Placebocontrolled study of the efficacy and safety of lamotrigine in patients with partial seizures

Autor: Matsuo, F., Bergen, D., Faught, E., Messenheimer, J. A., Dren, A. T., Rudd, G. D., Lineberry, C. G.
Zdroj: Neurology (Ovid); November 1993, Vol. 43 Issue: 11 p2284-2291, 8p
Abstrakt: 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 300 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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