Abstracts

RATIONALE: Evaluations of antiepileptic drugs (AEDs) have focused mainly on seizure frequency and side effects. As patients often have to make lifestyle changes to adapt to the uncertainty of seizures and accommodate AED side effects, assessment of health-related quality of life (QOL) should provide a more comprehensive evaluation of the treatment effects of AEDs. METHODS: In a trial comparing the effects of LAMICTAL?(LTG) to DEPAKOTE?(VPA) on weight gain, QOL assessments (QOL in Epilepsy Inventory-89, QOLIE-89) were added as secondary measures. Patients (? 12 years) had new onset partial or generalized seizures and had used LTG or VPA for <90 days prior to screen. They were randomized 1:1 to LTG or VPA, entered an 8 week escalation, then a 24 week maintenance phase. Target doses were 200-500 mg/day for LTG, 20-60 mg/kg/day for VPA based on clinical response. The probability of having an improvement on each of the QOLIE-89 17 subscales at week 32 was compared between LTG and VPA using stepwise logistic regression while controlling for age, gender, seizure frequency. RESULTS: There was no difference between LTG (n=65) and VPA (n=68) patients in mean age or gender. Mean screen weight was 155 lb for LTG, 161 lb for VPA. Mean weight gain at weeks 10 and 32 were negligible with LTG (1.4, 1.3 lb), and markedly higher (p?0.002) with VPA (5.8, 12.8 lb). Data from 53 LTG and 54 VPA patients (?18 yrs) were available for QOL analysis. LTG was associated with significant improvement in Health Perceptions (p=0.004), Energy/Fatigue (p=0.040), and Social Isolation (p=0.036) domains, versus VPA. The benefits of LTG over VPA trended to statistical significance for Medication Effects (p=0.074). The likelihood of having a QOL improvement with LTG was 4.0 times higher for Health Perceptions, 2.3 times higher for Energy/Fatigue, 2.8 times higher for Social Isolation versus VPA. CONCLUSIONS: LTG monotherapy was associated with significant improvement in QOL versus VPA in terms of Health Perceptions, Energy/Fatigue and Social Isolation. The study provides evidence for therapeutic benefits associated with LTG that may not be reflected by measuring seizure frequency alone.