Study demonstrates efficacy of CONCERTA in treating ADHD in presence of comorbid learning disability

May 26 2010

Turning in assignments, following instructions and focusing on learning something new are among the daily classroom challenges for children with Attention Deficit Hyperactivity Disorder (ADHD), according to the National Institute of Mental Health (NIMH).  New data presented today show efficacy of CONCERTA® (OROS® methylphenidate HCl Extended-Release Tablets CII) on ADHD symptoms in children with the condition who also may face other specific challenges.

CONCERTA® efficacy in treating ADHD symptoms in the presence of a comorbid learning disability was demonstrated in data announced at a major medical meeting here by Ortho-McNeil Janssen Scientific Affairs, L.L.C., supporting McNeil Pediatrics™, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. In a separate analysis, treatment with CONCERTA® was associated with significant differences in tests of reading fluency and of reading comprehension.

The new data are two analyses of randomized, double-blind, placebo-controlled studies that examined CONCERTA® efficacy in patients in a simulated classroom environment.

Effects of OROS® Methylphenidate Treatment on Behavior and Performance in Children with ADHD with and without Learning Disability (Poster NR5-8)  

The effect of CONCERTA® on behavior and performance were evaluated in 139 patients with ADHD, ages 9 to 12. In addition to a confirmed diagnosis of ADHD, approximately one-third of patients had verbal- or math-based learning disability. Significant improvements were seen in patients who received CONCERTA®, both in those with and those without a comorbid learning disability.

"The NIMH estimates approximately 20 to 30 percent of children with ADHD may be challenged by the presence of a coexisting learning disability, and we wanted to evaluate the efficacy of CONCERTA® on ADHD symptoms in children with this comorbidity," said H. Lynn Starr, M.D., Director of Medical Affairs for Ortho-McNeil Janssen Scientific Affairs, L.L.C., and lead author of Poster NR5-8.

"These are the first data, to our knowledge, using a double-blind, placebo-controlled, laboratory school study design to demonstrate significant efficacy of a stimulant in reducing ADHD symptoms in children with ADHD, with or without a comorbid learning disability," Dr. Starr noted.  "We hope this new insight is helpful for parents and healthcare professionals as they consider this treatment need."

Two measurements were used to evaluate CONCERTA® efficacy: the Permanent Product Measure of Performance (PERMP), which evaluates attention using a series of math problems (number of problems attempted and number of problems correct), and the Swanson, Kotkin, Agler, M-Flynn and Pelham (SKAMP) rating scale that evaluates classroom attention and behavior.

PERMP measurements showed patients attempted and completed significantly more math problems  when taking CONCERTA®, compared with when taking  placebo (p<0.0001).  Similar patterns were seen in SKAMP scores, with significant improvement in behavior and attention (p<0.0001).

Adverse events in 10 percent or more of patients were consistent with those previously reported for CONCERTA® and included headache, upper abdominal pain, decreased appetite, irritability and initial insomnia. No serious adverse events or deaths were reported.

Effect of OROS® Methylphenidate Treatment on Reading Performance in Children with ADHD (Poster NR5-19)

CONCERTA® treatment effect was evaluated on reading performance in 78 patients with ADHD, ages 9 to 12. The analysis demonstrated improvement on tests of oral reading fluency and silent reading comprehension with CONCERTA® treatment.

The analysis used two tests that measure reading skills: the Dynamic Indicators of Basic Early Literacy Skills (DIBELS), which measures reading rate, and the Gray Silent Reading Test (GSRT), which evaluates reading comprehension and accuracy.  

The average DIBELS score for patients when taking CONCERTA® was higher than when taking placebo, indicating significantly greater accuracy and a faster reading rate

Adverse events in 5 percent or more of patients were consistent with those previously reported for CONCERTA® and included decreased appetite, upper abdominal pain, headache, irritability, initial insomnia, dizziness, nasal congestion and pyrexia (elevated temperature).  No serious adverse events or deaths were reported.