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.

/pdf/permit-study-a-global-pooled-analysis-study-of-the-1ds7ly1992.pdf

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

Sleep disorders occur twice as often in epilepsy patients compared to healthy people and have a negative impact on seizure control and general quality of life. International and Russian publications on the effect of perampanel (PER) on sleep emphasise the positive effect of the drug on sleep quality, daytime sleepiness and sleep architecture. Objective : to evaluate the effect of PER (Fycompa®) on sleep quality and daytime sleepiness when used as an adjunct antiepileptic drug (AED) in the treatment of epilepsy in adults. Material and methods . The study included 106 patients aged 18 to 73 years with absolute predominance of focal epilepsy (n=96) who were prescribed PER as an adjunctive AED when previous therapy was insufficient, regardless of whether or not complaints of insomnia were present. The study was conducted from April 2022 to June 2023. The maximum observation period was 12 months. The study was multicenter (10 Russian clinical centres) and designed as an observational study, with patients being monitored prospectively, but some of the indicators were collected retrospectively, taking into account the conditions of real-life clinical practice. We assessed: sleep quality using the Pittsburgh Insomnia Scale (Ya.I. Levin modification), daytime sleepiness according to the Epworth scale, anxiety/depression level (Hospital Anxiety and Depression Scale, HADS), adverse events (AEs), efficacy/tolerability of combination therapy with PER for epilepsy at baseline, and after 1, 3, 6 and 12 months of therapy based on the number of completed questionnaires at each visit in the real-life clinical practice. Results . After a follow-up period of 12 months, the retention rate for complex therapy with PER was 84.9%. PER was discontinued in 15.1% of patients and in only 5.7% due to AEs. The most common AE was dizziness, which was observed with a frequency of over 10% (n=21), followed by irritability (n=9) and drowsiness (n=9) with the same frequency. No new, previously undescribed AEs were observed in this study. The use of PER as an additional AED led to a significant reduction in daytime sleepiness and an improvement in sleep quality after the first month of use; by the 12-month follow-up period, the daytime sleepiness index gradually decreased and reached normal levels, and sleep quality improved. The use of PER as part of a complex therapy led to a significant reduction in the initially elevated anxiety level. Conclusion . The use of PER as an additional AED in adults in dynamics significantly improves sleep quality and reduces daytime sleepiness after the first month of use, regardless of the duration of the disease and the order of PER administration. The use of PER as part of a complex therapy led to a decrease in the initially elevated anxiety level from subclinical to normal. 

Observational study of the effect of perampanel on sleep and daytime sleepiness in adult patients with epilepsy in real-life clinical practice

The real-world effectiveness and safety of perampanel in Europe: A scoping review

Objective : to retrospectively assess the Russian experience with perampanel (PER) in everyday clinical practice as an adjunctive medication for the treatment of patients aged 12 years or older with focal epilepsy (FE) Patients and methods  A multicenter retrospective study was conducted, during which the physicians filled out standard questionnaires assessing the characteristics of the disease and the therapy performed The maximum follow-up period was 12 months Each patient was included in the study only once for the duration of the study A total of 164 cases of pharmacoresistant FE were analyzed The patients' mean age was 377 years; the male to female ratio was 1:1 The disease duration over 10 years was in 687% of patients; structural epilepsy was present in 682% (temporal and frontal lesions in 534 and 391%, respectively) Results and discussion  Most (266%) patients were prescribed PER after three previous lines of therapy; before PEP administration, there was a maximum of 2 (509%) and 3 (296%) drugs, respectively, in the combination The initial frequency of all seizure types reached 9 [3; 34] per month; that of focal-onset bilateral tonic-clonic seizures was 3 [2; 6] per month Combined therapy including PER could lead to the disappearance of seizures in 227% of cases; the responders (by all seizure types) were 528%, whereas the remission rate of bilateral tonic-clonic seizures was 608% of patients, the responder rate was 27,8% At 12 months of follow-up, the therapy retention rate reached 807% (95% confidence interval, 723—891) Adverse events (AEs) were noted in 313% of patients; the most frequent AEs were drowsiness (104%), aggression (98%), irritability (67%); other AEs were observed in individual cases The average dose of PER was 8 mg Conclusion  PER was effective in patients with resistant PEs at a maximum follow-up of 12 months in routine clinical practice Remission of all seizure types was achieved in 227% of cases, the decrease in the number of seizures >50% was seen in 528% of cases; the therapy retention rate was 807% The drug had a therapeutic effect in all types of focal seizures and was most effective in focal-onset bilateral tonic-clonic seizures Along with its good clinical effect, PER demonstrated a predictable safety profile

/pdf/a-russian-retrospective-multicenter-open-label-observational-3kebyoi7fr.pdf

A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice

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A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice