title: Real-world data on eslicarbazepine acetate as add-on to antiepileptic monotherapy.
abstract: 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.
authors.affiliation: Epilepsy-Center Berlin-Brandenburg, Department of Neurology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Holtkamp
authors.affiliation: Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
authors.forename: R
authors.initials: R
authors.lastname: McMurray
authors.affiliation: Eisai Europe Ltd, Hatfield, Hertfordshire, UK.
authors.forename: M
authors.initials: M
authors.lastname: Bagul
authors.affiliation: BIAL - Portela & Ca. SA, S. Mamede do Coronado, Portugal.
authors.forename: R
authors.initials: R
authors.lastname: Sousa
authors.affiliation: Eisai GmbH Frankfurt, Frankfurt, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Kockelmann
mesh_terms: D000328:Adult; D000927:Anticonvulsants / Q000627:therapeutic use*; D003984:Dibenzazepines / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004828:Epilepsies, Partial / Q000188:drug therapy*; D005060:Europe; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D003984:Dibenzazepines; C416835:eslicarbazepine acetate
keywords: add-on; epilepsy; eslicarbazepine acetate; once-daily; partial-onset seizures; retention