PMID- 27521586 OWN - NLM STAT- MEDLINE DCOM- 20171219 LR - 20211204 IS - 1872-6844 (Electronic) IS - 0920-1211 (Linking) VI - 126 DP - 2016 Oct TI - Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: The FYDATA study. PG - 201-10 LID - S0920-1211(16)30121-8 [pii] LID - 10.1016/j.eplepsyres.2016.08.001 [doi] AB - 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. CI - Copyright (c) 2016 Elsevier B.V. All rights reserved. FAU - Villanueva, V AU - Villanueva V AD - Hospital Universitario y Politecnico La Fe, Valencia, Spain. Electronic address: villanueva_vichab@gva.es. FAU - Garces, M AU - Garces M AD - Hospital Universitario y Politecnico La Fe, Valencia, Spain. Electronic address: mergarces@gmail.com. FAU - Lopez-Gonzalez, F J AU - Lopez-Gonzalez FJ AD - Complejo Hospitalario, Universitario Santiago, Spain. Electronic address: javieritol@yahoo.com. FAU - Rodriguez-Osorio, X AU - Rodriguez-Osorio X AD - Complejo Hospitalario, Universitario Santiago, Spain. Electronic address: xiana.ro@gmail.com. FAU - Toledo, M AU - Toledo M AD - Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: mtoledo75@hotmail.com. FAU - Salas-Puig, J AU - Salas-Puig J AD - Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: javiersalaspuig@gmail.com. FAU - Gonzalez-Cuevas, M AU - Gonzalez-Cuevas M AD - Hospital Universitario Vall d'Hebron, Barcelona, Spain. Electronic address: montsegonzalezc@gmail.com. FAU - Campos, D AU - Campos D AD - Hospital Clinico Universitario, Valladolid, Spain. Electronic address: dm04cb@hotmail.com. FAU - Serratosa, J M AU - Serratosa JM AD - Fundacion Jimenez Diaz, Madrid, Spain. Electronic address: joseserratosa@me.com. FAU - Gonzalez-Giraldez, B AU - Gonzalez-Giraldez B AD - Fundacion Jimenez Diaz, Madrid, Spain. Electronic address: beagiraldez@yahoo.es. FAU - Mauri, J A AU - Mauri JA AD - Hospital Clinico Universitario, Zaragoza, Spain. Electronic address: jamauri@telefonica.net. FAU - Camacho, J L AU - Camacho JL AD - Hospital Clinico Universitario, Zaragoza, Spain. Electronic address: jlcv2002@hotmail.com. FAU - Suller, A AU - Suller A AD - Hospital Clinico Universitario, Zaragoza, Spain. Electronic address: anasm98@gmail.com. FAU - Carreno, M AU - Carreno M AD - Hospital Clinic Universitari, Barcelona, Spain. Electronic address: mcarreno@clinic.ub.es. FAU - Gomez, J B AU - Gomez JB AD - Hospital Clinic Universitari, Barcelona, Spain. Electronic address: jbgomezg@gmail.com. FAU - Montoya, J AU - Montoya J AD - Hospital Lluis Alcanyis, Xativa, Spain. Electronic address: Javier.montoya@uv.es. FAU - Rodriguez-Uranga, J AU - Rodriguez-Uranga J AD - Clinica Sagrado Corazon-Quiron, Sevilla, Spain. Electronic address: juanuranga@telefonica.net. FAU - Saiz-Diaz, R AU - Saiz-Diaz R AD - Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: rsaizdiaz@yahoo.com. FAU - Gonzalez-de la Aleja, J AU - Gonzalez-de la Aleja J AD - Hospital Universitario 12 de Octubre, Madrid, Spain. Electronic address: jesus_goal@yahoo.es. FAU - Castillo, A AU - Castillo A AD - Consorcio Hospital General Universitario, Valencia, Spain. Electronic address: s_castillo_ruiz@yahoo.es. FAU - Lopez-Trigo, J AU - Lopez-Trigo J AD - Consorcio Hospital General Universitario, Valencia, Spain. Electronic address: neurofisiologia_hgv@gva.es. FAU - Poza, J J AU - Poza JJ AD - Hospital Universitario Donosti, Spain. Electronic address: jjpoza@chdo.osakidetza.net. FAU - Flores, J AU - Flores J AD - Hospital Nuestra Senora Candelaria, Tenerife, Spain. Electronic address: josefloresgaldo@yahoo.es. FAU - Querol, R AU - Querol R AD - Hospital Universitario Infanta Cristina, Badajoz, Spain. Electronic address: roquepas63@gmail.com. FAU - Ojeda, J AU - Ojeda J AD - Hospital Universitario Infanta Sofia, Madrid, Spain. Electronic address: ojedamd@gmail.com. FAU - Giner, P AU - Giner P AD - Hospital Universitario Dr Peset, Valencia, Spain. Electronic address: giner_pau@gva.es. FAU - Molins, A AU - Molins A AD - Hospital Universitario Josep Trueta, Girona, Spain. Electronic address: amolinsalbanell@yahoo.es. FAU - Esteve, P AU - Esteve P AD - Hospital Verge de la Cinta, Tortosa, Spain. Electronic address: pestevebe@gmail.com. FAU - Baiges, J J AU - Baiges JJ AD - Hospital Verge de la Cinta, Tortosa, Spain. Electronic address: jbaiges.ebre.ics@gencat.cat. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20160804 PL - Netherlands TA - Epilepsy Res JT - Epilepsy research JID - 8703089 RN - 0 (Anticonvulsants) RN - 0 (Nitriles) RN - 0 (Pyridones) RN - H821664NPK (perampanel) SB - IM EIN - Epilepsy Res. 2017 Jan;129:174-175. PMID: 28017504 MH - Adolescent MH - Adult MH - Aged MH - Aged, 80 and over MH - Anticonvulsants/adverse effects/*therapeutic use MH - Child MH - Comorbidity MH - Epilepsies, Partial/complications/*drug therapy MH - Female MH - Follow-Up Studies MH - Humans MH - Logistic Models MH - Male MH - Mental Disorders/complications MH - Middle Aged MH - Nitriles MH - Pyridones/adverse effects/*therapeutic use MH - Retrospective Studies MH - Seizures/complications/drug therapy MH - Treatment Outcome MH - Young Adult OTO - NOTNLM OT - Antiepileptic drug OT - Epilepsy OT - Perampanel OT - Real-world EDAT- 2016/08/16 06:00 MHDA- 2017/12/20 06:00 CRDT- 2016/08/14 06:00 PHST- 2015/12/23 00:00 [received] PHST- 2016/07/18 00:00 [revised] PHST- 2016/08/03 00:00 [accepted] PHST- 2016/08/14 06:00 [entrez] PHST- 2016/08/16 06:00 [pubmed] PHST- 2017/12/20 06:00 [medline] AID - S0920-1211(16)30121-8 [pii] AID - 10.1016/j.eplepsyres.2016.08.001 [doi] PST - ppublish SO - Epilepsy Res. 2016 Oct;126:201-10. doi: 10.1016/j.eplepsyres.2016.08.001. Epub 2016 Aug 4.