title: Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study.
abstract: OBJECTIVE
  To evaluate the long-term safety, tolerability and efficacy of once-daily eslicarbazepine acetate (ESL) as adjunctive therapy in adults with partial-onset seizures.
  
  
  METHODS
  One-year open-label extension (OLE) study with ESL in patients who completed a randomised, double-blind placebo-controlled trial (study BIA-2093-302; Epilepsy Res. 89 (2010) 278-285). Starting dose was 800 mg once-daily, for 4 weeks; thereafter, dose could be individualised within the 400-1,200 mg range. Doses of concomitant antiepileptic drugs were to be kept stable.
  
  
  RESULTS
  Overall, 325 patients were enrolled (intent-to-treat population); 223 (68.6%) patients completed 1-year of treatment. ESL median dose was 800 mg once-daily. Compared to the baseline period of the double-blind study completed prior to this OLE study, median seizure frequency decreased by 32% in weeks 1-4, and between 37% and 39% thereafter. The responder rate (seizure reduction ≥ 50%) was 37% during weeks 1-4 and thereafter ranged between 38% and 42% per 12-week interval. Proportion of seizure-free patients per 12-week interval ranged between 5% and 11%. Improvements from baseline in several Quality of Life in Epilepsy Inventory-31 (QOLIE-31) and Montgomery Asberg Depression Rating Scale (MADRS) scores were observed. Adverse events (AEs) were reported by 83% of patients. AEs occurring in ≥ 10% of patients were dizziness, headache and somnolence. AEs were usually of mild to moderate intensity.
  
  
  CONCLUSIONS
  In this study, ESL demonstrated a sustained therapeutic effect and was well tolerated during 1-year add-on treatment of adults with partial-onset seizures. Additionally, significant improvements in quality of life domains and depressive symptoms were observed under long-term treatment with once-daily ESL.
authors.affiliation: Department of Neurology, University of Essen, Essen, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Hufnagel
authors.forename: Elinor
authors.initials: E
authors.lastname: Ben-Menachem
authors.forename: Alberto A
authors.initials: AA
authors.lastname: Gabbai
authors.forename: Amílcar
authors.initials: A
authors.lastname: Falcão
authors.forename: Luis
authors.initials: L
authors.lastname: Almeida
authors.forename: Patricio
authors.initials: P
authors.lastname: Soares-da-Silva
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000008:administration & dosage*; D003984:Dibenzazepines / Q000008:administration & dosage*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy* / Q000453:epidemiology; D004827:Epilepsy / Q000188:drug therapy / Q000453:epidemiology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate