Abstracts

During double-blind placebo-controlled trials in children/adolescents (2-16 yrs; N=97), topiramate (TPM) was associated with temporary weight loss or slowed weight gain in some patients, although no patients discontinued for this reason. To prospectively characterize TPM effects on growth, we analyzed body mass index (BMI) data for children/adolescents with refractory epilepsy participating in a study of TPM as adjunctive therapy under conditions that more closely reflect clinical practice.
554 children/adolescents (1-18 yrs) with seizures inadequately controlled with [ge]1 antiepileptic drug were enrolled in this prospective, open-label study and received TPM as adjunctive therapy; core study duration was 6 months. From weight and height measured at each study visit, BMI (kg/m²) was calculated for age-/gender-specific percentiles. To assess potential patterns in BMI percentile change, patients were grouped into strata representing underweight ([lt]5^th), [ldquo]below normal to normal[rdquo] (5^th-[lt]50^th), [ldquo]normal to upper normal[rdquo] (50^th-[lt]85^th), at risk of overweight (85^th-[lt]95^th), and overweight ([ge]95^th) BMI for age.
At baseline, most patients (68%) were in [ge]50^th BMI percentile, 49% were in [ge]75^th, and 17% were obese ([ge]95^th). [table1]Weight loss was cited as an adverse event contributing to discontinuation of TPM in only 1% of patients.
Children/adolescents in the lowest BMI percentiles at baseline were the least likely to experience weight loss and most likely to show weight gain, measured as BMI percentile change. BMI was reduced to underweight in only 6% of children/adolescents. Those with above-normal BMIs were most likely to lose weight.
[Supported by: Johnson [amp] Johnson Pharmaceutical Research [amp] Development]