Efficacy and safety of eslicarbazepine acetate monotherapy in patients converting from carbamazepine
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
29450890
DOI
10.1111/epi.14014
Knihovny.cz E-zdroje
- Klíčová slova
- antiepileptic drugs, focal seizures, refractory epilepsy, switching,
- MeSH
- antikonvulziva aplikace a dávkování škodlivé účinky MeSH
- blokátory sodíkových kanálů řízených napětím aplikace a dávkování škodlivé účinky MeSH
- dibenzazepiny aplikace a dávkování škodlivé účinky MeSH
- dospělí MeSH
- karbamazepin aplikace a dávkování škodlivé účinky MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- náhrada léků škodlivé účinky trendy MeSH
- nauzea chemicky indukované diagnóza MeSH
- refrakterní epilepsie diagnóza farmakoterapie MeSH
- senioři MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antikonvulziva MeSH
- blokátory sodíkových kanálů řízených napětím MeSH
- dibenzazepiny MeSH
- eslicarbazepine acetate MeSH Prohlížeč
- karbamazepin 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
Citace poskytuje Crossref.org
GENBANK
NCT00866775
