Effects of Open-Label Lisdexamfetamine Dimesylate on Self-Reported Quality of Life in Adults with ADHD
Abstract
Objective To assess improvements in quality of life measurements during the open-label portion of a trial examining duration of efficacy of lisdexamfetamine dimesylate in a simulated adult workplace environment. Methods A 4-week, open-label, dose-optimization phase followed by a randomized, double-blind, multicenter, placebo-controlled, 2-way crossover phase to evaluate safety and efficacy of lisdexamfetamine dimesylate in the adult workplace environment was conducted. Clinical assessments included the ADHD Impact Module for Adults (AIM-A) to assess the effect of lisdexamfetamine dimesylate on perception of quality of life and the Clinical Global Impressions-Severity/Improvement to assess symptom severity at baseline and improvement over time. Safety assessments included physical examination, treatment-emergent adverse events, vital signs, and electrocardiogram measurements. Results Questions 1 and 4 of the AIM-A suggest improvement from baseline in overall quality of life at week 4 with lisdexamfetamine dimesylate treatment. Post-hoc analysis revealed no significant differences attributable to either age or sex. Overall responses to questions 2 and 3, which related to overall life goals, did not change in a majority of participants during the 4-week open-label phase of this study. For all lisdexamfetamine dimesylate doses combined, treatment-emergent adverse events occurring in ≥ 5% of participants during the dose-optimization phase were decreased appetite (36.6%), dry mouth…
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A post hoc analysis of the Wigal et al trial noted least squares mean effect sizes of 0.9 for PERMP-A and 0.8 for PERMP-C for all post dose sessions, and medium to large effect sizes with LDX were maintained from 2 to 14 hours for all PERMP assessments.
“A post hoc analysis of this study noted LS mean effect sizes of 0.9 for PERMP-A and 0.8 for PERMP-C for all post dose sessions, and medium to large effect sizes with LDX were maintained from 2 to 14 hours for all PERMP assessments.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [37]
LDX demonstrated efficacy in QOL as assessed by AIM-A.
“Moreover, LDX demonstrated efficacy in QOL as assessed by AIM-A [31].”
Pooled analyses from two published 12-week open-label trials of psychostimulant medications in children and adolescents and a 4-week trial in adults reported improved QOL after treatment.
“Similarly, pooled analyses from two published 12 week open-label trials examining psychostimulant medications in children and adolescents (Berek et al. 2011) and a 4 week trial in adults (Brams et al. 2011) reported improved QOL after treatment.”
From Participant-Perceived Quality of Life in a Long-Term, Open-Label Trial of Lisdexamfetamine Dimesylate in Adolescents with Attention-Deficit/Hyperactivity Disorder (2014) · cites this paper as Brams et al. 2011
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Self-citation
- Authors
- Brams, M., Giblin, J., Gasior, M., Gao, J., & Wigal, T.
- Affiliations
- Takeda (United States) (US)
- University of California, Irvine (US)
- Corresponding author
- Brams, Matthew
- ORCID
- Brams, Matthew
- Venue
- Postgraduate Medicine
- Publisher
- Informa UK Limited
- Published
- 2011-05
- Volume
- 123
- Issue
- 3
- Pages
- 99-108
- ISSN
- 0032-5481 (ISSN-L)
- 1941-9260
- OpenAlex
- W2109605723
- Semantic Scholar
- 130fdaa4618c998b045d508f80e7fd96525440d6
- Cited by
- 15
- References
- 27
- Citations by year
- 2025: 2 · 2020: 1 · 2017: 4 · 2016: 1 · 2015: 2 · 2014: 2 · 2013: 1 · 2012: 1
- FWCI
- 0.98
- 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, quality of life, long-acting stimulants, dose optimization, treatment-emergent adverse events, work environment
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life, Workplace, Cross-Over Studies, Young Adult, Self Report
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