To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Study in Pediatrics Shows One Morning Dose of Adderall XR Safely And Effectively Controls Symptoms of ADHD During and Beyond the School Day URL: http://www.pslgroup.com/dg/21A56A.htm Doctor's Guide August 5, 2002
Once-Daily ADHD Therapy Gives Parents Control Over Medication, Provides Symptomatic Relief, From School to Homework to Play FLORENCE, KY -- August 5, 2002 -- A study published in this month's Pediatrics shows that one morning dose of Adderall XR™ (mixed salts of a single-entity amphetamine product) was well-tolerated and effective at controlling symptoms of attention deficit/hyperactivity disorder (ADHD) throughout the day. Involving more than 500 children, the study is one of the largest ADHD trials conducted in a home and school environment, and showed that Adderall XR was effective in children who previously had taken an ADHD medication, as well as those who never have taken an ADHD medication. Symptoms of ADHD include inattention, impulsivity, and hyperactivity, and may be serious enough to interfere with the child's ability to function normally in academic or social settings. "Children diagnosed with ADHD are significantly challenged in all aspects of their lives and should be treated with a medication that helps them at home, school, and in social situations. This study is important because it demonstrates the safety and effectiveness of Adderall XR in helping children improve their behavior during and beyond the school day," said the study's lead investigator Dr. Joseph Biederman, Professor of Psychiatry at the Harvard Medical School and Chief of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital. "Furthermore, once-daily dosing of Adderall XR gives parents control of when their children take the medication, thereby helping to reduce the stigma associated with in-school dosing." Clinical Safety and Efficacy of Adderall XR In this multi-center, randomized, double-blind, parallel-group, placebo- controlled trial involving 584 children (ages 6- 12), Adderall XR demonstrated statistically significant improvement in impulsivity, inattention, and hyperactivity in children with ADHD, as measured by parents and teachers, for up to 12 hours. The statistically significant improvement in symptom control observed at 4 p.m. was comparable to the improvement observed at 10 a.m. earlier the same day. In addition, these long-acting clinical effects eliminated the need for in-school administration of the medication. To be included in the clinical trial, the patients needed to satisfy the recognized diagnostic standard, the DSM-IV-TR, that defines criteria for ADHD. All children received placebo treatment in a single-blind fashion for a 1-week washout phase after discontinuing previous stimulant treatment. Then the children were randomized to receive a final dose level of either 10 mg, 20 mg, or 30 mg of Adderall XR, or placebo, administered once a day. The study design used a dose-escalation regimen for the Adderall XR treatment groups. In this design, all patients randomized to receive Adderall XR were given 10 mg for the first week of treatment. Those randomized to the 20-mg and 30-mg groups received 20 mg for the second week of treatment, and those randomized to the 30-mg group received 30 mg for the third week of treatment. Three days each week teachers evaluated the children in school at 10 a.m. and 2 p.m. using the Conners Global Index Scale (teacher's version, CGIS-T); on weekends parents evaluated the children at home at 10 a.m., 1 p.m., and 4 p.m. using the Conners Global Index Scale (parent's version, CGIS- P). Efficacy was also studied using the Clinical Global Impressions Scale for improvement (CGI), and the Parent Global Assessment for improvement (PGA). All of these scales are standard research assessment tools. Safety was assessed by recording adverse events, laboratory tests, and vital signs at each visit during the study. Physical exams and electrocardiograms (ECGs) were performed at the screening and the end of study visits. The most commonly observed side effects in the studies were consistent with those typically seen with medications in this class and included decreased appetite, loss of sleep (insomnia), abdominal pain, emotional lability, and nervousness. The majority of these side effects were mild and transient, and generally did not result in discontinuation from the study. Important to note is that Adderall XR demonstrated no clinically meaningful cardiovascular changes, as evidenced by the repeated ECG measurements. "ADHD medications that must be taken during the school day put the responsibility for dosing on school personnel or the child. With many schools lacking a school nurse, the responsibility for dispensing medication often falls in the hands of people who are not medically trained, including school secretaries, parent aides, and teachers," said Dr. Judith Vessey, Professor of Nursing at Boston College and research consultant to the National Association of School Nurses. "Dosing just once a day with Adderall XR benefits both the child and the people who support the child in his or her treatment." Adderall XR should not be prescribed for patients with symptomatic cardiovascular disease, moderate to severe high blood pressure, glaucoma, hyperthyroidism, known allergy to this type of medication, agitated states, or history of drug abuse or within 14 days of administration of a MAO inhibitor. Amphetamines have a high potential for abuse. Caution is advised in patients with a history of high blood pressure or mental illness. Report any new psychological symptoms to your physician. There is a potential for worsening of motor and phonic tics and Tourette's syndrome. About ADHD ADHD is thought to be the most commonly diagnosed psychiatric disorder among school-aged children. Children with ADHD often are inattentive, impulsive, and hyperactive -- difficulties serious enough to interfere with their ability to function normally in academic or social settings. Up to 66 percent of children with ADHD will continue to show symptoms into adulthood.(1) Although there is no "cure" for ADHD, physicians, parents, teachers, nurses, and advocates are finding ways to help people with the condition learn to adapt to their academic, social, and work settings. ADHD usually can be successfully managed with a combination of treatments, including educational approaches, psychological and behavioral therapies, and medication. A recent government-sponsored clinical trial(2) found that therapies that include carefully monitored medication are more effective than those that do not, such as behavioral therapy alone. Medication should be considered part of an overall multimodal treatment plan for ADHD. Shire supports the use of its medication only after a thorough assessment and diagnosis of ADHD by a physician. About Shire Pharmaceuticals Group plc Shire is an international specialty pharmaceutical company with a strategic focus on three therapeutic areas: central nervous system disorders, oncology, and anti-infectives. Reference: (1) Weiss G, Hechtman L, Milroy T, Perlman T. Psychiatric Status of Hyperactives as Adults: A Controlled Prospective 15-Year Follow-up of 63 Hyperactive Children. J Am Acad Child Adolesc Psychiatry. 1985;24:211-220. (2) The MTA Cooperative Group. A 14-Month Trial of Treatment Strategies for Attention-Deficit/Hyperactivity Disorder. Arch Gen Psychiatry. 1999;56:1073-1086. SOURCE: Shire Pharmaceuticals Group plc --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. 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