FYDATA STUDY: PERAMPANEL STUDY IN A REAL-LIFE SETTING

FYDATA STUDY: PERAMPANEL STUDY IN A REAL-LIFE SETTING

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...

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Bibliographic Details
Published in:Journal of neurology, neurosurgery and psychiatry Vol. 86; no. 11; p. e4
Main Authors: Villanueva, V, Garces, M, Gonzalez, FJ López, Rodriguez-Osorio, X, Uranga, JJ Rodriguez, López-Gomáriz, E, Montoya, J, Aldea, JJ Poza, Molins, A, Saiz-Diaz, R, Aleja, J González de la, Mauri, J Angel, Castillo, A, Picho, FJ Lopez-Trigo, Toledo, M, Puig, J Salas, Blance, D Campos, Flores, J
Format: Journal Article
Language:English
Published: London BMJ Publishing Group LTD 01-11-2015
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Summary: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.
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ISSN:0022-3050
1468-330X
DOI:10.1136/jnnp-2015-312379.55