Русский журнал детской неврологии. 2014; 9: 36-42
Применение нового антиэпилептического препарата перампанел (Файкомпа) в лечении эпилепсии (обзор зарубежной литературы)
https://doi.org/10.17650/2073-8803-2014-9-3-36-42Аннотация
Несмотря на значительные успехи, достигнутые в эпилептологии, резистентные эпилепсии составляют примерно 30 % среди всех форм эпилепсии, особенно у пациентов с фокальными приступами. В этих случаях сохраняется надежда на успех нейрохирургического лечения и синтез новых антиэпилептических препаратов (АЭП). Авторы представляют обзор, посвященный новому АЭП – перампанелу (Файкомпе). Рассматривается механизм действия препарата, особенности фармакокинетики, клинические и постмаркетинговые исследования эффективности, переносимости и безопасности. На основании представленных в литературе данных можно сделать вывод, что перампанел является перспективным препаратом для лечения парциальных и вторично-генерализованных приступов с высокой эффективностью и благоприятными показателями переносимости.
Список литературы
1. Elger C.E., Schmidt D. Modern management of epilepsy: а practical approach. Epilepsy Behav 2008;12(4):501–39.
2. Franco V., Crema F., Iudice A. et al. Novel treatment options for epilepsy: focus on perampanel. Pharmacol Res 2013;70(1): 35–40.
3. 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.
4. 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.
5. Hanada T. The discovery and development of perampanel for the treatment of epilepsy. Expert Opin Drug Discov 2014;9(4):449–58.
6. Kerling F., Kasper B.S. Efficacy of perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):25–9.
7. 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.
8. Krauss G.L. Perampanel: a selective AMPA antagonist for treating seizures. Epilepsy Curr 2013;13(6):269–72.
9. Krauss G.L., Bar M., Biton V. еt al. Tolerability and safety of perampanel: two randomized dose-escalation studies. Acta Neurol Scand 2012;125(1):8–15.
10. Krauss G.L., 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(7):1058–68.
11. 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.
12. Krauss G.L., Serratosa J.M., Villanueva V. еt al. Randomized phase III study 306: adjunctive perampanel for refractory partialonset seizures. Neurology 2012;78(18):1408–15.
13. Kwan P., Brodie M.J. Epilepsy after the first drug fails: substitution or add-on? Seizure 2000;9(7):464–8.
14. Kwan P., Brodie M.J. Refractory epilepsy: mechanisms and solutions. Expert Rev Neurother 2006;6(3):397–406.
15. 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.
16. Patsalos P.N. Drug interactions with the newer antiepileptic drugs (AEDs) – рart 2: pharmacokinetic and pharmacodynamic interactions between AEDs and drugs used to treat non-epilepsy disorders. Clin Pharmacokinet 2013;52(12):1045–61.
17. 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.
18. Rheims S., Ryvlin P. Profile of perampanel and its potential in the treatment of partial onset seizures. Neuropsychiatr Dis Treat 2013;9:629–37.
19. Rogawski M.A. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Curr 2011;11(2):56–63
20. Rugg-Gunn F. Adverse effects and safety profile of perampanel: a review of pooled data. Epilepsia 2014;55 Suppl 1:13–5.
21. Satlin A., Kramer L.D., Laurenza A. Development of perampanel in epilepsy. Acta Neurol Scand Suppl 2013;(197):3–8.
22. Serratosa J.M., Villanueva V., Kerling F., Kasper B.S. Safety and tolerability of perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):30–5.
23. 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.
24. Steinhoff B.J. Efficacy of perampanel: a review of pooled data. Epilepsia 2014; 55 Suppl 1:9–12.
25. Steinhoff B.J., Bacher M., Bast T. еt al. First clinical experiences with perampanel – the Kork experience in 74 patients. Epilepsia 2014;55 Suppl 1:16–8.
26. Steinhoff B.J., Ben-Menachem E., Ryvlin P. еt 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.
27. Steinhoff B.J., Hamer H., Trinka E. еt al. A multicenter survey of clinical experiences with perampanel in real life in Germany and Austria. Epilepsy Res 2014;108(5):986–8.
28. Zwart R., Sher E., Ping X. еt al. Perampanel, an Antagonist of α-Аmino-3- Нydroxy-5-Мethyl-4-Isoxazolepropionic Acid (AMPA) Receptors for the Treatment of Epilepsy: Studies in Human Epileptic Brain, Non-Epileptic Brain, and in Rodent Models. J Pharmacol Exp Ther 2014;351(1):124–33.
Russian Journal of Child Neurology. 2014; 9: 36-42
USE OF THE NEW ANTIEPILEPTIC DRUG PERAMPANEL (FYCOMPA) IN THE TREATMENT OF EPILEPSY: A REVIEW OF FOREIGN LITERATURE
https://doi.org/10.17650/2073-8803-2014-9-3-36-42Abstract
Despite a considerable advance made in epileptology, resistant epilepsies are about 30% among all epilepsy types particularly in patients with focal seizures. In these cases, there is hope for the success of neurosurgical treatment and the synthesis of new antiepileptic drugs (AEDs). The authors provide a review of the literature dealing the new AED perampanel (Fycompa) and consider its mechanism of action, pharmacokinetics, clinical and postmarketing trials of its efficacy, tolerability, and safety. Based on the data available in the literature, it may be concluded that parampanel is a promising highly effective and well tolerated AED to treat partial and secondary generalized seizures.
References
1. Elger C.E., Schmidt D. Modern management of epilepsy: a practical approach. Epilepsy Behav 2008;12(4):501–39.
2. Franco V., Crema F., Iudice A. et al. Novel treatment options for epilepsy: focus on perampanel. Pharmacol Res 2013;70(1): 35–40.
3. 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.
4. 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.
5. Hanada T. The discovery and development of perampanel for the treatment of epilepsy. Expert Opin Drug Discov 2014;9(4):449–58.
6. Kerling F., Kasper B.S. Efficacy of perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):25–9.
7. 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.
8. Krauss G.L. Perampanel: a selective AMPA antagonist for treating seizures. Epilepsy Curr 2013;13(6):269–72.
9. 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.
10. Krauss G.L., 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(7):1058–68.
11. 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.
12. 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.
13. Kwan P., Brodie M.J. Epilepsy after the first drug fails: substitution or add-on? Seizure 2000;9(7):464–8.
14. Kwan P., Brodie M.J. Refractory epilepsy: mechanisms and solutions. Expert Rev Neurother 2006;6(3):397–406.
15. 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.
16. Patsalos P.N. Drug interactions with the newer antiepileptic drugs (AEDs) – rart 2: pharmacokinetic and pharmacodynamic interactions between AEDs and drugs used to treat non-epilepsy disorders. Clin Pharmacokinet 2013;52(12):1045–61.
17. 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.
18. Rheims S., Ryvlin P. Profile of perampanel and its potential in the treatment of partial onset seizures. Neuropsychiatr Dis Treat 2013;9:629–37.
19. Rogawski M.A. Revisiting AMPA receptors as an antiepileptic drug target. Epilepsy Curr 2011;11(2):56–63
20. Rugg-Gunn F. Adverse effects and safety profile of perampanel: a review of pooled data. Epilepsia 2014;55 Suppl 1:13–5.
21. Satlin A., Kramer L.D., Laurenza A. Development of perampanel in epilepsy. Acta Neurol Scand Suppl 2013;(197):3–8.
22. Serratosa J.M., Villanueva V., Kerling F., Kasper B.S. Safety and tolerability of perampanel: a review of clinical trial data. Acta Neurol Scand Suppl 2013;(197):30–5.
23. 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.
24. Steinhoff B.J. Efficacy of perampanel: a review of pooled data. Epilepsia 2014; 55 Suppl 1:9–12.
25. 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.
26. 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.
27. Steinhoff B.J., 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(5):986–8.
28. Zwart R., Sher E., Ping X. et al. Perampanel, an Antagonist of α-Amino-3- Nydroxy-5-Methyl-4-Isoxazolepropionic Acid (AMPA) Receptors for the Treatment of Epilepsy: Studies in Human Epileptic Brain, Non-Epileptic Brain, and in Rodent Models. J Pharmacol Exp Ther 2014;351(1):124–33.
