(October 27, 2006) -- New data suggest that Strattera(R) (atomoxetine HCl) improved ADHD symptoms in children and adolescents who had both ADHD and a reading disorder, like dyslexia. Results were announced today at a meeting of child and adolescent psychiatrists.

The primary objective of the study was to measure Strattera's efficacy in treating the symptoms of ADHD in children and adolescents with ADHD and a comorbid reading disorder (ADHD+RD). Patients with ADHD alone were compared to patients with ADHD+RD. After taking Strattera for 16 weeks, both groups of patients aged 10 to 16 reported an improvement of nearly 50 percent in ADHD symptoms like inattentiveness, hyperactivity and impulsivity. Additionally, patients with ADHD+RD displayed an average reading composite improvement of approximately two years compared to 17 months for participants with ADHD alone. Reading composite is defined as the combined score for reading decoding and reading comprehension. Strattera is not approved to treat reading disorders.

"We are encouraged by the results of this study which highlight the importance of considering appropriate treatment options when treating ADHD in patients with ADHD and comorbid conditions," said Richard Rubin, M.D., clinical associate professor of psychiatry, University of Vermont College of Medicine. "Since ADHD is often combined with reading disabilities, considering treatment options that are effective in treating ADHD without having an adverse effect on reading performance may provide the best outcome."

The two most common developmental disabilities of school-age children are ADHD and learning disabilities, including a reading disorder, like dyslexia.(1,2) It is estimated that 15 - 30 percent of children with ADHD will also have a reading disorder.(2,3,4,5) While research suggests that students with both ADHD and a reading disorder are no more anxious, hyperactive or aggressive than students with ADHD only, the reading disorder does impact school performance, which may subsequently impact family and peer relationships.(6)

Study Highlights

* At the study endpoint, mean change from baseline to endpoint analyses revealed statistically significant improvement for both the patients with ADHD and the patients with ADHD and a comorbid reading disorder (ADHD+RD) on the ADHD RS Total Score (improved 52 percent and 49.2 percent, respectively)

* Age equivalence improvements (in months) were statistically significant for both groups on the following items:
-- Total reading composite: improved 17.2 months for the ADHD group and 23.5 months for the ADHD+RD group

-- Reading decoding (+17.8 months and +16.9 months, respectively)
-- Reading comprehension (+17.0 months and +26.0 months, respectively)

-- Spelling (+9.7 months and +8.7 months, respectively)

* In this study, Strattera was well tolerated with no differences between groups and commonly reported adverse events similar to those reported in previous studies. The most common adverse events (occurring in greater than 5 percent of patients taking Strattera) were somnolence, nausea, decreased appetite, headache, abdominal pain, vomiting, nasopharyngitis and cough.

Methods

In this open-label, parallel-design pilot study conducted in the United States, patients received 1.0 to 1.4 mg/kg of Strattera once daily for approximately 16 weeks. Patients with ADHD (n = 20) were compared to patients with ADHD+RD (n = 36).

All patients were required to have an ADHD symptom severity score at least 1.5 standard deviations above age and gender norms for at least one of the diagnostic subtypes: inattentive, hyperactive/impulsive, or the total score for the combined subtype as assessed by the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD RS). Patients diagnosed as ADHD+RD were also required to have at least a 22-point discrepancy between ability and achievement, based on intelligence quotient (K-BIT) and reading composite (K- TEA) scores. An IQ Composite score of >80 was required on the Kaufman Brief Intelligence Test (K-BIT) for the patient to participate in the study.

The ADHD RS was the primary efficacy measure. The second analysis measured patients' reading performance using the Kaufman Test of Educational Achievement (K-TEA) Reading Decoding, Comprehension and Spelling Subtests and Reading Composite Scale. The Working Memory Test Battery for Children (WMTB- C) and Life Participation Scale Investigator and Parent-Rated versions (LPS-C) were additional secondary measures. The patients were allowed to continue to receive educational services/assistance throughout the study.

Source: Lilly Press Release

Last updated: 10/06

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