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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Schoemaker, Rik Wade, Janet R. Stockis, Armel |
| Description | Country affiliation: Belgium Author Affiliation: Schoemaker R ( SGS Exprimo NV, Mechelen, Belgium.); Wade JR ( Current affiliation: Occams, Amstelveen, Netherlands.); Stockis A ( SGS Exprimo NV, Mechelen, Belgium.) |
| Abstract | Brivaracetam is a selective high-affinity ligand for synaptic vesicle protein 2A, recently approved as adjunctive therapy in the treatment of partial-onset (focal) seizures in patients 16 years of age and older with epilepsy. A population pharmacokinetic (PK) model and a population pharmacokinetic/pharmacodynamic (PKPD) model were developed describing brivaracetam plasma concentration and the relationship with daily seizure counts in adequate well-controlled efficacy trials. The effect of body weight on clearance and volume was implemented using allometric scaling, and a range of covariates were investigated for their influence on brivaracetam clearance. The PKPD model described daily seizure counts using a negative binomial distribution, taking previous day seizures into account, and using a mixture model to separate 'placebo-like' and 'response' subpopulations. The PK and PKPD models provided a good description of the data, documented using visual predictive checks. Coadministration with carbamazepine, phenytoin, and phenobarbital decreased brivaracetam exposure by 26%, 21%, and 19%, respectively, without significant effects on PD response. Covariate analysis indicated that levetiracetam coadministration reduced the fraction of subjects in the mixture model response population to 4% and identified baseline seizure frequency as a strong predictor for being assigned to the mixture model response population. Simulation allowed characterization of the dose-response curve, suggesting maximum response is obtained at brivaracetam 150-200 mg/day. |
| File Format | HTM / HTML |
| ISSN | 00912700 |
| Issue Number | 12 |
| Journal | The Journal of Clinical Pharmacology |
| Volume Number | 56 |
| e-ISSN | 15524604 |
| Language | English |
| Publisher | Wiley |
| Publisher Date | 2016-12-01 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | One Nation One Subscription (ONOS) |
| Subject Keyword | Discipline Pharmacology |
| Content Type | Text |
| Resource Type | Article |
| Subject | Pharmacology Pharmacology (medical) |
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