title: Long-term safety and efficacy of eslicarbazepine acetate in patients with focal seizures: results of the 1-year ESLIBASE retrospective study.
abstract: BACKGROUND
  Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED) licensed as adjunctive therapy in adults with partial-onset or focal seizures.
  
  
  OBJECTIVE
  To evaluate in a clinical practice setting the long-term efficacy and safety of ESL in patients with focal seizures.
  
  
  METHODS
  ESLIBASE was a retrospective study that included all patients with focal seizures who started ESL between January 2010 and July 2012 at 12 hospitals. ESL was prescribed individually according to real-life practice. Efficacy and safety were evaluated over 1 year. Switching from carbamazepine (CBZ) and oxcarbazepine (OXC) was assessed.
  
  
  RESULTS
  Three hundred and twenty-seven patients were included; 78% of patients were taking ≥2 other AEDs at baseline. Most (87%) began ESL because of poor seizure control and 13% because of adverse events (AEs) with CBZ or OXC. After 1 year, 237 patients (72.4%) remained on ESL. At 3, 6 and 12 months, the responder rate was 46.3%, 57.9%, and 52.5%, and 21.0%, 28.0%, and 25.3% of patients were seizure free. The responder rate significantly increased when ESL was combined with a non-sodium channel-targeting drug (non-SC drug) (66.7%) versus an SC drug (47.7%; p<0.001). At 12 months, 40.7% of patients had ≥1 AE; AEs led to treatment discontinuation in 16.2%. Dizziness, nausea, and somnolence were the most common AEs. The tolerability profile improved in >50% of the patients who switched from CBZ or OXC to ESL because of AEs.
  
  
  CONCLUSIONS
  ESL was well tolerated and effective in a real-world setting over 1 year. Side-effect profile improved when OXC and CBZ recipients were switched to ESL.
authors.affiliation: Hospital Universitario y Politécnico La Fe, Valencia, Spain. Electronic address: villanueva_vichab@gva.es.
authors.forename: V
authors.initials: V
authors.lastname: Villanueva
authors.affiliation: Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: J M
authors.initials: JM
authors.lastname: Serratosa
authors.affiliation: Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: E
authors.initials: E
authors.lastname: Guillamón
authors.affiliation: Hospital Universitario y Politécnico La Fe, Valencia, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Garcés
authors.affiliation: Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain.
authors.forename: B G
authors.initials: BG
authors.lastname: Giráldez
authors.affiliation: Hospital Universitario Vall d́Hebron, Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Toledo
authors.affiliation: Hospital Universitario Vall d́Hebron, Barcelona, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Salas-Puig
authors.affiliation: Complejo Hospitalario Universitario Santiago, Santiago de Compostela, Spain.
authors.forename: F J
authors.initials: FJ
authors.lastname: López González
authors.affiliation: Hospital Universitario Nuestra Señora Candelaria, Tenerife, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Flores
authors.affiliation: Instituto de Especialidades Neurológicas (IENSA), Clinica Sagrado Corazón, Sevilla, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Rodríguez-Uranga
authors.affiliation: Consorcio Hospital General Universitario Valencia, Valencia, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Castillo
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
authors.forename: J A
authors.initials: JA
authors.lastname: Mauri
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain.
authors.forename: J L
authors.initials: JL
authors.lastname: Camacho
authors.affiliation: Hospital Lluis Alcanyis, Xàtiva, Spain.
authors.forename: E
authors.initials: E
authors.lastname: López-Gomáriz
authors.affiliation: Hospital Universitario, Dr. Peset, Valencia, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Giner
authors.affiliation: Hospital Universitario, Dr. Peset, Valencia, Spain.
authors.forename: N
authors.initials: N
authors.lastname: Torres
authors.affiliation: Hospital de Manises, Manises, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Palau
authors.affiliation: Hospital Universitario Dr. JosepTrueta, Girona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Molins
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003984:Dibenzazepines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012640:Seizures / Q000188:drug therapy*; D018709:Statistics, Nonparametric; D013997:Time Factors; D061567:Voltage-Gated Sodium Channel Blockers / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D003984:Dibenzazepines; D061567:Voltage-Gated Sodium Channel Blockers; C416835:eslicarbazepine acetate
keywords: Antiepileptic drug; ESLIBASE; Eslicarbazepine acetate; Focal seizures; Real-life setting