Perampanel effectiveness and safety as early add-on treatment for focal-onset seizures: PEREAGAL study

Rodríguez‐Osorio, Xiana; Lema-Facal, Teresa; Rubio-Nazabal, Eduardo; Castro-Vilanova, M D; Pato-Pato, A; Abella-Corral, Javier; Corredera, E; López-Ferreiro, Ana; Puy-Núñez, Alfredo; López‐González, Francisco Javier

doi:10.1016/j.eplepsyres.2021.106570

Cited by 12 publications

(22 citation statements)

References 17 publications

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“…We showed a very high 12‐month retention rate of 90%, both in the whole sample and in the early add‐on group. This is in line with other studies that used add‐on PER to a monotherapy, 11 but higher than most other reports 10,13–15 . This difference may be due to different study designs, including patients that had tried more ASMs before the current therapeutic regimen, or to different study populations (focal epilepsies only vs the inclusion of generalized epilepsies).…”

Section: Discussionsupporting

confidence: 88%

“…Specific efficacy measures confirmed the usefulness of PER as single add‐on treatment. Median seizure number reduction and responders' rate were very high, in line with other studies, especially those with early use of PER 8,10,11 . Indeed, seizure freedom rates were high both in the early and in the late add‐on groups.…”

Section: Discussionsupporting

confidence: 88%

“…This study comprised 503 PWE, of whom a consistent portion of almost 200 subjects received PER as early (first or second) add-on ASM. The data from the present study have to be compared with several retrospective studies on PER use in real-life practice, [7][8][9][10][11][12][13][14][15] with different characteristics.…”

Section: Discussionmentioning

confidence: 99%

“…This is in line with other studies that used add-on PER to a monotherapy, 11 but higher than most other reports. 10,[13][14][15] This difference may be due to different study designs, including patients that had tried more ASMs before the current therapeutic regimen, or to different study populations (focal epilepsies only vs the inclusion of generalized epilepsies). Indeed, it is known that both efficacy and tolerability improve if PER is given as early add-on and not as part of a complex drug regimen.…”

Section: Discussionmentioning

confidence: 99%

“…They appear to be equally frequent in patients taking PER as a first add-on or as a late add-on. 10,11 We conducted a retrospective, observational study to evaluate the dose-related therapeutic response of PER, as a reliable proxy for overall tolerability and effectiveness, in people with epilepsy (PWE) aged >12 years, having received PER as part of routine clinical care and as adjunctive treatment to a background monotherapy.…”

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confidence: 99%

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Effectiveness of perampanel as the only add‐on: Retrospective, multicenter, observational real‐life study on epilepsy patients

et al. 2022

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Section: Discussionsupporting

confidence: 88%

Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Effectiveness of perampanel as the only add‐on: Retrospective, multicenter, observational real‐life study on epilepsy patients

et al. 2022

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Efficacy and Safety of adjunctive Perampanel in a prospective, real‐world, Phase IV study in Indian patients aged ≥12 years for Treatment of focal‐onset Epilepsy: Study 508

Ravat,

Rohatgi,

Kulkarni

et al. 2024

Epilepsia Open

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ObjectiveESPRITE (Study 508; NCT03836924) evaluated the real‐world safety, tolerability, and efficacy of adjunctive perampanel in patients aged ≥12 years with focal‐onset seizures (FOS), with or without focal to bilateral tonic‐clonic seizures (FBTCS), in India.MethodsESPRITE was a prospective, multicenter, single‐arm, observational, Phase IV study with a 6‐month Treatment Period. Patients were aged ≥12 years and had been prescribed perampanel for adjunctive treatment of FOS, with or without FBTCS. Assessments included incidence of treatment‐emergent adverse events (TEAEs; primary endpoint), median percent reduction in seizure frequency per 28 days from baseline, 50% responder rates, and seizure‐freedom rates.ResultsOverall, 200 patients were enrolled (199 patients in the Safety Analysis Set and 174 patients who completed all visits in the main efficacy analyses). TEAEs (all mild or moderate in severity) were reported in 18.1% (n=36/199) of patients (the most common were dizziness [3.0%] and irritability [2.0%]). TEAEs leading to discontinuation of perampanel were reported in 2.0% of patients; no deaths or serious TEAEs occurred. At 6 months, median percent reduction in seizure frequency was 100.0%, 50% responder rate was 83.3%, and seizure‐freedom rate was 49.4%.SignificanceAdjunctive perampanel (at a mean daily dose of 4 mg/day) was shown to be well tolerated and effective in patients aged ≥12 years with FOS, with or without FBTCS, from India.

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PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice

et al. 2021

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The PERaMpanel pooled analysIs of effecTiveness and tolerability (PERMIT) study was a pooled analysis of data from 44 real-world studies from 17 countries, in which people with epilepsy (PWE; focal and generalized) were treated with perampanel (PER). Retention and effectiveness were assessed after 3, 6, and 12 months, and at the last visit (last observation carried forward). Effectiveness assessments included 50% responder rate (≥ 50% reduction in seizure frequency from baseline) and seizure freedom rate (no seizures since at least the prior visit); in PWE with status epilepticus, response was defined as seizures under control. Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. The Full Analysis Set included 5193 PWE. Retention, effectiveness and safety/tolerability were assessed in 4721, 4392 and 4617, respectively. Retention on PER treatment at 3, 6, and 12 months was 90.5%, 79.8%, and 64.2%, respectively. Mean retention time on PER treatment was 10.8 months. The 50% responder rate was 58.3% at 12 months and 50.0% at the last visit, and the corresponding seizure freedom rates were 23.2% and 20.5%, respectively; 52.7% of PWE with status epilepticus responded to PER treatment. Overall, 49.9% of PWE reported AEs and the most frequently reported AEs (≥ 5% of PWE) were dizziness/vertigo (15.2%), somnolence (10.6%), irritability (8.4%), and behavioral disorders (5.4%). At 12 months, 17.6% of PWEs had discontinued due to AEs. PERMIT demonstrated that PER is effective and generally well tolerated when used to treat people with focal and/or generalized epilepsy in everyday clinical practice.

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Perampanel effectiveness and safety as early add-on treatment for focal-onset seizures: PEREAGAL study

Cited by 12 publications

References 17 publications

Effectiveness of perampanel as the only add‐on: Retrospective, multicenter, observational real‐life study on epilepsy patients

Effectiveness of perampanel as the only add‐on: Retrospective, multicenter, observational real‐life study on epilepsy patients

Efficacy and Safety of adjunctive Perampanel in a prospective, real‐world, Phase IV study in Indian patients aged ≥12 years for Treatment of focal‐onset Epilepsy: Study 508

PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice

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