PURPOSE: 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. MATERIALS AND METHODS: 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). RESULTS: 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 or increases in post-void residual volume and no clinically relevant changes in laboratory variables or vital signs. Two cases of dizziness but no other central nervous system drug related treatment emergent adverse events were reported. Improvements in all efficacy parameters and grade 3 or 4 urgency episodes observed by 3 weeks were further improved and/or maintained during the study. CONCLUSIONS: Once daily solifenacin oral suspension was well tolerated for up to 52 weeks in children 5 to less than 12 years old and adolescents 12 to less than 18 years old diagnosed with overactive bladder, with constipation and electrocardiogram QT prolonged as the most common adverse reactions, respectively. Improvements in efficacy at 3 weeks were sustained during the study.
RCT Entities:
PURPOSE: 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. MATERIALS AND METHODS: 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). RESULTS: 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 or increases in post-void residual volume and no clinically relevant changes in laboratory variables or vital signs. Two cases of dizziness but no other central nervous system drug related treatment emergent adverse events were reported. Improvements in all efficacy parameters and grade 3 or 4 urgency episodes observed by 3 weeks were further improved and/or maintained during the study. CONCLUSIONS: Once daily solifenacin oral suspension was well tolerated for up to 52 weeks in children 5 to less than 12 years old and adolescents 12 to less than 18 years old diagnosed with overactive bladder, with constipation and electrocardiogram QT prolonged as the most common adverse reactions, respectively. Improvements in efficacy at 3 weeks were sustained during the study.
Authors: Stacey Tannenbaum; Martin den Adel; Walter Krauwinkel; John Meijer; Adriana Hollestein-Havelaar; Frank Verheggen; Donald Newgreen Journal: Pharmacol Res Perspect Date: 2020-12