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Cited by 40Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

The efficacy and safety profile of lisdexamfetamine dimesylate, a prodrug of d-amphetamine, for the treatment of attention-deficit/hyperactivity disorder in children and adults

Najib, Jadwiga·2009·Clinical Therapeutics
DOI 10.1016/j.clinthera.2009.01.015
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Abstract

Background Lisdexamfetamine dimesylate (LDX) is a once-daily medication approved by the US Food and Drug Administration for the management of attention-deficit/hyperactivity disorder (ADHD) in children (aged 6-12 years) and adults.Objective This article reviews the pharmacologic and pharmacokinetic properties, clinical efficacy, and safety profile of LDX.Methods Studies, abstracts, reviews, and consensus statements published in English were identified through computerized searches of MEDLINE (1966-August 2008) and International Pharmaceutical Abstracts (1977-August 2008) using search headings lisdexamfetamine dimesylate, attention-deficit/hyperactivity disorder, NRP 104, NRP104-201, NRP104-301, NRP104-302, NRP104-303, and stimulant. Selected information provided by the manufacturer of LDX was included, as were all pertinent clinical trials. The reference lists of identified articles were also searched for pertinent information. Relevant abstracts presented at annual professional meetings were included as well.Results Several studies have evaluated the pharmacokinetics of LDX in pediatric patients (6-12 years of age) and healthy adults with ADHD. LDX, a prodrug that is therapeutically inactive until metabolized in the body to dextroamphetamine (d-amphetamine), follows linear pharmacokinetics at therapeutic doses (30-70 mg). The efficacy of LDX in the treatment of ADHD was established on the basis of 1 long-term and 2 short-term controlled clinical trials in children who met Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision, criteria for ADHD (either the combined or the hyperactive-impulsive subtype) and in 1 clinical trial with adults with ADHD. The efficacy trials in children found significant improvements in scores on the Swanson, Kotkin, Agler, M-Flynn, and Pelham deportment sub-scales, the Permanent Product Measure of Performance (Attempted and Correct), and the ADHD Rating Scale Version IV (ADHD-RS-IV) compared with placebo (all, P < 0.001). In the clinical studies designed to measure duration of effect, LDX, compared with placebo, provided efficacy for a full treatment day, up through and including 6 PM, based on parent ratings (Conners' Parent Rating Scale-Revised Short Form) in the morning, afternoon, and early evening (all, P < 0.001). Data from a long-term, open-label extension study that assessed the safety, tolerability, and efficacy of LDX for up to 12 months found LDX treatment resulted in significant improvement (>60%) from baseline in the ADHD-RS-IV at end point (P < 0.001), with good tolerability. The trial in adults found significant improvements in ADHD-RS scores at end point in patients receiving LDX (30,50, and 70 mg) (P < 0.001 for all active doses); significant improvements in ADHD-RS (using adult prompts) scores were observed at each postbaseline weekly assessment, with improvements noted within the first week in all active treatment arms. Results from human abuse liability studies noted that LDX had lower abuse-related drug-liking scores compared with immediate-release d-amphetamine at equivalent doses. The most common adverse events reported with LDX were typical of amphetamine products and included decreased appetite, insomnia, upper abdominal pain, headache, irritability, weight loss, and nausea.Conclusions Current evidence supports the efficacy and tolerability of LDX as a treatment option for the management of children (aged 6-12 years) and adults with ADHD. As such, LDX may be an integral part of a total treatment program for ADHD that can include other measures such as psychological, educational, and social interventions.

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  • LDX is not affected by variations in absorption related to changes in normal gastrointestinal transit times or variations in gastric pH.

    “Lisdexamfetamine dimesylate is not affected by variations in absorption related to changes in normal gastrointestinal transit times or variations in gastric pH.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [20]

  • In Ermer et al, no vital sign differences were noted between men and women, and no trends in pulse or blood pressure changes were observed according to age.

    “No vital sign differences were noted between men and women, and no trends in pulse or blood pressure changes were observed according to age.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [20]

  • In Ermer et al, 12 hours post dose, mean changes from time-matched baseline systolic and diastolic blood pressure were noted in participants aged 55 to 64 years (−3.9 to 18.5 mm Hg; −2.5 to 8.3 mm Hg), 65 to 74 years (−2.1 to 14.5 mm Hg; −0.8 to 9.4 mm Hg), and ≥75 years (−5.9 to 16.0 mm Hg; −0.6 to 9.5 mm Hg).

    “Likewise, 12 hours post dose, the following mean changes from time-matched baseline systolic and diastolic blood pressure, respectively, were noted in participants aged 55 to 64 years (−3.9 to 18.5 mm Hg; −2.5 to 8.3 mm Hg), 65 to 74 years (−2.1 to 14.5 mm Hg; −0.8 to 9.4 mm Hg), and ≥75 years (−5.9 to 16.0 mm Hg; −0.6 to 9.5 mm Hg).”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [20]

  • Ermer et al evaluated safety of LDX in healthy older adults and noted the drug's safety profile was consistent with prior data in healthy younger adults aged 18 to 55 years.

    “Ermer et al20 evaluated the safety of LDX in healthy older adults and noted that the drug’s safety profile was consistent with prior data in healthy younger adults aged 18 to 55 years.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [20]

  • In Ermer et al, mean change from baseline pulse ranged from −5.0 to 14.7, −4.3 to 9.5, and −3.0 to 14.7 beats per minute in participants aged 55 to 64, 65 to 74, and ≥75 years, respectively.

    “The mean change from baseline pulse ranged from −5.0 to 14.7, −4.3 to 9.5, and −3.0 to 14.7 beats per minute in participants aged 55 to 64, 65 to 74, and ≥75 years, respectively.”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [20]

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Authors
Najib, J.
Affiliations
Long Island University (US)
Corresponding author
Najib, Jadwiga
Venue
Clinical Therapeutics
Publisher
Elsevier BV
Published
2009-01
Volume
31
Issue
1
Pages
142-176
ISSN
0149-2918 (ISSN-L)
DOI
10.1016/j.clinthera.2009.01.015
OpenAlex
W2012332062
Cited by
40
References
80
Citations by year
2026: 1 · 2025: 2 · 2024: 4 · 2023: 1 · 2020: 1 · 2019: 1 · 2017: 2 · 2016: 3 · 2015: 3 · 2014: 4 · 2013: 3 · 2012: 4
FWCI
0.63
Type
journal article
Language
en
Open access
closed
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Clinical Therapeutics (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, prodrugs, d-amphetamine, pharmacokinetics, stimulant medication, clinical efficacy, safety profile, adverse effects, children, adults, long-term treatment, duration of effect, ADHD Rating Scale
MeSH terms
Lisdexamfetamine Dimesylate, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Child, Clinical Trials as Topic, Dextroamphetamine, Dose-Response Relationship, Drug, Humans, Prodrugs, Substance-Related Disorders

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