title: One-year clinical experience of perampanel in Spain: a multicentre study of efficacy and tolerability.
abstract: Perampanel, a non-competitive antagonist of the α-amino-3-hydroxy-5-methyl-4-isoxazole-propionic acid receptors, is the most recent antiepileptic drug available in Spain, marketed in January 2014. It was initially approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, but recently also for primary generalized tonic-clonic seizures. Although clinical trials provide essential information about the drug, they do not reflect daily clinical practice. This retrospective study shows the initial experience with perampanel in 11 Spanish hospitals during its first year post-commercialisation. All patients who started perampanel treatment were included, but efficacy and tolerability were only assessed in those patients with a minimum follow-up period of six months. In total, 256 patients were treated with perampanel before September 2014, and 253 had an observational period of one year. After six months, 216/256 patients (84%) continued on perampanel and 180/253 (71.1%) completed one year of treatment. The mean number of previous antiepileptic drugs used was 6.83 and the median number of concomitant antiepileptic drugs was 2. The mean perampanel dose was 7.06 mg and 8.26 mg at six and 12 months, respectively. The responder rate was 39.5% and 35.9% at both follow-up points, respectively. Adverse events were experienced by 91/253 (35.5%) and resulted in withdrawal in 37 (14.6%). The most common adverse events were somnolence, dizziness, and irritability. We found no significant differences between concomitant use of enzyme-inducing and non-inducing antiepileptic drugs, regarding efficacy, adverse effects, or withdrawals. Irritability was not influenced by concomitant use of levetiracetam, relative to other drugs, but was more frequently observed in patients with a history of psychiatric problems or learning disabilities.
authors.affiliation: Hospital Universitario Cruces, Baracaldo.
authors.forename: Iñigo
authors.initials: I
authors.lastname: Garamendi-Ruiz
authors.affiliation: Hospital Clínico San Carlos, Madrid.
authors.forename: María Eugenia
authors.initials: ME
authors.lastname: García-García
authors.affiliation: Hospital Universitario Miguel Servet, Zaragoza.
authors.forename: Vicente
authors.initials: V
authors.lastname: Bertol-Alegre
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza.
authors.forename: José Ángel
authors.initials: JÁ
authors.lastname: Mauri-Llerda
authors.affiliation: Hospital Clínico San Carlos, Madrid.
authors.forename: Irene
authors.initials: I
authors.lastname: García-Morales
authors.affiliation: Hospital Universitario Miguel Servet, Zaragoza.
authors.forename: Vanesa
authors.initials: V
authors.lastname: Garayoa-Irigoyen
authors.affiliation: Hospital Universitario Cruces, Baracaldo.
authors.forename: Marta
authors.initials: M
authors.lastname: Agúndez-Sarasola
authors.affiliation: Hospital de la Princesa, Madrid.
authors.forename: María
authors.initials: M
authors.lastname: De Toledo-Heras
authors.affiliation: Hospital Universitario Araba, Vitoria.
authors.forename: Vanessa
authors.initials: V
authors.lastname: García-Morales
authors.affiliation: Hospital Royo Villanova, Zaragoza.
authors.forename: María José
authors.initials: MJ
authors.lastname: García-Gomara
authors.affiliation: Hospital General de la Defensa, Zaragoza.
authors.forename: Carolina
authors.initials: C
authors.lastname: Arcos-Sánchez
authors.affiliation: Hospital de la Princesa, Madrid.
authors.forename: Ana
authors.initials: A
authors.lastname: Gago-Veiga
authors.affiliation: Hospital Galdakao Usansolo, Galdakao.
authors.forename: Inés
authors.initials: I
authors.lastname: Escalza-Cortina
authors.affiliation: Hospital Universitario Araba, Vitoria.
authors.forename: Eliana
authors.initials: E
authors.lastname: Rueda-Mena
authors.affiliation: Hospital de Alcañiz, Alcañiz.
authors.forename: Elena
authors.initials: E
authors.lastname: Muñoz-Fargas
authors.affiliation: Hospital Clínico Universitario Lozano Blesa, Zaragoza.
authors.forename: Sonia
authors.initials: S
authors.lastname: Santos-Lasaosa
authors.affiliation: Hospital de Alcañiz, Alcañiz.
authors.forename: José Antonio
authors.initials: JA
authors.lastname: Oliván-Usieto
authors.affiliation: Hospital de Barbastro, Barbastro, Spain.
authors.forename: Leyre Díaz de Cerio-
authors.initials: LD
authors.lastname: Julián
authors.affiliation: Hospital Universitario Cruces, Baracaldo.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Gómez-Esteban
authors.affiliation: Hospital Universitario Cruces, Baracaldo.
authors.forename: Ainhoa
authors.initials: A
authors.lastname: Marinas-Alejo
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use*; D004244:Dizziness / Q000139:chemically induced; D004827:Epilepsy / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007508:Irritable Mood / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009570:Nitriles; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*; D019233:Retreatment; D012189:Retrospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000927:Anticonvulsants; D009570:Nitriles; D011728:Pyridones; C551441:perampanel
keywords: AED treatment; adverse event; efficacy; epilepsy; perampanel