Assessing efficacy and tolerability of lamotrigine (Sazar®) in therapy of female idiopathic generalized epilepsy: a multicenter study

Abstract

Background. Idiopathic generalized epilepsy (IGE) comprises 15–20% among all types of epilepsy. However, specifics of administration for lamotrigine in IGE in the Russian Federation remain poorly investigated, especially in female subjects.Objective: to assess efficacy and potential adverse events (AEs) in girls and females with preserved childbearing potential and verified IGE upon initial treatment with lamotrigine, upon switching to lamotrigine from a first-antiepileptic drug (AED) that provided no full seizure control and/or was coupled to AEs, as well as while introducing lamotrigine as an adjunctive therapy in case a monotherapy achieved no therapeutic efficacy.Material and methods. There were enrolled 54 female patients aged 4 to 40 years (mean age 19.3 years, median 11 years). After verifying IGE, patients received a monotherapy with lamotrigine. In case a patient received a first monotherapy course, but achieved no full seizure control and/or was coupled to AEs due to administered AED, lamotrigine was prescribed as a second AED followed by a potential for further switch to a second monotherapy.Results. It was found that a first monotherapy resulted in the maximum remission rate in patients with isolated generalized tonic-clonic seizures. Lamotrigine efficiently suppressed EEG epiactivity, with observed EEG-remission in 8 out of 16 (50%) patients. While being administered as a second monotherapy, lamotrigine resulted in remission in 87.5% patients. A combination therapy with lamotrigine was required in 22 cases. Most commonly, it was combined with levetiracetam (15 patients). While administering a dual therapy with lamotrigine, remission was observed in 9 patients receiving basal therapy with this drug, as well as 3 and 1 patients receiving valproic acid and topiramate, respectively. Six more patients were observed to demonstrate more than 50% improvement (5 subjects in levetiracetam group and 1 in ethosuximide group).Conclusions. The study demonstrated high efficacy of administered lamotrigine as a first monotherapy as well as a second monotherapy and a combination therapy in girls, adolescent girls and females with IGE. Lamotrigine resulted in no serious AEs that might lead to its cancellation.