Mirabegron

(Myrbetriq®)

Myrbetriq®

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Drug updated on 4/15/2024

Dosage FormTablet (oral; 25 mg, 50 mg); Granules (oral; 8 mg/mL)
Drug ClassBeta-3 adrenergic agonists
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Myrbetriq tablet is indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and urinary frequency either alone or in combination with the muscarinic antagonist solifenacin succinate.
  • Myrbetriq tablet is indicated for the treatment of neurogenic detrusor overactivity (NDO) in patients aged 3 years and older who weigh 35 kg or more.
  • Myrbetriq granules is indicated for the treatment of neurogenic detrusor overactivity (NDO) in patients aged 3 years and older.

Summary
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  • Mirabegron (Myrbetriq) is indicated for the treatment of overactive bladder (OAB) in adults and neurogenic detrusor overactivity (NDO) in patients aged 3 years and older, either alone or in combination with solifenacin succinate.
  • A comprehensive study was conducted on 19 systematic reviews/meta-analyses concerning mirabegron's safety, effectiveness, and subgroup considerations compared to other treatments for OAB and NDO.
  • Multiple studies showed that mirabegron demonstrated comparable efficacy to antimuscarinic drugs in managing OAB symptoms but had a notably better safety profile with fewer adverse events such as dry mouth and constipation.
  • In populations with NDO due to spinal cord injury or multiple sclerosis, mirabegron showed effectiveness without definitively established superiority in urodynamic outcomes compared to antimuscarinics; however, it improved symptoms with fewer bothersome side effects across age groups, making it a versatile option.
  • Combination therapy of Mirabegron with solifenacin might offer enhanced efficacy at the cost of increased incidence of certain side effects like constipation and dry mouth compared to monotherapy, suggesting an alternative strategy for patients inadequately managed on monotherapy if they can tolerate these side effects.
  • Limited evidence suggests that Mirabegron may be effective in managing ureteral stent-related symptoms, indicating potential broader applicability outside its primary indications pending further research.
  • Compared against Vibegron, another β3-adrenoceptor agonist, both were efficacious in reducing OAB symptoms, though Vibegron potentially offered a slight advantage in increasing mean voided volume per micturition, while their safety profiles were broadly comparable, showing no significant increase versus placebo.
  • Mirabegron consistently emerged as a valuable option for long-term management, particularly appealing for those intolerant or inadequately managed by antimuscarinics, given benefits including sustained symptom control, tolerability, and a more favorable side effect profile.

Product Monograph / Prescribing Information

Document TitleYearSource
Myrbetriq (mirabegron) Prescribing Information.2021Astellas Pharma US Inc., Northbrook, IL

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Detrusor relaxing agents for neurogenic detrusor overactivity: a systematic review, meta-analysis and network meta-analysis.2024BJU International
Mirabegron add-on tamsulosin for men with overactive bladder symptoms: A pooled analysis of four randomized controlled trials.2024Urologia Internationalis
Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis. 2023International Brazilian Journal of Urology
Mirabegron and anticholinergics in the treatment of overactive bladder syndrome: A meta-analysis. 2023Revista Brasileira de Ginecologia e Obstetrícia
Efficacy and safety of vibegron compared with mirabegron for overactive bladder: a systematic review and network meta-analysis. 2023Lower Urinary Tract Symptoms
Urodynamic parameter improvements after mirabegron vs. antimuscarinics agents in non-neurogenic overactive bladder: a systematic review and meta-analysis of treatment effect. 2023European Review for Medical and Pharmacological Sciences
Comparison of different types of therapy for overactive bladder: a systematic review and network meta-analysis.2022Frontiers in Medicine
Efficacy and safety of mirabegron for treatment of neurogenic detrusor overactivity in adults with spinal cord injury or multiple sclerosis: a systematic review.2022Spinal Cord
Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis. 2022Drugs in Context
Efficacy of overactive neurogenic bladder treatment: a systematic review of randomized controlled trials. 2022Archives of Italian Urology and Andrology
Beta 3 adrenoreceptor agonist for the management of lower urinary tract symptoms in men with benign prostatic hyperplasia: a systematic review.2021International Neurology Journal
Monotherapy with mirabegron had a better tolerance than the anticholinergic agents on overactive bladder: a systematic review and meta-analysis.2021Medicine
The efficacy and safety of mirabegron in treating ureteral stent-related symptoms: a systematic review and meta-analysis.2021Lower Urinary Tract Symptoms
Efficacy of vibegron and mirabegron for overactive bladder: a systematic literature review and indirect treatment comparison.2021Advances in Therapy
Mirabegron for the treatment of ureteral stent-related symptoms: a systematic review and meta-analysis.2021European Urology Focus
The use of mirabegron in neurogenic bladder: a systematic review.2020World Journal of Urology
Comparative safety and efficacy of treatments for overactive bladder among older adults: a network meta‑analysis.2020Drugs and Aging
The relative efficacy and safety of mirabegron and onabotulinumtoxinA in patients with overactive bladder who have previously been managed with an antimuscarinic: A network meta-analysis.2019Urology
Updating the evidence on drugs to treat overactive bladder: a systematic review.2019International Urogynecology Journal

Clinical Practice Guidelines