucl.2016.04.001.

    Article  PubMed  Google Scholar 

  8. de Nunzio C, Franco G, Rocchegiani A, Iori F, Leonardo C, Laurenti C. The evolution of detrusor overactivity after watchful waiting, medical therapy and surgery in patients with bladder outlet obstruction. J Urol. 2003;169:535–9.

    Article  Google Scholar 

  9. Lee JY, Kim HW, Lee SJ, Koh JS, Suh HJ, Chancellor MB. Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder. BJU Int. 2004;94:817–20.

    Article  CAS  Google Scholar 

  10. Lightner DJ, Gomelsky A, Souter L, Vasavada SP. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU Guideline Amendment 2019. J Urol. 2019;202:558–63. https://doi.org/10.1097/JU.0000000000000309.

    Article  PubMed  Google Scholar 

  11. Gravas S, Cornu JN, Gacci M, Gratzke C, Herrmann TRW, Mamoulakis C, et al. Management of non-neurogenic male lower urinary tract symptoms including benign prostatic obstruction. EAU Guidelines. Edn. presented at the EAU Annual Congress Barcelona. 2019.

  12. Chapple CR, Khullar V, Gabriel Z, Muston D, Bitoun CE, Weinstein D. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol. 2008;54:543–62.

    Article  CAS  Google Scholar 

  13. Kaplan SA, Roehrborn CG, Abrams P, Chapple CR, Bavendam T, Guan Z. Antimuscarinics for treatment of storage lower urinary tract symptoms in men: a systematic review. Int J Clin Pract. 2011;65:487–507. https://doi.org/10.1111/j.1742-1241.2010.02611.x.

    Article  CAS  PubMed  Google Scholar 

  14. Chapple CR, Nazir J, Hakimi Z, Bowditch S, Fatoye F, Guelfucci F, et al. Persistence and adherence with mirabegron versus antimuscarinic agents in patients with overactive bladder: a retrospective observational study in UK clinical practice. Eur Urol. 2017;72:389–99. https://doi.org/10.1016/j.eururo.2017.01.037.

    Article  CAS  PubMed  Google Scholar 

  15. Andersson KE, Cardozo L, Cruz F, Lee KS, Sahai A, Wein AJ. Pharmacological treatment of urinary incontinence. In: Abrams P, Cardozo L, Wagg A, Wein AJ, editors. Incontinence. 6th ed. Bristol: International Continence Society; 2017.

    Google Scholar 

  16. Alexandre EC, Kiguti LR, Calmasini FB, Silva FH, da Silva KP, Ferreira R, et al. Mirabegron relaxes urethral smooth muscle by a dual mechanism involving β3-adrenoceptor activation and α1-adrenoceptor blockade. Br J Pharmacol. 2016;173:415–28. https://doi.org/10.1111/bph.13367.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  17. Khullar V, Amarenco G, Angulo JC, Cambronero J, Høye K, Milsom I, et al. Efficacy and tolerability of mirabegron, a β(3)-adrenoceptor agonist, in patients with overactive bladder: results from a randomised European-Australian phase 3 trial. Eur Urol. 2013;63:283–95. https://doi.org/10.1016/j.eururo.2012.10.016.

    Article  CAS  PubMed  Google Scholar 

  18. Chapple CR, Kaplan SA, Mitcheson DH, Klecka J, Cummings J, Drogendijk T, et al. Randomized double-blind, active-controlled phase 3 study to assess 12-month safety and efficacy of mirabegron, a β(3)-adrenoceptor agonist, in overactive bladder. Eur Urol. 2013;63:296–305. https://doi.org/10.1016/j.eururo.2012.10.048.

    Article  CAS  PubMed  Google Scholar 

  19. Nitti VW, Auerbach S, Martin NE, Calhoun A, Lee M, Herschorn S. Results of a randomized phase III trial of mirabegron in patients with overactive bladder. J Urol. 2013;189:1388–95. https://doi.org/10.1016/j.juro.2012.10.017.

    Article  CAS  PubMed  Google Scholar 

  20. Herschorn S, Barkin J, Castro-Diaz D, Frankel JM, Espuna-Pons M, Gousse AE, et al. A phase III, randomized, double-blind, parallel-group, placebo-controlled, multicentre study to assess the efficacy and safety of the β3 adrenoceptor agonist, mirabegron, in patients with symptoms of overactive bladder. Urology. 2013;82:313–20. https://doi.org/10.1016/j.urology.2013.02.077.

    Article  PubMed  Google Scholar 

  21. Batista JE, Kölbl H, Herschorn S, Rechberger T, Cambronero J, Halaska M, et al. The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial. Ther Adv Urol. 2015;7:167–79. https://doi.org/10.1177/1756287215589250.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  22. Yamaguchi O, Ikeda Y, Ohkawa S. Phase III study to assess long-term (52-week) safety and efficacy of Mirabegron, a β(3)-adrenoceptor agonist, in Japanese patients with overactive bladder. Low Urin Tract Symptoms. 2017;9:38–45. https://doi.org/10.1111/luts.12107.

    Article  CAS  PubMed  Google Scholar 

  23. • Tubaro A, Batista JE, Nitti VW, Herschorn S, Chapple CR, Blauwet MB, et al. Efficacy and safety of daily mirabegron 50 mg in male patients with overactive bladder: a critical analysis of five phase III studies. Ther Adv Urol. 2017;9:137–54. https://doi.org/10.1177/1756287217702797. Pooled analysis of randomized controlled trials showing mirabegron to be effective and safe in men with OAB with or without BPH associated LUTS.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  24. Nozawa Y, Kato D, Tabuchi H, Kuroishi K. Safety and effectiveness of mirabegron in patients with overactive bladder in a real-world clinical setting: a Japanese post-marketing study. Low Urin Tract Symptoms. 2018;10(2):122–30. https://doi.org/10.1111/luts.12148.

    Article  CAS  PubMed  Google Scholar 

  25. Otsuki H, Kosaka T, Nakamura K, Mishima J, Kuwahara Y, Tsukamoto T. β3-Adrenoceptor agonist mirabegron is effective for overactive bladder that is unresponsive to antimuscarinic treatment or is related to benign prostatic hyperplasia in men. Int Urol Nephrol. 2013;45:53–60. https://doi.org/10.1007/s11255-012-0343-5.

    Article  CAS  PubMed  Google Scholar 

  26. Maeda T, Kikuchi E, Hasegawa M, Ishioka K, Hagiwara M, Miyazaki Y, et al. Solifenacin or mirabegron could improve persistent overactive bladder symptoms after dutasteride treatment in patients with benign prostatic hyperplasia. Urology. 2015;85:1151–5. https://doi.org/10.1016/j.urology.2015.01.028.

    Article  PubMed  Google Scholar 

  27. • Wada N, Iuchi H, Kita M, Hashizume K, Matsumoto S, Kakizaki H. Urodynamic efficacy and safety of mirabegron add-on treatment with tamsulosin for Japanese male patients with overactive bladder. Low Urin Tract Symptoms. 2016;8:171–6. https://doi.org/10.1111/luts.12091. Prospective study showing urodynamic efficacy and safety of adding mirabegron to tamsulosin in men with OAB and BPH.

    Article  CAS  PubMed  Google Scholar 

  28. Matsuo T, Miyata Y, Kakoki K, Yuzuriha M, Asai A, Ohba K, et al. The efficacy of mirabegron additional therapy for lower urinary tract symptoms after treatment with α1-adrenergic receptor blocker monotherapy: prospective analysis of elderly men. BMC Urol. 2016;16:45. https://doi.org/10.1186/s12894-016-0165-3.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  29. Liao CH, Kuo HC. Mirabegron 25 mg monotherapy is safe but less effective in male patients with overactive bladder and bladder outlet obstruction. Urology. 2018;117:115–9. https://doi.org/10.1016/j.urology.2018.03.038.

    Article  PubMed  Google Scholar 

  30. • Nitti VW, Rosenberg S, Mitcheson DH, He W, Fakhoury A, Martin NE. Urodynamics and safety of the β3-adrenoceptor agonist mirabegron in males with lower urinary tract symptoms and bladder outlet obstruction. J Urol. 2013;190:1320–7. https://doi.org/10.1016/j.juro.2013.05.062. Randomized controlled trial showing urodynamic efficacy and safety of mirabegron in treating men with LUTS and BOO.

    Article  CAS  PubMed  Google Scholar 

  31. • Shin DG, Kim HW, Yoon SJ, Song SH, Kim YH, Lee YG, et al. Mirabegron as a treatment for overactive bladder symptoms in men (MIRACLE study): efficacy and safety results from a multicenter, randomized, double-blind, placebo-controlled, parallel comparison phase IV study. Neurourol Urodyn. 2019;38:295–304. https://doi.org/10.1002/nau.23852. Randomized controlled trial showing efficacy and safety of mirabegron in treating men with OAB.

    Article  CAS  PubMed  Google Scholar 

  32. •• Ichihara K, Masumori N, Fukuta F, Tsukamoto T, Iwasawa A, Tanaka Y. A randomized controlled study of the efficacy of tamsulosin monotherapy and its combination with mirabegron for overactive bladder induced by benign prostatic obstruction. J Urol. 2015;193:921–6. https://doi.org/10.1016/j.juro.2014.09.091. Randomized controlled trial showing superior effectiveness of adding mirabegron to tamsulosin at treating men with BOO and persistent OAB symptoms compared to tamsulosin alone.

    Article  CAS  PubMed  Google Scholar 

  33. •• Kakizaki H, Lee KS, Yamamoto O, Jong JJ, Kato D, Sumarsono B, et al. Mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: a randomized, placebo-controlled study (MATCH). Eur Urol Focus. 2019;6:729–37. https://doi.org/10.1016/j.euf.2019.10.019. Randomized controlled trial showing superior effectiveness of adding mirabegron to tamsulosin at treating men with LUTS and residual OAB symptoms compared to tamsulosin plus placebo.

    Article  PubMed  Google Scholar 

  34. •• Kaplan SA, Herschorn S, McVary KT, Staskin D, Chapple CR, Foley S, et al. Efficacy and safety of Mirabegron versus placebo add-on therapy in men with overactive bladder symptoms receiving tamsulosin for underlying benign prostatic hyperplasia: a randomized, phase 4 study (PLUS). J Urol. 2020;203:1163–71. https://doi.org/10.1097/JU.0000000000000738. Randomized controlled trial showing superior effectiveness of adding mirabegron to tamsulosin at treating OAB symptoms in men with BPH associated LUTS compared to tamsulosin plus placebo.

    Article  PubMed  Google Scholar 

  35. • Su S, Lin J, Liang L, Liu L, Chen Z, Gao Y. The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: a systematic review and meta-analysis. Medicine (Baltimore). 2020;99:e18802. https://doi.org/10.1097/MD.0000000000018802. Meta-analysis of randomized controlled trials showing the addition of mirabegron to be effective and safe in treating OAB symptoms induced by BPH in men already receiving tamsulosin.

    Article  Google Scholar 

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Correspondence to Steven A. Kaplan.

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This article is part of the Topical Collection on Benign Prostatic Hyperplasia

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Mullen, G.R., Kaplan, S.A. Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia. Curr Urol Rep 22, 5 (2021). https://doi.org/10.1007/s11934-020-01017-7

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