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An open-label prospective clinical study of the efficacy and tolerability of brand-name and generic levetiracetam in the monotherapy of focal epilepsy in adults

https://doi.org/10.14412/2074-2711-2018-1S-12-17

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Abstract

Objective: to comparatively evaluate the clinical efficacy and tolerability of monotherapy with levetiracetam (LEV), a brand-name drug (bLEV; Keppra, UCB Pharma, Belgium) and its generic (gLEV;  Epiterra, TEVA, Israel) in adolescent (over 16 years of age) and adult patients with focal epilepsy (FE) during a one-year follow-up period.

Patients and methods. The patients were divided into two groups: 1) bLEV (n = 143) and 2) gLEV (n = 63). Group 2 received monotherapy with gLEV at baseline, or was switched to it from  another drug within the international nonproprietary name, or to LEV from monotherapy with another antiepileptic drug (AED) due to  inefficiency and/or poor tolerability. The median doses of bLEV and  gLEV were 1000 and 1500 mg/day, respectively.

Results and discussion. The results of the clinical trial suggest that LEV shows high efficacy and excellent tolerance in FE therapy. The clinical efficacy of bLEV and gLEV at 12-month follow-up was  high and amounted to 82.5% for the two dosage forms. The  frequency of adverse events was 17.5% for both bLEV and gLEV. The median dose of LEV was 1000 mg/day for Group 1 and 1500 mg/day for Group 2. Higher LEV doses in Group 2 patients were probably  due to their longer disease duration. All patients taking LEV had an  excellent or good quality of life and, when switched from other AEDs,  showed even an improvement. The comparability of clinical  results suggests that there may be bLEV to gLEV and gLEV to bLEV  switches, especially during forced drug supply disruptions; however,  this substitution should be done only after mandatorily discussing  this matter with the patient and telling him about all possible  consequences of this substitution. 

About the Authors

V. A. Karlov
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473


P. N. Vlasov
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473


I. A. Zhidkova
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473


References

1. 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;54(3):551-63. doi: 10.1111/epi.12074

2. Власов ПН, Карлов ВА, Камелькова ЕГ. Результаты монотерапии леветирацетамом парциальной эпилепсии у взрослых. Журнал невропатологии и психиатрии. 2010; (11):15- 20 [Vlasov PN, Karlov VA, Kamel'kova EG. Results of monotherapy of levetiracetam of partial epilepsy in adults. Zhurnal Nevropatologii i Psikhiatrii. 2010;(11):15-20 (In Russ.)].

3. Карлов ВА. Эпилепсия у детей и взрослых, женщин и мужчин. Москва: Медицина; 2010. 718 с. [Karlov VA. Epilepsiya u detey i vzroslykh, zhenshchin i muzhchin [Epilepsy in children and adults, women and men]. Moscow: Meditsina; 2010. 718 p. (In Russ.)].

4. Карлов ВА, Власов ПН, Камелькова ЕГ, Шахабасова ЗС. Длительная монотерапия леветирацетамом парциальной эпилепсии у взрослых. Неврология, нейропсихиатрия психосоматика. 2012;(cпецвыпуск 1):43-7 [Karlov VA, Vlasov PN, Komelkova EG, Shakhabasova ZS. Long-term levetiracetam monotherapy for partial epilepsy in adults. Nevrologiya, Neyropsikhiatriya, Psikhosomatika = Nevrology, Neiropsikhiatry, Psikhosomatiks. 2012;4(1S):43-7 (In Russ.)]. doi: 10.14412/2074-2711-2012-2498

5. Johannessen Landmark C, Patsalos PN. Drug interactions involving the new secondand third generation antiepileptic drugs. Expert Rev Neurother. 2010;10:119-40. doi: 10.1586/ern.09.136

6. Карлов ВА, Авакян ГН, Калинин ВВ и др. Псевдофармакорезистентность эпилепсии – современное состояние, проблемы и пути решения. Заключение совета экспертов по эпилептологии. Эпилепсия и пароксизмальные состояния. 2015;(1):69 [Karlov VA, Avakyan GN, Kalinin VV, et al. Pseudopharmacoresistance of epilepsy – the current state, problems and solutions. Conclusion of the Council of Experts on Epileptology. Epilepsiya i Paroksizmal'nye Sostoyaniya. 2015;(1):69 (In Russ.)].

7. Multisource (Generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish Interchangeability. WHO Technical Report Series. 2006;937 Ann 7:347-90.

8. Федеральный закон «Об обращении лекарственных средств» №61-ФЗ от 12.04.2010 (ред. от 03.07.2016) [The Federal Law "On the circulation of medicinal products" No. 61-ФЗ of 12.04.2010 (as amended on 03.07.2016)].

9. Карлов ВА, Власов ПН, Хабибова АО. Возможности формализованых методов в объективизации динамики тяжести течения эпилепсии. Неврологический вестник (Казань). 1998;29(1-2):30-3 [Karlov VA, Vlasov PN, Khabibova AO. Possibilities of formalized methods in the objectivization of the dynamics of the severity of epilepsy. Nevrologicheskiy Vestnik (Kazan'). 1998;29(1-2):30-3 (In Russ.)].

10. Trinka E, Marson AG, van Paesschen W, et al.; KOMET Study Group. KOMET: an unblinded, randomised, two parallel-group, stratified trial comparing the effectiveness of levetiracetam with controlled-release carbamazepine and extended-release sodium valproate as monotherapy in patients with newly diagnosed epilepsy. J Neurol Neurosurg Psychiatry. 2013;84(10):1138-47. doi: 10.1136/jnnp-2011-300376

11. Карлов ВА, Власов ПН, Жидкова ИА. Предварительные результаты эффективности генерического препарата леветирацетама (эпитерра) в монотерапии эпилепсии у взрослых пациентов. Неврология, нейропсихиатрия, психосоматика. 2015;(спецвыпуск 1):36-40 [Karlov VA, Vlasov PN, Zhidkova IA. Efficacy of generic levetiracetam (epiterra) in monotherapy for epilepsy in adult patients: Preliminary results. Nevrologiya, Neyropsikhiatriya, Psikhosomatika = Nevrology, Neiropsikhiatry, Psikhosomatiks. 2015; (1S):36- 40 (In Russ.)]. doi: 10.14412/2074-2711-2015-1S-36-40

12. Hagemann A, May TW, Nieder E, et al. Quality of life, anxiety and depression in adult patients after add-on of levetiracetam and conversion to levetiracetam monotherapy. Epilepsy Res. 2013;104(1-2):140-50. doi: 10.1016/j.eplepsyres.2012.08.005

13. Markoula S, Chatzistefanidis D, Gatzonis S, et al. Brand-to-generic levetiracetam switch in patients with epilepsy in a routine clinical setting. Seizure. 2017;48:1-6. doi: 10.1016/j.seizure.2017.03.012

14. Зырянов СК, Фитилев СБ, Шкребнева ИИ, Возжаев АВ. Взаимозаменяемость препаратов – клиническая эффективность, безопасность. Неврология, нейропсихиатрия, психосоматика. 2017;(спецвыпуск 1):4-10 [Zyryanov SK, Fitilev SB, Shkrebneva II, Vozzhaev AV. Drug interchangeability: Clinical efficacy and safety. Nevrologiya, Neiropsikhiatriya, Psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2017;(1S):4-10 (In Russ.)]. doi: 10.14412/2074-2711-2017-1S-4-10

15. Privitera MD, Welty TE, Gidal BE, et al. Generic-to-generic lamotrigine switches in people with epilepsy: the randomised controlled EQUIGEN trial. Lancet Neurol. 2016;15(4):365-72. doi: 10.1016/S1474-4422(16)00014-4

16. Рудакова И.Г., Белова Ю.А. Эффективность лечения эпилепсии в Московской области в современных условиях лекарственного обеспечения. Неврология, нейропсихиатрия, психосоматика. 2015;7(3):10-4 [Rudakova IG, Belova YuA. Efficiency of epilepsy treatment in the Moscow Region under the present-day conditions of drug provision. Nevrologiya, Neyropsikhiatriya, Psikhosomatika = Nevrology, Neiropsikhiatry, Psikhosomatiks. 2015;7(3):10-4 (In Russ.)]. doi: 10.14412/2074-2711-2015-3-10-14

17. Antiepileptic drugs: new advice on switching between different manufacturers’ products for a particular drug. Available from: www.gov.uk/


For citation:


Karlov V.A., Vlasov P.N., Zhidkova I.A. An open-label prospective clinical study of the efficacy and tolerability of brand-name and generic levetiracetam in the monotherapy of focal epilepsy in adults. Neurology, Neuropsychiatry, Psychosomatics. 2018;10(1S):12-17. (In Russ.) https://doi.org/10.14412/2074-2711-2018-1S-12-17

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ISSN 2074-2711 (Print)
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