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Eslicarbazepine Acetate: A Review of Its Use as Adjunctive Therapy in Refractory Partial-Onset Seizures
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  • 作者:Gillian M. Keating (1)
  • 刊名:CNS Drugs
  • 出版年:2014
  • 出版时间:July 2014
  • 年:2014
  • 卷:28
  • 期:7
  • 页码:583-600
  • 全文大小:537 KB
  • 参考文献:1. Stephen LJ, Brodie MJ. Antiepileptic drug monotherapy versus polytherapy: pursuing seizure freedom and tolerability in adults. Curr Opin Neurol. 2012;25(2):164-2. CrossRef
    2. National Institute for Health and Care Excellence. The epilepsies: the diagnosis and management of the epilepsies in adults and children in primary and secondary care (NICE clinical guideline 137). 2013. http://www.nice.org.uk/nicemedia/live/13635/57779/57779.pdf. Accessed 3 Feb 2014.
    3. Berg AT, Berkovic SF, Brodie MJ, et al. Revised terminology and concepts for organization of seizures and epilepsies: report of the ILAE commission on classification and terminology, 2005-009. Epilepsia. 2010;51(4):676-5. CrossRef
    4. Sunovion Pharmaceuticals Inc. Aptiom? (eslicarbazepine acetate) tablets, for oral use: US prescribing information. 2013. http://www.aptiom.com. Accessed 13 Jun 2014.
    5. European Medicines Agency. Zebinix (eslicarbazepine acetate): EU summary of product characteristics. 2014. http://www.ema.europa.eu. Accessed 13 Jun 2014.
    6. Gil-Nagel A, Lopes-Lima J, Ben-Menachem E, et al. An integrated data analysis from three placebo-controlled clinical studies on over-read electrocardiograms of epileptic patients treated with eslicarbazepine acetate: are there any effects on cardiac impulse transmission? (abstract no. p832). Epilepsia. 2011;52(Suppl 6):252.
    7. Vaisleib I, Penovich P, Shneker B, et al. Effects of eslicarbazepine acetate on cardiac function in patients with refractory partial-onset seizures: a pooled analysis of three phase III controlled studies (abstract no. P3.238 and poster). In: 66th American Academy of Neurology Annual Meeting, 26 April- May 2014, Philadelphia, PA.
    8. Blum D, Mintzer S, Wechsler RT, et al. Effects of eslicarbazepine acetate on serum lipids in statin users and non users: pooled analysis of placebo-controlled trials (poster no. 2.139). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    9. Elger C, Halász P, Maia J, et al. Efficacy and safety of eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures: a randomized, double-blind, placebo-controlled, parallel-group phase III study. Epilepsia. 2009;50(3):454-3. CrossRef
    10. Ben-Menachem E, Gabbai AA, Hufnagel A, et al. Eslicarbazepine acetate as adjunctive therapy in adult patients with partial epilepsy. Epilepsy Res. 2010;89(2-):278-5. CrossRef
    11. Gil-Nagel A, Lopes-Lima J, Almeida L, et al. Efficacy and safety of 800 and 1200 mg eslicarbazepine acetate as adjunctive treatment in adults with refractory partial-onset seizures. Acta Neurol Scand. 2009;120(5):281-. CrossRef
    12. Sperling M, Harvey JJ, Biraben A, et al. Adjunctive eslicarbazepine acetate in patients with refractory partial-onset seizures: efficacy results of a 12?week randomized placebo-controlled study (poster no. 3.210). In: 67th Annual American Epilepsy Society Meeting; 6-0 Dec 2013, Washington, DC.
    13. Hebeisen S, Brady K, Konrad D, et al. Inhibitory effects of eslicarbazepine acetate and its metabolites against neuronal voltage-gated sodium channels (abstract no. p851). Epilepsia. 2011;52(Suppl 6):257-.
    14. Bonifácio MJ, Brady K, Hebeisen S, et al. Effects of eslicarbazepine, R-licarbazepine and oxcarbazepine on ion transmission through CAV2.1 and CAV3.2 channels (abstract no. 3.211). Epilepsy Curr. 2013;13(Suppl 1):415.
    15. Brady K, Hebeisen S, Konrad D, et al. The effects of eslicarbazepine, R-licarbazepine, oxcarbazepine and carbamazepine on ion transmission through CaV3.2 channels (abstract no. p858). Epilepsia. 2011;52(Suppl 6):260.
    16. Wright LC, Bulling A, Hebeisen S, et al. Effects of eslicarbazepine, R-licarbazepine, oxcarbazepine and carbamazepine on glycine GLYRA3 receptor-mediated inward currents (abstract no. p375). Epilepsia. 2011;52(Suppl 6):119.
    17. Bulling A, Hebeisen S, Konrad D, et al. Effects of eslicarbazepine, R-licarbazepine and carbamazepine on NMDA and AMPA receptor-mediated currents (abstract no. p852). Epilepsia. 2011;52(Suppl 6):258.
    18. Soares-da-Silva P, Bulling A, Hebeisen S, et al. The effects of eslicarbazepine, R-licarbazepine and carbamazepine on ion transmission through KV7.2 channels (abstract no. p854). Epilepsia. 2011;52(Suppl 6):258-.
    19. Bonifácio MJ, Hebeisen S, Soares-da-Silva P. Effects of eslicarbazepine and carbamazepine on ion transmission through CaV2.1 (P/Q-type) and CaV3.2 (T-type) calcium channels (abstract no. P483). Epilepsia. 2013;54(Suppl 3):153.
    20. Bonifacio MJ, Bulling A, Hebeisen S, et al. Eslicarbazepine and R-licarbazepine do not have effects on ion transmission through alpha1, alpha2, alpha3 and alpha5 GABA channels (abstract no. p853). Epilepsia. 2011;52(Suppl 6):258.
    21. D?ser A, Dickhof G, Uebachs M, et al. The effects of eslicarbazepine on transient Na+ currents in chronically epileptic human hippocampus (abstract no. P797). Epilepsia. 2013;54(Suppl 3):251.
    22. Pires N, Palma N, Loureiro AI, et al. Effects of eslicarbazepine acetate, eslicarbazepine, carbamazepine and oxcarbazepine in the maximal electroconvulsive shock test in the mice (abstract no. p373). Epilepsia. 2011;52(Suppl 6):118.
    23. Torr?o L, Machado R, Pires N, et al. Effects of eslicarbazepine acetate, eslicarbazepine, carbamazepine and oxcarbazepine in the 6-Hz psychomotor seizure model in the mice (abstract no. p374). Epilepsia. 2011;52(Suppl 6):118-.
    24. Buschmann F, Metternich B, Wagner K, et al. Effects of eslicarbazepine on cognition in patients with focal epilepsy (abstract no. p745). Epilepsia. 2011;52(Suppl 6):226-.
    25. Levy-Cooperman N, Blum D, Cheng H, et al. Abuse potential assessment of eslicarbazepine acetate in healthy male and female recreational sedative users (poster no. 3.209). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    26. Almeida L, Soares-da-Silva P. Eslicarbazepine acetate (BIA 2-093). Neurotherapeutics. 2007;4(1):88-6. CrossRef
    27. Bialer M, Soares-da-Silva P. Pharmacokinetics and drug interactions of eslicarbazepine acetate. Epilepsia. 2012;53(6):935-6. CrossRef
    28. Verrotti A, Loiacono G, Rossi A, et al. Eslicarbazepine acetate: an update on efficacy and safety in epilepsy. Epilepsy Res. 2014;108(1):1-0. CrossRef
    29. Bonifácio MJ, Sheridan RD, Parada A, et al. Interaction of the novel anticonvulsant, BIA 2-093, with voltage-gated sodium channels: comparison with carbamazepine. Epilepsia. 2001;42(5):600-. CrossRef
    30. Ambrósio AF, Silva AP, Malva JO, et al. Inhibition of glutamate release by BIA 2-093 and BIA 2-024, two novel derivatives of carbamazepine, due to blockade of sodium but not calcium channels. Biochem Pharmacol. 2001;61(10):1271-. CrossRef
    31. Parada A, Soares-da-Silva P. The novel anticonvulsant BIA 2-093 inhibits transmitter release during opening of voltage-gated sodium channels: a comparison with carbamazepine and oxcarbazepine. Neurochem Int. 2002;40(5):435-0. CrossRef
    32. Doeser A, Soares-da-Silva P, Beck H, et al. The effects of eslicarbazepine on persistent Na+ current and the role of the Na+ channel β subunits. Epilepsy Res. 2014;108(2):202-1. CrossRef
    33. Benes J, Parada A, Figueiredo AA, et al. Anticonvulsant and sodium channel-blocking properties of novel 10,11-dihydro-5H-dibenz[b, f]azepine-5-carboxamide derivatives. J Med Chem. 1999;42(14):2582-. CrossRef
    34. Sierra-Paredes G, Oreiro-García MT, Vázquez-Illanes MD, et al. Effect of eslicarbazepine acetate (BIA 2-093) on latrunculin A-induced seizures and extracellular amino acid concentrations in the rat hippocampus. Epilepsy Res. 2007;77(1):36-3. CrossRef
    35. Sierra-Paredes G, Nú?ez-Rodriguez A, Vázquez-López A, et al. Anticonvulsant effect of eslicarbazepine acetate (BIA 2-093) on seizures induced by microperfusion of picrotoxin in the hippocampus of freely moving rats. Epilepsy Res. 2006;72(2-):140-. CrossRef
    36. Potschka H, Soerensen J, Pekcec A, et al. Effect of eslicarbazepine acetate in the corneal kindling progression and the amygdala kindling model of temporal lobe epilepsy. Epilepsy Res. 2014;108(2):212-2. CrossRef
    37. Milovan D, Almeida L, Romach MK, et al. Effect of eslicarbazepine acetate and oxcarbazepine on cognition and psychomotor function in healthy volunteers. Epilepsy Behav. 2010;18(4):366-3. CrossRef
    38. Vaz-da-Silva M, Nunes T, Almeida L, et al. Evaluation of eslicarbazepine acetate on cardiac repolarization in a thorough QT/QTc study. J Clin Pharmacol. 2012;52(2):222-3. CrossRef
    39. Kharidia J, Blum D, Cheng H. A pharmacokinetic study comparing eslicarbazepine acetate administered orally as crushed or intact tablet in healthy volunteers (abstract no. 1.232). Epilepsy Curr. 2013;13(Suppl 1):106.
    40. Loureiro AI, Fernandes-Lopez C, Bonifacio MJ, et al. The metabolism and elimination pathway through glucuronidation of eslicarbazepine acetate and its metabolites (abstract no. p338). Epilepsia. 2011;52(Suppl 6):108.
    41. Perucca E, Elger C, Halász P, et al. Pharmacokinetics of eslicarbazepine acetate at steady-state in adults with partial-onset seizures. Epilepsy Res. 2011;96(1-):132-. CrossRef
    42. Almeida L, Falc?o A, Maia J, et al. Single-dose and steady-state pharmacokinetics of eslicarbazepine acetate (BIA 2-093) in healthy elderly and young subjects. J Clin Pharmacol. 2005;45(9):1062-. CrossRef
    43. Maia J, Almeida L, Falc?o A, et al. Effect of renal impairment on the pharmacokinetics of eslicarbazepine acetate. Int J Clin Pharmacol Ther. 2008;46(3):119-0. CrossRef
    44. Almeida L, Soares-da-Silva P. Safety, tolerability, and pharmacokinetic profile of BIA 2-093, a novel putative antiepileptic, in a rising multiple-dose study in young healthy humans. J Clin Pharmacol. 2004;44(8):906-8. CrossRef
    45. Almeida L, Soares-da-Silva P. Safety, tolerability and pharmacokinetic profile of BIA 2-093, a novel putative antiepileptic agent, during first administration to humans. Drugs R D. 2003;4(5):269-4. CrossRef
    46. Fontes-Ribeiro C, Nunes T, Falc?o A, et al. Eslicarbazepine acetate (BIA 2-093): relative bioavailability and bioequivalence of 50?mg/mL oral suspension and 200?mg and 800?mg tablet formulations. Drugs R D. 2005;6(5):253-0. CrossRef
    47. Almeida L, Potgieter JH, Maia J, et al. Pharmacokinetics of eslicarbazepine acetate in patients with moderate hepatic impairment. Eur J Clin Pharmacol. 2008;64(3):267-3. CrossRef
    48. Almeida L, Nunes T, Sicard E, et al. Pharmacokinetic interaction study between eslicarbazepine acetate and lamotrigine in healthy subjects. Acta Neurol Scand. 2010;121(4):257-4. CrossRef
    49. Falc?o A, Fuseau E, Nunes T, et al. Pharmacokinetics, drug interactions and exposure-response relationship of eslicarbazepine acetate in adult patients with partial-onset seizures: population pharmacokinetic and pharmacokinetic/pharmacodynamic analyses. CNS Drugs. 2012;26(1):79-1. CrossRef
    50. Maia J, Vaz-da-Silva M, Almeida L, et al. Effect of food on the pharmacokinetic profile of eslicarbazepine acetate (BIA 2-093). Drugs R D. 2005;6(4):201-. CrossRef
    51. Fontes-Ribeiro C, Macedo T, Nunes T, et al. Dosage form proportionality and food effect of the final tablet formulation of eslicarbazepine acetate: randomized, open-label, crossover, single-centre study in healthy volunteers. Drugs R D. 2008;9(6):447-4. CrossRef
    52. Nunes T, Rocha JF, Falc?o A, et al. Steady-state plasma and cerebrospinal fluid pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine in healthy volunteers. Epilepsia. 2013;54(1):108-6. CrossRef
    53. Falc?o A, Maia J, Almeida L, et al. Effect of gender on the pharmacokinetics of eslicarbazepine acetate (BIA 2-093), a new voltage-gated sodium channel blocker. Biopharm Drug Dispos. 2007;28(5):249-6. CrossRef
    54. Zhang C, Zuo Z, Kwan P, et al. In vitro transport profile of carbamazepine, oxcarbazepine, eslicarbazepine acetate, and their active metabolites by human P-glycoprotein. Epilepsia. 2011;52(10):1894-04. CrossRef
    55. Perucca E, Fauchoux N, Falc?o A, et al. In healthy subjects, concomitant use of carbamazepine with eslicarbazepine acetate can decrease exposure to eslicarbazepine: lack of pharmacokinetic effects of eslicarbazepine acetate on carbamazepine and its 10,11-epoxide metabolite confirms findings from clinical phase III studies (abstract no. p346). Epilepsia. 2011;52(Suppl 6):110.
    56. Nunes T, Sicard E, Almeida L, et al. Pharmacokinetic interaction study between eslicarbazepine acetate and topiramate in healthy subjects. Curr Med Res Opin. 2010;26(6):1355-2. CrossRef
    57. Falc?o A, Rocha JF, Pinto R, et al. Pharmacokinetic drug interaction study between eslicarbazepine acetate 1200?mg and phenytoin 300?mg: a phase I, open-label, multiple dose administration study in healthy volunteers (abstract no. P528). Epilepsia. 2013;54(Suppl 3):166.
    58. Falc?o A, Pinto R, Nunes T, et al. Effect of repeated administration of eslicarbazepine acetate on the pharmacokinetics of simvastatin in healthy subjects. Epilepsy Res. 2013;106(1-):244-. CrossRef
    59. Vaz-da-Silva M, Almeida L, Falc?o A, et al. Effect of eslicarbazepine acetate on the steady-state pharmacokinetics and pharmacodynamics of warfarin in healthy subjects during a three-stage, open-label, multiple-dose, single-period study. Clin Ther. 2010;32(1):179-2. CrossRef
    60. Vaz da Silva M, Costa R, Soares E, et al. Effect of eslicarbazepine acetate on the pharmacokinetics of digoxin in healthy subjects. Fundam Clin Pharmacol. 2009;23(4):509-4. CrossRef
    61. Falc?o A, Vaz-da-Silva M, Gama H, et al. Effect of eslicarbazepine acetate on the pharmacokinetics of a combined ethinylestradiol/levonorgestrel oral contraceptive in healthy women. Epilepsy Res. 2013;105(3):368-6. CrossRef
    62. Rocha J-F, Vaz-da-Silva M, Almeida L, et al. Effect of eslicarbazepine acetate on the pharmacokinetics of metformin in healthy subjects. Int J Clin Pharmacol Ther. 2009;47(4):255-1. CrossRef
    63. Vazquez B, Wechsler R, Rosenfeld W, et al. Co-administration of carbamazepine with eslicarbazepine acetate decreases eslicarbazepine exposure: a population pharmacokinetic analysis (abstract no. P3.243 plus poster). In: 66th American Academy of Neurology Annual Meeting, April 26–May 3 2014, Philadelphia, PA.
    64. Jacobson M, Gidal BE, Kharidia J, et al. Effects of concomitant antiepileptic drugs on eslicarbazepine acetate: a population pharmacokinetic analysis (poster no. 3.202). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    65. Elger C, Bialer M, Cramer JA, et al. Eslicarbazepine acetate: a double-blind, add-on, placebo-controlled exploratory trial in adult patients with partial-onset seizures. Epilepsia. 2007;48(3):497-04. CrossRef
    66. US Food and Drug Administration. Medical review(s) for application number 022416Orig1s000. 2013. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/022416Orig1s000TOC.cfm. Accessed 17 March 2014.
    67. Gil-Nagel A, Elger C, Ben-Menachem E, et al. Efficacy and safety of eslicarbazepine acetate as add-on treatment in patients with focal-onset seizures: integrated analysis of pooled data from double-blind phase III clinical studies. Epilepsia. 2013;54(1):98-07. CrossRef
    68. Biton V, Krauss G, Blum D, et al. Efficacy of eslicarbazepine acetate in patients with refractory partial-onset seizures: a pooled analysis of three phase III controlled studies (poster no. 2.127). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    69. Elger C, Steinhoff B, Serratosa J, et al. A post-hoc analysis of the time to onset of efficacy after initiation of eslicarbazepine acetate as adjunctive therapy in adult patients with refractory partial-onset seizures (abstract no. 1.230). Epilepsy Curr. 2013;13(Suppl 1):105-.
    70. Carre?o M, Ben-Menachem E, O’Brien TJ, et al. A post-hoc exploratory analysis of the effect of eslicarbazepine acetate as adjunctive treatment in adult patients with partial onset seizures and comorbid clinically relevant depressive symptoms (abstract no. 3.229). Epilepsy Curr. 2013;13(Suppl 1):422-.
    71. Chung S, Krauss G, Sperling M, et al. Efficacy of eslicarbazepine acetate in patients with refractory partial-onset seizures treated with or without concomitant carbamazepine: a pooled analysis of three phase III controlled studies (abstract no. P3.239 plus poster). In: 66th American Academy of Neurology Annual Meeting, 26 April- May 2014, Philadelphia, PA.
    72. Anastassopoulos KP, Velez F, Sousa R, et al. Impact of seizure frequency reduction on health-related quality of life among clinical trial subjects with refractory partial-onset seizures: a pooled analysis of phase III clinical trials of eslicarbazepine acetate (abstract no. P6.180 plus poster). In: 66th American Academy of Neurology Annual Meeting, 26 April- May 2014, Philadelphia, PA.
    73. Halász P, Cramer JA, Hodoba D, et al. Long-term efficacy and safety of eslicarbazepine acetate: results of a 1-year open-label extension study in partial-onset seizures in adults with epilepsy. Epilepsia. 2010;51(10):1963-. CrossRef
    74. Hufnagel A, Ben-Menachem E, Gabbai AA, et al. Long-term safety and efficacy of eslicarbazepine acetate as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy: results of a 1-year open-label extension study. Epilepsy Res. 2013;103(2-):262-. CrossRef
    75. Gil-Nagel A, Elger C, Ben-Menachem E, et al. Efficacy of eslicarbazepine acetate as adjunctive therapy of adult patients with partial-onset seizures up to one year of follow-up (abstract no. 1277). J Neurol Sci. 2013;333:e43. CrossRef
    76. Serrano-Castro PJ, Payan-Ortiz M, Cimadevilla JM, et al. Eslicarbazepine acetate in clinical practice: efficacy and safety results (in Spanish). Rev Neurol. 2013;56(6):309-4.
    77. Dias Correia F, Freitas J, Magalh?es R, et al. Two-year clinical experience with eslicarbazepine acetate in a tertiary hospital in Porto, Portugal (abstract no. P221). Epilepsia. 2013;54 Suppl 3:75.
    78. Keogh S, McDonald P, Lawthom C, et al. Safety and efficacy of eslicarbazepine acetate (Zebinix) in everyday clinical practice using a retrospective multicentre audit (abstract). J Neurol Sci. 2013;333(Suppl 1):e64. CrossRef
    79. Damodaran D, Rigby J, Cooper P, et al. Clinical effectiveness of eslicarbazepine acetate (Zebinex) as an add-on therapy in localization related epilepsy over 12?months (abstract no. 3.247). Epilepsy Curr. 2013;13(Suppl):430-.
    80. Massot A, Vivanco R, Principe A, et al. Post-authorisation study of eslicarbazepine as treatment for drug-resistant epilepsy: preliminary results (in Spanish). Neurologia. 2014;29(2):94-01. CrossRef
    81. Rogin J, Resnick T, Strom L, et al. Incidence of allergic reaction adverse events during adjunctive treatment with eslicarbazepine (abstract no. P3.241 and poster). In: 66th American Academy of Neurology Annual Meeting, 26 April- May 2014, Philadelphia, PA.
    82. Benbadis S, Biton V, Jacobsen M, et al. Safety of eslicarbazepine acetate in patients with refractory partial-onset seizures treated with or without concomitant carbamazepine: a pooled analysis of three phase III controlled studies (abstract no. P3-237 plus poster). In: 66th American Academy of Neurology Annual Meeting, 26 April- May 2014, Philadelphia, PA.
    83. Rogin JB, Abou.Khalil B, Blum D, et al. Eslicarbazepine acetate as adjunctive treatment for refractory partial-onset seizures: pooled analysis of safety data from three phase III controlled trials (poster no. 2.126). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    84. Krauss G, Biton V, Harvey JJ, et al. Adverse event profile of eslicarbazepine acetate according to dose titration in phase III controlled studies of patients with refractory partial-onset seizures (poster no. 3.208). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    85. Perucca E, Tomson T. The pharmacological treatment of epilepsy in adults. Lancet Neurol. 2011;10(5):446-6. CrossRef
    86. Ambrósio AF, Soares-da-Silva P, Carvalho CM, et al. Mechanisms of action of carbamazepine and its derivatives, oxcarbazepine, BIA 2-093, and BIA 2-024. Neurochem Res. 2002;27(1-):121-0. CrossRef
    87. Volosov A, Xiaodong S, Perucca E, et al. Enantioselective pharmacokinetics of 10-hydroxycarbazepine after oral administration of oxcarbazepine to healthy Chinese subjects. Clin Pharmacol Ther. 1999;66(6):547-3. CrossRef
    88. Elger C, Bialer M, Falc?o A, et al. Pharmacokinetics and tolerability of eslicarbazepine acetate and oxcarbazepine at steady state in healthy volunteers. Epilepsia. 2013;54(8):1453-1. CrossRef
    89. Novartis Pharmaceuticals UK Ltd. Trileptal (oxcarbazepine) film-coated tablets: UK summary of product characteristics. 2013. http://www.medicines.org.uk/emc/medicine/2673/SPC/Trileptal+150+mg%2c+300+mg%2c+600+mg+Film-coated+tablets/. Accessed 9 May 2014.
    90. Stephen LJ, Brodie MJ. Pharmacotherapy of epilepsy: newly approved and developmental agents. CNS Drugs. 2011;25(2):89-07. CrossRef
    91. Fattore C, Perucca E. Novel medications for epilepsy. Drugs. 2011;71(16):2151-8. CrossRef
    92. Chang XC, Yuan H, Wang Y, et al. Eslicarbazepine acetate add-on for drug-resistant partial epilepsy. Cochrane Database Syst Rev. 2011;12:CD008907.
    93. Bial—Portela C.S.A. Eslicarbazepine acetate (BIA 2 093) as therapy for refractory partial seizures in children (ClinicalTrials.gov identifier NCT00988156). US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT00988156. Accessed 7 Feb 2014.
    94. Sperling MR, Harvey J, Blum D, et al. Conversion to monotherapy with eslicarbazepine acetate in adults with partial-onset seizures: results of a North-American study (poster). In: 67th Annual American Epilepsy Society Meeting, 6-0 Dec 2013, Washington, DC.
    95. Bial—Portela C.S.A. Efficacy and safety of eslicarbazepine acetate as monotherapy for patients with newly diagnosed partial-onset seizures (ClinicalTrials.gov identifier NCT01162460). US National Institutes of Health, ClinicalTrials.gov. 2013. http://www.clinicaltrials.gov/ct2/show/NCT01162460. Accessed 7 Feb 2014.
    96. Nikolaos T, Stylianos G, Chryssoula N, et al. The effect of long-term antiepileptic treatment on serum cholesterol (TC, HDL, LDL) and triglyceride levels in adult epileptic patients on monotherapy. Med Sci Monit. 2004;10(4):MT50-2.
    97. Br?mswig S, Sudhop T, Luers C, et al. Lipoprotein(a) concentration increases during treatment with carbamazepine. Epilepsia. 2003;44(3):457-0. CrossRef
    98. Chuang YC, Chuang HY, Lin TK, et al. Effects of long-term antiepileptic drug monotherapy on vascular risk factors and atherosclerosis. Epilepsia. 2012;53(1):120-. CrossRef
    99. European Medicines Agency. Zebinix (eslicarbazepine acetate): EU CHMP assessment report. 2009. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/000988/WC500047229.pdf. Accessed 17 Jan 2014.
  • 作者单位:Gillian M. Keating (1)

    1. Adis, Level 1, 5 The Warehouse Way, Northcote 0627, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand
  • ISSN:1179-1934
文摘
Eslicarbazepine acetate (Aptiom?, Zebinix?) is approved for the adjunctive treatment of partial-onset seizures in adults aged ?8?years. Adjunctive therapy with oral eslicarbazepine acetate 800 or 1,200?mg once daily was associated with a significantly lower standardized seizure frequency (primary endpoint) than placebo in patients aged ?8?years with refractory partial-onset seizures in three, randomized, double-blind, multinational, phase III trials. In a fourth randomized, double-blind, multinational, phase III trial in patients aged ?6?years with refractory partial-onset seizures, adjunctive eslicarbazepine acetate 1,200?mg once daily, but not 800?mg once daily, was associated with a significantly lower standardized seizure frequency (primary endpoint). Responder rates were significantly higher with eslicarbazepine acetate 1,200?mg once daily than with placebo in these four trials, and with eslicarbazepine acetate 800?mg once daily than with placebo in two trials. The efficacy of eslicarbazepine acetate was maintained in the longer term, according to the results of 1-year extension studies. Adjunctive therapy with oral eslicarbazepine acetate was generally well tolerated in patients with refractory partial-onset seizures, with most adverse events being of mild to moderate severity. In conclusion, eslicarbazepine acetate is a useful option for the adjunctive treatment of patients with refractory partial-onset seizures.

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