Pharmacoepidemiology of antiepileptic drugs in children

With the pharmacotherapy of epilepsy, there is a decrease in the number of seizures or their complete cessation. The aim of the study was to conduct a comparative analysis of the efficacy and safety of antiepileptics traditionally used in medicine (valproate, carbamazepine) and new-generation analogs (topiramate) in the treatment of epilepsy in children and adolescents. The study was conducted in 2014 and 2018, at the Center for Epileptology and Neurology, Moscow (Russian Federation). In 2014, 777 medical records of children registered with epileptologists were studied, in 2018 - 840 medical records of children. The age interval of 3 months is 18 years. Favorable outcomes of epilepsy therapy with different drugs were calculated, with different approaches monotherapy and polytherapy. A favorable outcome meant remission, which lasted more than 1 year and more than 3 years. In 2014 and 2018, monotherapy prevailed among the treatment methods. With monotherapy, valproates are used more often (up to 70%), carbamazepine is used 3.0 times less often (p ≤ 0.01 relative to valproates). The use of topiramate is 10 times less than the number of valproate therapy (p ≤ 0.0001), and barbiturates - 15 times (p ≤ 0.0001). Among the new generation drugs, topiramate was often used, with monotherapy, with symptomatic forms of epilepsy (10.4% in 2014 and 7.9% in 2018, p ≤ 0.05), as well as with a cryptogenic form (9.6% and 4.4%, respectively, p ≤ 0.05). The chosen type of therapy can significantly affect the number of side effects. With polytherapy, in 2014, side effects were observed in 44.1% compared with monotherapy (18.1%, at p ≤ 0.01), in 2018 - 45.1% against 20.9% (at p ≤ 0.01). Topiramate showed lower efficacy compared with carbamazepine in all years of the study with monotherapy (0.65, at p ≤ 0.04). The results did not confirm the effectiveness of the new drugs. There was no difference in efficacy and safety between traditional drugs (valproate, carbamazepine) and new generation drugs (topiramate and others). In 2014 and 2018, monotherapy (72.8%) over polytherapy (27.2%) prevailed among the treatment methods for epilepsy. Among the drugs, valproate was predominant (65.8%), and in all identified forms of epilepsy. The new generation of drugs did not show statistically significant advantages compared to traditionally used ones. The method of polytherapy of epilepsy in children gives a twofold increase in the likelihood of side effects (p ≤ 0.01). © 2021 Journal of Pharmaceutical Negative Results.