Mirabegron

(Myrbetriq®)

Mirabegron

Drug updated on 9/4/2024

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.

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Summary
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  • Myrbetriq (mirabegron) 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.
  • This summary is based on the review of 19 systematic reviews/meta-analyses. [1-19]
  • Neurogenic Detrusor Overactivity (NDO): Mirabegron improved some urodynamic and bladder diary outcomes with fewer bothersome side effects compared to antimuscarinics, which showed significant improvements but had higher adverse event rates. No superiority or inferiority was established between mirabegron and antimuscarinics.
  • Overactive Bladder Symptoms (OABS): Mirabegron as an add-on to tamsulosin was effective in reducing urgency episodes, urgency urinary incontinence episodes, and in improving total International Prostate Symptom Score (IPSS) and quality of life index.
  • Long-term Efficacy for Overactive Bladder (OAB): Vibegron demonstrated greater improvement in daily total urinary incontinence episodes compared to mirabegron.
  • Neurogenic Detrusor Overactivity due to Spinal Cord Injury (SCI) or Multiple Sclerosis (MS): Mirabegron showed similar clinical efficacy to anticholinergics in MS patients but was not satisfactory in improving urodynamic parameters in SCI patients.
  • Neurogenic Detrusor Overactivity (NDO): Mirabegron was associated with fewer side effects compared to antimuscarinics, particularly with a lower incidence of xerostomia.
  • Overactive Bladder Symptoms (OABS): The combination of mirabegron and tamsulosin was well-tolerated, although there was a potential increase in post-void residual urine volume.
  • Long-term Safety for OAB: Mirabegron showed a safety profile comparable to vibegron and tolterodine but had a higher risk of nasopharyngitis and cardiovascular adverse events.
  • Mirabegron showed fewer side effects in patients with neurogenic detrusor overactivity (NDO), particularly in those with spinal cord injury (SCI), but lacked significant urodynamic improvement in this subgroup. In older adults (aged 65+), mirabegron had a favorable safety profile with no increased risk of dry mouth or constipation.

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