Long-Term Safety and Efficacy of Solifenacin in Children and Adolescents with Overactive Bladder

The Journal of Urology
Donald NewgreenStéphane Bolduc

Abstract

We evaluated the long-term safety and efficacy of once daily oral solifenacin suspension in children (5 to less than 12 years old) and adolescents (12 to less than 18 years old) with overactive bladder. We conducted a 40-week, open label extension of a 12-week double-blind, placebo controlled trial. Outcome measures included incidence and severity of adverse events (primary end point), laboratory variables, vital signs, 12-lead electrocardiogram, post-void residual volume, and change from baseline to end of treatment in mean number of micturitions and incontinence episodes per 24 hours, number of incontinence-free days per 7 days and number of grade 3 or 4 urgency episodes per 24 hours (adolescents only). A total of 119 children and 29 adolescents were enrolled in the study. The incidence of drug related treatment emergent adverse events was 34.7% (children) and 37.9% (adolescents), the most common of which were constipation (11.9%), electrocardiogram QT prolonged (8.5%) and dry mouth (4.2%) in children, and electrocardiogram QT prolonged (13.8%) and nausea (6.9%) in adolescents. Adverse events resulted in 10.2% (children) and 13.8% (adolescents) of participants discontinuing treatment. There were no cases of urinary retention ...Continue Reading

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Citations

Jan 16, 2018·F1000Research·Bronagh McDonnell, Lori Ann Birder
Oct 24, 2019·Expert Opinion on Pharmacotherapy·Tiernan Middleton, Pamela Ellsworth
May 31, 2020·European Journal of Pediatrics·Serdar TekgulHasan Serkan Dogan
Nov 25, 2020·Pharmacology Research & Perspectives·Stacey TannenbaumDonald Newgreen
Dec 8, 2019·Journal of Pediatric Urology·Charlotte Victoria Melling, Anju Goyal

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