Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

Robert L Findling, Ann C. Childress, Suma Krishnan, James J. McGough

Research output: Contribution to journalArticle

Abstract

Introduction: Lisdexamfetamine dimesylate (LDX), a prodrug stimulant, is indicated for attention-deficit/hyperactivity disorder (ADHD) in children 6-12 years of age and in adults. In short-term studies, once-daily LDX provided efficacy throughout the day. This study presented here was conducted to assess the long-term safety, tolerability, and effectiveness of LDX in 6- to 12-year-olds with ADHD. Methods: This open-label, multicenter, single-arm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for ADHD. Following 1-week screening and washout periods, subjects were titrated to LDX 30, 50, or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months. The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness. Results: Of 272 subjects receiving LDX, 147 completed the study. Most adverse events were mild to moderate and occurred during the first 4 weeks. There were no clinically meaningful changes in blood pressure or electrocardiographic parameters. From baseline to endpoint, mean ADHD Rating Scale scores improved by 27.2 points (P80% of subjects at endpoint and >95% of completers at 12 months were rated "improved." Conclusion: Long-term 30, 50, and 70 mg/day LDX was generally well tolerated and effective in children with ADHD.

Original languageEnglish (US)
Pages (from-to)614-620
Number of pages7
JournalCNS Spectrums
Volume13
Issue number7
StatePublished - Jul 2008
Externally publishedYes

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Attention Deficit Disorder with Hyperactivity
Safety
Prodrugs
Diagnostic and Statistical Manual of Mental Disorders
Lisdexamfetamine Dimesylate
Blood Pressure

ASJC Scopus subject areas

  • Neuropsychology and Physiological Psychology

Cite this

Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. / Findling, Robert L; Childress, Ann C.; Krishnan, Suma; McGough, James J.

In: CNS Spectrums, Vol. 13, No. 7, 07.2008, p. 614-620.

Research output: Contribution to journalArticle

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