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PI‐45
Author(s) -
Otoul C.,
De Smedt H.,
Stockis A.
Publication year - 2006
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2005.12.066
Subject(s) - levetiracetam , antiepileptic drug , epilepsy , medicine , pharmacology , pediatrics , anesthesia , psychiatry
BACKGROUND To assess levetiracetam (LEV) add‐on treatment effect on plasma concentrations of other antiepileptic drugs (AEDs) in paediatrics with epilepsy. METHODS Retrospective analysis of plasma concentrations from a single placebo‐controlled Phase III trial and a pooled study population (2 Phase I‐II, 1 Phase III, 1 long‐term follow‐up). Multiple AED plasma levels at baseline and during evaluation period with concomitant LEV or placebo were evaluated by repeated measures covariance analysis, after logarithmic transformation and using 90% confidence interval (CI) of the geometric mean ratio between both periods. RESULTS Phase III data; 187 children receiving any concomitant AED, alone or in combination. Pooled analysis data; 164 children included receiving a single other AED. In the pooled population, geometric mean plasma concentrations (CV= coefficient of variation) varied from baseline to LEV period: carbamazepine (CBZ): 7.8–8.1 μg/mL (CV=34%); valproate (VPA): 90–103 μg/mL (CV=31%); topiramate (TPM): 11.3–12.8 μg/mL (CV=45%) and lamotrigine (LTG): 8.0–8.7 μg/mL (CV=56%). In the Phase III study, the geometric mean ratio of concentration (LEV/placebo evaluation vs. baseline) was centered around 100% for CBZ, VPA, TPM and LTG and CI were within the 80–125% range. CONCLUSION LEV did not appear to modify plasma concentrations of CBZ, VPA, TPM and LTG in children with epilepsy. Dose adjustment is unnecessary of these AEDs when LEV is added to, or removed from, therapeutic regimen. Clinical Pharmacology & Therapeutics (2005) 79 , P19–P19; doi: 10.1016/j.clpt.2005.12.066