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Conventional and controlled release valproate in children with epilepsy: a cross-over study comparing plasma levels
O F Brouwer1, M S Pieters, P M Edelbroek
1Department of Neurology, University Hospital, Leiden, Netherlands.
Insights
A new controlled-release valproate formulation (VPA-CR) showed similar plasma levels and cognitive effects to conventional valproate (VPA) in children with epilepsy. VPA-CR offers improved convenience and compliance for young patients.
Area of Science:
- Pediatric Neurology
- Pharmacokinetics
- Epilepsy Treatment
Background:
- Epilepsy management in children requires effective and convenient medication.
- Conventional valproate (VPA) requires multiple daily doses, potentially impacting compliance.
- Controlled-release formulations aim to improve dosing convenience and patient adherence.
Purpose of the Study:
- To evaluate plasma levels and behavioral effects of a new controlled-release valproate formulation (VPA-CR) in children with epilepsy.
- To compare VPA-CR with conventional valproate (VPA) monotherapy.
- To assess the impact of VPA-CR on cognitive functions like attention and vigilance.
Main Methods:
- Plasma valproate levels were monitored over a 12-hour period in children with epilepsy.
- Neuropsychological assessments of attention and vigilance were conducted.
- Comparisons were made between conventional valproate (VPA) monotherapy and VPA-CR once-daily regimen.
Main Results:
- No significant differences were observed in mean diurnal trough and peak valproate plasma levels between VPA and VPA-CR.
- Cognitive performance showed no significant differences between VPA and VPA-CR treatments.
- No correlation was found between cognitive performance and valproate plasma levels during either treatment.
Conclusions:
- VPA-CR demonstrates comparable pharmacokinetic profiles and cognitive effects to conventional VPA in children.
- The once-daily administration of VPA-CR offers potential advantages in compliance and convenience for pediatric epilepsy patients.
- VPA-CR represents a viable alternative for managing childhood epilepsy, potentially enhancing treatment adherence.
Abstract:
We studied plasma levels and behavioural effects of a newly developed controlled release formulation of valproate (VPA-CR) in children with epilepsy. Valproate plasma levels and performances in attention and vigilance tasks were monitored during a 12-h period (daytime), both during monotherapy of conventional valproate (VPA) and 4 weeks after switching to a similar dosage of VPA-CR taken once daily. There was no significant difference between the two formulations with respect to mean diurnal trough and peak valproate plasma levels, and to mean fluctuation. The significantly higher Cmax/Cmin ratio during VPA-CR seems mainly due to low valproate plasma levels early in the morning. Neuropsychological assessment showed no significant differences, either between patients and controls, or within patients and controls when comparing the results obtained on the VPA and VPA-CR day. During both VPA and VPA-CR treatment, no correlation was found between cognitive performance and valproate plasma levels. The advantage of VPA-CR is that the once daily regimen may increase compliance and is more convenient for schoolchildren.