Oxcarbazepine as the initial monotherapy of focal epilepsy in adolescents and adults
https://doi.org/10.14412/2074-2711-2021-3-67-74
Abstract
Oxcarbazepine (OXC) is an antiepileptic drug (AED) used in children and adults as initial and adjunctive therapy for focal epilepsy (FE). It has been used in Russia since 2007; however, only a few studies have been published on its use in Russian patients to date.
Objective: to assess the effectiveness and tolerability of OXC as initial therapy for FE in adults and adolescents, as well as to study epileptiform activity index (EAI) changes during treatment and its relationship with treatment effectiveness and tolerability.
Patients and methods. We evaluated treatment effectiveness and tolerability and EAI in 89 adults with newly diagnosed FE aged 15–75 years for 12 months. Patients were divided into three subgroups according to the OXC treatment regimen. Side Effects of Anti-Epileptic Drugs (SIDAED) scale was used to assess treatment tolerability. Retention rate and seizure frequency changes were used to evaluate treatment effectiveness. EAI changes were assessed with video electroencephalography monitoring (4–24 h) during each visit (baseline, after 1, 3, 6, and 12 months).
Results and discussion. The retention rate in patients on OXC monotherapy after 12 months was 71.9%, almost one-half of them (46.1%) achieved sustained remission. More than half of patients (52.9%) were prescribed 1200 mg/day of OXC, 12.3% – <1200 mg/day, and only in 6.7% of patients the dose exceeded 1200 mg/day. Side effects were observed in 9% of the cases. A 2.54-fold reduction in mean EAI index was observed during follow-up representing treatment effectiveness.
Conclusion. OXC, as the initial AED for FE, has demonstrated high treatment effectiveness and tolerability. In addition, total EAI 2.5-fold reduction allows its usage as an additional quantitative marker of OXC treatment effectiveness.
About the Authors
T. N. PushkarRussian Federation
20, Delegatskaya St., Build. 1, Moscow 127473
A. M. Azhigova
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473
P. N. Vlasov
Russian Federation
Pavel Nikolaevich Vlasov
20, Delegatskaya St., Build. 1, Moscow 127473
A. B. Kozhokaru
Russian Federation
23, Marshala Novikova St., Moscow 123098
References
1. Annegers JF, Dubinsky S, Coan SP, et al. The incidence of epilepsy and unprovoked seizures in multiethnic, urban health maintenance organizations. Epilepsia. 1999 Apr;40(4):502-6. doi: 10.1111/j.1528-1157.1999.tb00748.x
2. Hirtz D, Thurman DJ, Gwinn-Hardy K, et al. How common are the «common» neurologic disorders? Neurology. 2007 Jan 30;68(5):326-37. doi: 10.1212/01.wnl.0000252807.38124.a3
3. Sander JW, Shorvon SD. Epidemiology of the epilepsies. J Neurol Neurosurg Psychiatry. 1996 Nov;61(5):433-43. doi: 10.1136/jnnp.61.5.433
4. Karlov VA. Epilepsiya u detey i vzroslykh zhenshchin i muzhchin [Epilepsy in children and adult women and men]. Moscow: Binom; 2019 (In Russ.).
5. Kalilani L, Sun X, Pelgrims B, et al. The epidemiology of drug-resistant epilepsy: A systematic review and meta-analysis. Epilepsia. 2018 Dec;59(12):2179-93. doi: 10.1111/epi.14596. Epub 2018 Nov 13.
6. Kwan P, Brodie MJ. Epilepsy after the first drug fails: substitution or add-on? Seizure. 2000 Oct;9(7):464-8. doi: 10.1053/seiz.2000.0442
7. Glauser T, Ben-Menachem E, Bourgeois B, et al. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013 Mar;54(3):551- 63. doi: 10.1111/epi.12074. Epub 2013 Jan 25.
8. Santulli L, Coppola A, Balestrini S, Striano S. The challenges of treating epilepsy with 25 antiepileptic drugs. Pharmacol Res. 2016 May;107:211-9. doi: 10.1016/j.phrs.2016.03.016. Epub 2016 Mar 16.
9. Belousova ED, Mukhin KYu, Yermolenko NA, et al. Efficiency and safety of monotherapy with trileptal (oxcarbazepine) in children and adolescents. Zhurnal nevrologii i psikhiatrii im. C.C. Korsakova. 2010;110(5):45-50 (In Russ.).
10. Geng H, Wang C. Efficacy and safety of oxcarbazepine in the treatment of children with epilepsy: a meta-analysis of randomized controlled trials. Neuropsychiatr Dis Treat. 2017 Mar 2;13:685-95. doi: 10.2147/NDT.S130269. eCollection 2017.
11. Mukhin KYu, Pylayeva OA, Borodin RA, Mukhina LN. Comparative efficаcy and tolerability of monotherapy with Depakine chronosphere, drugs of carbamazepine group with extended release and oxcarbazepine in symptomaticand cryptogenic focal epilepsy (Svt. Luka’s Institute of Child Neurology and Epilepsy). Russkiy zhurnal detskoy nevrologii. 2015;10(1):4-15 (In Russ.).
12. Petrukhin AS, Voronkova KV, Belousova ED, et al. Assessment of efficacy, tolerability and safety of Trileptal® monotherapy in children with focal epilepsy. Prospective open multicentric 24-week study. Russkiy zhurnal detskoy nevrologii. 2009;4(1):14-25 (In Russ.).
13. Burd SG, Glukhova LIu, Badalian OL. Efficacy and safety of the mono- and combined therapy with oxcarbazepine in adult patients. Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova. 2010;110(6):66-9 (In Russ.).
14. Zenkov LR. The role of oxcarbazepine in the treatment of epilepsy. Consilium medicum. 2005;7(8):710-4 (In Russ.).
15. Kanner AM, Ashman E, Gloss D, et al. Practice guideline update summary: Efficacy and tolerability of the new antiepileptic drugs II: Treatment-resistant epilepsy: Report of the American Epilepsy Society and the Guideline Development, Dissemination, and Implementation Subcommittee of the American Academy of Neurology. Epilepsy Curr. Jul-Aug 2018;18(4):269-78. doi: 10.5698/1535-7597.18.4.269
16. Vlasov PN, Molochkova VV. The use of oxcarbazepine (trileptal) in young epileptic women. Zhurnal nevrologii i psikhiatrii im. S.S. Korsakova. 2009;(6):72-5 (In Russ.).
17. Fisher RS, Acevedo C, Arzimanoglou A, et al. A practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
18. Uijl SG, Uiterwaal CSMP, Aldenkamp AP, et al. A cross-sectional study of subjective complaints in patients with epilepsy who seem to be well-controlled with anti-epileptic drugs. Seizure. 2006 Jun;15(4):242-8. doi: 10.1016/j.seizure.2006.02.009. Epub 2006 Mar 23.
19. Marson AG, Appleton R, Baker GA, et al. A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial. Health Technol Assess. 2007 Oct;11(37):iii-iv, ix-x, 1- 134. doi: 10.3310/hta11370
20. Koch MW, Polman SKL. Oxcarbazepine versus carbamazepine monotherapy for partial onset seizures. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD006453. doi: 10.1002/14651858.CD006453.pub2
21. Schachter SC, Vazquez B, Fisher RS, et al. Oxcarbazepine: double-blind randomized, placebo-controlled, monotherapy trial for partial seizures. Neurology. 1999 Mar 10;52(4):732-7. doi: 10.1212/wnl.52.4.732
22. French JA, Baroldi P, Brittain ST, Johnson JK. Efficacy and safety of extendedrelease oxcarbazepine (Oxtellar XRTM) as adjunctive therapy in patients with refractory partial-onset seizures: a randomized controlled trial. Acta Neurol Scand. 2014 Mar;129(3):143- 53. doi: 10.1111/ane.12207. Epub 2013 Dec 21.
23. Bill PA, Vigonius U, Pohlmann H, et al. A double-blind controlled clinical trial of oxcarbazepine versus phenytoin in adults with previously untreated epilepsy. Epilepsy Res. 1997 Jun;27(3):195-204. doi: 10.1016/s0920-1211(97)00024-7
24. Christe W, Kramer G, Vigonius U, et al. A double-blind controlled clinical trial: oxcarbazepine versus sodium valproate in adults with newly diagnosed epilepsy. Epilepsy Res. 1997 Mar;26(3):451-60. doi: 10.1016/s0920-1211(96)01013-3
25. Bonnett L, Smith CT, Smith D, et al. Prognostic Factors for Time to Treatment Failure and Time to 12 Months of Remission for Patients With Focal Epilepsy: Post-Hoc, Subgroup Analyses of Data From the SANAD Trial. Lancet Neurol. 2012 Apr;11(4):331-40. doi: 10.1016/S1474-4422(12)70018-2. Epub 2012 Feb 28.
26. Pauletto G, Bergonzi P. Oxcarbazepine reduces seizure frequency in a high proportion of patients with both newly diagnosed and refractory partial seizures in clinical practice. Seizure. 2006 Apr;15(3):150-5. doi: 10.1016/j.seizure.2005.12.008. Epub 2006 Jan 24.
27. Martinez W, Ingenito A, Blakeslee M, et al. Efficacy, safety, and tolerability of oxcarbazepine monotherapy. Epilepsy Behav. 2006 Nov;9(3):448-56. doi: 10.1016/j.yebeh.2006.04.022. Epub 2006 Sep 7.
28. Dogan EA, Usta BE, Bilgen R, et al. Efficacy, tolerability, and side effects of oxcarbazepine monotherapy: a prospective study in adult and elderly patients with newly diagnosed partial epilepsy. Epilepsy Behav. 2008 Jul;13(1):156-61. doi: 10.1016/j.yebeh.2008.02.001. Epub 2008 Mar 10.
29. Novartis. Oxcarbazepine. Data on file. Basle; 1998.
30. Berghuis B, van der Palen J, de Haan G-J, et al. Carbamazepine- and oxcarbazepineinduced hyponatremia in people with epilepsy. Epilepsia. 2017 Jul;58(7):1227-33. doi: 10.1111/epi.13777. Epub 2017 May 24.
Review
For citations:
Pushkar TN, Azhigova AM, Vlasov PN, Kozhokaru AB. Oxcarbazepine as the initial monotherapy of focal epilepsy in adolescents and adults. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2021;13(3):67-74. (In Russ.) https://doi.org/10.14412/2074-2711-2021-3-67-74