Mirabegron

(Myrbetriq®)

Mirabegron

Drug updated on 12/11/2024

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 pediatric patients aged 3 years and older and weighing 35 kg or more
  • Myrbetriq granules is indicated for the treatment of NDO in pediatric patients aged 3 years and older.

Latest News

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Summary
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  • This summary is based on the review of 27 systematic review(s)/meta-analysis(es). [1-27]
  • In children and adolescents with idiopathic refractory overactive bladder (OAB), mirabegron monotherapy led to high improvement rates in both objective and subjective outcomes, with strong compliance across studies.
  • Among adults with OAB, mirabegron 25 mg and 50 mg significantly improved urgency urinary incontinence, total incontinence, and nocturia versus placebo; mirabegron 50 mg showed greater efficacy in certain outcomes compared to tolterodine 4 mg and solifenacin 5 mg.
  • For adults with neurogenic lower urinary tract dysfunction (NLUTD), mirabegron treatment significantly enhanced maximum cystometric capacity, urodynamic function, and quality of life measures, with efficacy noted in patients with both multiple sclerosis and spinal cord injury.
  • In men with benign prostatic hyperplasia (BPH) and OAB, the combination of mirabegron and tamsulosin effectively improved OAB symptoms, including micturitions, urgency episodes, total symptom scores, and mean volume voided.
  • Mirabegron demonstrated a generally well-tolerated safety profile, comparable to placebo in adverse events, with commonly reported side effects including nasopharyngitis, dry mouth, constipation, headache, and hypertension.
  • Compared to antimuscarinics, mirabegron was associated with fewer overall adverse events, particularly lower rates of gastrointestinal disorders and dry mouth.
  • In pediatric populations, common adverse effects included headaches, constipation, rhinitis/nasopharyngitis, and blurred vision.
  • Studies show mirabegron is effective and safe across diverse populations, with high improvement and compliance rates in children and adolescents with idiopathic refractory OAB, significant efficacy and safety in adults with OAB (including varied age groups and ethnicities), notable urodynamic and quality-of-life benefits in adults with NLUTD (e.g., MS and SCI), effective symptom management in men with BPH and OAB when combined with tamsulosin, and a favorable safety profile for older adults, particularly regarding reduced dry mouth and constipation compared to antimuscarinics.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Safety and effectiveness of mirabegron for children and adolescents with refractory idiopathic overactive bladder for improving urinary symptoms: a systematic review2024Central European Journal of Urology
Mirabegron Versus Placebo and Other Therapeutic Modalities in the Treatment of Patients with Overactive Bladder Syndrome-A Systematic Review2024European Urology Focus
Mirabegron 50 mg once daily, long-term treatment maximizes benefit in middle-aged and older people with overactive bladder syndrome: a systematic review and meta-analysis of nine phase II/III, randomized, double-blind, parallel-design, placebo-controlled, multicenter, and multinational trials2024Frontiers in Surgery
Safety and efficacy of beta-3 adrenergic agonists in treating neurogenic lower urinary tract dysfunction: A systematic review and meta-analysis2024Investigative and Clinical Urology
An individual participant meta-analysis of mirabegron in multiple sclerosis and spinal cord injury2024Neurourology and Urodynamics
Safety and efficacy of an alpha(1) -blocker plus mirabegron compared with an alpha(1) -blocker plus antimuscarinic in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia and overactive bladder: A systematic review and network meta-analysis2024Neurourology and Urodynamics
Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis2023International Braz J Urol
Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis2023Revista Brasileira de Ginecologia e Obstetricia
Urodynamic parameter improvements after mirabegron vs. antimuscarinics agents in non-neurogenic overactive bladder: a systematic review and meta-analysis of treatment effect2023European Review for Medical and Pharmacological Sciences
Efficacy of overactive neurogenic bladder treatment: A systematic review of randomized controlled trials2022Archivio Italiano di Urologia, Andrologia
Comparison of different types of therapy for overactive bladder: A systematic review and network meta-analysis2022Frontiers in Medicine
Long-term efficacy and safety of vibegron versus mirabegron and anticholinergics for overactive bladder: a systematic review and network meta-analysis2022Drugs in Context
Efficacy and safety of mirabegron for treatment of neurogenic detrusor overactivity in adults with spinal cord injury or multiple sclerosis: a systematic review2022Spinal Cord
beta3-Adrenoceptor Agonist for the Treatment of Bladder Dysfunction in Children: A Systematic Review and Meta-Analysis2022The Journal of Urology
The Efficacy and Safety of Mirabegron for the Treatment of Neurogenic Lower Urinary Tract Dysfunction: A Systematic Review and Meta-analysis2021Frontiers in Pharmacology
Monotherapy with mirabegron had a better tolerance than the anticholinergic agents on overactive bladder: A systematic review and meta-analysis2021Medicine
Beta 3 Adrenoreceptor Agonist for the Management of Lower Urinary Tract Symptoms in Men With Benign Prostatic Hyperplasia: A Systematic Review2021International Neurourology Journal
Efficacy of Vibegron and Mirabegron for Overactive Bladder: A Systematic Literature Review and Indirect Treatment Comparison2021Advances in Therapy
Adverse events associated with mirabegron 50mg versus placebo: A systematic review and meta-analysis2021Progres en Urologie
Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia2021Current Urology Reports
Beyond Antimuscarinics: A Review of Pharmacological and Interventional Options for Overactive Bladder Management in Men2021European Urology
Persistence and Adherence of Anticholinergics and Beta-3 Agonist for the Treatment of Overactive Bladder: Systematic Review and Meta-Analysis, and Network Meta-Analysis2021Journal of Urology
Treatment of Non-neurogenic Lower Urinary Tract Symptoms-A Review of Key Publications from 2018 Onward2021European Urology Focus
Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis2020Drugs & Aging
Mirabegron in female patients with overactive bladder syndrome: What's new? A systematic review and meta-analysis2020European Journal of Obstetrics, Gynecology, and Reproductive Biology
The efficacy and safety of mirabegron on overactive bladder induced by benign prostatic hyperplasia in men receiving tamsulosin therapy: A systematic review and meta-analysis2020Medicine
The use of mirabegron in neurogenic bladder: a systematic review2020World Journal of Urology

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