Discussion
weight gain, Spencer, ADHD
SPENCER, DRUG EFFECT
The safety and tolerability results from this 1-year open-label study of SDX/d-MPH in children with ADHD have been previously reported (Childress et al. Other studies of MPH in children with ADHD also observed similarly higher baseline weight and height than their reference samples (Swanson et al. A The mean weight changes as a percent from baseline-by-baseline BMI quartile groups showed that all four baseline BMI quartile groups had an initial weight decrease during the first to fourth months in the treatment phase, with a notable smaller and shorter weight decrease in baseline BMI quartile 1 compared with the other three baseline BMI quartile groups.The relative weight gain after the initial decline through the end of treatment was higher in subjects in the first and second baseline BMI quartile groups compared with subjects in the third and fourth baseline BMI quartile groups. This difference in weight gain indicates that subjects with a higher baseline BMI experienced a larger initial reduction in weight gain than subjects with a lower baseline BMI. Relative weight gain after ∼3 months of treatment appeared similar between all baseline BMI quartiles.With respect to height, the positive mean baseline height The change in height The effects of long-term treatment of stimulants on weight and height in pediatric patients are well documented (Spencer et al. However, that study was of a much shorter span than the current study, consisting of a 3-week dose optimization phase followed by a 2-week maintenance phase, and it is possible that study had not reached maximum effect on body weight that may have been measured later in treatment had the treatment continued.In a 21-month study with a dose-optimized long-acting MPH formulation in 407 children aged 6–13 years with ADHD (Spencer et al. In a more recent 12-month open-label safety study of extended-release MPH in children aged 4–5 years with ADHD, subjects entering the study were heavier and taller than the reference population (Childress et al. In the extended-release MPH study (Childress et al. The limitations of this study include the open-label nature of the study design and the lack of a control placebo arm or a comparator product. The analysis of a drug effect on body weight changes over time by itself is limited because children are expected to grow and gain weight as they age, even during SDX/d-MPH treatment. In addition, some of the subjects who entered this study were not stimulant naive, as some had been previously treated with SDX/d-MPH in the antecedent pivotal study. Thus, previous stimulant exposure may have impacted baseline height and weight measures, resulting in an underestimate of growth velocity changes.