Drug updated on 9/4/2024
Dosage Form | Tablet (oral; 25 mg, 50 mg); Granules (oral; 8 mg/mL) |
Drug Class | Beta-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.
Latest News
Summary
- 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 Title | Year | Source |
---|---|---|
Myrbetriq (mirabegron) Prescribing Information. | 2021 | Astellas Pharma US Inc., Northbrook, IL |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
Document Title | Year | Source |
---|---|---|
Perioperative medication management - adult/pediatric - inpatient/ambulatory clinical practice guideline. | 2022 | UW Health |
Diagnosis and treatment of non-neurogenic overactive bladder (OAB) in adults: an AUA/SUFU guideline (2019). | 2019 | American Urological Association |
Insights into the management of overactive bladder: what difference can mirabegron make? | 2019 | Journal of Urological Surgery |