Efficacy and Safety of Lamotrigine as Add-on Therapy in 132 Children and Adult Iranian Patients with Treatment-Resistant Epilepsy

ABSTRACT

This study was initiated to evaluate the long-term safety, tolerability and efficacy of seizure control of lamotrigine [LTG] in children and adult patients with partial seizures [PS] with or without secondary generalized seizure. A total of 132 patients [age 5-41 years] with treatment-resistant epilepsy received LTG as add-on therapy for up to four years. Overall, patients were treated with LTG for 27-226 weeks. The global assessment of seizure control compared to the three-month period before starting LTG treatment indicated that seizure control was gradually maintained during long-term LTG treatment for up to four years. The medical history of 23 patients who had a significant decrease in the number of seizures with LTG treatment indicated a subjective improvement in behavior, alertness, and quality of life. All 132 patients who received LTG as add-on therapy had used 2-4 anti-convulsive medications 2- 7 years before entering this open continuation study. Patients had 7-45 seizures per month throughout the 3 months before entering this study. The overall decrease in the number of seizures was 58% after patients started receiving L T G. LTG was well tolerated. The majority of adverse effects were classified as being mild in intensity and only 5 patients [4%] were withdrawn from the study due to adverse effects [skin rash]