TY - JOUR
T1 - Effectiveness and tolerability of perampanel in children and adolescents with refractory epilepsies—An Italian observational multicenter study
AU - De Liso, Paola
AU - Vigevano, Federico
AU - Specchio, Nicola
AU - De Palma, Luca
AU - Bonanni, Paolo
AU - Osanni, E.
AU - Coppola, Giangennaro
AU - Parisi, P.
AU - Grosso, Salvatore
AU - Verrotti, Alberto
AU - Spalice, A.
AU - Nicita, Francesco
AU - Zamponi, Nelia
AU - Siliquini, Sabrina
AU - Giordano, Lucio
AU - Martelli, P.
AU - Guerrini, Renzo
AU - Rosati, Anna
AU - Ilvento, Lucrezia
AU - Belcastro, Vincenzo
AU - Striano, Pasquale
AU - Vari, M. S.
AU - Capovilla, Giuseppe
AU - Beccari, F.
AU - Bruni, Oliviero
AU - Luchetti, Anna
AU - Gobbi, Giuseppe
AU - Russo, Angelo
AU - Pruna, D.
AU - Tozzi, Alberto Eugenio
AU - Cusmai, Raffaella
PY - 2016/11/1
Y1 - 2016/11/1
N2 - Purpose To evaluate the efficacy and tolerability of Perampanel (PER) in children and adolescents with refractory epilepsies in daily clinical practice conditions. Patients and methods This Italian multicenter retrospective observational study was performed in 16 paediatric epilepsy centres. Inclusion criteria were: (i) ≤18 years of age, (ii) history of refractory epilepsy, (iii) a follow-up ≥5 months of PER add-on therapy. Exclusion criteria were: (i) a diagnosis of primary idiopathic generalized epilepsy, (ii) variation of concomitant AEDs during the previous 4 weeks. Response was defined as a ≥50% reduction in monthly seizure frequency compared with the baseline. Results 62 patients suffering from various refractory epilepsies were included in this study: 53% were males, the mean age was 14.2 years (range 6–18 years), 8 patients aged <12 years. Mean age at epilepsy onset was 3.4 years and the mean duration of epilepsy was 10.8 years (range 1–16), which ranged from 2 seizures per-month up to several seizures per-day (mean number = 96.5). Symptomatic focal epilepsy was reported in 62.9% of cases. Mean number of AEDs used in the past was 7.1; mean number of concomitant AEDs was 2.48, with carbamazepine used in 43.5% of patients. Mean PER daily dose was 7.1 mg (2–12 mg). After an average of 6.6 months of follow-up (5–13 months), the retention rate was 77.4% (48/62). The response rate was 50%; 16% of patients achieved ≥75% seizure frequency reduction and 5% became completely seizure free. Seizure aggravation was observed in 9.7% of patients. Adverse events were reported in 19 patients (30.6%) and led to PER discontinuation in 4 patients (6.5%). The most common adverse events were behaviour disturbance (irritability and aggressiveness), dizziness, sedation and fatigue. Conclusion PER was found to be a safe and effective treatment when used as adjunctive therapy in paediatric patients with uncontrolled epilepsy.
AB - Purpose To evaluate the efficacy and tolerability of Perampanel (PER) in children and adolescents with refractory epilepsies in daily clinical practice conditions. Patients and methods This Italian multicenter retrospective observational study was performed in 16 paediatric epilepsy centres. Inclusion criteria were: (i) ≤18 years of age, (ii) history of refractory epilepsy, (iii) a follow-up ≥5 months of PER add-on therapy. Exclusion criteria were: (i) a diagnosis of primary idiopathic generalized epilepsy, (ii) variation of concomitant AEDs during the previous 4 weeks. Response was defined as a ≥50% reduction in monthly seizure frequency compared with the baseline. Results 62 patients suffering from various refractory epilepsies were included in this study: 53% were males, the mean age was 14.2 years (range 6–18 years), 8 patients aged <12 years. Mean age at epilepsy onset was 3.4 years and the mean duration of epilepsy was 10.8 years (range 1–16), which ranged from 2 seizures per-month up to several seizures per-day (mean number = 96.5). Symptomatic focal epilepsy was reported in 62.9% of cases. Mean number of AEDs used in the past was 7.1; mean number of concomitant AEDs was 2.48, with carbamazepine used in 43.5% of patients. Mean PER daily dose was 7.1 mg (2–12 mg). After an average of 6.6 months of follow-up (5–13 months), the retention rate was 77.4% (48/62). The response rate was 50%; 16% of patients achieved ≥75% seizure frequency reduction and 5% became completely seizure free. Seizure aggravation was observed in 9.7% of patients. Adverse events were reported in 19 patients (30.6%) and led to PER discontinuation in 4 patients (6.5%). The most common adverse events were behaviour disturbance (irritability and aggressiveness), dizziness, sedation and fatigue. Conclusion PER was found to be a safe and effective treatment when used as adjunctive therapy in paediatric patients with uncontrolled epilepsy.
KW - Adolescents
KW - Antiepileptic drug
KW - Children
KW - Perampanel
KW - Refractory epilepsy
KW - Treatment outcome
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U2 - 10.1016/j.eplepsyres.2016.08.021
DO - 10.1016/j.eplepsyres.2016.08.021
M3 - Article
VL - 127
SP - 93
EP - 100
JO - Epilepsy Research
JF - Epilepsy Research
SN - 0920-1211
ER -