Article Text

PDF
055
FYDATA STUDY: PERAMPANEL STUDY IN A REAL-LIFE SETTING
  1. V Villanueva1,
  2. M Garces1,
  3. FJ López Gonzalez2,
  4. X Rodriguez-Osorio2,
  5. JJ Rodriguez Uranga3,
  6. E López-Gomáriz4,
  7. J Montoya4,
  8. JJ Poza Aldea5,
  9. A Molins6,
  10. R Saiz-Diaz7,
  11. J González de la Aleja7,
  12. J Angel Mauri8,
  13. A Castillo9,
  14. FJ Lopez-Trigo Picho9,
  15. M Toledo10,
  16. J Salas Puig10,
  17. D Campos Blance11,
  18. J Flores12
  1. 1Hospital Universitario y Politécnico La Fe, Valencia, Spain
  2. 2Complejo Hospitalario Universitario Santiago, Spain
  3. 3Clinica Sagrado Corazón-Quirón, Sevilla, Spain
  4. 4Hospital LLuis Alcanyis, Xátiva, Spain
  5. 5Hospital Universitario Donosti, Donostia, Spain
  6. 6Hospital Universitario Josep Trueta, Girona, Spain
  7. 7Hospital Universitario 12 de Octubre, Madrid, Spain
  8. 8Hospital Clínico Universitario, Zaragoza, Spain
  9. 9Consorcio Hospital General Universitario, Valencia, Spain
  10. 10Hospital Universitario Vall d&Hebron, Barcelona, Spain
  11. 11Hospital Clinico Universitario, Valladolid, Spain
  12. 12Hospital Nuestra Señora Candelaria, Tenerife

Abstract

FYDATA is a multi-centre, retrospective, 1-year, observational study (inclusion criteria: written informed consent to review clinical charts; patients ≥12 years old; partial-onset seizure [POS] diagnosis; perampanel treatment according to clinical practice as add-on therapy; patients with ≥1 POS in year prior to starting perampanel). The source of data was patient clinical records collected by physicians. An interim analysis was performed at 3 months in 111 patients (mean age: 37.8 years; mean epilepsy duration: 24 years). Mean seizure number/month at onset was 19.3. At baseline, patients had tried a mean of 8.3 antiepileptic drugs (AEDs) and half were taking ≥3 concomitant AEDs. 31% of patients had a comorbid psychiatric condition. At 3 months, with a mean perampanel dose of 5.4 mg, 9% of patients were seizure-free and 44% were responders (≥50% reduction in seizure number). Adverse events were reported by 41.4% of patients; most frequent were irritability (13.5%), somnolence (10.8%) and dizziness (9.9%). Irritability and aggressiveness were more frequent if patients had a comorbid psychiatric condition – personality disorder/hyperactivity. Preliminary results at 3 months in refractory POS patients receiving adjunctive perampanel in a real-life setting showed a promising response. Study sponsors: Eisai Inc. Writing support: Choice Healthcare Solutions; funding, Eisai Ltd.

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.