The long-term tolerability and effectiveness of extended release mixed amphetamine salts (Adderall XR) in children with attention deficit hyperactivity disorder (ADHD) were evaluated in a 24-month, multicenter, open-label extension of 2 placebo-controlled studies at UCLA, Massachusetts General Hospital, UC-Irvine, Maitland, FL, and Shire Pharmaceutical, Wayne, PA. The initial dose of Adderall XR was 10 mg daily in 568 children, aged 6-12 years, and was increased by 10 mg weekly to optimal effective levels (maximum 30 mg/d). Quarterly Conners Global Index Scale, Parent version (CGIS-P) was used to assess effectiveness, and adverse events, physical examinations, and laboratory tests were monitored to assess tolerability. Significant improvements (>30%, p<0.001) in CGIS-P scores were maintained through the trial, and treatment was generally well tolerated. Adverse events (AE) included headache (15%), anorexia (15%), and insomnia (11%); 15% withdrew from the study because of AE (weight loss, anorexia, insomnia, depression, and emotional lability). Serious AE were reported in 18 subjects (3%); only 2, both convulsions, were judged possibly drug-related, at doses of 10 and 20 mg/d. None required subsequent treatment with anticonvulsants. Mean systolic blood pressure increased by 3.5 mmHg, diastolic by 2.6 mmHg, pulse by 3.4 beats per min. (Changes in vital signs, ECG, and cardiovascular-related AEs to be reported later). [1]

COMMENT. This paper is something of a cliff-hanger. The promise of a second installment in a subsequent publication is frustrating. The effectiveness and general tolerability of Adderall XR is well known, but answers to the concerns regarding cardiovascular events are anxiously awaited. Hopefully, we can expect this report soon.

Atomoxetine-induced blood pressure increase. A significant elevation in blood pressure is noted in 3 adolescent boys while taking doses of 80 mg/day atomoxetine [2]. Other drugs were given in combination, compromising the significance of the report, but our own practice of monitoring BP, pulse, height, and weight regularly in ADHD patients will be continued.