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Clinical experience with mirabegron in pediatric patients with spina bifida under 3 years of age
Ioana Fugaru1, Brian VanderBrink1, Katie Mueller1
1Division of Pediatric Urology, Cincinnati Children's Hospital, Cincinnati, OH, United States of America.
Insights
Beta-3 agonist (B3) shows promise for treating neurogenic bladder in children under three with spina bifida. It improved bladder compliance and capacity, especially for those with antimuscarinic side effects.
Area of Science:
- Pediatric Urology
- Neurogenic Bladder Management
- Pharmacological Interventions
Background:
- Mirabegron suspension, a beta-3 agonist (B3), received FDA approval in 2021 for pediatric patients over 3 years old.
- The study addresses the off-label use of B3 in younger children with spina bifida and neurogenic bladder.
- Evaluation focuses on safety, tolerability, and urodynamic effects of B3 in this specific pediatric population.
Purpose of the Study:
- To assess the safety and tolerability of beta-3 agonist (B3) therapy in children under 3 with spina bifida and neurogenic bladder.
- To evaluate the impact of B3 on urodynamic parameters in this patient group.
- To determine the efficacy of B3 as a primary, adjuvant, or alternative therapy.
Main Methods:
- Retrospective study of spina bifida patients under 3 years old treated with off-label B3.
- Patients were categorized into primary, adjuvant, or alternative therapy groups.
- Data collected included demographics, clinical information, and urodynamic results from regular urological evaluations.
Main Results:
- Nineteen patients received B3, with a median age of 24 months.
- Bladder compliance improved in nearly all patients; bladder capacity increased or was preserved.
- All patients switched from antimuscarinics (AM) to B3 reported resolution of adverse effects, with no B3 discontinuations due to side effects.
Conclusions:
- Beta-3 agonist (B3) therapy can be beneficial for neurogenic bladder in spina bifida patients under 3 years old.
- B3 is particularly advantageous for children experiencing intolerable adverse effects from antimuscarinic medications.
- The findings support the consideration of B3 in managing neurogenic bladder in this vulnerable pediatric population.
Introduction:
Mirabegron suspension, a beta-3-agonist [B3], has been approved in the United States for use in pediatric patients older than 3 years of age in 2021. We sought to evaluate the safety, tolerability and impact on urodynamic studies of the introduction of B3 in the management of neurogenic bladder for children younger than 3 years with spina bifida at our center.
Methods:
A retrospective study was performed at our institution with spina bifida patients younger than 3 years old treated with off label use of B3. Patients were stratified into three clinically distinct groups (primary, adjuvant, and alternative therapy). Patients were seen for the first outpatient urological visit at 3 months of age and subsequently underwent clinical and urologic evaluation at various timepoints. Patient demographics, clinical information and investigation results were extracted from the medical record.
Results:
19 patients received B3 at a median age of 24 months (IQR 13-29 months). Four patients were primarily treated with B3, ten patients were switched to B3 due to intolerable adverse effects of antimuscarinics [AM] (AM to B3) and five patients received it as adjunct therapy (B3+AM). The measured bladder compliance was improved in all but one of the patients exposed to B3. Bladder capacity increased in patients on primary or adjuvant B3 and was preserved in patients on B3 as alternative to AM. All ten (10) patients who were on alternative B3 reported resolution of the AM adverse effects which motivated the pharmacological agent change. The medication was not discontinued in any patient due to adverse effects.
Conclusions:
Spina bifida patients with neurogenic bladder younger than 3 years old may benefit from additional therapy with beta-3 agonist, particularly those experiencing intolerable adverse effects from antimuscarinics.