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Multicenter Study
. 2021 Jul;38(7):603-610.
doi: 10.1007/s40266-021-00865-3. Epub 2021 Jun 2.

Adjunctive Perampanel in Older Patients With Epilepsy: A Multicenter Study of Clinical Practice

Simona Lattanzi  1 , Claudia Cagnetti  2 , Nicoletta Foschi  2 , Roberta Ciuffini  3 , Elisa Osanni  4 , Valentina Chiesa  5 , Filippo Dainese  6 , Fedele Dono  7 , Maria Paola Canevini  5   8 , Giacomo Evangelista  7 , Francesco Paladin  6 , Emanuele Bartolini  9 , Federica Ranzato  10 , Annacarmen Nilo  11 , Giada Pauletto  12 , Daniela Marino  13 , Eleonora Rosati  14 , Paolo Bonanni  4 , Alfonso Marrelli  15
Affiliations
Multicenter Study

Adjunctive Perampanel in Older Patients With Epilepsy: A Multicenter Study of Clinical Practice

Simona Lattanzi et al. Drugs Aging. 2021 Jul.

Abstract

Background: Clinical data regarding use of newer antiseizure medications (ASMs) in an older population are limited. In randomized-controlled, placebo-controlled trials, older patients are under-represented, and protocols deviate markedly from routine clinical practice, limiting the external validity of results. Studies performed in a naturalistic setting are a useful complement to characterize the drug profile. Perampanel is a third-generation ASM and the first and only non-competitive alfa-amino-3-hydroxyl-5-methyl-4-isoxazole-propionate receptor antagonist.

Objective: The aim of this study was to assess the effectiveness and tolerability of adjunctive perampanel over a 1-year period in a population of older patients with epilepsy treated in a real-world setting.

Methods: Older (≥ 65 years of age) patients prescribed add-on perampanel at 12 Italian epilepsy centers were retrospectively identified. Seizure occurrence, adverse events (AEs), and drug withdrawal were analyzed. Effectiveness outcomes included the rates of seizure response (≥ 50% reduction in baseline monthly seizure frequency), seizure freedom, and treatment discontinuation. Safety and tolerability outcomes were the rate of treatment discontinuation due to AEs and the incidence of AEs.

Results: A total of 92 patients with a median age of 69 (range 65-88) years were included. The median daily dose of perampanel at 12 months was 6 mg (interquartile range 4-6 mg). At 12 months, 53 (57.6%) patients were seizure responders, and 22 (23.9%) patients were seizure free. Twenty (21.7%) patients discontinued perampanel; the reasons for treatment withdrawal were insufficient efficacy (n = 6/20; 30.0%), AEs (n = 12/20; 60.0%), and a combination of both (n = 2/20; 10%). The most common AEs included irritability (8.7%), somnolence (4.3%), and dizziness/vertigo (4.3%). The rate of behavioral and psychiatric AEs was higher in patients with history of psychiatric comorbidities (p = 0.044). There were no differences in the occurrence of behavioral and psychiatric AEs according to the concomitant use of levetiracetam (p = 0.776) and history of cognitive decline (p = 0.332).

Conclusions: Adjunctive perampanel was associated with improvement in seizure control and good tolerability in a real-life setting and can represent a viable therapeutic option in older patients with epilepsy.

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Conflict of interest statement

Simona Lattanzi has received speaker's or consultancy fees from Eisai, GW Pharmaceuticals, and UCB Pharma and has served on advisory boards for Angelini, Arvelle Therapeutics, BIAL, and GW Pharmaceuticals. Valentina Chiesa has received speaker's or consultancy fees from Eisai, UCB Pharma, and Livanova. Fedele Dono has received speaker's fees from Eisai. Maria Paola Canevini has received speaker’s or consultancy fees from Bial, EISAI, Italfarmaco, Sanofi, and UCB. All other authors have nothing to disclose.

Figures

Fig. 1
Fig. 1
Clinical response to adjunctive perampanel. Rates of seizure response, seizure freedom, and seizure worsening at 3, 6, and 12 months are reported. Percentages are estimated on the full study population (n = 92). Seizure response was defined as a reduction in seizure frequency ≥ 50% in comparison with baseline seizure frequency. Seizure freedom at each time point was defined as the occurrence of no seizures since at least the previous visit. Seizure worsening was defined as an increase in seizure frequency > 25% in comparison with baseline seizure frequency. Seizure-free patients were included in the seizure response group unless they were already free from seizures during the baseline period
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