Long-term efficacy and safety of lamotrigine in drug resistant epilepsy

The aim of long-term open label study is evaluation of anticonvulsant efficacy and toxicity of Lamictal(R) in patients with refractory epilepsy. The trial included 78 patients, aged 3-55, who had previously been treated with 1-3 antiepileptic drugs. Mean duration of epilepsy was 16,3 years (3-37y.). Lamotrigine (LTG) was added to previous treatment in all patients. LTG was given twice a day, with daily dosage from 50-650 mg (mean 370 mg/day). Follow-up period was from 6 to 28 months, average 14.5. Finally 59 patients (76%) were on bitherapy, 9 (11%) were on monotherapy and IO (13%) on polytherapy. 5 patients (8.3%) became seizures free and more than 50% reduction of seizures we observed in 27 patients (45,3%) with partial seizures. 6 patients (20.7%) with secondary generalized tonic-clonic seizure became seizure free, in 11 patients (38%) we observed more than 50% reduction. Reduction in seizure frequency was statistically significant in both groups (t-test paired, p=0.002 and p=0.001). In 27 patients (33%) were reported side effects, mainly aggression and vision disturbances. In 6 of patients (7.7%) LTG was discontinued due to side effects or lack of efficacy.