Effectiveness and tolerability of perampanel in сhildren and adolescents (own experience of Svt. Luka’s Institute of Child Neurology and Epilepsy)
| Autor: | K. Y. Mukhin, O. A. Pylaeva, M. Y. Bobylova |
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| Jazyk: | ruština |
| Rok vydání: | 2022 |
| Předmět: | |
| Zdroj: | Русский журнал детской неврологии, Vol 16, Iss 4, Pp 8-30 (2022) |
| Druh dokumentu: | article |
| ISSN: | 2073-8803 2412-9178 |
| DOI: | 10.17650/2073-8803-2021-16-4-8-30 |
| Popis: | Despite the significant advances in epileptology, including various new effective treatments for drug-resistant epilepsy in children, there is still a relatively large proportion of patients ineligible for surgery and alternative treatments (such as vagus nerve stimulation and ketogenic diet). Drug-resistant epilepsy accounts for approximately 30 % of all forms of epilepsy and is particularly common among patients with focal seizures. The search for new antiepileptic drugs (AEDs) is critical for these patients.Perampanel (Fycompa®, Eisai) is a novel AED that employs a fundamentally different mechanism of action compared to existing AEDs. Perampanel is a powerful highly selective non-competitive postsynaptic AMPA receptor antagonist acting at the level of neocortex and in the hippocampus. Phase III clinical trials demonstrated its high efficacy and good tolerability in patients with drug-resistant focal seizures. Randomized placebo-controlled trials assessing the efficacy of perampanel as add-on therapy showed that perampanel at a dose of 4–12 mg/day significantly reduced the frequency of focal seizures in patients with drug-resistant epilepsy along with a good safety and tolerability profile.Open-label observational studies and studies analyzing long-term therapy also demonstrated high efficacy and safety of long-term treatment with perampanel (up to 3 years), as well as good retention rate. The drug has a once-daily dosing schedule, which is very comfortable for patients.In 2012, perampanel (Fycompa®) was approved for epilepsy patients in the USA and Europe. In 2013, it was approved in Russia as an add-on therapy for patients aged 12 years and older with focal and secondary generalized seizures. On 29.06.2015, it was also approved for polytherapy of generalized tonic-clonic seizures in patients aged 12 years and older with idiopathic generalized epilepsy.On 07.12.2020, perampanel was approved for children aged 4 years and older (body weight >30 kg) as a part of polytherapy for focal and secondary generalized seizures and for children aged 7 years and older with idiopathic generalized epilepsy as a part of polytherapy for generalized tonic-clonic seizures.Currently, there is limited evidence of perampanel efficacy in children in Russia.The study aimed to evaluate the efficacy and tolerability of perampanel in children (aged 4–11 years) and adolescents (aged 12–18 years) with epilepsy treated and followed-up at Svt. Luka’s Institute of Child Neurology and Epilepsy.Materials and methods. This study included 136 patients (aged 4–18 years; 75 males and 61 females) who received perampanel and were followed-up for at least 6 months at our institution. Patients were divided into two groups: children (aged 4–11 years; n = 105) and adolescents (aged 12–18 years; n = 31).The following types of epilepsy were diagnosed in study participants: structural focal epilepsy (n = 60), genetic epilepsy (n = 61; including Dravet syndrome, Angelman syndrome, Lafora disease, mutations in the PCDH19, PHACTR1, CDKL5, ARX, PING, SCN2A, KIAA2022 genes, chromosome microdeletions, etc.), focal epilepsy of unknown etiology (n = 12), idiopathic epilepsy (n = 3). In all cases, perampanel was used as an additional AED, often in combination with valproic acid. Dose adjustment was performed according to the package insert (by increments of 2 mg either weekly or every 2 weeks) up to a therapeutic dose of 4–12 mg/day at bedtime.Results. In children (aged 4–11 years; n = 105), seizure remission was achieved in 29 cases (27.6 %). Fifty-five children (52.4 %) had ≥50 % efficacy, whereas 17 children (16.2 %) had |
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