2014 年 7 巻 1 号 p. 55-65
Purpose: To evaluate the efficacy and safety of lamotrigine monotherapy in patients with newly diagnosed partial seizures including secondarily generalized seizures or generalized tonic-clonic seizures, and those with recurrent seizures in Japan and South Korea.
Methods: The study was a multi-center, open-label, evaluation of lamotrigine monotherapy in patients with newly diagnosed epilepsy or epilepsy with recurrent seizures. The primary endpoint was the seizure-free rate in the maintenance phase.
Results: A total of 67 patients were enrolled; 52 patients completed 6 weeks of treatment (the escalation phase) and 42 patients completed 30 weeks of treatment (the escalation phase and the maintenance phase). The seizure-free rate in the maintenance phase for all seizure types was 43.1%. Adverse events (AEs) were reported in 82% (53/65) of patients. The most common AEs were headache (14/65, 22%), nasopharyngitis (12/65, 18%) and rash (7/65, 11%).
Conclusion: The seizure-free rate with lamotrigine monotherapy in the maintenance phase was 43.1% for all seizure types. Lamotrigine monotherapy appears to be effective in patients with newly diagnosed epilepsy and those with recurrent seizures in Japan and South Korea. The safety profile of lamotrigine in this monotherapy study was similar to that observed in patients with adult bipolar disorder treated with lamotrigine monotherapy.