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Cited by 90Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

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.·2008·CNS Spectrums
DOI 10.1017/s1092852900016898
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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 shortterm 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, singlearm 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 (P<.0001). Improvements occurred during each of the first 4 weeks, and were maintained throughout. Based on Clinical Global Impression-Improvement scale scores, >80% 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.

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Crossref · 10.1017/s1092852900016898

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  • In that follow-up, lisdexamfetamine was well tolerated, and the only adverse effects reported by more than 5% of subjects were insomnia and irritability.

    “Lisdexamfetamine was well tolerated, and the only adverse effects were insomnia and irritability, reported by more than 5% of the subjects.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [19]

  • In Findling et al follow-up of 272 children, improvements in ADHD-RS-IV scores started at one week and were sustained throughout the 11-month dose-maintenance phase.

    “Improvements in ADHD-RS-IV scores started at one week and were sustained throughout the study.”

    From Update on optimal use of lisdexamfetamine in the treatment of ADHD (2013) · cites this paper as [19]

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Authors
Findling, R. L., Childress, A. C., Krishnan, S., & McGough, J. J.
Affiliations
  • University Hospitals of Cleveland (US)
  • Center for Psychiatry and Behavioral Medicine (US)
  • University of California, Los Angeles (US)
ORCID
Venue
CNS Spectrums
Publisher
Cambridge University Press (CUP)
Published
2008-07
Volume
13
Issue
7
Pages
614-620
ISSN
  • 1092-8529 (ISSN-L)
  • 2165-6509
DOI
10.1017/s1092852900016898
OpenAlex
W76668800
Cited by
90
References
1
Citations by year
2026: 2 · 2025: 4 · 2024: 5 · 2023: 2 · 2022: 2 · 2021: 3 · 2020: 3 · 2019: 2 · 2018: 2 · 2017: 3 · 2016: 1 · 2015: 2 · 2014: 10 · 2013: 12 · 2012: 7
FWCI
7.03
Type
journal article
Language
en
Open access
closed
Licence
www.cambridge.org/core/terms (unspecified, 2320 d)
Locations
  • CNS Spectrums (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
lisdexamfetamine dimesylate, attention deficit hyperactivity disorder, children, long-term treatment, stimulant efficacy, tolerability, adverse events, maintenance therapy, ADHD Rating Scale, CGI-I
MeSH terms
Lisdexamfetamine Dimesylate, Administration, Oral, Appetite, Attention Deficit Disorder with Hyperactivity, Child, Dextroamphetamine, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Headache, Humans, Sleep Initiation and Maintenance Disorders, Male, Psychiatric Status Rating Scales, Time Factors, Weight Loss, Treatment Outcome, Diagnostic and Statistical Manual of Mental Disorders

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