To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: AAP: Long Acting Adderall (Amphetamine Mixed Salts) Safe and Effective for Attention Deficit/Hyperactivity Disorder URL: http://www.pslgroup.com/dg/20B596.htm Doctor's Guide October 22, 2001
By Alison Palkhivala Special to DG News
SAN FRANCISCO, CA -- October 22, 2001 -- A long acting version of Adderall (amphetamine mixed salts) is safe and effective for the treatment of attention deficit/hyperactivity disorder.
Adderall is a stimulant medication that has been used for several years for the treatment of attention deficit/hyperactivity disorder (ADHD). Like other stimulants used to treat ADHD, the manufacturer has developed a long acting version of the drug that requires only once daily dosing.
The latest results with long acting Adderall were presented yesterday (Oct. 21) at the National Conference and Exhibition of the American Academy of Pediatrics (AAP) by Joseph Biederman, MD, professor of psychiatry at Harvard Medical School and chief of pediatric psychopharmacology at Massachusetts General Hospital, in Boston, Massachusetts, United States.
Dr. Biederman and colleagues conducted a multicenter, double-blind, parallel-group, placebo-controlled trial with 563 children aged six to 12 who were diagnosed with ADHD confirmed by Diagnostic and Statistical Manual - Revision IV criteria.
The children were randomized to receive a single daily morning dose of long acting Adderall 10 mg, 20mg, or 30 mg, or a placebo for three weeks. Eighty percent of the participants were boys. Prior to initiation of therapy, there was a one-week washout period of any previous stimulant medication.
Overall, 509 children completed the study. Efficacy of the therapy was based on results of the Conners Global Index Scale for Teachers (CGIS-T), the Conners Global Index Scale for Parents (CGIS-P), the Clinical Global Impressions Scale for improvement (CGI), and the Parent Global Assessment for Improvement (PGA).
Based on an intent-to-treat analysis of the various assessment tool scores, children treated with Adderall compared to placebo showed significant improvement in their behavior in the morning, afternoon, and evening in a dose-dependent fashion. Beneficial effects were generally evident within one week. Side effects were mild and generally not dose-dependent. The most common adverse events were insomnia, headaches, abdominal pain, anorexia, and emotional lability.
According to Dr. Biederman, these results provide, "documentation that this medication administered once a day works all day long."
The research was funded by Shire Pharmaceutical Development Inc, manufacturers of long acting Adderall. The drug is not yet on the market but is expected to be approved by the FDA shortly.
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