PMID- 22882018
OWN - NLM
STAT- MEDLINE
DCOM- 20130304
LR  - 20130107
IS  - 1528-1167 (Electronic)
IS  - 0013-9580 (Linking)
VI  - 54
IP  - 1
DP  - 2013 Jan
TI  - Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients 
      with focal-onset seizures: integrated analysis of pooled data from double-blind 
      phase III clinical studies.
PG  - 98-107
LID - 10.1111/j.1528-1167.2012.03605.x [doi]
AB  - PURPOSE: To evaluate the efficacy and safety profile of eslicarbazepine acetate 
      (ESL) added to stable antiepileptic therapy in adults with partial-onset 
      seizures. METHODS: Data from 1,049 patients enrolled from 125 centers, in 23 
      countries, in three phase III double-blind, randomized, placebo-controlled 
      studies were pooled and analyzed. Following a 2-week titration period, ESL was 
      administered at 400 mg, 800 mg, and 1,200 mg once-daily doses for 12 weeks. KEY 
      FINDINGS: Seizure frequency was significantly reduced with ESL 800 mg (p < 
      0.0001) and 1,200 mg (p < 0.0001) compared to placebo. Median relative reduction 
      in seizure frequency was, respectively, 35% and 39% (placebo 15%) and responder 
      rate was 36% and 44% (placebo 22%). ESL was more efficacious than placebo 
      regardless of gender, geographic region, epilepsy duration, age at time of 
      diagnosis, seizure type, and number and type of concomitant antiepileptic drugs 
      (AEDs). Incidence of adverse events (AEs) and AEs leading to discontinuation were 
      dose dependent. AEs occurred mainly during the first weeks of treatment, with no 
      difference between groups after 6 weeks. Most common AEs (>10% patients) were 
      dizziness, somnolence, and headache. The incidence of AEs in ESL groups compared 
      to placebo was generally consistent among different subpopulations. SIGNIFICANCE: 
      Once-daily ESL 800 mg and 1,200 mg showed consistent results across all efficacy 
      and safety end points. Results were independent of study population 
      characteristics and type and number of concomitant AEDs.
CI  - Wiley Periodicals, Inc. (c) 2012 International League Against Epilepsy.
FAU - Gil-Nagel, Antonio
AU  - Gil-Nagel A
AD  - Department of Neurology, Hospital Ruber International, Madrid, Spain.
FAU - Elger, Christian
AU  - Elger C
FAU - Ben-Menachem, Elinor
AU  - Ben-Menachem E
FAU - Halasz, Peter
AU  - Halasz P
FAU - Lopes-Lima, Jose
AU  - Lopes-Lima J
FAU - Gabbai, Alberto A
AU  - Gabbai AA
FAU - Nunes, Teresa
AU  - Nunes T
FAU - Falcao, Amilcar
AU  - Falcao A
FAU - Almeida, Luis
AU  - Almeida L
FAU - da-Silva, Patricio Soares
AU  - da-Silva PS
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120806
PL  - United States
TA  - Epilepsia
JT  - Epilepsia
JID - 2983306R
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/administration & dosage/adverse effects/*therapeutic use
MH  - Dibenzazepines/administration & dosage/adverse effects/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/*drug therapy
MH  - Female
MH  - Humans
MH  - Male
EDAT- 2012/08/14 06:00
MHDA- 2013/03/05 06:00
CRDT- 2012/08/14 06:00
PHST- 2012/08/14 06:00 [entrez]
PHST- 2012/08/14 06:00 [pubmed]
PHST- 2013/03/05 06:00 [medline]
AID - 10.1111/j.1528-1167.2012.03605.x [doi]
PST - ppublish
SO  - Epilepsia. 2013 Jan;54(1):98-107. doi: 10.1111/j.1528-1167.2012.03605.x. Epub 
      2012 Aug 6.