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Cited by 17Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentNeuroethics, Human Enhancement, Biomedical Innovations

Effect Size of Lisdexamfetamine Dimesylate in Adults with Attention-Deficit/Hyperactivity Disorder

Wigal, Timothy, Brams, Matthew, Gasior, Maria, Gao, Joseph, Giblin, John·2011·Postgraduate Medicine
DOI 10.3810/pgm.2011.03.2275
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Abstract

OBJECTIVE: To examine duration of efficacy of lisdexamfetamine dimesylate (LDX) in adults with attention-deficit/hyperactivity disorder (ADHD) by effect size in performance and symptom improvement in a simulated adult workplace environment (AWE). METHODS: Adults (aged 18-55 years) with ADHD enrolled in the AWE study of LDX with open-label dose-optimization and randomized, placebo-controlled, double-blind, 2-way crossover phases. Efficacy measures included the Permanent Product Measure of Performance (PERMP)-Attempted (-A) and PERMP-Correct (-C) scores assessed throughout the day and the ADHD Rating Scale IV (ADHD-RS-IV) with adult prompts. Model-based least-squares (LS) mean effect size was assessed for PERMP and post-hoc ADHD-RS-IV with adult prompts. Remission was defined as an ADHD-RS-IV total scores ≤ 18. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. RESULTS: Least-squares mean (standard error [SE]) effect sizes were 0.9 (0.17) for PERMP-A and 0.8 (0.16) for PERMP-C for all postdose sessions. For PERMP-A, postdose LS mean (SE) effect sizes were 0.5 (0.15), 0.8 (0.16), 0.7 (0.16), 0.7 (0.16), 0.7 (0.16), and 0.6 (0.16) at 2, 4, 8, 10, 12, and 14 hours, respectively. Medium-to-large effect sizes (0.5-0.8) were generally maintained from 2 to 14 hours for all PERMP assessments. Overall LS mean (SE) ADHD-RS-IV total and subscale effect sizes were -1.2 (0.19), -1.2 (0.19), and -1.0 (0.17), respectively. Remission was achieved in 67.6% of participants receiving LDX. Treatment-emergent adverse events (≥ 5% with LDX) during the 4-week dose-optimization phase were decreased appetite, dry mouth, headache, insomnia, upper respiratory tract infection, irritability, nausea, anxiety, and feeling jittery. During the crossover week on LDX, there were no TEAEs ≥ 5%. CONCLUSIONS: In adults studied in the AWE, medium-to-large model-based effect sizes were maintained from 2 to 14 hours postdose, on a performance-based measure of productivity, suggesting participants experienced improvement in sustained attention throughout the day and into the evening hours. Lisdexamfetamine dimesylate demonstrated a safety profile consistent with long-acting stimulants.

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  • In the overall study population, mean change from baseline to end point in ADHD-RS-IV total score was −7.8 for patients who received placebo and −17.5 for patients treated with LDX.

    “in the overall study population, the mean change from baseline to end point in ADHD-RS-IV total score was reported at −7.8 for patients who received placebo and −17.5 for patients treated with LDX”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [36]

  • In that post hoc analysis, mean changes at end point from screening ADHD-RS-IV total scores were −5.5 and −14.8 for the 36 participants receiving placebo and LDX.

    “Mean changes at end point from screening ADHD-RS-IV total scores were −5.5 and −14.8 for those 36 participants receiving placebo and LDX”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [36]

  • In a post hoc analysis of the Adler et al trial, of 414 participants, 41 had previously been treated with amphetamines, of which 36 remained symptomatic with ADHD-RS-IV >18 scores at screening.

    “of the 414 participants in the overall study population, 41 had previously been treated with amphetamines; of which 36 remained symptomatic with ADHD-RS-IV >18 scores at screening”

    From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [36]

Cites

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Research works printed but not linked: 5

  1. Adler LA, 2002, J Clin Psychiatry, 63, 29
  2. Adler L, 2009, Prim Psychiatry, 16, 57
  3. Faraone SV, 2008, P & T, 33, 700
  4. Faraone SV, 2009, P&T, 34, 678
  5. Adler LA, 2009, J ADHD Relate Disord, 1, 14

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Authors
Wigal, T., Brams, M., Gasior, M., Gao, J., & Giblin, J.
Affiliations
  • University of California, Irvine (US)
  • Baylor College of Medicine (US)
  • Takeda (United States) (US)
Corresponding author
Wigal, Timothy
ORCID
Brams, Matthew
Venue
Postgraduate Medicine
Publisher
Informa UK Limited
Published
2011-03
Volume
123
Issue
2
Pages
169-176
ISSN
  • 0032-5481 (ISSN-L)
  • 1941-9260
DOI
10.3810/pgm.2011.03.2275
OpenAlex
W2319564505
Cited by
17
References
34
Citations by year
2023: 1 · 2022: 1 · 2018: 2 · 2017: 1 · 2016: 3 · 2015: 2 · 2013: 3 · 2012: 3
FWCI
1.38
Type
journal article
Language
en
Open access
closed
Locations
  • Postgraduate Medicine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
  • Life Sciences › Neuroscience › Cognitive Neuroscience › Neuroethics, Human Enhancement, Biomedical Innovations
Keywords
lisdexamfetamine dimesylate, adult ADHD, effect size, employee performance, symptom remission, treatment-emergent adverse events, dose optimization, stimulant medication, ADHD Rating Scale-IV, sustained efficacy, xerostomia, insomnia, irritability, appetite loss, jitteriness, upper respiratory tract infection
MeSH terms
Lisdexamfetamine Dimesylate, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Double-Blind Method, Female, Humans, Male, Middle Aged, Neuropsychological Tests, Remission Induction, Severity of Illness Index, Treatment Outcome, Cross-Over Studies, Young Adult

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