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Aims  As an extension of a phase 2/3 study evaluating the efficacy and safety of lisdexamfetamine dimesylate (LDX) 30, 50, or 70 mg/d for 4 weeks in Japanese patients aged 6‐17 years with attention‐deficit/hyperactivity disorder (ADHD), this study evaluated its long‐term safety and efficacy.    Methods  This was a multicenter, open‐label study of LDX for 53 weeks. Safety was assessed by regular medical examination for treatment‐emergent adverse events (TEAEs); regular recording of body weight, vital signs, and laboratory test values; and completion of dependence questionnaires. Efficacy was assessed using Japanese versions of the ADHD‐Rating Scale‐IV (ADHD‐RS‐IV) and Conners' 3rd edition Parent Rating Scale (Conners 3); plus Clinical Global Impression‐Improvement (CGI‐I), Clinical Global Impression‐Severity, and Parent Global Assessment (PGA) scales.    Results  Of 132 enrolled patients, 104 completed the trial. Most frequent treatment‐related TEAEs were decreased appetite (73.5%), initial insomnia (39.4%), and weight decrease (22.0%). Most TEAEs were mild (82.6% of patients). There were no serious or severe TEAEs or deaths. No treatment‐related TEAEs were associated with blood pressure or pulse rate, and no patient had a QTcF interval >500 ms. Statistically significant improvement from baseline to week 53 was observed in the mean ADHD‐Rating Scale‐IV total score and mean Conners 3 subscale scores. Most patients showed improvement on the CGI‐I (78%) and PGA (76.5%) scales.    Conclusions  No significant safety issues were observed with LDX 30, 50, or 70 mg/d administered for 1 year in Japanese children and adolescents with ADHD. LDX was associated with long‐term reductions in ADHD symptoms and severity.

Long‐term study of lisdexamfetamine dimesylate in Japanese children and adolescents with attention‐deficit/hyperactivity disorder