Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder.
BACKGROUND
Lisdexamfetamine dimesylate (LDX), a prodrug stimulant, is indicated for attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years of age and in adults. In short-term studies, once-daily LDX provided efficacy throughout the day. This study presented here was conducted to assess the long-term safety, tolerability, and effectiveness of LDX in 6- to 12-year-olds with ADHD.


METHODS
This open-label, multicenter, single-arm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for ADHD. Following 1-week screening and washout periods, subjects were titrated to LDX 30, 50, or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months. The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness.


RESULTS
Of 272 subjects receiving LDX, 147 completed the study. Most adverse events were mild to moderate and occurred during the first 4 weeks. There were no clinically meaningful changes in blood pressure or electrocardiographic parameters. From baseline to endpoint, mean ADHD Rating Scale scores improved by 27.2 points (P<.0001). Improvements occurred during each of the first 4 weeks, and were maintained throughout. Based on Clinical Global Impression-Improvement scale scores, >80% of subjects at endpoint and >95% of completers at 12 months were rated "improved."


CONCLUSIONS
Long-term 30, 50, and 70 mg/day LDX was generally well tolerated and effective in children with ADHD.
Findling
Robert L
RL
Child and Adolescent Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio 44106, USA. robert.findling@uhhospitals.org
Childress
Ann C
AC
Krishnan
Suma
S
McGough
James J
JJ
D000284:Administration, Oral; D001066:Appetite / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003913:Dextroamphetamine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006261:Headache / Q000139:chemically induced; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate; D008297:Male; D011569:Psychiatric Status Rating Scales / Q000706:statistics & numerical data; D007319:Sleep Initiation and Maintenance Disorders / Q000139:chemically induced; D013997:Time Factors; D016896:Treatment Outcome; D015431:Weight Loss / Q000187:drug effects
D000069478:Lisdexamfetamine Dimesylate; D003913:Dextroamphetamine