PMID- 20299189
OWN - NLM
STAT- MEDLINE
DCOM- 20100908
LR  - 20220316
IS  - 1872-6844 (Electronic)
IS  - 0920-1211 (Linking)
VI  - 89
IP  - 2-3
DP  - 2010 May
TI  - Eslicarbazepine acetate as adjunctive therapy in adult patients with partial 
      epilepsy.
PG  - 278-85
LID - 10.1016/j.eplepsyres.2010.01.014 [doi]
AB  - OBJECTIVE: To investigate the efficacy and safety of once-daily eslicarbazepine 
      acetate (ESL) when used as add-on treatment in adults with > or = 4 partial-onset 
      seizures per 4-week despite treatment with 1 to 3 antiepileptic drugs (AEDs). 
      METHODS: This double-blind, parallel-group, multicenter study consisted of an 
      8-week observational baseline period, after which patients were randomized to 
      placebo (n=100) or once-daily ESL 400 mg (n=96), 800 mg (n=101), or 1200 mg 
      (n=98). Patients then entered a 14-week double-blind treatment phase. All 
      patients started on their full maintenance dose except for those in the ESL 1200 
      mg group who received once-daily ESL 800 mg for 2 weeks before reaching their 
      full maintenance dose. RESULTS: Seizure frequency per 4-week (primary endpoint) 
      over the 14-week double-blind treatment period was significantly lower than 
      placebo in the ESL 800 mg and 1200 mg (p<0.001) groups. Responder rate (> or = 
      50% reduction in seizure frequency) was 13.0% (placebo), 16.7% (400 mg), 40.0% 
      (800 mg, p<0.001), and 37.1% (1200 mg, p<0.001). Median relative reduction in 
      seizure frequency was 0.8% (placebo), 18.7% (400 mg), 32.6% (800 mg, p<0.001), 
      and 32.8% (1200 mg). Discontinuation rates due to adverse events (AEs) were 3.0% 
      (placebo), 12.5% (400 mg), 18.8% (800 mg), and 26.5% (1200 mg). The most common 
      (>5%) AEs in any group were dizziness, somnolence, headache, nausea, diplopia, 
      abnormal coordination, vomiting, blurred vision, and fatigue. The majority of AEs 
      were of mild or moderate severity. CONCLUSIONS: Treatment with once-daily 
      eslicarbazepine acetate 800 mg and 1200 mg was more effective than placebo and 
      generally well tolerated in patients with partial-onset seizures refractory to 
      treatment with 1 to 3 concomitant AEDs.
CI  - Copyright 2010 Elsevier B.V. All rights reserved.
FAU - Ben-Menachem, E
AU  - Ben-Menachem E
AD  - Department of Clinical Neuroscience and Physiology, Sahlgren Academy, Sahlgren 
      University Hospital, Goteborg, Sweden.
FAU - Gabbai, A A
AU  - Gabbai AA
FAU - Hufnagel, A
AU  - Hufnagel A
FAU - Maia, J
AU  - Maia J
FAU - Almeida, L
AU  - Almeida L
FAU - Soares-da-Silva, P
AU  - Soares-da-Silva P
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20100317
PL  - Netherlands
TA  - Epilepsy Res
JT  - Epilepsy research
JID - 8703089
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*administration & dosage/adverse effects
MH  - Dibenzazepines/*administration & dosage/adverse effects
MH  - Dizziness/chemically induced
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Drug Synergism
MH  - Epilepsies, Partial/*drug therapy/physiopathology
MH  - Female
MH  - Headache/chemically induced
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - Seizures/*drug therapy
MH  - Treatment Outcome
EDAT- 2010/03/20 06:00
MHDA- 2010/09/09 06:00
CRDT- 2010/03/20 06:00
PHST- 2009/12/11 00:00 [received]
PHST- 2010/01/17 00:00 [revised]
PHST- 2010/01/18 00:00 [accepted]
PHST- 2010/03/20 06:00 [entrez]
PHST- 2010/03/20 06:00 [pubmed]
PHST- 2010/09/09 06:00 [medline]
AID - S0920-1211(10)00035-5 [pii]
AID - 10.1016/j.eplepsyres.2010.01.014 [doi]
PST - ppublish
SO  - Epilepsy Res. 2010 May;89(2-3):278-85. doi: 10.1016/j.eplepsyres.2010.01.014. 
      Epub 2010 Mar 17.