Growth and sexual maturation in a 2-year, open-label clinical study of lisdexamfetamine dimesylate in children and adolescents with ADHD

Introduction Individuals with attention-deficit/hyperactivity disorder (ADHD) may require long-term medication. Objectives To measure growth and sexual maturation of children and adolescents with ADHD receiving lisdexamfetamine dimesylate (LDX) in a 2-year trial (SPD489-404). Aims To investigate the impact of long-term LDX treatment on growth and maturation. Methods Participants (6–17 years) received dose-optimized, open-label LDX (30–70 mg/day) for 104 weeks. Weight, height and BMI z-scores were derived using the Centers for Disease Control and Prevention norms [1] . Sexual maturation was assessed using the Tanner scale (participant-rated as closest to their stage of development based on standardized drawings). Results Of 314 enrolled participants, 191 (60.8%) completed the study. Mean z-scores at baseline and last on-treatment assessment (LOTA) were 0.53 (standard deviation, 0.963) and 0.02 (1.032) for weight, 0.61 (1.124) and 0.37 (1.131) for height, and 0.32 (0.935) and–0.27 (1.052) for BMI. In general, z-scores shifted lower over the first 36 weeks and then stabilized. At LOTA, most participants remained at their baseline Tanner stage or shifted higher, based on development of hair (males, 95.5%; females, 92.1%) or genitalia/breasts (males, 94.7%; females, 98.4%). Conclusions Consistent with previous studies of stimulants used to treat ADHD [2] , z-scores for weight, height and BMI decreased, mostly in the first year, then stabilized. No clinically concerning trends of LDX treatment on sexual maturation or the onset of puberty were observed.