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Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. | LitMetric

AI Article Synopsis

  • The study aimed to analyze how the antimuscarinic drug solifenacin affects children with overactive bladder (OAB) or neurogenic detrusor overactivity (NDO) by using data from three clinical trials.
  • The trials included a 12-week placebo-controlled study for children and adolescents with OAB, and two 52-week open-label studies for younger patients with NDO, allowing adjustments in solifenacin dosages based on weight.
  • Findings showed that while solifenacin’s pharmacokinetics (PK) were similar in both patient groups, adolescents exhibited higher plasma clearance and volume of distribution compared to younger children, but both groups had similar exposure levels after dosing.

Article Abstract

The aim of this investigation was to characterize and compare the pharmacokinetics (PK) of the antimuscarinic drug solifenacin in pediatric patients with overactive bladder (OAB) or neurogenic detrusor overactivity (NDO) utilizing data from three phase III trials. LION was a placebo-controlled, 12-week trial in children (5-<12 years) and adolescents (12-<18 years) with OAB. MONKEY and MARMOSET were open-label, 52-week trials in children and adolescents or younger children (6 months-<5 years), respectively, with NDO. During the trials, solifenacin doses could be titrated to weight-adjusted pediatric equivalent doses (PEDs) of 2.5, 5, 7.5, or 10 mg day . Nonlinear mixed effects modeling was used to develop population PK models to characterize the PK in patients with either OAB or NDO. Overall, 194 children and adolescents received solifenacin. At the time of PK sampling, the majority (119/164 [72.6%] patients) were receiving PED10 once daily. All population models included first-order oral absorption, a lag time, and interindividual variability. PK analysis showed that apparent clearance was similar in both patient populations. Mean apparent oral plasma clearance (CL/F), apparent volume of distribution during the terminal phase (V /F), and terminal half-life (t ) were higher in adolescents than in children, but median time to maximum plasma concentration (t ) was similar. Dose-normalized exposure results were similar for both younger and older patients with OAB or NDO. In conclusion, population PK modeling was used to successfully characterize solifenacin PK in pediatric patients with OAB or NDO. Similar solifenacin PK characteristics were observed in both populations.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685239PMC
http://dx.doi.org/10.1002/prp2.684DOI Listing

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