Abstracts

Unlike many pharmacotherapies for mood disorders, lamotrigine has not been shown to be associated with weight gain. This study evaluated the safety and efficacy of lamotrigine, compared to placebo, as a monotherapy for weight loss in obese adult patients. Patients were randomized to 200mg/day of lamotrigine or placebo. Eligibility included a body mass index (BMI) of 30-39.99. The primary endpoint was weight change after 26 weeks. Secondary endpoints included percent body fat, BMI, serum lipids, HbA1c, and patient satisfaction and quality of life. Analysis of covariance was carried out using change from Baseline to Week 26 or LOCF. Forty patients were randomized. The mean change in body weight from Baseline to LOCF was [ndash]6.4 [plusmn] 10.26 kg and [ndash]1.2 [plusmn] 7.09 kg for lamotrigine and placebo respectively. Mean baseline body weight was not statistically different at baseline (207.9 kg[ndash]lamotrigine, 225.0 kg-placebo). There was a statistically significant difference (p=0.0421) in mean change in BMI from Baseline to LOCF (-1.5 [plusmn] 2.78 and [ndash]0.1 [plusmn] 1.05 for lamotrigine and placebo, respectively). No serious adverse events were reported. The most frequently reported adverse event was mild to moderate headaches for both treatment groups. Patients were more satisfied with lamotrigine therapy compared to placebo (p=0.0065). There were no significant differences in the other secondary endpoints between the two treatment groups. Lamotrigine demonstrated a statistically significant difference in mean change in BMI and a trend toward a decrease in body weight, with no negative impact on serum lipids or HbA1c. (Supported by GlaxoSmithKline.)