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
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.
Keywords
About the Authors
P. N. VlasovRussian Federation
Pavel Nikolaevich Vlasov.
20, Delegatskaya St., Build. 1, Moscow 127473.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
V. A. Karlov
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
I. A. Zhidkova
Russian Federation
20, Delegatskaya St., Build. 1, Moscow 127473.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
D. V. Dmitrenko
Russian Federation
1, Partisan Zheleznyak St., Krasnoyarsk 660022.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
I. G. Rudakova
Russian Federation
61/2, Shchepkin St., Moscow 129110.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
T. V. Danilova
Russian Federation
49, Butlerov St., Kazan 420012.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
V. A. Kalinin
Russian Federation
89, Chapaevskaya St., Samara 443099.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
O. V. Grebenyuk
Russian Federation
2, Moskovsky High Road, Tomsk 634050.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
A. P. Gertsen
Russian Federation
43/5, Noyabrskaya St., Orenburg 460050.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
Ya. S. Zhuravlev
Russian Federation
2, Maisky Lane, Staritsa, Orenburg District, Orenburg Region 460551.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
A. Yu. Karas
Russian Federation
151/8, Bolshaya Sadovaya St., Saratov 410071.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
E. N. Paramonova
Russian Federation
186/1, Krasnyi Prospect, Novosibirsk 630049.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
I. V. Ponomareva
Russian Federation
287, Pobeda Prospect, Chelyabinsk 454021.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
O. I. Miguskina
Russian Federation
23, Tankists St., Novosibirsk 630120.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
N. A. Sobyanina
Russian Federation
85, Pushkin St., Perm 641990.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
D. V. Sukhova
Russian Federation
35, Repin St., Izhevsk 426035.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
Yu. V. Salomatin
Russian Federation
43, Donskaya St., Moscow 115419.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
M. L. Ertakhova
Russian Federation
79, Lenin St., Izhevsk 426009.
Competing Interests: The conflict of interest has not affected the results of the investigation.
T. M. Goguadze
Russian Federation
9i, Obvodnoi Kanal Embankment, Saint Petersburg 191167.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
A. P. Shamray
Russian Federation
19, Lugovaya St., Barnaul 656056.
Competing Interests:
The conflict of interest has not affected the results of the investigation.
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Review
For citations:
Vlasov PN, Karlov VA, Zhidkova IA, Dmitrenko DV, Rudakova IG, Danilova TV, Kalinin VA, Grebenyuk OV, Gertsen AP, Zhuravlev YS, Karas AY, Paramonova EN, Ponomareva IV, Miguskina OI, Sobyanina NA, Sukhova DV, Salomatin YV, Ertakhova ML, Goguadze TM, Shamray AP. A Russian retrospective multicenter open-label observational study based on medical documentation on the use of perampanel in everyday clinical practice. Nevrologiya, neiropsikhiatriya, psikhosomatika = Neurology, Neuropsychiatry, Psychosomatics. 2020;12(3):47-55. https://doi.org/10.14412/2074-2711-2020-3-47-55