Estudio retrospectivo de la efectividad de la lamotrigina en monoterapia para el tratamiento de crisis epilépticas. Estudio ERELMO

Abstract

The efficacy and tolerability of lamotrigine (LTG) in monotherapy and in combination therapy have been demonstrated in clinical trials. The aim of the ERELMO study was to retrospectively evaluate the effectiveness and safety of LTG, as monotherapy in the control of epileptic seizures in routine clinical practice in Spain. 446 clinical records were selected of patients with LTG treatment in the twelve months previously to the beginning of the study. The main endpoints retrospectively analyzed were effectiveness (percentage of patients with 50% or greater reduction in seizure frequency, improvement in seizure control, percentage of patients remaining-seizure free at 2, 6 and 12 months of LTG monotherapy), and safety (adverse event profile reported and treatment withdrawal). The mean age was 41 years old, 57.8% were women. LTG monotherapy treatment (mean maintenance dose was 217.2 mg/day) reduced mean seizure frequency as compared with the basal condition at different study time points (2, 6, 12 months; p < 0.0001). At the end of the study 77% of the patients were seizure free. Loss of treatment effectiveness was shown in 8.5% of patients. Adverse reactions were reported by 15% of patients, the most frequent being insomnia, somnolence, headache and rash. At the end of the study, 88.8% patients were still receiving LTG monotherapy. The present study supports the use of LTG monotherapy due to its effectiveness and good tolerability to promote treatment compliance in usual clinical conditions in patients with epilepsy.