TY - JOUR
T1 - Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (adderall XR) in children with ADHD
AU - McGough, James J.
AU - Biederman, Joseph
AU - Wigal, Sharon B.
AU - Lopez, Frank A.
AU - McCracken, James T.
AU - Spencer, Thomas
AU - Zhang, Yuxin
AU - Tulloch, Simon J.
N1 - Funding Information:
This research was supported by Shire Pharmaceutical Development Inc., Wayne, PA. The authors acknowledge the contributions of the SLI381.302 Study Group and thank Tracey I. Fine, M.S., and Dana Randall, Pharm. D., for assistance with manuscript preparation.
PY - 2005/6
Y1 - 2005/6
N2 - Objective: To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR®) in children with attention-deficit/hyperactivity disorder (ADHD). Method: This was a 24-month, multi-center, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12 years. Subjects (N = 568) began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimal effectiveness (maximum dose, 30 mg/d). Effectiveness was assessed with analysis of quarterly Conners Global Index Scale, Parent version (CGIS-P) scores. Tolerability was assessed by monitoring adverse events (AEs), vital signs, physical examinations, and serial laboratory tests. Results: Significant improvements (>30%, p < .001) in CGIS-P scores were maintained during long-term treatment. Treatment was well tolerated, and most AEs were mild. The most frequently reported drug-related AEs included anorexia, insomnia, and headache. The incidence of drug-related AEs increased with increasing MAS XR dose, suggesting a dose relationship. Changes in laboratory values and vital signs were modest and not clinically meaningful. Conclusions: In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment.
AB - Objective: To evaluate the long-term tolerability and effectiveness of extended-release mixed amphetamine salts (MAS XR; Adderall XR®) in children with attention-deficit/hyperactivity disorder (ADHD). Method: This was a 24-month, multi-center, open-label extension of TWO placebo-controlled studies of MAS XR in children with ADHD aged 6 to 12 years. Subjects (N = 568) began treatment with MAS XR 10 mg once daily, with 10-mg weekly dose increases to optimal effectiveness (maximum dose, 30 mg/d). Effectiveness was assessed with analysis of quarterly Conners Global Index Scale, Parent version (CGIS-P) scores. Tolerability was assessed by monitoring adverse events (AEs), vital signs, physical examinations, and serial laboratory tests. Results: Significant improvements (>30%, p < .001) in CGIS-P scores were maintained during long-term treatment. Treatment was well tolerated, and most AEs were mild. The most frequently reported drug-related AEs included anorexia, insomnia, and headache. The incidence of drug-related AEs increased with increasing MAS XR dose, suggesting a dose relationship. Changes in laboratory values and vital signs were modest and not clinically meaningful. Conclusions: In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment.
KW - Adderall XR
KW - Amphetamine
KW - Attention-deficit/hyperactivity disorder
KW - Long-term treatment
UR - http://www.scopus.com/inward/record.url?scp=19344365581&partnerID=8YFLogxK
U2 - 10.1097/01.chi.0000157550.94702.a2
DO - 10.1097/01.chi.0000157550.94702.a2
M3 - Article
AN - SCOPUS:19344365581
SN - 0890-8567
VL - 44
SP - 530
EP - 538
JO - Journal of the American Academy of Child and Adolescent Psychiatry
JF - Journal of the American Academy of Child and Adolescent Psychiatry
IS - 6
ER -