Effectiveness and Tolerability of Perampanel in Monotherapy in the Treatment of Focal and Generalized Tonic-Clonic Seizures: Results of 12 Months Follow Up of a National Multicenter Study
Abstract number :
3.325
Submission category :
7. Antiepileptic Drugs / 7E. Other
Year :
2019
Submission ID :
2422219
Source :
www.aesnet.org
Presentation date :
12/9/2019 1:55:12 PM
Published date :
Nov 25, 2019, 12:14 PM
Authors :
Nuria Garcia Barragan, Hospital Ramón y Cajal; Adolfo Jimenez-Huete, Hospital Ruber Internacional; Irene Garcia-Morales, Hospital Clínico San Carlos. Madrid; Beatriz Parejo, Hospital Clínico San Carlos. Madrid; Azoye González-Hernández, Hospital S. Roque
Rationale: Perampanel (PER) is an antiepileptic drug (AED) with a novel mechanism, acting as a non-competitive antagonist of AMPA receptors of glutamate. It is approved for the treatment of focal seizures with or without secondary generalization and primary generalized tonic-clonic seizures. Perampanel has proven better efficacy and tolerability when used as early add on but there is still lack of evidence when it is used as monotherapy. In this study, we wanted to evaluate the effectiveness and tolerability of perampanel in monotherapy (PER-MT) in patients with focal and generalized tonic-clonic seizures (GTCS) according to daily clinical practice in Spain. Methods: Multicenter, observational and retrospective study of patients with focal and generalized tonic-clonic seizures who were treated with PER-MT in 20 different hospitals in Spain. Effectiveness, tolerability and safety were evaluated at 3, 6 and 12 months of PER-MT. Results: We included 98 patients in this analysis with PER-MT. Mean age was 49.6+-21.7 years; 51% women. The mean follow-up was 14+-9.5 months. The most frequent epilepsy type was focal (72.4%); 73.4% of patients had antecedents of GTCS. Mean number of previous AEDs was 1.8+-1.6. Most patients (79.6%) achieved PER monotherapy by reduction of concomitant AEDs after a conversion period. Median PER dose at last visit was 5.2+-1.9 mg/day. Retention rate at 3, 6 and 12 months were 93.8%, 89.3% and 81% respectively. In an intention to treat analysis, seizure free patients at 3, 6 and 12 months were 71.1%, 65.3% and 53% respectively. This was observed both in patients with focal seizures and GTCS. Adverse events (AES) were reported on 47 patients (46%) during PER-MT, leading to discontinuation in 15 patients (15.4%). Psychiatric AES were recorded in 28 patients (28.5%) with discontinuation of PER-MT in 13 of them. Conclusions: This national multicenter study shows that PER-MT is an effective antiepileptic drug in the treatment of focal and GTCS at relatively low doses in a significant number of patients. PER-MT is also well tolerated as shown by the high retention rate and good safety profile found among most of our patients. Funding: No funding
Antiepileptic Drugs