Your browser doesn't support javascript.
loading
Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: The FYDATA study.
Villanueva, V; Garcés, M; López-González, F J; Rodriguez-Osorio, X; Toledo, M; Salas-Puig, J; González-Cuevas, M; Campos, D; Serratosa, J M; González-Giráldez, B; Mauri, J A; Camacho, J L; Suller, A; Carreño, M; Gómez, J B; Montoya, J; Rodríguez-Uranga, J; Saiz-Diaz, R; González-de la Aleja, J; Castillo, A; López-Trigo, J; Poza, J J; Flores, J; Querol, R; Ojeda, J; Giner, P; Molins, A; Esteve, P; Baiges, J J.
Afiliação
  • Villanueva V; Hospital Universitario y Politécnico La Fe, Valencia, Spain. Electronic address: villanueva_vichab@gva.es.
  • Garcés M; Hospital Universitario y Politécnico La Fe, Valencia, Spain. Electronic address: mergarces@gmail.com.
  • López-González FJ; Complejo Hospitalario, Universitario Santiago, Spain. Electronic address: javieritol@yahoo.com.
  • Rodriguez-Osorio X; Complejo Hospitalario, Universitario Santiago, Spain. Electronic address: xiana.ro@gmail.com.
  • Toledo M; Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: mtoledo75@hotmail.com.
  • Salas-Puig J; Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: javiersalaspuig@gmail.com.
  • González-Cuevas M; Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: montsegonzalezc@gmail.com.
  • Campos D; Hospital Clínico Universitario, Valladolid, Spain. Electronic address: dm04cb@hotmail.com.
  • Serratosa JM; Fundación Jiménez Diaz, Madrid, Spain. Electronic address: joseserratosa@me.com.
  • González-Giráldez B; Fundación Jiménez Diaz, Madrid, Spain. Electronic address: beagiraldez@yahoo.es.
  • Mauri JA; Hospital Clínico Universitario, Zaragoza, Spain. Electronic address: jamauri@telefonica.net.
  • Camacho JL; Hospital Clínico Universitario, Zaragoza, Spain. Electronic address: jlcv2002@hotmail.com.
  • Suller A; Hospital Clínico Universitario, Zaragoza, Spain. Electronic address: anasm98@gmail.com.
  • Carreño M; Hospital Clinic Universitari, Barcelona, Spain. Electronic address: mcarreno@clinic.ub.es.
  • Gómez JB; Hospital Clinic Universitari, Barcelona, Spain. Electronic address: jbgomezg@gmail.com.
  • Montoya J; Hospital Lluis Alcanyis, Xátiva, Spain. Electronic address: Javier.montoya@uv.es.
  • Rodríguez-Uranga J; Clinica Sagrado Corazón-Quirón, Sevilla, Spain. Electronic address: juanuranga@telefonica.net.
  • Saiz-Diaz R; Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: rsaizdiaz@yahoo.com.
  • González-de la Aleja J; Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: jesus_goal@yahoo.es.
  • Castillo A; Consorcio Hospital General Universitario, Valencia, Spain. Electronic address: s_castillo_ruiz@yahoo.es.
  • López-Trigo J; Consorcio Hospital General Universitario, Valencia, Spain. Electronic address: neurofisiologia_hgv@gva.es.
  • Poza JJ; Hospital Universitario Donosti, Spain. Electronic address: jjpoza@chdo.osakidetza.net.
  • Flores J; Hospital Nuestra Señora Candelaria, Tenerife, Spain. Electronic address: josefloresgaldo@yahoo.es.
  • Querol R; Hospital Universitario Infanta Cristina, Badajoz, Spain. Electronic address: roquepas63@gmail.com.
  • Ojeda J; Hospital Universitario Infanta Sofia, Madrid, Spain. Electronic address: ojedamd@gmail.com.
  • Giner P; Hospital Universitario Dr Peset, Valencia, Spain. Electronic address: giner_pau@gva.es.
  • Molins A; Hospital Universitario Josep Trueta, Girona, Spain. Electronic address: amolinsalbanell@yahoo.es.
  • Esteve P; Hospital Verge de la Cinta, Tortosa, Spain. Electronic address: pestevebe@gmail.com.
  • Baiges JJ; Hospital Verge de la Cinta, Tortosa, Spain. Electronic address: jbaiges.ebre.ics@gencat.cat.
Epilepsy Res ; 126: 201-10, 2016 10.
Article em En | MEDLINE | ID: mdl-27521586
BACKGROUND: Real-world data of current antiepileptic drugs (AEDs) used to treat focal seizures is of importance to understand the efficacy and safety outside of the clinical trial setting. Here we report real-world data from a large series of patients treated with perampanel for 1year. METHODS: FYDATA was a multicentre, retrospective, 1-year observational study assessing the efficacy and safety of adjuvant perampanel in patients ≥12 years of age with focal epilepsy in a real-world setting. At 12 months, the proportion of patients who were seizure free, median percentage seizure reduction, proportion of responders, retention rate and proportion of patients with adverse events (AEs) were assessed. Analyses were also performed to identify any patient-, medication- and disease-related factors associated with a large clinical response or carry a risk for AEs. RESULTS: A total of 464 patients were included in the study with a retention rate of 60.6% at 1year. The mean number of prior AEDs was 7.8. The median percentage reduction in overall seizures was 33.3% (75% for secondary generalised seizures) after 1year, with 7.2% of patients achieving seizure freedom. Furthermore, patients on non-enzyme-inducing AEDs were more likely to achieve seizure freedom, and logistic regression revealed that patients aged ≥65 years, those with epilepsy due to a vascular aetiology and those who had received fewer prior AEDs showed a better clinical response to perampanel. A total of 62.9% of the patients experienced AEs at 12 months; dizziness, somnolence and irritability were the most frequent AEs. Patients with prior psychiatric comorbidities (hyperactivity and personality disorder) were more likely to experience psychiatric AEs with perampanel, and slower titration schedules were associated with less AEs overall. CONCLUSION: Perampanel, for the treatment of focal epilepsy in a real-world setting in a refractory population, over 1year, demonstrates a similar efficacy and safety profile to that observed in clinical trials. Our results have implications for the optimisation of perampanel use in a clinical setting.
Assuntos
Palavras-chave

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridonas / Epilepsias Parciais / Anticonvulsivantes Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Aged / Aged80 / Child / Female / Humans / Male / Middle aged Idioma: En Revista: Epilepsy Res Assunto da revista: CEREBRO / NEUROLOGIA Ano de publicação: 2016 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Piridonas / Epilepsias Parciais / Anticonvulsivantes Tipo de estudo: Diagnostic_studies / Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Adolescent / Adult / Aged / Aged80 / Child / Female / Humans / Male / Middle aged Idioma: En Revista: Epilepsy Res Assunto da revista: CEREBRO / NEUROLOGIA Ano de publicação: 2016 Tipo de documento: Article