A retrospective, real‐world experience of perampanel monotherapy in patient with first new onset focal seizure: A Thailand experience

Chinvarun, Yotin

doi:10.1002/epi4.12555

Cited by 19 publications

(37 citation statements)

References 18 publications

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“…To the best of our knowledge there are no previous studies that specifically evaluate the efficacy of PER in childhood absence epilepsies, however PER demonstrated good effectiveness and a good safety profile when used as primary therapy or conversion to monotherapy at relatively low doses, in a clinical setting with adult patients with focal seizures and generalized tonic-clonic seizures (40). Real-world data of PER monotherapy in treatment-naïve patients (≥15 years) with focal onset seizures demonstrated good effectiveness and a good safety profile at relatively low doses (41,42). In a recent review by Toledano and Gil-Nagel (43) the authors evaluated outcomes of two retrospective multicentre studies in which PER was used as monotherapy; the study shows that low doses (6-8 mg/day) of PER were effective and well tolerated in a subgroup of patients with less severe epilepsies than patients who participated in clinical trials (where PER was used as add-on therapy).…”

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Perampanel and childhood absence epilepsy: A real life experience

et al. 2022

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ObjectivesThe aim of our study was to evaluate the effectiveness and tolerability of perampanel (PER) as first add-on and as second line monotherapy in subjects with childhood absence epilepsy.MethodsOur sample consisted of 20 patients with childhood absence epilepsy, aged between 8 and 10, already in therapy with a first antiseizure medication with incomplete seizure control. PER was added as first add-on in a dose ranging from 3 to 8 mg/die with 1- 2 mg/week increments. The patients that were seizure-free were shifted to a PER monotherapy. All patients underwent a standardized neuropsychological evaluation in order to assess non-verbal intelligence and executive functions before adding PER and after 6 months of drug therapy. All parents completed two questionnaires, in order to assess the emotional-behavioral problems and parental stress.Results15/20 patients responded to add-on PER and were seizure-free, in 3/20 patients we observed a reduction of seizure frequency <50%, and in the 2 remaining patients the add-on therapy with PER did not lead to a reduction in seizures frequency from baseline. The patients who were seizure-free were switched to PER monotherapy. 9/15 patients remained seizure-free in monotherapy with PER. In the first month of therapy with PER 2/20 patients (10%) reported mild, transient side effects of irritability, headache and dizziness, which did not lead to discontinuation of therapy. Adjunctive treatment with PER did not negatively affect non-verbal intelligence, executive functions, emotional/behavioral symptoms of children and parental stress levels.SignificanceOur clinical experience in real life showed that PER appears to be effective in the control of absence seizures in childhood absence epilepsy, with a favorable tolerability profile. PER would seem effective on absence seizures even in monotherapy. Further studies with larger samples, longer follow-up and controlled vs. placebo (or other first choice antiseizure medications) are needed to confirm our data.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Perampanel and childhood absence epilepsy: A real life experience

et al. 2022

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“…To our knowledge, only three clinical practice studies have to date specifically investigated the use of PER monotherapy in clinical practice, all of which were included in PERMIT [12][13][14]. There is currently very limited evidence for direct head-to-head comparisons of ASMs as monotherapy in the real-world or pragmatic-use setting, particularly for PWE with generalized-onset seizures.…”

Section: Discussionmentioning

confidence: 99%

“…Real-world clinical practice data are required to complement evidence from clinical trials, by providing data on PWE who are more diverse in terms of clinical characteristics than those recruited for clinical trials and additional information on the individualized treatment strategies employed in clinical practice [9][10][11]. To date, few clinical practice studies have specifically investigated the use of PER as monotherapy [12][13][14].…”

Section: Introductionmentioning

confidence: 99%

Perampanel Monotherapy for Focal and Generalized Epilepsy in Clinical Practice

Chinvarun

Delgado

Astner-Rohracher

et al. 2023

Acta Neurologica Scandinavica

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Objectives. To investigate the effectiveness, safety, and tolerability of perampanel (PER) when used as monotherapy to treat focal or generalized epilepsy in everyday clinical practice, using data from the PERMIT study. Methods. PERMIT was a pooled analysis of 44 real-world studies from 17 countries, in which people with focal and generalized epilepsy were treated with PER. This post hoc analysis included people with epilepsy (PWE) from PERMIT who were treated with PER monotherapy at baseline. Retention and effectiveness were assessed after 3, 6, and 12 months. Effectiveness assessments included ≥50% responder rate and seizure freedom rate (no seizures since at least the prior visit). Safety and tolerability were assessed by evaluating adverse events (AEs) and discontinuation due to AEs. Results. Overall, 268 PWE were treated with PER monotherapy at baseline. Retention was assessed for 168 PWE, effectiveness for 183 PWE, and safety and tolerability for 197 PWE. Retention rates were 91.1%, 87.3%, and 73.3% at 3, 6, and 12 months, respectively. At 12 months, responder rates were 84.2% overall, 82.9% in PWE with only focal-onset seizures at baseline, and 88.0% in those with only generalized-onset seizures at baseline; corresponding freedom rates were 62.9%, 57.7%, and 80.0%, respectively. AEs were reported for 45.2% of PWE. The most frequently reported AEs (≥5% of PWE) were dizziness/vertigo (16.8%), irritability (11.2%), somnolence (9.1%), and depression (6.6%). Over 12 months, 13.7% discontinued due to AEs. Conclusions. PER was effective when used as monotherapy in clinical practice, particularly in those with generalized-onset seizures, and was generally well tolerated.

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“…Chinvarun et al [18] conducted a real-world retrospective study for the assessment of safety and efficacy of PER monotherapy in patients (n=41) aged over 15 years with new focal onset seizures, with or without partial bilateral tonic-clonic seizures. Monotherapy of PER imbibed the most effective ability inducing retention rate at an observational point at 3 months is 88%, at 6 months is 73%, at 12 months is 61%.…”

Section: Real-world Studiesmentioning

confidence: 99%