PMID- 28921040
OWN - NLM
STAT- MEDLINE
DCOM- 20180608
LR  - 20220316
IS  - 1432-1459 (Electronic)
IS  - 0340-5354 (Print)
IS  - 0340-5354 (Linking)
VI  - 264
IP  - 11
DP  - 2017 Nov
TI  - Euro-Esli: a European audit of real-world use of eslicarbazepine acetate as a 
      treatment for partial-onset seizures.
PG  - 2232-2248
LID - 10.1007/s00415-017-8618-5 [doi]
AB  - The Euro-Esli study was an exploratory pooled analysis of data from 14 European 
      clinical practice studies, which was conducted to audit the real-world 
      effectiveness, safety, and tolerability of eslicarbazepine acetate (ESL) as an 
      adjunctive treatment for partial-onset seizures. Retention and effectiveness were 
      assessed after 3, 6, and 12 months of ESL treatment, and at the final visit. 
      Safety and tolerability were assessed throughout ESL treatment by evaluating 
      adverse events (AEs) and ESL discontinuation due to AEs. Data from 2058 patients 
      (52.1% male; mean age 44.0 years) were included. All 2058 patients were assessed 
      for safety and 1975 (96.0%) patients were assessed for effectiveness. After 
      12 months, retention, responder (>/=50% seizure frequency reduction), and seizure 
      freedom rates were 73.4, 75.6, and 41.3%, respectively. AEs were reported for 
      34.0% of patients and led to discontinuation in 13.6% of patients. The most 
      frequently reported AEs were dizziness (6.7% of patients), fatigue (5.4%), and 
      somnolence (5.1%). No unexpected safety signals emerged over a median duration of 
      follow-up of >5 years. Subgroup analyses revealed that ESL was significantly more 
      effective in patients aged >/=65 versus <65 years, in patients who were not 
      receiving treatment with other sodium channel blockers versus those who were 
      receiving treatment with other sodium channel blockers, and in patients who were 
      receiving <2 versus >/=2 concomitant antiepileptic drugs at baseline. Euro-Esli is 
      the largest ESL clinical practice study conducted to date. This study provides 
      strong and reassuring evidence of ESL's safety profile, and complements the data 
      from clinical trials.
FAU - Villanueva, Vicente
AU  - Villanueva V
AD  - Multidisciplinary Epilepsy Unit, Neurology Service, Hospital Universitario y 
      Polotecnico La Fe, Avda Fernando Abril Martorell 106, 46026, Valencia, Spain. 
      villanueva_vichab@gva.es.
AD  - Refractory Epilepsy Unit, Hospital Universitario y Politecnico La Fe, 46026, 
      Valencia, Spain. villanueva_vichab@gva.es.
FAU - Holtkamp, Martin
AU  - Holtkamp M
AD  - Department of Neurology, Epilepsy-Center Berlin-Brandenburg, 
      Charite-Universitatsmedizin, Chariteplatz 1, 10117, Berlin, Germany.
FAU - Delanty, Norman
AU  - Delanty N
AD  - Division of Neurology, Beaumont Hospital, Beaumont Road, Dublin 9, Ireland.
FAU - Rodriguez-Uranga, Juan
AU  - Rodriguez-Uranga J
AD  - Centro de Neurologia Avanzada, Avenida Manuel Siurot no 43-A, 41013, Seville, 
      Spain.
FAU - McMurray, Rob
AU  - McMurray R
AD  - European Knowledge Centre, Eisai Europe Ltd, Mosquito Way, Hatfield, 
      Hertfordshire, AL10 9SN, UK.
FAU - Santagueda, Patricia
AU  - Santagueda P
AD  - Multidisciplinary Epilepsy Unit, Neurology Service, Hospital Universitario y 
      Polotecnico La Fe, Avda Fernando Abril Martorell 106, 46026, Valencia, Spain.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170918
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Anticonvulsants)
RN  - 0 (Dibenzazepines)
RN  - BEA68ZVB2K (eslicarbazepine acetate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Anticonvulsants/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Dibenzazepines/*therapeutic use
MH  - Dose-Response Relationship, Drug
MH  - Europe
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Seizures/*drug therapy
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC5656697
OTO - NOTNLM
OT  - Antiepileptic drug
OT  - Clinical practice
OT  - Epilepsy
OT  - Eslicarbazepine acetate
OT  - Pooled analysis
OT  - Real world
COIS- CONFLICTS OF INTEREST: VV has participated in advisory boards and pharmaceutical 
      industry-sponsored symposia for Eisai, UCB Pharma, Merck Sharp and Dohme, Bial, 
      Pfizer, GSK, Esteve, Novartis, Medtronic, and Cyberonics. MH has received 
      speaker's honoraria and/or consultancy fees from Bial, Desitin, Eisai, 
      GlaxoSmithKline, Janssen-Cilag, LivaNova, Novartis, Shire, and UCB. ND has served 
      on Advisory Boards for Eisai, UCB Pharma, Sanofi, and Lundbeck, and has provided 
      educational lectures about epilepsy to Eisai, Scandinavia. JRU has participated 
      in advisory boards for UCB, Eisai, Bial, and Pfizer. RM is a current employee of 
      Eisai Europe Ltd. PS has received honoraria from Eisai, Bial, and UCB. ETHICAL 
      STANDARDS: All human studies outlined in this article were approved by the 
      appropriate ethics committees and have, therefore, been performed in accordance 
      with the ethical standards laid down in the 1964 Declaration of Helsinki and its 
      later amendments. INFORMED CONSENT: All persons gave their informed consent prior 
      to their inclusion in the studies, according to the protocol.
EDAT- 2017/09/19 06:00
MHDA- 2018/06/09 06:00
PMCR- 2017/09/18
CRDT- 2017/09/19 06:00
PHST- 2017/07/14 00:00 [received]
PHST- 2017/09/05 00:00 [accepted]
PHST- 2017/09/04 00:00 [revised]
PHST- 2017/09/19 06:00 [pubmed]
PHST- 2018/06/09 06:00 [medline]
PHST- 2017/09/19 06:00 [entrez]
PHST- 2017/09/18 00:00 [pmc-release]
AID - 10.1007/s00415-017-8618-5 [pii]
AID - 8618 [pii]
AID - 10.1007/s00415-017-8618-5 [doi]
PST - ppublish
SO  - J Neurol. 2017 Nov;264(11):2232-2248. doi: 10.1007/s00415-017-8618-5. Epub 2017 
      Sep 18.