Effectiveness and safety of perampanel monotherapy for focal and generalized tonic‐clonic seizures: Experience from a national multicenter registry

Abstract

Objective: To assess the effectiveness and tolerability of perampanel (PER) monotherapy in routine clinical practice for the treatment of focal onset and generalized tonic-clonic seizures (GTCS). Methods: This multicenter, retrospective, observational study was conducted in patients aged ≥12 years treated with PER as primary monotherapy or converted to PER monotherapy by progressive reduction of background antiepileptic drugs. Outcomes included retention, responder, and seizure-free rate after 3, 6, and 12 months and tolerability throughout the follow-up. Results: A total of 98 patients (mean age = 49.6 ± 21.7 years, 51% female) with focal seizures and/or GTCS were treated with PER monotherapy for a median exposure of How to cite this article: Toledano DelgadoR, García-Morales I, Parejo-Carbonell B, et al. Effectiveness and safety of perampanel monotherapy for focal and generalized tonic-clonic seizures: Experience from a national multicenter registry.

Optimal Use of Perampanel in Asian Patients with Epilepsy: Expert Opinion

“…The median maintenance dose of perampanel used was 4 mg/day (interquartile range: 4-6). 10 At 3, 6, and 12 months since initiation of perampanel treatment, respectively, retention rates were 93.8%, 89.3%, and 80.9%, responder rates were 79.6%, 70.1%, and 52.8%, and seizure freedom rates were 62.7%, 56.1%, and 41.5%. Regardless of whether perampanel monotherapy was given as the primary or secondary treatment, retention rates did not vary (P=0.57).…”

“…Based on clinical trial data and real-world experience, perampanel is observed to have broad-spectrum efficacy in a range of seizure types when used as both monotherapy and adjunctive therapy. [7][8][9][10][11][12] Clinical studies and real-world evidence have demonstrated the benefits of initiating perampanel at low doses (≤6 mg) [7][8][9][10][11][12] and utilizing a slow titration strategy (increasing dose by 2 mg at ≥2-week intervals). 7,[14][15][16] Initiating perampanel at an early stage (as initial monotherapy or early adjunctive therapy) has also been shown to be associated with better patient outcomes; these data are described below.…”

“…The FYDATA study was a retrospective, multicenter, observational study investigating the safety and efficacy of perampanel as an early adjunctive in patients with FOS (N=464). 14 A large proportion of patients were highly treatment refractory, with an average (range) of 7.8 (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18) prior and 2.8 (1-5) concurrent ASMs prescribed. At 1 year, the perampanel retention rate was 60.6%.…”

“…Perampanel is a first-in-class AMPA receptor antagonist approved for the treatment of epilepsy and has broadspectrum efficacy. [7][8][9][10][11][12] Perampanel is indicated by the US Food and Drug Administration for treatment of focal onset seizures (FOS), with or without focal-to-bilateral tonicclonic seizures (FBTCS), in patients ≥4 years of age (monotherapy and adjunctive therapy) and as adjunctive therapy in the treatment of primary generalized tonicclonic seizures (GTCS) in patients with epilepsy ≥12 years of age. 13 In addition, perampanel has a once-daily dosing schedule that supports patient adherence.…”

Perampanel Reduces Hyperthermia-Induced Seizures in Dravet Syndrome Mouse Model

“…This is consistent with reports of PER used as monotherapy. An examination of data from a national multicenter registry showed that when PER was administered as monotherapy in patients with focal or generalized tonic-clonic seizures, it was effective at a low dose in most patients (Toledano Delgado et al, 2020). When used as monotherapy, the effectiveness of PER was also reported for the patients with genetic generalized epilepsy (Alsaadi et al, 2019).…”