Efficacy and safety of mirabegron in pediatric population: A systematic review

Abstract

Introduction: Mirabegron, a b3-adrenoceptor (b3-AR) agonist approved for the treatment of overactive bladder (OAB) symptoms in the adult population, is the first of a new class of compounds with a different mechanism of action. Mirabegron act during the bladder storage phase by relaxing the detrusor muscle thus increase bladder capacity without any significant impact on voiding. Although antimuscarinic agents are commonly used for daytime incontinence associated with overactive bladder and also for patient with congenital cause such as spina bifida, mirabegron could be an effective treatment option in children with neurogenic bladder, as shown in adult populations. In this systematic review, we aimed to evaluate the available literature regarding efficacy and safety of mirabegron in pediatric population. Method: This systematic review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Result: The symptoms analyzed were frequency, urgency, nocturnal enuresis (NE) and daytime incontinence (DI). 37 (53%) out of 70 children were still receiving treatment at 6 months; 30 received mirabegron monotherapy, and 7 received combination therapy with anticholinergic (Solifenacin n = 4, Desmopressin n = 2, both n = 1). After six months, blood pressure monitoring and ECGs were normal in all patients. For patients on monotherapy, 6 of 17 (35%) had improvement in NE, 11 of 19 (58%) in DI, 12 of 20 (60%) in frequency, and 8 of 21 (38%) in urgency symptoms. For patients receiving combination therapy, 2 of 6 (33%) had improvement in NE, 2 of 4 in DI (50%), 2 of 4 (50%) in frequency, and 4 of 6 (67%) had improvement in urgency. Conclusion: The CV safety of mirabegron, the only clinically available β3-adrenoceptor agonist, appears to be good and comparable with that of antimuscarinic agents, the current first-line therapy for OAB. However, Further long-term data are desirable especially in patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure. Highlights