Abstracts

To assess the efficacy and tolerability of lamotrigine (LAMICTAL, LTG) as adjunctive therapy in the treatment of primary generalized tonic-clonic (PGTC) seizures in patients with a history of absence seizures. The effect of LTG on PGTC seizures has not been previously evaluated in a placebo-controlled trial. Therefore, a randomized, blinded, placebo-controlled study was conducted to assess the efficacy and tolerability of adjunctive therapy with LTG in the treatment of PGTC seizures in patients [ge]2 years of age. These results were presented previously. A sub-analysis of the data was performed for patients with a history of absence seizures and those results are presented here., Patients with a diagnosis of epilepsy with PGTC seizures who were receiving 1 or 2 antiepileptic drugs (AEDs) at entry were eligible. Patients with partial seizures were excluded based on seizure history and screening electroencephalograms. There were three phases: Baseline; Escalation, during which drug was titrated to a target dose (12 wks if 2-12yrs, 7 wks if [gt]12yrs); Maintenance, during which doses of drug and concomitant AEDs were maintained for 12wks., Thirty-eight (18 LTG, 20 placebo (PBO)) patients with a history of days with absence seizures received drug. Median percent decrease from Baseline in PGTC seizures during the entire treatment period (ETP) was 64% in the LTG group and 30% in the PBO group. This was similar to the efficacy in the overall study population. The median percent change from Baseline in absence seizures during the ETP was a 26% decrease in the LTG group and a 100% increase in the PBO group.[italic] [/italic]The most common treatment-emergent adverse events (AEs) were headache (22% LTG, 35% PBO) and nausea (22% LTG, 10% PBO)., Adjunctive LTG therapy was effective in controlling PGTC seizures and was well tolerated among patients with a history of absence seizures., (Supported by GlaxoSmithKline Research and Development.)