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Dexmethylphenidate Does Not Present Cardiac Risk to Healthy Children With ADHD: Presented at AACAP

By Maria Bishop

BOSTON, MA -- October 29, 2007 -- Cardiovascular adverse events do not limit treatment with dexmethylphenidate extended release (ER) for otherwise healthy children with attention-deficit hyperactivity disorder (ADHD), according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP).

A randomised, placebo-controlled study of dexmethylphenidate ER reported a safe cardiovascular profile when dosed at up to 30 mg. This 5-week study was led by Thomas Spencer, MD, Assistant Director, Clinical and Research Program in Pediatric Psychopharmacology, Massachusetts General Hospital, Boston, Massachusetts, United States, and results were presented here on October 25.

The sympathomimetic effects of stimulants may alter cardiovascular parameters, and the United States Food & Drug Administration recently required changes to the labelling of stimulants to warn of the possibility of sudden death in patients with underlying serious cardiac abnormalities. Stimulants are considered first-line treatment for ADHD.

After a 1- to 4-week washout screening phase (depending on previous medication), 253 children aged 6 to 12 years old were randomised to one of four treatment arms (1:1:1:1 ratio): dexmethylphenidate ER 30 mg/day; 20 mg/day; 10 mg/day; or placebo. Patients were titrated upwards from 5 mg/day in week 1, and increased weekly by 10 mg/day depending on the treatment arm.

Mean changes in vital signs (systolic/diastolic blood pressure, heart rate) were not clinically relevant in any arm, and were similar to placebo, noted Dr. Spencer. All changes were found to be unrelated to the drug dose.

No serious cardiovascular events were reported, and no patients discontinued or reduced the study drug dose due to cardiovascular adverse events.

Cardiovascular adverse events in general were infrequent in this trial, but appeared more often in the 10-mg and 30-mg groups (3.1% and 3.4%, respectively, for cardiac disorders such as tachycardia, bradycardia and bundle branch block versus 1.7% and 1.6% in the 20-mg and placebo groups, respectively). Flushing, a vascular effect, occurred in one patient in the 20-mg arm.

Baseline demographics and characteristics were comparable in all the groups.

Funding for this study was provided by Novartis Pharmaceuticals Corporation.


[Presentation title: Cardiovascular Safety of Dexmethylphenidate Extended Release in Children With ADHD. Abstract B2]

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