By Bryan DeBusk, PhD
MUNICH, Germany -- July 18, 2008 -- The prodrug stimulant lisdexamfetamine (LDX) safely and effectively improves measures of attention-deficit hyperactivity disorder (ADHD) in adults, according to research presented here at the 26th Collegium Internationale Neuro-Psychopharmacologicum (CINP) Congress.
The results were presented in a poster session on July 16 by David Goodman, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland, and Adult Attention Deficit Disorder Centre of Maryland, Lutherville, Maryland.
After a 7- to 28-day washout period, 481 patients (aged 18 to 55 years) with moderate to severe ADHD were randomised to 4 weeks of treatment with LDX at a daily dose of 30 mg (n = 115), 50 mg (n = 117), or 70 mg (n = 120) or to placebo. ADHD Rating Scale (ADHD-RS) scores were well-matched across groups at baseline.
Patients in the LDX groups achieved better scores on the ADHD-RS compared with placebo (30 mg, -16.2; 50 mg, -17.4; 70 mg, -18.6; placebo, -8.2; all P < .0001). No differences were noted among the different dosages of LDX. Improvements were noted as early as 1 week after the start of treatment (30 mg, -12.2; 50 mg, -11.5; 70 mg, -13.4; placebo, -5.7; all P < .0001).
Patients in the LDX group reported decreased appetite (27%), dry mouth (26%), and insomnia (19%). No differences were seen in overall sleep quality between LDX-treated groups and placebo as subjectively measured by the Pittsburgh Sleep Questionnaire at baseline and follow-up. Most patients reported a lessening of adverse effects over the course of the study.
Dr. Goodman expects the results will encourage physicians to consider LDX for adult patients with ADHD. "Hopefully, physicians will acknowledge the validity of adult ADHD and prescribe long-acting, once-daily, low-abuse-potential medications for these patients," he concluded.
Funding for this study was provided by Shire Pharmaceuticals.
[Presentation title: Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder. Abstract P10-15]
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