<abstract xmlns="http://www.w3.org/1999/xhtml"><sec id="j_joepi-2016-0007_s_001"><h3>Introduction</h3><p><bold>Perampanel (PER) (Fycompa) <italic>5’-(2-cyanophenyl)-1’-phenyl-2,3’-bipyridinyl-6’(1’H)-on</italic></bold> is the newest antiepileptic drug and is the first-in-class selective non-competitive antagonist of ionotropic AMPA glutamate receptors of the postsynaptic neuronal membrane.</p><p><bold>The aim</bold> was to summarize Russian experience in using PER in daily clinical practice, and for this purpose the results of its use as an add-on treatment for focal epilepsy were assessed retrospectively</p></sec><sec id="j_joepi-2016-0007_s_002"><h3>Material and Method</h3><p>The results of the study of PER efficacy and safety in 52 patients with refractory focal epilepsy are presented. Mean age was 28.9 ± 14.0 years; proportion of male patients was 56%, duration of the disease over 10 years - 69.2%, symptomatic epilepsy - 76.9%, with frontal - 46.2% and temporal - 44.2% localization of epileptic lesion. Majority of patients - 71.2% started PER treatment after 3 preceding lines of therapy</p></sec><sec id="j_joepi-2016-0007_s_003"><h3>Results</h3><p>The baseline seizure frequency of all types was 127.3 ± 82.3 per month; secondary generalized seizures - 6.7 ± 1.9 per month. After PER was added, a significant decrease in seizure frequency was observedalready during the first month, to 52.1 ± 29.3 seizures per month (Sign test, p = 0.00001) for seizures of all types and to 3.7 ± 1.7 (Sign test, p = 0.00001) for secondary generalized seizures. In an overwhelming majority of cases, duration of PER treatment was more than 6 months. In 58% of patients, seizure frequency decreased by more than 50% (responders). Seizure-free status for all seizure types was observed in 9% of cases at 12 month, and absence of secondary generalized seizures only was achieved in 31% of patients. Adverse events were observed in 30.1% of patients: aggression – 11.5% and drowsiness – 9.6%, with all other AEs observed more rarely. PER dose was reduced due to side effects in 7 patients (13.5%), and in 4 patients (7.7%) PER was discontinued. Average PER dose in adult patients was as low as 6 mg.</p></sec><sec id="j_joepi-2016-0007_s_004"><h3>Conclusions</h3><p>PER was effective in the treatment of refractory forms of focal epilepsy, reducing seizure frequency on average by 76% by the second month of treatment. In addition to a good clinical effect, PER demonstrated a rather acceptable and predictable safety profile.</p></sec></abstract>

IntroductionPerampanel (PER) (Fycompa) 5’-(2-cyanophenyl)-1’-phenyl-2,3’-bipyridinyl-6’(1’H)-on is the newest antiepileptic drug and is the first-in-class selective non-competitive antagonist of ionotropic AMPA glutamate receptors of the postsynaptic neuronal membrane.The aim was to summarize Russian experience in using PER in daily clinical practice, and for this purpose the results of its use as an add-on treatment for focal epilepsy were assessed retrospectivelyMaterial and MethodThe results of the study of PER efficacy and safety in 52 patients with refractory focal epilepsy are presented. Mean age was 28.9 ± 14.0 years; proportion of male patients was 56%, duration of the disease over 10 years - 69.2%, symptomatic epilepsy - 76.9%, with frontal - 46.2% and temporal - 44.2% localization of epileptic lesion. Majority of patients - 71.2% started PER treatment after 3 preceding lines of therapyResultsThe baseline seizure frequency of all types was 127.3 ± 82.3 per month; secondary generalized seizures - 6.7 ± 1.9 per month. After PER was added, a significant decrease in seizure frequency was observedalready during the first month, to 52.1 ± 29.3 seizures per month (Sign test, p = 0.00001) for seizures of all types and to 3.7 ± 1.7 (Sign test, p = 0.00001) for secondary generalized seizures. In an overwhelming majority of cases, duration of PER treatment was more than 6 months. In 58% of patients, seizure frequency decreased by more than 50% (responders). Seizure-free status for all seizure types was observed in 9% of cases at 12 month, and absence of secondary generalized seizures only was achieved in 31% of patients. Adverse events were observed in 30.1% of patients: aggression – 11.5% and drowsiness – 9.6%, with all other AEs observed more rarely. PER dose was reduced due to side effects in 7 patients (13.5%), and in 4 patients (7.7%) PER was discontinued. Average PER dose in adult patients was as low as 6 mg.ConclusionsPER was effective in the treatment of refractory forms of focal epilepsy, reducing seizure frequency on average by 76% by the second month of treatment. In addition to a good clinical effect, PER demonstrated a rather acceptable and predictable safety profile.

Russian experience of using perampanel in daily clinical practice. Preliminary report

Journal of Epileptology

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IntroductionPerampanel (PER) (Fycompa) 5’-(2-cyanophenyl)-1’-phenyl-2,3’-bipyridinyl-6’(1’H)-on is the newest antiepileptic drug and is the first-in-class...

Russian experience of using perampanel in daily clinical practice. Preliminary report

Publicado en línea: 25 ene 2016

Páginas: 7 - 14

Recibido: 05 may 2016

Aceptado: 22 jun 2016

DOI: https://doi.org/10.21307/joepi-2016-0007

Palabras clave
perampanel, refractory focal/partial epilepsy, efficacy, tolerability, safety, adverse events, side effects

© 2016 Pavel Vlasov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Russian experience of using perampanel in daily clinical practice. Preliminary report

Publicado en línea: 25 ene 2016

Páginas: 7 - 14

Recibido: 05 may 2016

Aceptado: 22 jun 2016

DOI: https://doi.org/10.21307/joepi-2016-0007

Palabras claveperampanel, refractory focal/partial epilepsy, efficacy, tolerability, safety, adverse events, side effects

© 2016 Pavel Vlasov et al., published by Sciendo

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

Palabras clave
perampanel, refractory focal/partial epilepsy, efficacy, tolerability, safety, adverse events, side effects