References
- Anderson L.L., Thompson C.H., Hawkins N.A., Nath R.D., Petersohn A.A., Rajamani S. et al.: Antiepileptic activity of preferential inhibitors of persistent sodium current. Epilepsia, 2014, 55: 1274–1283.
- Bell G.S., Mula M., Sander J.W.: Suicidality in people taking antiepileptic drugs: what is the evidence? CNS Drugs, 2009, 23: 281–292. doi:10.2165/00023210-200923040-00002.
- Bialer M., Johannessen S.I., Levy R.H., Perucca E., Tomson T., White H.S.: Progress report on new antiepileptic drugs: a summary of the Eleventh Eilat Conference (EILAT XI). Epilepsy Res., 2013,103: 2–30. doi: 10.1016/j.eplepsyres.2012.10.001.
- Bocquet H., Bagot M., Roujeau J.C.: Drug-induced pseudolymphoma and drug hypersensitivity syndrome (Drug Rash with Eosinophilia and Systemic Symptoms: DRESS). Semin. Cutan. Med. Surg., 1996, 15, 250–257.
- Calle A.M., Aguirre N., Ardila J.C., Cardona Villa R.: DRESS syndrome: A literature review and treatment algorithm. World Allergy Organ J., 2023, 16: 100673. doi: 10.1016/j.wao-jou.2022.100673.
- Christensen J., Vestergaard M., Mortensen P.B., Sidenius P., Agerbo E.: Epilepsy and risk of suicide: a population-based case-control study. Lancet Neurol., 2007, 6: 693–698.
- Cherubini E.: Phasic GABAA-mediated inhibition. In: Noebels J.L., Avoli M., Rogawski M.A. et al. (eds).: Jasper’s Basic Mechanisms of the Epilepsies [Internet]. 4th ed. Bethesda (MD): National Center for Biotechnology Information (US), 2012.
- Chung S.S., French J.A., Kowalski J., Krauss G.L., Lee S.K., Maciejowski M. et al.: Randomized phase 2 study of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology, 2020, 94: e2311–2322.
- Coleman C.I., Limone B., Sobieraj D.M., Lee S., Roberts M.S., Kaur R. et al.: Dosing frequency and medication adherence in chronic disease. J. Manag. Care Pharm., 2012, 18: 527–539.
- Connor G.: Long-term Cenobamate for Uncontrolled Focal Seizures in Patients Living in a Group Home or With Developmental Disability (P4-1.006). Neurology, 2023, 100 (Suppl. 2): 0191; doi: 10.1212/WNL.0000000000201804
- Elakkary S., Hagemann A., Klimpel D., Bien C.G., Brandt C.: A retrospective non-interventional study evaluating the pharma-cokinetic interactions between cenobamate and clobazam. Epilepsia, 2023, 64: e36– 42. https://doi.org/10.1111/epi.17515
- Elliott T., Ridley-Pryor T., Gienapp A.J., Wheless J.W.: Initial real-world experience with cenobamate in adolescents and adults: a single center experience. Pediatr. Neurol., 2022, 129: 19–23.
- French J.A., Chung S.S., Krauss G.L., Lee S.K., Maciejowski M., Rosenfeld W.E. et al.: Long-term safety of adjunctive cenobamate in patients with uncontrolled focal seizures: open-label extension of a randomized clinical study. Epilepsia, 2021, 62: 2142–2150.
- Gaitatzis A., Sisodiya S.M., Sander J.W.: The somatic comorbidity of epilepsy: a weighty but often unrecognized burden. Epilepsia, 2012, 53: 1282–1293.
- Greene S., Kwak C., Kamin M., Vernillet L.: The effect of cenobamate on the single dose pharmacokinetics of multiple cytochrome P450 probes using a cocktail approach in healthy subjects [abstract]. Clin. Pharmacol. Ther., 2019, 105 (suppl. 1): S97.
- Guignet M., Campbell A., White H.S.: Cenobamate (XCOPRI): can preclinical and clinical evidence provide insight into its mechanism of action? Epilepsia, 2020, 61: 1–11.
- Hirsch L.J., Weintraub D.B., Buchsbaum R., Spencer H.T., Straka T., Hager M. et al.: Predictors of lamotrigine-associated rash. Epilepsia, 2006, 47: 318–322. doi: 10.1111/j.1528-1167.2006.00423.x
- Kanner A.M.: Suicidality in Patients With Epilepsy: Why Should Neurologists Care? Front. Integr. Neurosci., 2022, 16. https://doi.org/10.3389/fnint.2022.898547
- Motika P.V., Spencer D.C.: Treatment of epilepsy in the elderly. Curr. Neurol. Neurosci. Rep., 2016, 16: 96.
- Kim S.H., Lee H., Kim D.W.: Switching antiepileptic drugs to once-daily dosing regimens in epilepsy patients Acta Neurol Scand., 2021, 143: 51–55. doi: 10.1111/ane.13333Epub 2020 Aug 26.PMID: 32762074
- Klein P., Aboumatar S., Brandt C., Dong F., Krauss G.L., Mizne S. et al.: Long-term efficacy and safety from an open-label extension of adjunctive cenobamate in patients with uncontrolled focal seizures. Neurology, 2022, 99: e989– 998.
- Klein P., Devinsky O., French J., Harden C., Krauss G.L., Mc-Carter R. et al.: Suicidality risk of newer antiseizure medications: a meta-analysis. JAMA Neurol., 2021, 78: 1118–1127. doi:10.1001/jamaneurol.2021.2480.
- Krauss G.L., Klein P., Brandt C.: Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial. Lancet Neurol., 2020, 19: 38–48. https://doi.org/10.1016/S1474-4422(19)30399-0
- Latimer D.R., Edinoff A.N., Ruff R.D., Rooney K.C., Penny K.M., Patel S.B. et al.: Cenobamate, a sodium channel inhibitor and positive allosteric modulator of GABAAion channels, for partial onset seizures in adults: A comprehensive review and clinical implications. Neurol. Int., 2021, 13: 252–265.
- Löscher W., Schmidt D.: Experimental and clinical evidence for loss of effect (tolerance) during prolonged treatment with antiepileptic drugs. Epilepsia, 2006, 47: 1253–1284.
- Löscher W., Sills G.J., White H.S.: The ups and downs of alkyl-carbamates in epilepsy therapy: How does cenobamate differ? Epilepsia, 2021, 62: 596–614.
- Lattanzi S., Trinka E., Zaccara G., Striano P., Del Giovane C., Silvestrini M. et al.: Adjunctive cenobamate for focal-onset seizures in adults: a systematic review and meta-analysis. CNS Drugs, 2020, 34: 1105–1120.
- Mula M.: Epilepsy and mood disorders. In: The comorbidities of epilepsy. M. Mula (ed.), Elsevier, 2019, pp 299–314.
- Mula M., Kanner A.M., Schmitz B., Schachter S.: Antiepileptic drugs and suicidality: an expert consensus statement from the task force Commentary 29 on therapeutic strategies of the ILAE commission on neuropsychobiology. Epilepsia, 2013, 54: 199–203. doi:10.1111/j. 1528-1167.2012.03688.x
- Nakamura M., Cho J.H., Shin H., Jang I.S.: Effects of ceno-bamate (YKP3089), a newly developed anti-epileptic drug, on voltage-gated sodium channels in rat hippocampal CA3 neurons. Eur. J. Pharmacol., 2019, 855: 175–82.
- O’Dwyer R., Stern S., Wade, C., Guggilam A., Rosenfeld W.E.: Safety and Efficacy of Cenobamate for the Treatment of Focal Seizures in Older Patients (P4-1.002) Neurology, 2023, 100 (Suppl. 2): 1897. doi: 10.1212/WNL.0000000000202181
- Ontozry. Summary of product characteristics. Accessed July 2023: https://www.ema.europa.eu/en/documents/product-in-formation/ontozry-epar-product-information_en.p
- O’Rourke G., O’Brien J.J.: Identifying the barriers to antiepileptic drug adherence among adults with epilepsy. Seizure, 2017, 45: 160–168.
- Peña-Ceballos J., Moloney P.B., Munteanu T., Doyle M., Colleran N., Liggan B. et al.: Adjunctive cenobamate in highly active and ultra-refractory focal epilepsy: A „real-world” retrospective study. Epilepsia, 2023, 64: 1225–1235. doi: 10.1111/epi.17549. Epub 2023 Feb 27. PMID: 36790345.
- Roberti R., De Caro C., Iannone L.F., Zaccara G., Lattanzi S., Russo E.: Pharmacology of cenobamate: mechanism of action, pharmacokinetics, drug-drug interactions and tolerability. CNS Drugs, 2021, 35: 609–618. doi: 10.1007/s40263-021-00819-88.
- Rosenfeld W.E., Abou-Khalil B., Aboumatar S., Bhatia P., Biton V., Krauss G.L. et al.: Post hoc analysis of a phase 3, multicenter, open-label study of cenobamate for treatment of uncontrolled focal seizures: effects of dose adjustments of concomitant antiseizure medications. Epilepsia, 2021, 62: 3016–3028.
- Sander J.W., Rosenfeld W.E., Halford J.J., Steinhoff B.J,. Biton V., Toledo M.: Long-term individual retention with cenobamate in adults with focal seizures: pooled data from the clinical development program. Epilepsia, 2022, 63: 139–149.
- Sharma R., Nakamura M., Neupane C., Jeon B.H., Shin H., Melnick S.M. et al.: Positive allosteric modulation of GABAA receptors by a novel antiepileptic drug cenobamate. Eur. J. Pharmacol., 2020, 879: 173117.
- Singh A.: Cenobamate for treatment-resistant focal seizures: current evidence and place in therapy. J. Cent. Nerv. Syst. Dis., 2022, 14: 1–5.
- Smith M.C., Klein P., Krauss G.L., Rashid S., Seiden L.G., Stern J.M. et al.: Dose adjustment of concomitant antiseizure medications during cenobamate treatment: expert opinion consensus recommendations. Neurol. Ther., 2022, 11: 1705–1720.
- Sperling M.R., Abou-Khalil B., Aboumatar S., Bhatia P., Biton V., Klein P. et al.: Efficacy of cenobamate for uncontrolled focal seizures: post hoc analysis of a phase 3, multicenter, open-label study. Epilepsia, 2021, 62: 3005–3015.
- Sperling M.R., Klein P., Aboumatar S., Gelfand M., Halford J.J., Krauss G.L. et al.: Cenobamate (YKP3089) as adjunctive treatment for uncontrolled focal seizures in a large, phase 3, multicenter, open-label safety study. Epilepsia, 2020, 61:1099–1108
- Stafstrom C.E.: Persistent sodium current and its role in epilepsy. Epilepsy Curr., 2007, 7: 15. https://doi.org/10.1111/j.1535-7511.2007.00156.x.
- Steinhoff B.J., Sanchez-Alvarez J., Majkowska-Zwolinska B., Maciejowski M., Steinhoff B.J, Rosenfeld W., Serratosa J.M, Brandt C., Klein P., Toledo M., Krauss G.L. et al.: Practical guidance for the management of adults receiving adjunctive cenobamate for the treatment of focal epilepsy – expert opinion. Epilepsy Behav., 2021, 123: 10827
- St Louis E.K.: Truly “rational” polytherapy: maximizing efficacy and minimizing drug interactions, drug load, and adverse effects. Curr. Neuropharmacol., 2009, 7: 96–105.
- Vernillet, L.; Greene, S.A.; Kamin, M.: Pharmacokinetics of Cenobamate: Results From Single and Multiple Oral Ascending-Dose Studies in Healthy Subjects. Clin. Pharmacol. Drug Dev., 2020, 9: 428–443.
- Vernillet L., Kamin M.: Drug–drug interactions between cenobamate and other antiepileptic drugs: results from phase I studies with carbamazepine, phenobarbital, phenytoin, and divalproex sodium [abstract]. Clin. Pharmacol. Ther., 2018, 103 (Suppl. S1): 91.
- Vernillet L., Greene S.A., Kamin M.: Pharmacokinetics of cenobamate: Results from single and multiple oral ascending-dose studies in healthy subjects. Clin. Pharmacol. Drug Dev., 2020, 4: 428–443.
- Villanueva V., Brandt C.: Efficacy and safety of cenobamate as adjunctive therapy in patients with uncontrolled focal seizures: results from two doubleblind, placebo-controlled, international studies [abstract]. Eur. J. Neurol., 2020, 27 (suppl. 1): 60.
- Villanueva V., Santos-Carrasco D., Cabezudo-García P., Gómez-Ibáñez A., Garcés M., Serrano-Castro P. et al.: Real-world safety and effectiveness of cenobamate in patients with focal onset seizures: Outcomes from an Expanded Access Program. Epilepsia Open, 2023 May 7. doi:10.1002/epi4.12757.
- Wang L., Mei X.-L.: Drug reaction with eosinophilia and systemic symptoms: retrospective analysis of 104 cases over one decade. Chin. Med. J., 2017, 130: 943–949.
- Vossler D.G.: Remarkably high efficacy of cenobamate in adults with focal-onset seizures: A double-blind, randomized, placebo-controlled trial. Epilepsy Curr., 2020, 20: 85–87.
- Wolfson A.R., Zhou L., Li Y., Phadke N.A., Chow O.A., Blumenthal K.G.: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome identified in the electronic health record allergy module. J. Allergy Clin. Immuno Pract., 2019, 7: 633–640.
- Zaccara G., Lattanzi S.: Comorbidity between epilepsy and cardiac arrhythmias: implication for treatment. Epilepsy Behav., 2019, 97: 304–312. doi:10.1016/j.yebeh.2019.05.038.
- Zaccara G., Franciotta D., Perucca E.: Idiosyncratic adverse reactions to antiepileptic drugs. Epilepsia, 2007, 48: 1223–1244. doi:10.1111/j.1528-1167.2007.01041.x.
- Zhang L., Wang J., Wang C.: Efficacy and safety of cenobamate in patients with uncontrolled focal seizures: a meta-analysis. Acta Neurol. Scand., 2021, 144: 58–66.
- Zhang N., Shon J., Kim M.J., Yu C., Zhang L., Huang S.M.: Role of CYP3A in Oral Contraceptives Clearance. Clin. Transl. Sci., 2018, 11: 251–260.