Growth and puberty in a 2-year open-label study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder
Background: Stimulant medications for the treatment of
attention-deficit/hyperactivity disorder have a history of
safe and effective use; however, concerns exist that they
may adversely affect growth trajectories in children and
adolescents.
Objective: The objective of this study was to evaluate the
longer-term effects of lisdexamfetamine dimesylate on
weight, height, body mass index and pubertal development
in children and adolescents with attention-deficit/hyperactivity disorder.
Methods: Children and adolescents aged 6–17 years with
attention-deficit/hyperactivity disorder took open-label
lisdexamfetamine dimesylate (30, 50 or 70 mg/day) in this
open-label 2-year safety and efficacy study. Safety evaluations included treatment-emergent adverse events, measurement of weight, height and body mass index, and selfreported pubertal status using Tanner staging.
Results: The safety analysis population comprised all
enrolled participants (N = 314) and 191 (60.8%) completed
the study. Weight decrease was reported as a treatmentemergent adverse event in 63 participants (20.1%) and two
participants (0.6%) discontinued the study as a result of
treatment-emergent adverse events of weight decrease