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Title: Lisdexamfetamine Dimesylate Effective in Treating Adult Attention-Deficit Hyperactivity Disorder: Presented at AACAP

"Lisdexamfetamine Dimesylate Effective in Treating Adult Attention-Deficit Hyperactivity Disorder: Presented at AACAP"

By Maria Bishop BOSTON, MA -- October 30, 2007 -- Lisdexamfetamine dimesylate (LDX) is significantly more effective than placebo in improving attention-deficit hyperactivity disorder rating scales (ADHD-RS) in adults, according to research presented here at the 54th Annual Meeting of the American Academy of Child & Adolescent Psychiatry (AACAP). This drug has already demonstrated efficacy and safety in children age 6 to 12 years. A 4-week, double-blind study of LDX examined the results in 336 adults (18 to 55 years) with moderate to severe ADHD, who, following a washout period, were randomised to one of four doses of LDX (30 mg/day; 50 mg/day, 70 mg/day) or placebo in a 2:2:2:1 ratio. The ADHD-RS mean decrease in total scores at endpoint was 16.2 in the 30 mg/day group, 17.4 in the 50 mg/day group, and 18.6 in the 70 mg/day group. These differences reached statistical significance ([P <.0001) in all treatment groups. The mean decrease in total ADHD-RS score for the placebo group at endpoint was 8.2, which did not reach significance.

Changes occurred from baseline in ADHD-RS total score at each post-baseline visit, starting at week 1 (P <.001), said lead author Lenard Adler, MD, Associate Professor of Psychiatry, and Director, Neurology and Child & Adolescent Psychiatry, New York University School of Medicine, New York, New York, United States.

At 4 weeks, scores on the Clinical Global Impression (CGI) scale, an investigator-rated evaluation of a subject's baseline severity and improvement over time, showed significant improvements for all LDX groups (over 50% in each group) compared with placebo (P <.01).

The intent-to-treat population consisted of 414 patients, but 71 further subjects (17% LDX, 16% placebo) did not finish the study. Of 358 LDX-treated subjects, 21 discontinued due to adverse events, compared with one placebo-treated subject. Thus, this analysis is on a cohort of 336 subjects.

Resting heart rate was increased in all active doses compared with placebo at 4 weeks, the researchers noted. Two serious adverse events occurred in the LDX groups, but neither was determined to be related to the treatment. The incidence of adverse events in general was highest in the first week of LDX treatment, and subsequently decreased in each following treatment week.

Funding for this study was provided by Shire Pharmaceuticals Group plc.

[Presentation title: Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder: Abstract B34]

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