PMID- 26915469
OWN - NLM
STAT- MEDLINE
DCOM- 20161213
LR  - 20220316
IS  - 1600-0404 (Electronic)
IS  - 0001-6314 (Print)
IS  - 0001-6314 (Linking)
VI  - 134
IP  - 1
DP  - 2016 Jul
TI  - Real-world data on eslicarbazepine acetate as add-on to antiepileptic 
      monotherapy.
PG  - 76-82
LID - 10.1111/ane.12574 [doi]
AB  - OBJECTIVE: To assess retention, tolerability, and safety, efficacy and effects on 
      quality of life (QoL) of eslicarbazepine acetate (ESL) add-on treatment over 6 
      months in a real-world adult population with partial-onset seizures. METHODS: 
      This non-interventional, multicenter, prospective study was performed in eight 
      European countries. Adult patients (n = 247) for whom the physician had decided 
      to initiate ESL as add-on to an existing antiepileptic drug (AED) monotherapy 
      were invited to participate. The study comprised three visits: baseline, and 
      after 3 and 6 months. Data on ESL retention, efficacy, tolerability, safety, and 
      QoL were collected. RESULTS: After 6 months, the retention rate of ESL was 82.2%, 
      and 81.8% of patients reported a reduction of seizure frequency of at least 50%; 
      39.2% of patients reported seizure freedom at this time. The mean QOLIE-10 score 
      improved from 2.9 (SD +/- 0.8) at baseline to 2.1 (SD +/- 0.8) after 6 months. 109 
      adverse events (AEs) were reported in 57 patients (26.0%); the majority were 
      rated as related to ESL by the investigator and led to a discontinuation of ESL 
      in 25 patients (11.4%). Eight patients (3.7%) suffered at least one serious AE. 
      The most frequently reported AEs were dizziness, headache, convulsion, and 
      fatigue. CONCLUSIONS: This study shows that ESL was well tolerated and 
      efficacious as add-on therapy to one baseline AED. The use of ESL in patients 
      less refractory than those included in previous clinical trials led to higher 
      responder and seizure freedom rates. No new safety issues were observed.
CI  - (c) 2016 Esai Europe Ltd. Acta Neurologica Scandinavica published by John Wiley & 
      Sons Ltd.
FAU - Holtkamp, M
AU  - Holtkamp M
AD  - Epilepsy-Center Berlin-Brandenburg, Department of Neurology, Charite - 
      Universitatsmedizin Berlin, Berlin, Germany.
FAU - McMurray, R
AU  - McMurray R
AD  - Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
FAU - Bagul, M
AU  - Bagul M
AD  - Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
FAU - Sousa, R
AU  - Sousa R
AD  - BIAL - Portela & Ca. SA, S. Mamede do Coronado, Portugal.
FAU - Kockelmann, E
AU  - Kockelmann E
AD  - Eisai GmbH Frankfurt, Frankfurt, Germany.
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20160224
PL  - Denmark
TA  - Acta Neurol Scand
JT  - Acta neurologica Scandinavica
JID - 0370336
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adult
MH  - Anticonvulsants/*therapeutic use
MH  - Dibenzazepines/*therapeutic use
MH  - Drug Therapy, Combination
MH  - Epilepsies, Partial/*drug therapy
MH  - Europe
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Quality of Life
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5067651
OTO - NOTNLM
OT  - add-on
OT  - epilepsy
OT  - eslicarbazepine acetate
OT  - once-daily
OT  - partial-onset seizures
OT  - retention
EDAT- 2016/02/27 06:00
MHDA- 2016/12/15 06:00
PMCR- 2016/10/18
CRDT- 2016/02/27 06:00
PHST- 2016/02/03 00:00 [accepted]
PHST- 2016/02/27 06:00 [entrez]
PHST- 2016/02/27 06:00 [pubmed]
PHST- 2016/12/15 06:00 [medline]
PHST- 2016/10/18 00:00 [pmc-release]
AID - ANE12574 [pii]
AID - 10.1111/ane.12574 [doi]
PST - ppublish
SO  - Acta Neurol Scand. 2016 Jul;134(1):76-82. doi: 10.1111/ane.12574. Epub 2016 Feb 
      24.