title: Early add-on lacosamide in a real-life setting: results of the REALLY study.
abstract: OBJECTIVE
  Many patients with epilepsy are treated with antiepileptic drug (AED) polytherapy. Several factors influence the choice of early add-on therapy, and deciding on the most appropriate drug can be difficult. This study aimed to assess the efficacy and tolerability of lacosamide as early add-on therapy in patients with partial-onset seizures.
  
  
  METHODS
  REALLY (REtrospective study of lAcosamide as earLy add-on aLong one Year) was a multicenter, retrospective, 1-year, real-life study. Patients included were aged older than 16 years, had partial-onset seizures, and were treated with lacosamide as add-on therapy after one or two prior AEDs. Data were collected retrospectively from clinical records. The primary study objective was to assess the efficacy of lacosamide over 12 months (seizure-free and responder rates), and the secondary objective was to assess the tolerability of lacosamide at 3, 6, and 12 months [adverse events (AEs) and discontinuation].
  
  
  RESULTS
  One hundred and ninety-nine patients were enrolled in the study; 89 patients (44.7 %) had tried one AED and 110 patients (55.3 %) had tried two AEDs before lacosamide. At 12 months, the proportion of patients who were seizure free was 44.9 %, and 76 % of patients were responders. The seizure-free rate at 12 months for patients who had previously received one or two AEDs was 58 and 34.3 %, and the responder rate at 12 months was 83.0 and 70.4 %, respectively. The AE rate was 21.5 % at 3 months, 27.1 % at 6 months, and 31.2 % at 12 months, with 7.0 % of patients discontinuing treatment because of an AE. The most common AE reported was dizziness (11.6 %). Cryptogenic epilepsy, a higher number of prior AEDs, and the use of a sodium channel blocker at onset were associated with a worse outcome. The number of concomitant AEDs decreased over 1 year (Z = 5.89; p < 0.001). Twenty-two patients were converted to lacosamide monotherapy with at least one evaluation ≥6 months from the beginning of monotherapy conversion.
  
  
  CONCLUSIONS
  Lacosamide was effective and well tolerated as early add-on treatment in patients who had received one or two previous AEDs.
authors.affiliation: Hospital Universitario y Politécnico La Fe, Bulevard Sur, s/n, Carretera de Malilla, 46026, Valencia, Spain, vevillanuevah@yahoo.es.
authors.forename: Vicente
authors.initials: V
authors.lastname: Villanueva
authors.forename: Mercedes
authors.initials: M
authors.lastname: Garcés
authors.forename: Elena
authors.initials: E
authors.lastname: López-Gomáriz
authors.forename: José María
authors.initials: JM
authors.lastname: Serratosa
authors.forename: Beatriz
authors.initials: B
authors.lastname: González-Giráldez
authors.forename: Jaime
authors.initials: J
authors.lastname: Parra
authors.forename: Juan
authors.initials: J
authors.lastname: Rodríguez-Uranga
authors.forename: Manuel
authors.initials: M
authors.lastname: Toledo
authors.forename: Francisco Javier
authors.initials: FJ
authors.lastname: López González
authors.forename: Pedro
authors.initials: P
authors.lastname: Bermejo
authors.forename: Pau
authors.initials: P
authors.lastname: Giner
authors.forename: Ascensión
authors.initials: A
authors.lastname: Castillo
authors.forename: Albert
authors.initials: A
authors.lastname: Molins
authors.forename: Dulce
authors.initials: D
authors.lastname: Campos
authors.forename: José Ángel
authors.initials: JÁ
authors.lastname: Mauri
authors.forename: Rosario
authors.initials: R
authors.lastname: Muñoz
authors.forename: Macarena
authors.initials: M
authors.lastname: Bonet
authors.forename: Pedro
authors.initials: P
authors.lastname: Serrano-Castro
authors.forename: Ana
authors.initials: A
authors.lastname: del Villar
authors.forename: Rosa Ana
authors.initials: RA
authors.lastname: Saiz-Díaz
mesh_terms: D000081:Acetamides / Q000008:administration & dosage* / Q000627:therapeutic use; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000927:Anticonvulsants / Q000008:administration & dosage* / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D000078334:Lacosamide; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012640:Seizures / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D000081:Acetamides; D000927:Anticonvulsants; D000078334:Lacosamide