Abstracts

To evaluate the impact of initiating therapy with either valproate (VPA) or lamotrigine (LTG) on body weight and serum lipid levels in women with epilepsy (WWE). Eligibility criteria for this prospective, randomized, open-label, multicenter study (LAM30007) included age 13-40 years, regular menstrual cycles; no concurrent hormonal medications; no prior LTG or VPA; and either newly diagnosed [[lt]2 weeks prior antiepileptic drug (AED)] or inadequately controlled epilepsy (only 1 chronic AED[ge]3 months). Subjects were randomized to VPA or LTG and were treated for up to 12 months. Fasting serum lipid levels and body weight were measured at baseline and every three months during the study. To exclude the confounding effect of puberty on the results, a post-hoc analysis was conducted in women who were [gt]2 years post menarche. An Analysis of Covariance model comparing end of study measurements to screen was used, including the screening measurement and group center as covariates. A total of 363 women (177 LTG, 186 VPA) ages 12 to 40 years were evaluated. The mean weight gain in the VPA group was 2.8 kg (SD=3.35) and 0.2 (SD=3.90) kg in the LTG group (p[lt]0.001). Mean serum triglyceride concentrations increased 8.4 mg/dL (SD=37.5) in women taking VPA, while they decreased slightly in the LTG group (0.2 mg/dL, SD=36.3, p=0.019). The serum total cholesterol levels showed a slight decrease in both treatment groups, but there was a mean decrease of 2.6 mg/dL (SD=10.3) in serum HDL-cholesterol levels in VPA treated women, whereas a slight increase of 0.6 mg/dL (SD=9.2) was observed during LTG treatment (p=0.001). This large, multiethnic, prospective, randomized study indicates that VPA is associated with weight gain and unfavorable changes in serum lipid levels in WWE, whereas LTG does not seem to affect body weight or serum lipid levels. (Supported by GlaxoSmithKline.)