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From the University of Alabama at Birmingham (Dr. Gilliam), Birmingham, AL; Department of Neurology (Dr. Vazquez), Hospital for Joint Diseases, New York, NY; Department of Neuroscience and Neurology (Dr. Sackellares), University of Florida and VA Medical Center, Gainesville, FL; Department of Neurology (Dr. Chang), LAC-USC Medical Center, Los Angeles, CA; and Glaxo Wellcome Research and Development (Drs. Messenheimer, Risner, and Rudd, and J. Nyberg), Research Triangle Park, NC.
Address correspondence and reprint requests to Frank Gilliam, MD, University of Alabama at Birmingham, 1719 6th Avenue South, Room 312, Birmingham, AL 35294-0021.
Objective: We report the results of a double-blind, double-dummy, active-control study designed to evaluate the efficacy and safety of lamotrigine (LTG) administered as monotherapy to adult outpatients with partial seizures.
Background: The effectiveness of LTG as add-on therapy for partial seizures in adults has previously been established.
Methods: After an 8-week baseline during which patients continued their baseline antiepileptic drug (carbamazepine or phenytoin monotherapy), 156 patients were randomly assigned to receive increasing doses of LTG (target 250 mg b.i.d.) or valproic acid (VPA; target low dose of 500 mg b.i.d.) during the first 4 weeks of an 8-week transition period. Carbamazepine or phenytoin was withdrawn over the next 4 weeks; then patients entered a 12-week monotherapy period. Study drug treatment was discontinued in patients who met predetermined escape criteria for seizure worsening.
Results: More patients receiving LTG were successfully maintained on monotherapy compared with patients receiving VPA (56% versus 20%; p < 0.001). The time to meet the escape criteria was also significantly longer in LTG-treated patients (median = 168 days) than in VPA-treated patients (median = 57 days; p = 0.001). The incidence of adverse events during the monotherapy period was lower than during the transition period. Four LTG patients and five VPA patients reported serious adverse events. Two of those patients experienced a rash that led to withdrawal soon after adding LTG to carbamazepine.
Conclusions: We conclude that LTG is effective and well tolerated when administered as monotherapy in adult patients with partial seizures.
Funded in part by Glaxo Wellcome Research and Development.
Received January 7, 1998. Accepted in final form April 25, 1998.
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