Pregabalin Population Pharmacokinetic and Exposure-Response Analyses for Focal Onset Seizures in Children (4-16 years) and Adults, to Support Dose Recommendations in Children.

ABSTRACT: Pregabalin is approved in multiple countries as adjunctive therapy for adult patients with focal onset seizures (FOS; previously termed partial onset seizures). This study used population pharmacokinetic (PK) and exposure-response (E-R) analyses from pooled pregabalin concentration and efficacy data to compare pregabalin exposure and E-R relationships in pediatric and adult patients with FOS, to support pediatric dosage recommendations. A one-compartment disposition model was used, with first-order absorption and body surface area-normalized creatinine clearance on clearance. Individual pregabalin average steady-state concentrations were predicted and used in an E-R analysis of efficacy. The E-R relationship of pregabalin was similar in pediatric (4-16 years) and adult patients with FOS af

SUBMITTER: Chan PLS 

PROVIDER: S-EPMC8359225 | biostudies-literature | 2021 Jul

REPOSITORIES: biostudies-literature