Safety evaluation of perampanel as monotherapy or first adjunctive therapy in patients with epilepsy

References

• Brodie MJ, Barry SJE, Bamagous GA, et al. Patterns of treatment response in newly diagnosed epilepsy. Neurology. 2012;78(20):1548–1554.
   PubMed Web of Science ®Google Scholar
• Cramer JA, Mintzer S, Wheless J, et al. Adverse effects of antiepileptic drugs: a brief overview of important issues. Expert Rev Neurother. 2010;10(6):885–891.
   PubMed Web of Science ®Google Scholar
• Gambardella A, Tinuper P, Acone B, et al. Selection of antiseizure medications for first add-on use: a consensus paper. Epilepsy Behav. 2021;122:108087.
   PubMed Web of Science ®Google Scholar
• Bonanni P, Gambardella A, Tinuper P, et al. Perampanel as first add-on antiseizure medication: Italian consensus clinical practice statements. BMC Neurol. 2021;21(1):410.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). FYCOMPA® prescribing information. December 2021. Available at: https://www.fycompa.com/-/media/Files/Fycompa/Fycompa_Prescribing_Information.pdf. Accessed 2022 Feb 28.
   Google Scholar
• European Medicines Agency (EMA). FYCOMPA® Annex I: summary of product characteristics. July 2022. Available at: https://www.ema.europa.eu/en/documents/product-information/fycompa-epar-product-information_en.pdf. Accessed 2022 Aug 8.
   Google Scholar
• 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(7):1331–1340.
   PubMed Web of Science ®Google Scholar
• French JA, Krauss GL, Biton V, et al. Adjunctive perampanel for refractory partial-onset seizures: randomized phase III study 304. Neurology. 2012;79(6):589–596.
   PubMed Web of Science ®Google Scholar
• 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.
   PubMed Web of Science ®Google Scholar
• Krauss GL, Serratosa JM, Villanueva V, et al. Randomized phase III study 306: adjunctive perampanel for refractory partial-onset seizures. Neurology. 2012;78(18):1408–1415.
   PubMed Web of Science ®Google Scholar
• French JA, Krauss GL, Wechsler RT, et al. Perampanel for tonic-clonic seizures in idiopathic generalized epilepsy: a randomized trial. Neurology. 2015;85(11): 950–957.
   PubMed Web of Science ®Google Scholar
• Yamamoto T, Lim SC, Ninomiya H, et al. Efficacy and safety of perampanel monotherapy in patients with focal-onset seizures with newly diagnosed epilepsy or recurrence of epilepsy after a period of remission: the open-label Study 342 (FREEDOM Study). Epilepsia Open. 2020;5(2):274–284.
   PubMedGoogle Scholar
• Eisai News Release. Approval of antiepileptic drug Fycompa® in Japan for monotherapy and pediatric indications for partial-onset seizures, as well as a new formulation. 2020. Available at: https://www.eisai.com/news/2020/pdf/enews202004pdf.pdf. Accessed 2021 Dec 20.
   Google Scholar
• European Medicines Agency (EMA). Fycompa Assessment Report. 2020. Available at: https://www.ema.europa.eu/en/documents/variation-report/fycompa-h-c-2434-ii-0047-epar-assessment-report-variation_en.pdf. Accessed 2022 Mar 1.
   Google Scholar
• Gil-Nagel A, Burd S, Toledo M, et al. A retrospective, multicentre study of perampanel given as monotherapy in routine clinical care in people with epilepsy. Seizure. 2018;54:61–66.
   PubMed Web of Science ®Google Scholar
• Wechsler RT, Wheless J, Zafar M, et al. PROVE: retrospective, non-interventional, Phase IV study of perampanel in real-world clinical care of patients with epilepsy. Epilepsia Open. 2022;7(2):293–305.
   PubMedGoogle Scholar
• Yamamoto T, Gil-Nagel A, Wheless JW, et al. Perampanel monotherapy for the treatment of epilepsy: clinical trial and real-world evidence. Epilepsy Behav. 136; 2022 108885.
   PubMed Web of Science ®Google Scholar
• Toledano Delgado R, García‐Morales I, Parejo‐Carbonell B, et al. Effectiveness and safety of perampanel monotherapy for focal and generalized tonic-clonic seizures: experience from a national multicenter registry. Epilepsia. 2020;61(6):1109–1119.
   PubMed Web of Science ®Google Scholar
• Chinvarun Y. A retrospective, real-world experience of perampanel monotherapy in patient with first new onset focal seizure: a Thailand experience. Epilepsia Open. 2022;7(1):67–74.
   PubMedGoogle Scholar
• Kim JH, Kim DW, Lee SK, et al. First add-on perampanel for focal-onset seizures: an open-label, prospective study. Acta Neurol Scand. 2020;141(2):132–140.
   PubMed Web of Science ®Google Scholar
• Im K, Lee S-A, Kim JH, et al. Long-term efficacy and safety of perampanel as a first add-on therapy in patients with focal epilepsy: three-year extension study. Epilepsy Behav. 2021;125:108407.
   PubMed Web of Science ®Google Scholar
• Abril Jaramillo J, Estévez María JC, Girón Úbeda JM, et al. Effectiveness and safety of perampanel as early add-on treatment in patients with epilepsy and focal seizures in the routine clinical practice: Spain prospective study (PERADON). Epilepsy Behav. 2020;102:106655.
   PubMed Web of Science ®Google Scholar
• Santamarina E, Bertol V, Garayoa V, et al. Efficacy and tolerability of perampanel as a first add-on therapy with different anti-seizure drugs. Seizure. 2020;83:48–56.
   PubMed Web of Science ®Google Scholar
• Rea R, Traini E, Renna R, et al. Efficacy and impact on cognitive functions and quality of life of perampanel as first add-on therapy in patients with epilepsy: a retrospective study. Epilepsy Behav. 2019;98(Pt A):139–144.
   PubMedGoogle Scholar
• Canas N, Félix C, Silva V, et al. Comparative 12-month retention rate, effectiveness and tolerability of perampanel when used as a first add-on or a late add-on treatment in patients with focal epilepsies: the COM-PER study. Seizure. 2021;86:109–115.
   PubMed Web of Science ®Google Scholar
• Villanueva V, D’Souza W, Goji H, et al. PERMIT study: a global pooled analysis study of the effectiveness and tolerability of perampanel in routine clinical practice. J Neurol. 2022;269(4):1957–1977.
   PubMed Web of Science ®Google Scholar
• Takenaka O, Ferry J, Saeki K, et al. Pharmacokinetic/pharmacodynamic analysis of adjunctive perampanel in subjects with partial-onset seizures. Acta Neurol Scand. 2018;137(4):400–408.
   PubMed Web of Science ®Google Scholar
• Gidal BE, Laurenza A, Hussein Z, et al. Perampanel efficacy and tolerability with enzyme-inducing AEDs in patients with epilepsy. Neurology. 2015;84(19):1972–1980.
   PubMed Web of Science ®Google Scholar
• Kwan P, Brodie MJ, Laurenza A, et al. Analysis of pooled phase III trials of adjunctive perampanel for epilepsy: impact of mechanism of action and pharmacokinetics on clinical outcomes. Epilepsy Res. 2015;117:117–124.
   PubMed Web of Science ®Google Scholar
• Steinhoff BJ, Patten A, Williams B, et al. Efficacy and safety of adjunctive perampanel 4 mg/d for the treatment of focal seizures: a pooled post hoc analysis of four randomized, double-blind, phase III studies. Epilepsia. 2020;61(2):278–286.
   PubMed Web of Science ®Google Scholar
• 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):1481–1489.
   PubMed Web of Science ®Google Scholar
• Trinka E, Lattanzi S, Carpenter K, et al. Exploring the evidence for broad-spectrum effectiveness of perampanel: a systematic review of clinical data in generalised seizures. CNS Drugs. 2021;35(8):821–837.
   PubMed Web of Science ®Google Scholar
• Chung S, Williams B, Dobrinsky C, et al. Perampanel with concomitant levetiracetam and topiramate: post hoc analysis of adverse events related to hostility and aggression. Epilepsy Behav. 2017;75:79–85.
   PubMed Web of Science ®Google Scholar
• Ettinger AB, LoPresti A, Yang H, et al. Psychiatric and behavioral adverse events in randomized clinical studies of the noncompetitive AMPA receptor antagonist perampanel. Epilepsia. 2015;56(8):1252–1263.
   PubMed Web of Science ®Google Scholar
• Maguire M, Ben-Menachem E, Patten A, et al. A post-approval observational study to evaluate the safety and tolerability of perampanel as an add-on therapy in adolescent, adult, and elderly patients with epilepsy. Epilepsy Behav. 2022;126:108483.
   PubMed Web of Science ®Google Scholar
• Witt JA, Helmstaedter C. The impact of perampanel on cognition: a systematic review of studies employing standardized tests in patients with epilepsy. Seizure. 2022;94:107–111.
   PubMed Web of Science ®Google Scholar
• Villanueva V, Garcés M, López-González FJ, et al. Safety, efficacy and outcome-related factors of perampanel over 12 months in a real-world setting: the FYDATA study. Epilepsy Res. 2016;126:201–210.
   PubMed Web of Science ®Google Scholar
• Vazquez B, Tomson T, Dobrinsky C, et al. Perampanel and pregnancy. Epilepsia. 2021;62(3):698–708.
   PubMed Web of Science ®Google Scholar
• Maguire M. Response to “Perampanel and pregnancy: could experience be a gloomy lantern that does not even illuminate its bearer?” Epilepsy Behav. 2022;129:108654.
   PubMed Web of Science ®Google Scholar
• Fogarasi A, Flamini R, Milh M, et al. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia. 2020;61(1):125–137.
   PubMed Web of Science ®Google Scholar
• Segal E, Moretz K, Wheless J, et al. PROVE-phase IV study of perampanel in real-world clinical care of patients with epilepsy: interim analysis in pediatric patients. J Child Neurol. 2022;37(4):256–267.
   PubMed Web of Science ®Google Scholar
• Leppik IE, Wechsler RT, Williams B, et al. Efficacy and safety of perampanel in the subgroup of elderly patients included in the phase III epilepsy clinical trials. Epilepsy Res. 2015;110:216–220.
   PubMed Web of Science ®Google Scholar
• Seiden LG, Connor GS. The importance of drug titration in the management of patients with epilepsy. Epilepsy Behav. 2022;128:108517.
   PubMed Web of Science ®Google Scholar
• Rohracher A, Zimmermann G, Villanueva V, et al. Perampanel in routine clinical use across Europe: pooled, multicenter, observational data. Epilepsia. 2018;59(9):1727–1739.
   PubMed Web of Science ®Google Scholar
• Inoue Y, Sumitomo K, Matsutani K, et al. Evaluation of real-world effectiveness of perampanel in Japanese adults and older adults with epilepsy. Epileptic Disord. 2022;24(1):123–132.
   PubMed Web of Science ®Google Scholar
• Lattanzi S, Cagnetti C, Foschi N, et al. Adjunctive perampanel in older patients with epilepsy: a multicenter study of clinical practice. Drugs Aging. 2021;38(7):603–610.
   PubMed Web of Science ®Google Scholar
• Food and Drug Administration (FDA). BRIVIACT® (brivaracetam) prescribing information. Sept 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205836Orig1s011;205837Orig1s009;205838Orig1s008lbl.pdf. Accessed 2022 Feb 28.
   Google Scholar
• Food and Drug Administration (FDA). XCOPRI® (cenobamate tablets) prescribing information. August 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212839s001lbl.pdf. Accessed 2022 Feb 28.
   Google Scholar
• Food and Drug Administration (FDA). APTIOM® (eslicarbazepine acetate) prescribing information. March 2019. Available at: http://www.aptiom.com/Aptiom-Prescribing-Information.pdf. Accessed 2022 Feb 28.
   Google Scholar
• Food and Drug Administration (FDA). VIMPAT® (lacosamide) prescribing information. October 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022253s049,022254s039,022255s031lbl.pdf. Accessed 2022 Feb 28.
   Google Scholar
• Food and Drug Administration (FDA). LAMICTAL® (lamotrigine) prescribing information. March 2021. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020241s064,020764s057,022251s028lbl.pdf. Accessed 2022 Mar 8.
   Google Scholar
• Food and Drug Administration (FDA). KEPPRA® (levetiracetam) prescribing information. October 2020. Available at: https://www.ucb.com/_up/ucb_com_products/documents/Keppra_IR_Current_COL_10_2020.pdf. Accessed 2022 Feb 28.
   Google Scholar
• Jeon J, Oh J, Yu KS. A meta-analysis: efficacy and safety of anti-epileptic drugs prescribed in Korea as monotherapy and adjunctive treatment for patients with focal epilepsy. Transl Clin Pharmacol. 2021;29(1):6–20.
   PubMedGoogle Scholar
• Lattanzi S, Trinka E, Zaccara G, et al. Third-Generation antiseizure medications for adjunctive treatment of focal-onset seizures in adults: a systematic review and network meta-analysis. Drugs. 2022;82(2):199–218.
   PubMed Web of Science ®Google Scholar
• Zhu LN, Chen D, Xu D, et al. Newer antiepileptic drugs compared to levetiracetam as adjunctive treatments for uncontrolled focal epilepsy: an indirect comparison. Seizure. 2017;51:121–132.
   PubMed Web of Science ®Google Scholar
• Trinka E, Tsong W, Toupin S, et al. A systematic review and indirect treatment comparison of perampanel versus brivaracetam as adjunctive therapy in patients with focal-onset seizures with or without secondary generalization. Epilepsy Res. 2020;166:106403.
   PubMed Web of Science ®Google Scholar
• Zhuo C, Jiang R, Li G, et al. Efficacy and tolerability of second and third generation anti-epileptic drugs in refractory epilepsy: a network meta-analysis. Sci Rep. 2017;7(1):2535.
   PubMedGoogle Scholar
• Zaccara G, Giovannelli F, Giorgi FS, et al. Tolerability of new antiepileptic drugs: a network meta-analysis. Eur J Clin Pharmacol. 2017;73(7):811–817.
   PubMed Web of Science ®Google Scholar
• Steinhoff BJ, Klein P, Klitgaard H, et al. Behavioral adverse events with brivaracetam, levetiracetam, perampanel, and topiramate: a systematic review. Epilepsy Behav. 2021;118:107939.
   PubMed Web of Science ®Google Scholar
• Klein P, Devinsky O, French J, et al. Suicidality Risk of newer antiseizure medications: a meta-analysis. JAMA Neurol. 2021;78(9):1118–1127.
   PubMed Web of Science ®Google Scholar
• Gidal BE, Ferry J, Reyderman L, et al. Use of extended-release and immediate-release anti-seizure medications with a long half-life to improve adherence in epilepsy: a guide for clinicians. Epilepsy Behav. 2021;120:107993.
   PubMed Web of Science ®Google Scholar
• Gidal BE, Majid O, Ferry J, et al. The practical impact of altered dosing on perampanel plasma concentrations: pharmacokinetic modeling from clinical studies. Epilepsy Behav. 2014;35:6–12.
   PubMed Web of Science ®Google Scholar
• Lee JW, Kim JA, Kim MY, et al. Evaluation of persistence and healthcare utilization in patients treated with anti-seizure medications as add-on therapy: a nationwide cohort study in South Korea. Epilepsy Behav. 2022;126:108459.
   PubMed Web of Science ®Google Scholar
• Laliberté F, Duh MS, Barghout V, et al. Real-world impact of antiepileptic drug combinations with versus without perampanel on healthcare resource utilization in patients with epilepsy in the United States. Epilepsy Behav. 2021;118:107927.
   PubMed Web of Science ®Google Scholar
• Faught E, Li X, Choi J, et al. Real-world analysis of hospitalizations in patients with epilepsy and treated with perampanel. Epilepsia Open. 2021;6(4):645–652.
   PubMedGoogle Scholar
• Kanner AM, Patten A, Ettinger AB, et al. Does a psychiatric history play a role in the development of psychiatric adverse events to perampanel … and to placebo? Epilepsy Behav. 2021;125:108380.
   PubMed Web of Science ®Google Scholar
• Deleo F, Quintas R, Turner K, et al. The impact of perampanel treatment on quality of life and psychiatric symptoms in patients with drug-resistant focal epilepsy: an observational study in Italy. Epilepsy Behav. 2019;99:106391.
   PubMed Web of Science ®Google Scholar