Drug updated on 4/15/2024
| 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.
Summary
- 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 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 |