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Stimulant beats nonstimulant in interim study of ADHD children.

Children with attention-deficit hyperactivity disorder demonstrated greater improvement in symptoms such as hyperactivity, impulsivity, and attention with Concerta than with atomoxetine, according to interim results from the first direct comparison of the two treatments.

Symptom improvement was significantly greater with Concerta than with atomoxetine (Strattera) at each consecutive week of the 3-week study. The magnitude of the difference increased over time.

Stimulant medications such as methylphenidate HCI have been considered the best treatment for ADHD for more than 40 years, but the recent introduction of nonstimulant treatments such as atomoxetine and extended-release formulations like the OROS (osmotic-release oral system) extended-release system used in the once-daily methylphenidate have brought new treatment options to clinicians. The prospective, randomized, open-label study of more than 1,300 children was conducted by more than 300 physicians across the country. It was sponsored by McNeil Pharmaceuticals, the manufacturer of Concerta.

In another study, investigators found that children with ADHD who took once-daily, extended release formulations of Concerta saw greater improvements during the school day than those who took that formulation of Metadate CD. The treatment results, however, were similar between the two groups in the afternoon.

In this multisite study, 184 children aged 6-12 years who had been diagnosed with ADHD were randomized to receive near-equal doses of Metadate, Concerta, or placebo once daily in the morning for 1 week.

On day 7, the children attended a laboratory school where trained observers on attention and deportment rated them over a 12-hour period (Pediatrics [online] 113[3], 2004: http://pediatrics.aappublications.org/cgi/content/full/113/3/e206).

The investigators found that the behavioral effects of Metadate CD were greater than those for Concerta across the day. These findings can help to "guide the selection of the most appropriate once-daily stimulant treatment for the child with ADHD," the investigators said. Celltech Pharmaceuticals Inc., which markets Metadate CD, funded that study.

Jason E. Kemner of McNeil Pharmaceuticals said the most interesting aspect of the Concerta vs. Straterra study is that differences between the two products were seen at the first evaluation, and as the study went along, those differences got larger.

Subjects in the Formal Observation of Concerta Versus Strattera (FOCUS) study were newly diagnosed or inadequately managed on current treatment and had an investigator Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD RS) score of 24 and a Clinical Global Impressions-Severity of Illness (CGI-S) score of 3.

To date, 422 children have been randomized to methylphenidate HCI and 229 to atomoxetine. Medication was initiated and titrated according to each product's package insert. ADHD-RS scores at baseline were similar in the methylphenidate HCI and atomoxetine groups (39.77 vs. 38.87, respectively). The 3-week duration of the study was not a limitation and is a relatively common length for an ADHD trial, said Mr. Kemner, McNeil's manager of outcomes research and health economics.

The results confirm the general impressions of many clinicians about stimulants versus non-stimulants. Dr. David Goodman of the department of psychiatry and behavioral sciences at Johns Hopkins University, Baltimore, said in an interview.

"I'm not sure any clinician is going to be surprised by the outcome. It confirms what they see in practice." Dr. Goodman said. "If you want a quick response and improvement in symptoms for ADHD, then stimulant medications like Concerta are demonstrated effective consistently in research."

BY PATRICE G. W. NORTON

Contributing Writer
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Title Annotation:Child/Adolescent Psychiatry; Attention deficit hyperactivity disorder
Author:Norton, Patrice G.W.
Publication:Clinical Psychiatry News
Geographic Code:1USA
Date:Jun 1, 2004
Words:559
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