PEREAGAL Study: preliminary 6 months results of Perampanel use for focal seizures as early add-on treatment.
Abstract number :
3.252
Submission category :
7. Antiepileptic Drugs / 7F. Other
Year :
2016
Submission ID :
195881
Source :
www.aesnet.org
Presentation date :
12/5/2016 12:00:00 AM
Published date :
Nov 21, 2016, 18:00 PM
Authors :
Xiana Rodríguez Osorio, Complexo Hospitalario Universitario of Santiago de Compostela; Francisco Javier López González, Complexo Hospitalario Universitario of Santiago de Compostela, Santiago, Spain; Teresa Lema Facal, Complexo Hospitalario Universitario
Rationale: Perampanel is an antiepileptic drug with a novel mechanism acting as a non-competitive antagonist of AMPA receptors of glutamate. It has been approved for treatment of focal seizures with or without secondary generalization (SGS) and primary generalized tonic-clonic seizures. Methods: Multicentric observational 1 year study of patients with focal epilepsy treated with perampanel as early add-on according to daily clinical practice. Data at 3, 6 and 12 months is recorded. Patients had previously received a maximum of 2 AEDs and take 0-2 FAEs as concomitant treatment. Efficacy and tolerability are analyzed. Results: N=64 patients were included. N=44 and N=27 reached 3 and 6 months of follow-up respectively. N=42 (65.6%) were males. Median age was 46 [34,58] years old and median time of evolution of epilepsy was 9 [3, 23.75] years. Patients were previously treated with 1 [0,1] AEDs and were concomitantly taking 1 [1,2] AEDs. Median dose of perampanel at 6 months was 4 [4,6] mg/day. After 3 months, N=6 patients (14.29%) were seizure free, with a global > 50% efficacy in N=25 (59.52%). At 6 months, N=17 were responders (62.96%), with N=11 of them (40.74%) free of seizures. N=17 patients reported adverse events after 3 months (only N=1 was considered severe: irritability leading to withdrawal). N=10 patients reported adverse events after 6 months (none severe). The most frequent was somnolence followed by irritability. Four treatments were stopped after 3 months and none after 6 months of follow-up. N=20 of the patients included suffered from SGS. N=12 reached 3 months of follow-up and N=9 (75%) patients were free of these type of seizures, with N=2 additional responders. N=5 were followed for 6 months: N=4 (80%) were SGS-free and N=1 had >50% reduction. Conclusions: Perampanel has showed efficacy in focal epilepsies as early add-on treatment, with spectacular results in secondary generalized tonic-clonic seizures. Longer follow-up is needed to certify these preliminary results. Funding: This study is supported by EISAI. It has the Ethics Committee Approval of our Institution. Study code: FJL-PER-2015-01.
Antiepileptic Drugs