The first combined Russian experience of using perampanel in children and adolescents with epilepsy in everyday clinical practice

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Abstract

Background. Real world data help to provide more information on the effects and tolerability of therapy. However, data on the use of perampanel in Russian population of children remain limited.

Aim. To conduct a retrospective analysis of perampanel efficacy and tolerability in children and adolescents with epilepsy in real clinical practice.

Materials and methods. A total of 106 children aged 4–18 years receiving perampanel as part of combination therapy for epilepsy were observed at 18 centers. Seizure frequency at 1–3, after 6 and 12 months of treatment, presence and type of adverse events (AEs) were analyzed. The main assessed efficacy parameters were seizure control, significant (≥50 %) decrease in seizure frequency. All other outcomes (<50 % decrease, no change or increased seizure frequency) were considered to be no effect. The assessed safety parameters were the percentage of patients with or without AEs and the percentage of perampanel withdrawals due to AEs.

Results. We defined 3 age groups for comparison: children 4–6, 7–11 and 12–17 years old. Perampanel efficacy was 69 % (seizure control – 23.6 %, ≥50 % decrease in seizure frequency – 45.3 %). The mean duration of the effect was 7.3 ± 4.1 months. No significant difference in efficacy between age groups was found. However, some greater efficacy of perampanel was noted in adolescents: absence of effect in the form of remission or significant decrease in seizures frequency was noted only in 25.5 %, with 40 % in children 4–11 years old. Among those with inefficacy, 3.8 % reported seizure aggravation. AEs occurred in only 23 % of patients, with the least frequent occurrence in adolescents (11.8 %) and the most frequent in children aged 7–11 years (40 %). The most frequent AEs was sluggishness and/or drowsiness. Discontinuation of perampanel due to AEs was required in 7.6 %.

Conclusion. Perampanel has demonstrated high efficacy and good tolerability in real clinical practice among children from 4 years of age and adolescents with partial (focal) and secondary generalized seizures. The AEs that developed were not serious and very rarely led to withdrawal of the therapy. The results are comparable to those of phase III studies and previous real-world data. The usage of perampanel in children with primary generalized seizures should be further investigated.

About the authors

O. A. Rakhmanina

Tyumen State Medical University, Ministry of Health of Russia

Author for correspondence.
Email: olga-rakh@yandex.ru
ORCID iD: 0000-0001-9218-2531

Оlga Aleksandrovna Rakhmanina

54 Odesskaya St., Tyumen 625023

Russian Federation

I.   V. Volkov

“SibNeuroMed” LLC

Email: fake@neicon.ru
ORCID iD: 0000-0002-7816-7535

5 Vokzalnaya magistral, Novosibirsk 630091

Russian Federation

O.  K. Volkova

City Children’s Clinical Emergency Hospital

Email: fake@neicon.ru
ORCID iD: 0000-0003-3314-3895

3 Krasnyy prospect, Novosibirsk 630091

Russian Federation

Yu.  A. Aleksandrov

“Homeopathic practice” LLC

Email: fake@neicon.ru
ORCID iD: 0000-0003-3887-5219

124B Sovetskaya St., Irkutsk 664009

Russian Federation

M.  V. Barkhatov

Federal Siberian Scientific and Clinical Center of the Federal Medical and Biological Agency of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0002-6372-4677

26 Kolomenskaya St., Krasnoyarsk 660037

Russian Federation

I. S. Bakhtin

Children’s Regional Clinical Hospital, Ministry of Health of the Krasnodar Region

Email: fake@neicon.ru
ORCID iD: 0000-0003-3600-687X

1 Ploschad Pobedy, Krasnodar 350007

Russian Federation

G.  M. Berezhnaya

Regional Children’s Clinical Hospital

Email: fake@neicon.ru
ORCID iD: 0000-0003-3917-422X

3 Semashko St., Stavropol 355029

Russian Federation

S.  R. Boldyreva

Children’s City Multidisciplinary Clinical Specialized Center for High Medical Technologies

Email: fake@neicon.ru

14 Avangardnaya St., Saint Petersburg 198205

Russian Federation

E.  N. Bochkova

Regional Children’s Clinical Hospital

Email: fake@neicon.ru

339-oy Strelkovoy Divizii St., Rostov-on-Don 344015

Russian Federation

E.   K. Gorbunova

Regional Clinical Hospital

Email: fake@neicon.ru

74 Klinicheskaya St., Kaliningrad 236016

Russian Federation

A.  Yu. Karas

MC “Epicenter”

Email: fake@neicon.ru
ORCID iD: 0000-0001-9089-9627

151/8 Bolshaya Sadovaya St., Saratov 410071

Russian Federation

D.  V. Morozov

Chair of Children’s Neurology, Kazan State Medical Academy

Email: fake@neicon.ru
ORCID iD: 0000-0003-4389-9143

11 Mushtary St., Kazan 420012, Republic of Tatarstan

Russian Federation

S.   R. Nurmukhametova

Bashkir State Medical University, Ministry of Health of Russia

Email: fake@neicon.ru

3 Lenina St., Ufa 450000

Russian Federation

N.  Yu. Perunova

“Medical Center Neurology” LLC

Email: fake@neicon.ru

52 Amundsena St., Ekaterinburg 620146

Russian Federation

S.  N. Sivkova

Children’s City Hospital No. 8

Email: fake@neicon.ru

11 Bari Galeeva St., Kazan 420061, Republic of Tatarstan

Russian Federation

E.   V. Telegina

“Vesna Medical Group” LLC

Email: fake@neicon.ru

95G Monastyrskaya St., Perm 614015

Russian Federation

T.  R. Tomenko

Ural Federal University named after the first President of Russia B.N. Yeltsin

Email: fake@neicon.ru
ORCID iD: 0000-0002-0652-1996

51 Lenina St., Ekaterinburg 620083

Russian Federation

Zh.  M. Tsotsonava

Astrakhan State Medical University, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0003-3275-5099

121 Bakinskaya St., Astrakhan 414000

Russian Federation

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