Russian experience with perampanel in routine clinical practice
https://doi.org/10.14412/2074-2711-2016-1S-11-17
Abstract
small number of the patients had not attained the age of 12 years); the proportion of men was 56%; the disease duration was over 10 years (69.2%); symptomatic epilepsy was in 76.9% with an epileptic focus being in the frontal (46.2%) and temporal (44.2%) regions. PER was prescribed to the majority (71.2%) of patients after three previous therapy lines. The baseline monthly rates of all types of seizures were 127.29±82.29; those of generalized seizures were 6.72±1.90.
Results and discussion. After addition of PER to therapy just within the first month, there was a significant reduction in the frequency of all types of seizures to 52.06±29.26 per month (Sign test; p = 0.00001) and in that of secondary generalized seizures to 3.71±1.71 (Sign test; p=0.00001). The duration of PER administration was more than 6 months in the overwhelming majority of cases. In 58% of the patients, the frequency of seizures decreased by more than 50% (respondents). The lack of all types of seizures was noted in 8%; that of only secondary generalized seizures was in 31%. Adverse events were observed in 30.1% of the patients (aggression in 11.5% and somnolence in 9.6%; others were seen more rarely). The dose of PER was decreased because of side effects in 7 (13.5%) patients; the drug was discontinued in 4 (7.7%). The mean dose of PER for adults was as high as 6 mg.
About the Authors
V. A. KarlovRussian Federation
O. V. Belyaev
Russian Federation
P. N. Vlasov
Russian Federation
I. A. Zhidkova
Russian Federation
I. V. Volkov
Russian Federation
D. V. Dmitrenko
Russian Federation
A. Yu. Karas
Russian Federation
T. V. Kazennykh
Russian Federation
O. I. Miguskina
Russian Federation
A. V. Moskvicheva
Russian Federation
E. N. Paramonova
Russian Federation
I. V. Ponomareva
Russian Federation
A. V. Chervyakov
Russian Federation
References
1. Карлов ВА. Фармакорезистентность и толерантность. В кн.: Эпилепсия у детей и взрослых женщин и мужчин: руководство для врачей. Москва: Медицина; 2010. C. 667-76 [Karlov VA. Pharmacoresistance and tolerance. In: Epilepsiya u detei i vzroslykh muzhchin i zhenshchin [Epilepsy in children and adult men and women]. Moscow: Medicina; 2010. P. 667-76].
2. Авакян ГН. Эпидемиология эпилепсии и оптимизация терапии фокальных эпилепсий. Эпилепсия и пароксизмальные состояния. 2014;(1):3-5 [Avakyan GN. The epidemiology of epilepsy and optimization of therapy of focal epilepsy. Epilepsiya i Paroksizmal'nye Sostoyaniya. 2014;(1):3-5 (In Russ.)].
3. Rogawski MA. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents. 2011;11:56-63. doi: 10.5698/1535-7511-11.2.56
4. Hanada T, Hashizume Y, Tokuhara N, et al. Perampanel: a novel, orally active, noncompetitive AMPA-receptor antagonist that reduces seizure activity in rodent models of epilepsy. Epilepsia. 2011;52:1331-40. doi: 10.1111/j.1528-1167.2011.03109.x
5. French JA, Krauss GL, Wechsler RT, et al. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy. A randomized trial. Neurology. 2015;85:1-8. doi: 10.1212/WNL.0000000000001930
6. Steinhoff BJ, Ben-Menachem E, Ryvlin P, et al. Efficacy and safety of adjunctive perampanel for the treatment of refractory partial seizures: A pooled analysis of three phase III studies. Epilepsia. 2013;54(8):1481-9. doi: 10.1111/epi.12212
7. Инструкция по применению лекарственного препарата для медицинского применения от 29.06.2015. Файкомпа®. Регистрационный номер: ЛП-002200. Международное непатентованное название: Перампанел [Instructions for use of the drug for medical use from 06/29/2015. Faykompa®. Registration number: PL-002200. International nonproprietary name: Perampanel].
8. Белоусова ЕД. Эффективность и переносимость перампанела в качестве дополнительного препарата у подростков с резистентной парциальной эпилепсией: результаты рандомизированного двойного слепого плацебо-контролируемого исследования, проведенного в Российской Федерации. Эпилепсия и пароксизмальные состояния. 2014;(1):27-33 [Belousova ED. Efficacy and tolerability perampanela as an additional medication in adolescents with refractory partial epilepsy: a randomized, double-blind, placebo-controlled study conducted in the Russian Federation. Epilepsiya i Paroksizmal'nye Sostoyaniya. 2014;(1):27-33 (In Russ.)].
9. Власов ПН. Эффективность и переносимость: результаты двойного слепого плацебоконтролируемого и продленного открытого исследования оценки долговременной безопасности и эффективности перампанела в РФ. Эпилепсия и пароксизмальные состояния. 2014;(1):10-2 [Vlasov PN. Efficacy and tolerability: results of a double-blind, placebo-controlled, and extended open study evaluating the long-term safety and efficacy perampanela in Russia. Paroksizmal'nye Sostoyaniya. 2014;(1): 10-2 (In Russ.)].
10. French JA, Krauss GL, Steinhoff BJ, et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: Results of randomized global phase III study 305. Epilepsia. 2013;54(1):117-125.
11. Krauss GL, Serratosa JM, Villanueva V, et al. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology. 2012;78:1408-15. doi: 10.1212/WNL.0b013e318254473a
12. Krauss GL, Perucca E, Ben-Menachem E, et al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarily generalized seizures: Results from phase III extension study 307. Epilepsia. 2014;55:1058-68. doi: 10.1111/epi.12643
13. Steinhoff BJ, Bacher M, Bast T, et al. First clinical experiences with perampanel – the Kork experience in 74 patients. Epilepsia. 2014;55 (Suppl 1):16-8. doi: 10.1111/epi.12492
14. French JA, Krauss GL, Steinhoff BJ, et al. Evaluation of adjunctive perampanel in patients with refractory partial-onset seizures: results of randomized global phase III study 305. Epilepsia. 2013;54:117-25. doi: 10.1111/j.15281167.2012.03638.x
15. Steinhoff BJ, Hamer H, Trinka E, et al. A multicenter survey of clinical experiences with perampanel in real life in Germany and Austria. Epilepsy Res. 2014;108:986-8. doi: 10.1016/j.eplepsyres.2014.03.015
16. Renroe B, Yang H, Williams B. Interim efficacy and safety analysis of adjunctive perampanel in the adolescent population from the extension phase of 3 double-blind, placebo-controlled phase 3 (core) studies in patients with refractory partial-onset seizures. 42nd Annual Meeting of the Child Neurology Society; 30 Oct-2 Nov 2013; Austin, TX, USA, 2013.
17. Mula M, Kanner AM, Schmitz B, Schachter S. Antiepileptic drugs and suicidality: An expert consensus statement from the Task Force on Therapeutic Strategies of the ILAE Commission on Neuropsychobiology. Epilepsia. 2013;54(1):199-203. doi: 10.1111/j.1528-1167.2012.03688.x
18. Meador KJ, Yang H, Pina-Garza JE, et al. Cognitive effects of adjunctive perampanel for partial-onset seizures: A randomized trial. Epilepsia. 2016;57(2):243-51. doi: 10.1111/epi.13279
19. Patsalos PN. Drug Interactions With the Newer Antiepileptic Drugs (AEDs) – Part 1: Pharmacokinetic and Pharmacodynamic Interactions Between AEDs. Clin Pharmacokinet. 2013a;(52):927-66. doi: 10.1007/s40262-013-0087-0
20. Patsalos PN. Drug Interactions with the Newer antiepileptic drugs (AEDs) – Part 2: Pharmacokinetic and Pharmacodynamic Interactions Between AEDs and Drugs Used to Treat Non-epilepsy Disorders. Clin Pharmacokinet. 2013b;52:1045-61. doi: 10.1007/s40262-013-0088-z
Review
For citations:
Karlov VA, Belyaev OV, Vlasov PN, Zhidkova IA, Volkov IV, Dmitrenko DV, Karas AY, Kazennykh TV, Miguskina OI, Moskvicheva AV, Paramonova EN, Ponomareva IV, Chervyakov AV. Russian experience with perampanel in routine clinical practice. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2016;(1S):11-17. (In Russ.) https://doi.org/10.14412/2074-2711-2016-1S-11-17