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, multicenter, 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.
RCT Entities:
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, multicenter, 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.
Authors: Atilla Turgay; Lawrence Ginsberg; Elias Sarkis; Rakesh Jain; Ben Adeyi; Joseph Gao; Bryan Dirks; Thomas Babcock; Brian Scheckner; Cynthia Richards; Robert Lasser; Robert L Findling Journal: J Child Adolesc Psychopharmacol Date: 2010-12 Impact factor: 2.576
Authors: Eric Q Wu; Paul Hodgkins; Rym Ben-Hamadi; Juliana Setyawan; Jipan Xie; Vanja Sikirica; Ella X Du; Sherry Y Yan; M Haim Erder Journal: CNS Drugs Date: 2012-07-01 Impact factor: 5.749
Authors: Panayotis K Thanos; Iliyan Ivanov; John K Robinson; Michael Michaelides; Gene-Jack Wang; James M Swanson; Jeffrey H Newcorn; Nora D Volkow Journal: Pharmacol Biochem Behav Date: 2009-10-08 Impact factor: 3.533