Study Shows Treatment With ADHD Medication May Be As Effective In African American Children With ADHD As In Caucasian Children With ADHD
Data Suggests Greater Improvement With CONCERTA?versus Strattera?Among Both Groups
African American and Caucasian children with Attention Deficit/Hyperactivity Disorder (ADHD) who took CONCERTA?(methylphenidate HCl) CII demonstrated greater improvement in symptoms such as hyperactivity, impulsivity and attention than they did with Strattera?(atomoxetine), according to a subgroup analysis of results from the first comparative evaluation of the two medications.
According to results of a study titled Formal Observation of CONCERTA?versus Strattera?(FOCUS), response to treatment with CONCERTA? a stimulant medication, and Strattera? a non-stimulant, was consistent among all patient populations, regardless of ethnic background. Physicians participating in the study observed notable differences between the two medications as early as one week after both treatments began, with CONCERTA?consistently producing significantly greater improvement in ADHD symptoms in both African American and Caucasian children each week of the study.
More than 1,300 children with ADHD between the ages of six and 12, of whom 14 percent (n=183) were African American, completed the three-week community-based open label trial, which was conducted by over 300 physicians across the country. Researchers shared results today at the 102nd Annual Convention and Scientific Assembly of the National Medical Association, the largest and oldest national organization representing African American physicians and their patients in the United States.
"Compared to the vast amount of published literature on Caucasian children with ADHD, there is very little research available to evaluate how African American children with ADHD respond to pharmacological treatment," noted study co-author Lynn Starr, M.D., associate director, Medical Affairs, McNeil Consumer and Specialty Pharmaceuticals. "This portion of the FOCUS study was specifically designed to address this scientific void, and the findings further confirm published research which suggests that treatment with ADHD medication may be as effective in African American children as in Caucasian children."
About the Study
Male and female subjects between the ages of six and 12 years old who met DSM-IV criteria for a primary diagnosis of ADHD or any subtype of the disorder participated in the randomized, open-labeled, parallel-design multi-center study.
Patients in the study included newly diagnosed ADHD patients, treatment naive subjects and patients who were taking medication for ADHD before enrollment but were not achieving satisfactory management of their symptoms. Participants were randomly assigned by their physician to receive CONCERTA?(n= 850) or Strattera?(n=473) for a three-week period. Among the African American children who participated in the study, 125 received CONCERTA?and 58 received Strattera?
Study medication was taken once each day in accordance with each product's dosing instructions. CONCERTA?therapy was initiated at 18 mg once daily; Strattera?at 0.5 mg/kg per day. During the course of the study, investigators were allowed to increase doses to achieve clinically meaningful management of symptoms.
Physician assessments were made at baseline and once a week during the course of the study using established tools such as the Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) and a Clinical Global Impressions (CGI)-Improvement of Illness score.
CONCERTA?Yields Greater Improvement of ADHD Symptoms
CONCERTA?consistently produced significantly greater improvement compared with Strattera?on the basis of reduced ADHD-RS scores. Similar improvements also were seen with the physician-rated CGI scores. Differences in ADHD-RS scores between treatment groups showed a significantly greater rate of improvement in inattentive and hyperactive behavior (symptom score improvement per week; p<0.001) in the CONCERTA?group.
The types of adverse events in this study were consistent with the known safety profile of both medications.
The study was sponsored by McNeil Consumer and Specialty Pharmaceuticals, U.S. marketers of CONCERTA?
About CONCERTA?
CONCERTA?(methylphenidate HCl) CII is a once-daily extended-release formulation of methylphenidate approved to treat ADHD. CONCERTA?uses an advanced OROS?extended-release delivery system to deliver a controlled rate of medication throughout the day. Because of its unique OROS?system, CONCERTA?minimizes the ups and downs in blood levels experienced with stimulant medications taken several times a day.
CONCERTA?should not be taken by patients with: significant anxiety, tension or agitation; allergies to methylphenidate or other ingredients in CONCERTA? glaucoma, Tourette's syndrome, tics or family history of Tourette's syndrome; current/recent use of monoamine oxidase inhibitors (MAOIs). Abuse of methylphenidate may lead to dependence. CONCERTA?should not be taken by children under six years of age.
In clinical studies with patients using CONCERTA? the most common side effects were headache, stomach pain, sleeplessness and decreased appetite. For more information about CONCERTA? including full U.S. prescribing information, please visit http://www.concerta.net or call 1-888-440-7903.
About McNeil Consumer and Specialty Pharmaceuticals
McNeil Consumer and Specialty Pharmaceuticals, a division of McNeil-PPC, Inc., markets prescription pharmaceuticals and over-the-counter (OTC) products. Prescription products include CONCERTA?(methylphenidate HCl) CII for attention deficit hyperactivity disorder and FLEXERIL?(cyclobenzaprine HCl) 5 mg for the relief of muscle spasm associated with acute, painful musculoskeletal conditions. The company's OTC products include complete lines of TYLENOL?Acetaminophen and MOTRIN?IB Ibuprofen products for adults and children. Other McNeil Consumer and Specialty Pharmaceuticals brands include IMODIUM?A-D anti-diarrheal, ST. JOSEPH?Adult Regimen Aspirin and NIZORAL?A-D Shampoo.
CONCERTA?and OROS?are registered trademarks of Alza Corporation.
Strattera?is a registered trademark of Eli Lilly and Company.
