Mirabegron is significantly useful in children above three years with lower urinary tract dysfunction, suggests a study published in the Neurourology and Urodynamics.
A group of researchers from Poland performed a study to evaluate the efficacy and safety of mirabegron in children and adolescents (aged 3 to <18 years) with neurogenic detrusor overactivity (NDO) using clean intermittent catheterization.
The researchers conducted an open-label, multicentre, baseline-controlled, Phase III study (NCT02751931), participants received once-daily mirabegron at an adult dose equivalent of 25 mg. The dose was increased to 50 mg equivalent unless there were safety/tolerability concerns. The primary endpoint changed from baseline to Week 24 in maximum cystometric capacity (MCC). Secondary urodynamic assessments, Pediatric Incontinence Questionnaire (PIN-Q), Patient Global Impression of Severity (PGI-S), Clinician Global Impression of Change (CGI-C), and Acceptability questionnaires were included.
The results of the study are as follows:
Overall, 86 participants received treatment; 68 were included in efficacy assessments.
A statistically significant increase in maximum cystometric capacity (MCC) from baseline to Week 24 was observed; this increase was apparent from Week 4.
Significant increases in bladder compliance, bladder volume until the first detrusor contraction, average volume per catheterization, maximum daytime catheterized volume and number of dry days per week. Significant decreases in detrusor pressure and number of leakage episodes per day were also observed.
Significant improvement in, Patient Global Impression of Severity (PGI-S) but not Pediatric An incontinence Questionnaire (PIN-Q) was observed.
Most participants reported their condition had either much or very much improved using the Clinician Global Impression of Change (CGI-C).
Mirabegron was well tolerated in this population with a profile aligned with that in adults.
The researchers concluded that Mirabegron was effective and well-tolerated in the treatment of pediatric patients with neurogenic detrusor overactivity (NDO).
Reference:
Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open-label, phase 3, a dose-titration study by Baka-Ostrowska M et. al published in the Neurourology and Urodynamics.
https://doi.org/10.1002/nau.24657