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We evaluated the efficacy and safety of lamotrigine(300 and 500 mg/day)as add-on therapy in a multicenter,randomized,double-blind,parallel-group, placebo-controlled study of 216 patients with refractory partial seizures. During 6 months of treatment,median seizure frequency decreased by 8%with placebo,20%with 30 mg lamotrigine,and 36%with 500 mg lamotrigine.Seizure frequency decreased by>/=50%in one-third of the 500-mg group and one-fifth of the 300-mg group.Reductions in seizure frequency and seizure days were statistically significant,compared with placebo,for the 500-mg group but not the 300-mg group.Most adverse events were minor and resolved over time.Nine percent of patients on lamotrigine withdrew because of adverse experiences.Lamotrigine plasma concentrations appeared to be a linear function of dose,and the drug did not affect plasma concentrations of concomitant antiepileptic drugs.Lamotrigine was safe,effective,and well tolerated as add-on therapy for refractory partial seizures. |
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