Abstracts

Rationale: Perampanel is approved as adjunctive therapy for partial-onset epilepsy in patients aged 12 years and older. A novel mechanism of action has been described as a highly selective, noncompetitive, AMPA receptor antagonist. Real-life studies provide useful information about antiepileptic drug (AED) use in the daily clinical practice setting. Methods: FYDATA is a multicenter, retrospective, 1-year, observational study. Thirteen tertiary hospital centers participated in the study. The inclusion criteria were: 1) written informed consent to review clinical charts; 2) patients older than 12 years; 3) diagnosis of partial-onset seizures; 4) treatment with perampanel according to clinical practice as add-on therapy; 5) patients with at least 1 partial seizure in the year prior to starting perampanel. The source of data was patient clinical records collected by physicians. It included demographic data, past AED history, psychiatric comorbidity, epilepsy type, number of seizures (efficacy), adverse events (AE; safety), and changes in the concomitant AED at each visit (when a new AED is started there is, as a minimum, a baseline visit and visits at 3, 6 and 12 months). Results: An interim analysis of clinical charts was performed at 3 months in 111 patients. The mean age of the sample was 37.8 ± 12.8 years and the mean duration of epilepsy was 24 ± 14 years. The mean number of seizures per month at onset was 19.3 ± 41 (median 5.8). At baseline, the patient had tried a mean of 8.3 AEDs (range 2-18) and half of the patients were taking concomitant≥ 3 AEDs. Thirty-one percent of patients had a comorbid psychiatric condition.At 3 months the mean dose of perampanel was 5.4 mg (range: 2-8 mg) and the median was 6 mg. At 3 months, 9% of the patients were seizure-free and 44.1% were responder (at least 50% reduction in number of seizures). No differences were observed in efficacy if concomitant enzyme inducer AEDs (phenytoin, carbamazepine, oxcarbazepine) were used or not. Adverse events were reported by 41.4% of the patients. The most frequent were irritability (13.5%), somnolence (10,8%) and dizziness (9.9%). Side effects were mild or moderate, and just 2 patients had to discontinue because of side effects before 3 months.Irritability and aggressiveness were statistically more frequent if patients had a comorbid psychiatric condition (p=0.002)- personality disorder/hyperactivity- . Conclusions: Preliminary results at 3 months in patients with partial epilepsy on perampanel as add-on therapy in a refractory population in real-life setting showed a promising response. Few severe adverse events were observed over 3 months. Some comorbid conditions should be considered in order to improve tolerability.