Weight Gain Associated with Valproate Vs. Lamotrigine Monotherapy in Adolescents with Epilepsy: A Randomized, Double-Blind Clinical Trial
Abstract number :
2.212
Submission category :
Year :
2001
Submission ID :
3059
Source :
www.aesnet.org
Presentation date :
12/1/2001 12:00:00 AM
Published date :
Dec 1, 2001, 06:00 AM
Authors :
V. Biton, MD, Arkansas Epilepsy Program, Little Rock, AR; A. Vuong, BS, GlaxoSmithKline, Research Triangle Park, NC; A.E. Hammer, BS, GlaxoSmithKline, Research Triangle Park, NC; P.S. Barrett, PharmD, GlaxoSmithKline, Research Triangle Park, NC; A. Metz,
RATIONALE: LAMICTAL[reg] (LTG) and DEPAKOTE[reg] (VPA) are commonly used antiepileptic drugs. Marked weight gain is frequently reported with VPA. In some children, mainly adolescent girls, weight gain can have serious psychosocial effects and undermine self-esteem. Available data suggest that LTG, unlike VPA, does not cause weight gain in adolescents.
METHODS: Patients were [gte]12 years old with new onset partial or generalized seizures. Patients who had used LTG or VPA for [gt]90 days prior to screen were excluded. Patients were randomized 1:1 to LTG or VPA, entered an 8-week Escalation, then a 24-week Maintenance Phase. The target doses were 200-500 mg/day for LTG and 20-60 mg/kg/day for VPA based on clinical response. The primary endpoint was weight change at weeks 10, 14, 20, 26 and 32 from screen weight.
RESULTS: Study results were presented previously (Neurology 2001;56:172-177). For adolescents ([gte]12 and [lt]18 years), LTG group: n=12, 58% female, mean age 14.8 yrs; VPA group: n=13, 54% female, mean age 14.3 yrs. The mean screen weight was 63 lb [plusminus] 15 for LTG patients, 60 lb [plusminus] 18 for VPA patients. The mean screen Body Mass Index (BMI) was 22.7 [plusminus] 3 for LTG patients and 22.7 [plusminus] 7 for VPA patients. During Maintenance, the mean dose was 265 mg/day for LTG and 1516 mg/day for VPA. The mean weight changes at weeks 10, 14, 20, 26, 32 were higher in VPA patients (7.0, 10.0, 10.0, 12.5, 13.9 lb) than in LTG patients (2.6, 2.4, 1.3, 1.7, 1.9 lb). When weight was compared to the patient[scquote]s screen weight, approximately twice as many patients taking VPA gained [gte]5% (73% for VPA, 36% for LTG) or [gte]10% (45% for VPA, 27% for LTG). At week 32, the mean BMI change was higher in VPA patients (+2.1) than LTG patients (-0.09). During this 8-month study the percentage of adolescents who were seizure-free was 31% (VPA) and 25% (LTG).
CONCLUSIONS: In this monotherapy study, weight and BMI remained stable in adolescents taking LTG, but increased markedly in adolescents taking VPA. The weight gain with VPA was pronounced within 10 weeks of starting therapy and continued to increase during the study. LTG appeared to have comparable efficacy with better tolerability than VPA.
Support: This study was supported by GlaxoSmithKline.
Disclosure: Salary - GlaxoSmithKline; Grant - GlaxoSmithKline; Stock - GlaxoSmithKline