Русский журнал детской неврологии. 2014; 9: 14-19
Применение перампанела (Файкомпы) в лечении эпилепсии (опыт Института детской неврологии и эпилепсии им. Святителя Луки)
https://doi.org/10.17650/2073-8803-2014-9-4-14-19Аннотация
Перампанел (Файкомпа, OOO «Эйсай») – новейший антиэпилептический препарат, зарегистрированный для применения в дополнительной терапии у пациентов 12 лет и старше с фокальными и вторично-генерализованными приступами. Перампанел был лицензирован в США и странах Европы в 2012 г.; в 2013 г. зарегистрирован и в 2014 г. поступил на фармацевтический рынок России. Перампанел имеет принципиально иной механизм антиэпилептического действия, отличный от других антиэпилептических
препаратов. Перампанел – мощный высокоселективный неконкурентный ингибитор ионотропных AMPA-рецепторов (α-амино3-гидрокси-5-метил-4-изоксазолпропионовой кислоты) постсинаптических мембран нейронов на уровне неокортекса и гиппокампа. Эффективность и переносимость перампанела при резистентных фокальных приступах были доказаны в клинических исследованиях III фазы. Рандомизированные плацебо-контролируемые исследования дополнительной терапии перампанелом продемонстрировали, что прием препарата один раз в день в дозе 4–12 мг/сут достоверно уменьшает частоту фокальных приступов у пациентов с фармакорезистентной эпилепсией при благоприятных показателях безопасности и переносимости. Открытые обсервационные исследования, исследования длительной терапии также продемонстрировали благоприятные показатели эффективности и безопасности при продолжительном лечении (до 3 лет) и длительное сохранение терапевтического эффекта. Целью исследования было изучение эффективности и переносимости перампанела (Файкомпы) в дополнительной терапии у пациентов с резистентными формами эпилепсии. В исследование были включены 12 пациентов (6 – мужского пола и 6 – женского пола) в возрасте от 3 до 37 лет, принимавших Файкомпу с периодом катамнестического наблюдения свыше 6 мес. Все пациенты страдали тяжелыми резистентными формами эпилепсии (6 случаев – генетические заболевания, 6 – симптоматические фокальные эпилепсии). Отмечена эффективность и хорошая переносимость Файкомпы. В целом уменьшение продолжительности и/или тяжести приступов было отмечено в 83 % случаев. Серьезных побочных эффектов не зарегистрировано. Авторы сделали выводы о благоприятных перспективах применения Файкомпы в разных популяциях пациентов с эпилепсией.
Список литературы
1. Власов П.Н. Клинический случай применения Файкомпы. Эпилепсия и пароксизмальные состояния 2014;(спецвыпуск):5. [Vlasov P.N. Clinical case of application of fycompa. Epilepsy and Paroxysmal States 2014;(special issue):5. (In Russ.)].
2. Жидкова И.А. Управление нежелательными явлениями, возникающими на фоне приема перампанела. Эпилепсия и пароксизмальные состояния 2014;(спецвыпуск):13–4. [Zhidkova I.A. Management of undesirable phenomena that arise on the background of perampanel intake. Epilepsy and Paroxysmal States 2014;(special issue):13–4. (In Russ.)].
3. Мухин К.Ю., Пылаева О.А., Миронов М.Б. Применение перампанела у ребенка с резистентной эпилепсией при синдроме Ангельмана. Эпилепсия и пароксизмальные состояния 2014;(спецвыпуск):15. [Mukhin K.Yu., Pylaeva O.A., Mironov M.B. Perampanel for children with resistant epilepsy of the Angelman syndrome. Epilepsy and Paroxysmal States 2014; (special issue):15. (In Russ.)].
4. Перунова Н.Ю. Клинический случай применения Файкомпы. Эпилепсия и пароксизмальные состояния 2014;(спецвыпуск):9. [Perunova N.Yu. Clinical case of application of Fycompa. Epilepsy and Paroxysmal States 2014;(special issue):9. (In Russ.)].
5. Biro A., Stephani U., Tarallo T. et al. Effectiveness and tolerability of Perampanel in children and adolescents with refractory epilepsy. Eur J Paediatr Neurol 2013;17 (Suppl 1):S47–8.
6. Franco V., Crema F., Iudice A. et al. Novel treatment options for epilepsy: focus on perampanel. Pharmacol Res 2013;70(1): 35–40.
7. French J.A., Krauss G.L., Biton V. et al. Adjunctive perampanel for refractory partialonset seizures: randomized phase III study 304. Neurology 2012;79(6):589–96.
8. French J.A., Krauss G.L., Steinhoff B.J. 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):117–25.
9. Hanada T. The discovery and development of perampanel for the treatment of epilepsy. Expert Opin Drug Discov 2014;9(4):449–58.
10. Kerling F., Kasper B.S. Efficacy f perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):25–9.
11. Ko D., Ramsay R.E. Perampanel: expanding therapeutic options for patients with medically refractory secondary generalized convulsive seizures. Acta Neurol Scand Suppl 2013;(197):36–43.
12. Krauss G.L. Perampanel: a selective AMPA antagonist for treating seizures. Epilepsy Curr 2013;13(6):269–72.
13. Krauss G.L., Bar M., Biton V. et al. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand 2012;125(1):8–15.
14. Krauss G.L., Perucca E., Ben-Menachem E. еt al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarilygeneralized seizures: results from phase III extension study 307. Epilepsia 2014;55(7):1058–68.
15. Krauss G.L., Perucca E., Ben-Menachem E. еt al. Perampanel, a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partialonset seizures: interim results from phase III, extension study 307. Epilepsia 2013;54(1): 126–34.
16. Krauss G.L., Serratosa J.M., Villanueva V. et al. Randomized phase III study 306: adjunctive perampanel for refractory partialonset seizures. Neurology 2012;78(18):1408–15.
17. Patsalos P.N. Drug interactions with the newer antiepileptic drugs (AEDs) – part 1: pharmacokinetic and pharmacodynamic interactions between AEDs. Clin Pharmacokinet 2013;52(11):927–66.
18. Rektor I., Krauss G.L., Bar M. et al. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand 2012;126(4):263–9.
19. Rheims S., Ryvlin P. Profile of perampanel and its potential in the treatment of partial onset seizures. Neuropsychiatr Dis Treat 2013;9:629–37.
20. Rogawski M.A. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011:11(2):56–63.
21. Satlin A., Kramer L.D., Laurenza A. Development of perampanel in epilepsy. Acta Neurol Scand Suppl 2013;(197):3–8.
22. Shih J.J., Tatum W.O., Rudzinski L.A. New drug classes for the treatment of partial onset epilepsy: focus on perampanel. Ther Clin Risk Manag 2013;9:285–93.
23. Steinhoff B.J. Efficacy of perampanel: a review of pooled data. Epilepsia 2014;55 Suppl 1:9–12.
24. Steinhoff B.J., Bacher M., Bast T. et al. First clinical experiences with perampanel – the Kork experience in 74 patients. Epilepsia 2014;55 Suppl 1: 16–8.
25. Steinhoff B.J., 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.
26. Zwart R., Sher E., Ping X. et al. Perampanel, an аntagonist of α-amino-3- hydroxy-5-methyl-4-isoxazolepropionic acid receptors for the treatment of epilepsy: studies in human epileptic brain, nonepileptic brain, and in rodent models. J Pharmacol Exp Ther 2014;351(1): 124–33.
Russian Journal of Child Neurology. 2014; 9: 14-19
PERAMPANEL (FYCOMPA) FOR TREATMENT OF EPILEPSY (EXPERIENCE OF THE SVT. LUKA'S INSTITUTE OF CHILD NEUROLOGY AND EPILEPSY)
https://doi.org/10.17650/2073-8803-2014-9-4-14-19Abstract
Perampanel (Fycompa, Eisai LLC) is the most recent antiepileptic drug registered for application for additional therapy of patients of 12 y.o. and older with focal and secondary generalized seizures. Perampanel was licensed in the USA and European countries in 2012; it was registered in 2013 and entered the pharmaceutical market of Russia in 2014. Perampanel has a fundamentally different mechanism of antiepileptic action, different from other antiepileptic drugs. Perampanel is a powerful highly selective noncompetitive inhibitor of ionotropic AMPA receptors of postsynaptic membranes of neurons on level of the neocortex and the hippocampus. Efficacy and tolerability of perampanel with resistant focal seizures were proved in clinical studies of the III phase. Randomized placebo controlled studies of additional therapy with perampanel demonstrated the fact that intake of the drug in the dosage of 4 to 12 mg/day, which validly decreases the frequency of focal seizures of patients with pharmacoresistant epilepsy with favorable indicators of safety and tolerability. Open observational studies as well as long-term therapy studies also demonstrated favorable indicators of efficacy and safety with long-term treatment (up to 3 years) and long-term maintenance of therapeutic effect. The objective of the evaluation was study of efficacy and tolerability of perampanel (Fycompa) for additional therapy of patients with resistant forms of epilepsy. The study included 12 patients (6 males and 6 females) at the age of 3 to 37 y.o. with the intake of Fycompa with the period of follow-up study of over 6 months. All patients suffered from severe resistant forms of epilepsy (6 cases are genetic diseases, 6 cases are symptomatic focal epilepsy). Efficacy and good tolerability of Fycompa were marked. In general, decreasing of duration and/or severity of seizures was marked in 83% of cases. No serious side effects were registered. The authors made the conclusion of favorable prospectives of intake of Fycompa in various populations of patients that suffer from epilepsy.
References
1. Vlasov P.N. Klinicheskii sluchai primeneniya Faikompy. Epilepsiya i paroksizmal'nye sostoyaniya 2014;(spetsvypusk):5. [Vlasov P.N. Clinical case of application of fycompa. Epilepsy and Paroxysmal States 2014;(special issue):5. (In Russ.)].
2. Zhidkova I.A. Upravlenie nezhelatel'nymi yavleniyami, voznikayushchimi na fone priema perampanela. Epilepsiya i paroksizmal'nye sostoyaniya 2014;(spetsvypusk):13–4. [Zhidkova I.A. Management of undesirable phenomena that arise on the background of perampanel intake. Epilepsy and Paroxysmal States 2014;(special issue):13–4. (In Russ.)].
3. Mukhin K.Yu., Pylaeva O.A., Mironov M.B. Primenenie perampanela u rebenka s rezistentnoi epilepsiei pri sindrome Angel'mana. Epilepsiya i paroksizmal'nye sostoyaniya 2014;(spetsvypusk):15. [Mukhin K.Yu., Pylaeva O.A., Mironov M.B. Perampanel for children with resistant epilepsy of the Angelman syndrome. Epilepsy and Paroxysmal States 2014; (special issue):15. (In Russ.)].
4. Perunova N.Yu. Klinicheskii sluchai primeneniya Faikompy. Epilepsiya i paroksizmal'nye sostoyaniya 2014;(spetsvypusk):9. [Perunova N.Yu. Clinical case of application of Fycompa. Epilepsy and Paroxysmal States 2014;(special issue):9. (In Russ.)].
5. Biro A., Stephani U., Tarallo T. et al. Effectiveness and tolerability of Perampanel in children and adolescents with refractory epilepsy. Eur J Paediatr Neurol 2013;17 (Suppl 1):S47–8.
6. Franco V., Crema F., Iudice A. et al. Novel treatment options for epilepsy: focus on perampanel. Pharmacol Res 2013;70(1): 35–40.
7. French J.A., Krauss G.L., Biton V. et al. Adjunctive perampanel for refractory partialonset seizures: randomized phase III study 304. Neurology 2012;79(6):589–96.
8. French J.A., Krauss G.L., Steinhoff B.J. 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):117–25.
9. Hanada T. The discovery and development of perampanel for the treatment of epilepsy. Expert Opin Drug Discov 2014;9(4):449–58.
10. Kerling F., Kasper B.S. Efficacy f perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):25–9.
11. Ko D., Ramsay R.E. Perampanel: expanding therapeutic options for patients with medically refractory secondary generalized convulsive seizures. Acta Neurol Scand Suppl 2013;(197):36–43.
12. Krauss G.L. Perampanel: a selective AMPA antagonist for treating seizures. Epilepsy Curr 2013;13(6):269–72.
13. Krauss G.L., Bar M., Biton V. et al. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand 2012;125(1):8–15.
14. Krauss G.L., Perucca E., Ben-Menachem E. et al. Long-term safety of perampanel and seizure outcomes in refractory partial-onset seizures and secondarilygeneralized seizures: results from phase III extension study 307. Epilepsia 2014;55(7):1058–68.
15. Krauss G.L., Perucca E., Ben-Menachem E. et al. Perampanel, a selective, noncompetitive α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor antagonist, as adjunctive therapy for refractory partialonset seizures: interim results from phase III, extension study 307. Epilepsia 2013;54(1): 126–34.
16. Krauss G.L., Serratosa J.M., Villanueva V. et al. Randomized phase III study 306: adjunctive perampanel for refractory partialonset seizures. Neurology 2012;78(18):1408–15.
17. Patsalos P.N. Drug interactions with the newer antiepileptic drugs (AEDs) – part 1: pharmacokinetic and pharmacodynamic interactions between AEDs. Clin Pharmacokinet 2013;52(11):927–66.
18. Rektor I., Krauss G.L., Bar M. et al. Perampanel Study 207: long-term open-label evaluation in patients with epilepsy. Acta Neurol Scand 2012;126(4):263–9.
19. Rheims S., Ryvlin P. Profile of perampanel and its potential in the treatment of partial onset seizures. Neuropsychiatr Dis Treat 2013;9:629–37.
20. Rogawski M.A. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Currents 2011:11(2):56–63.
21. Satlin A., Kramer L.D., Laurenza A. Development of perampanel in epilepsy. Acta Neurol Scand Suppl 2013;(197):3–8.
22. Shih J.J., Tatum W.O., Rudzinski L.A. New drug classes for the treatment of partial onset epilepsy: focus on perampanel. Ther Clin Risk Manag 2013;9:285–93.
23. Steinhoff B.J. Efficacy of perampanel: a review of pooled data. Epilepsia 2014;55 Suppl 1:9–12.
24. Steinhoff B.J., Bacher M., Bast T. et al. First clinical experiences with perampanel – the Kork experience in 74 patients. Epilepsia 2014;55 Suppl 1: 16–8.
25. Steinhoff B.J., 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.
26. Zwart R., Sher E., Ping X. et al. Perampanel, an antagonist of α-amino-3- hydroxy-5-methyl-4-isoxazolepropionic acid receptors for the treatment of epilepsy: studies in human epileptic brain, nonepileptic brain, and in rodent models. J Pharmacol Exp Ther 2014;351(1): 124–33.
