Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
29450890
DOI
10.1111/epi.14014
Knihovny.cz E-resources
- Keywords
- antiepileptic drugs, focal seizures, refractory epilepsy, switching,
- MeSH
- Anticonvulsants administration & dosage adverse effects MeSH
- Voltage-Gated Sodium Channel Blockers administration & dosage adverse effects MeSH
- Dibenzazepines administration & dosage adverse effects MeSH
- Adult MeSH
- Carbamazepine administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Drug Substitution adverse effects trends MeSH
- Nausea chemically induced diagnosis MeSH
- Drug Resistant Epilepsy diagnosis drug therapy MeSH
- Aged MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Anticonvulsants MeSH
- Voltage-Gated Sodium Channel Blockers MeSH
- Dibenzazepines MeSH
- eslicarbazepine acetate MeSH Browser
- Carbamazepine MeSH
OBJECTIVE: To evaluate the influence of prior use of carbamazepine (CBZ) and other antiepileptic drugs (AEDs) with a putatively similar mechanism of action (inhibition of voltage-gated sodium channels; VGSCs) on seizure outcomes and tolerability when converting to eslicarbazepine acetate (ESL), using data pooled from 2 controlled conversion-to-ESL monotherapy trials (studies: 093-045, 093-046). METHODS: Adults with treatment-resistant focal (partial-onset) seizures were randomized 2:1 to ESL 1600 or 1200 mg once daily. The primary efficacy endpoint was study exit (meeting predefined exit criteria related to worsening seizure control) versus an historical control group. Other endpoints included change in seizure frequency, responder rate, and tolerability. Endpoints were analyzed for subgroups of patients who received CBZ (or any VGSC inhibitor [VGSCi]) during baseline versus those who received other AEDs. RESULTS: Of 365 patients in the studies, 332 were evaluable for efficacy. The higher risk of study exit in the subgroups that received CBZ (or any VGSCi) during baseline, versus other AEDs, was not statistically significant (hazard ratios were 1.49 for +CBZ vs -CBZ [P = .10] and 1.27 for +VGSCi vs. -VGSCi [P = .33]). Reductions in seizure frequency and responder rates were lower in patients who converted from CBZ or other VGSCi compared with those who converted from other AEDs. There were no notable differences in overall tolerability between subgroups, but the incidence of some adverse events (eg, dizziness, somnolence, nausea) differed between subgroups and/or between treatment periods. SIGNIFICANCE: Baseline use of CBZ or other major putative VGSC inhibitors did not appear to significantly increase the risk of study exit due to worsening seizure control, or to increase the frequency of side effects when converting to ESL monotherapy. However, bigger improvements in efficacy may be possible in patients converting to ESL monotherapy from an AED regimen that does not include a VGSC inhibitor.
Department of Neurology Thomas Jefferson University Philadelphia PA USA
Sunovion Pharmaceuticals Inc Marlborough MA USA
University of Colorado Anschutz Medical Campus Aurora CO USA
References provided by Crossref.org
GENBANK
NCT00866775
