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A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice

https://doi.org/10.14412/2074-2711-2020-3-47-55

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Abstract

Objective: to retrospectively assess the Russian experience with perampanel (PER) in everyday clinical practice as an adjunctive medication for the treatment of patients aged 12 years or older with focal epilepsy (FE).

Patients and methods. A multicenter retrospective study was conducted, during which the physicians filled out standard questionnaires assessing the characteristics of the disease and the therapy performed. The maximum follow-up period was 12 months. Each patient was included in the study only once for the duration of the study. A total of 164 cases of pharmacoresistant FE were analyzed. The patients' mean age was 37.7 years; the male to female ratio was 1:1. The disease duration over 10 years was in 68.7% of patients; structural epilepsy was present in 68.2% (temporal and frontal lesions in 53.4 and 39.1%, respectively)

Results and discussion. Most (26.6%) patients were prescribed PER after three previous lines of therapy; before PEP administration, there was a maximum of 2 (50.9%) and 3 (29.6%) drugs, respectively, in the combination. The initial frequency of all seizure types reached 9 [3; 34] per month; that of focal-onset bilateral tonic-clonic seizures was 3 [2; 6] per month. Combined therapy including PER could lead to the disappearance of seizures in 22.7% of cases; the responders (by all seizure types) were 52.8%, whereas the remission rate of bilateral tonic-clonic seizures was 60.8% of patients, the responder rate was 27,8%. At 12 months of follow-up, the therapy retention rate reached 80.7% (95% confidence interval, 72.3—89.1). Adverse events (AEs) were noted in 31.3% of patients; the most frequent AEs were drowsiness (10.4%), aggression (9.8%), irritability (6.7%); other AEs were observed in individual cases. The average dose of PER was 8 mg.

Conclusion. PER was effective in patients with resistant PEs at a maximum follow-up of 12 months in routine clinical practice. Remission of all seizure types was achieved in 22.7% of cases, the decrease in the number of seizures >50% was seen in 52.8% of cases; the therapy retention rate was 80.7%. The drug had a therapeutic effect in all types of focal seizures and was most effective in focal-onset bilateral tonic-clonic seizures. Along with its good clinical effect, PER demonstrated a predictable safety profile.

About the Authors

P. N. Vlasov
A.I. Evdokimov Moscow State University of Medicine and Dentistry, Ministry of Health of Russia
Russian Federation

Pavel Nikolaevich Vlasov.

20, Delegatskaya St., Build. 1, Moscow 127473.



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.



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.



D. V. Dmitrenko
Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University, Ministry of Health of Russia
Russian Federation

1, Partisan Zheleznyak St., Krasnoyarsk 660022.



I. G. Rudakova
M.F. Vladimirsky Moscow Regional Clinical Research Institute
Russian Federation

61/2, Shchepkin St., Moscow 129110.



T. V. Danilova
Kazan State Medical University, Ministry of Health of Russia
Russian Federation

49, Butlerov St., Kazan 420012.



V. A. Kalinin
Samara State Medical University, Ministry of Health of Russia
Russian Federation

89, Chapaevskaya St., Samara 443099.



O. V. Grebenyuk
Siberian State Medical University, Ministry of Health of Russia
Russian Federation

2, Moskovsky High Road, Tomsk 634050.



A. P. Gertsen
OOO «Epilepsy 56»
Russian Federation

43/5, Noyabrskaya St., Orenburg 460050.



Ya. S. Zhuravlev
Orenburg Regional Clinical Mental Hospital Two
Russian Federation

2, Maisky Lane, Staritsa, Orenburg District, Orenburg Region 460551.



A. Yu. Karas
OOO «Epineuro»
Russian Federation

151/8, Bolshaya Sadovaya St., Saratov 410071.



E. N. Paramonova
OOO «Algorithm», Center of Epilepsy and Paroxysmal States
Russian Federation

186/1, Krasnyi Prospect, Novosibirsk 630049.



I. V. Ponomareva
Regional Clinical Hospital Three
Russian Federation

287, Pobeda Prospect, Chelyabinsk 454021.



O. I. Miguskina
City Clinical Hospital Eleven
Russian Federation

23, Tankists St., Novosibirsk 630120.



N. A. Sobyanina
Perm Territorial Clinical Hospital
Russian Federation

85, Pushkin St., Perm 641990.



D. V. Sukhova
Sergey Berezin Medical Institute
Russian Federation

35, Repin St., Izhevsk 426035.



Yu. V. Salomatin
Z.P. Solovyev Research and Practical Psychoneurology Center, Moscow Healthcare Department
Russian Federation

43, Donskaya St., Moscow 115419.



M. L. Ertakhova
Republican Children's Clinical Hospital, Ministry of Health of the Udmurt Republic
Russian Federation

79, Lenin St., Izhevsk 426009.



T. M. Goguadze
City Mental Hospital Six, City Epileptology Center
Russian Federation

9i, Obvodnoi Kanal Embankment, Saint Petersburg 191167.



A. P. Shamray
Yu.K. Erdman Altai Territorial Clinical Mental Hospital
Russian Federation

19, Lugovaya St., Barnaul 656056.



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For citation:


Vlasov P.N., Karlov V.A., Zhidkova I.A., Dmitrenko D.V., Rudakova I.G., Danilova T.V., Kalinin V.A., Grebenyuk O.V., Gertsen A.P., Zhuravlev Y.S., Karas A.Yu., Paramonova E.N., Ponomareva I.V., Miguskina O.I., Sobyanina N.A., Sukhova D.V., Salomatin Y.V., Ertakhova M.L., Goguadze T.M., Shamray A.P. A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice. Neurology, Neuropsychiatry, Psychosomatics. 2020;12(3):47-55. (In Russ.) https://doi.org/10.14412/2074-2711-2020-3-47-55

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ISSN 2074-2711 (Print)
ISSN 2310-1342 (Online)