Long-term treatment outcomes with lisdexamfetamine dimesylate for adults with attention-deficit/hyperactivity disorder stratified by baseline severity
Abstract
Objective To examine the impact of baseline severity on lisdexamfetamine dimesylate (LDX) efficacy in a long-term study of adults with attention-deficit/hyperactivity disorder (ADHD). Research design and methods Adults from a 4-week, placebo-controlled, forced dose-escalation study with LDX (30-70 mg/day) or placebo were enrolled in a long-term, open-label dose-optimization study for an additional 12 months. In post hoc analyses, participants were stratified by baseline severity (from the prior short-term study) with Clinical Global Impressions-Severity (CGI-S) scores of 4 (moderately), 5 (markedly), or ≥6 (severely/extremely ill). ADHD-Rating Scale IV (ADHD-RS-IV) with adult prompts (primary) and CGI-Improvement (CGI-I) were used to assess effectiveness. Clinical response was defined as a ≥30% decrease in ADHD-RS-IV from baseline and a CGI-I of 1 or 2; symptomatic remission was defined as ADHD-RS-IV ≤18. Treatment-emergent adverse events (TEAEs) were monitored. Results Participants had baseline CGI-S scores of 4 (n = 114), 5 (n = 188), or ≥6 (n = 43). At endpoint, mean (SD) change from baseline in ADHD-RS-IV was greater (p Conclusions Some aspects of these analyses (e.g., open-label design without placebo control, inclusion and exclusion criteria of the demographic profile of participants, and the post hoc nature of the statistical analysis) limit interpretation. However, long-term LDX treatment demonstrated increased degree of symptom improvement with greater baseline sympt…
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In that post hoc analysis, for AAQoL, the least squares mean difference for total score was 21, and improvement was observed from baseline with LDX compared with placebo for all AAQoL subscales.
“for AAQoL, the least squares (LS) mean difference for total score was 21, and improvement was observed from baseline with LDX compared with placebo for all AAQoL subscales”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [33]
In a post hoc analysis of the 10-week Adler et al trial, LDX compared with placebo produced significant improvements in AIM-A scores in subscales of Performance and Daily Functioning, Impact of Symptoms: Daily Interference, Impact of Symptoms: Bother/Concern, Relationships/Communications, Living with ADHD, and General Well-Being.
“there were significant improvements in AIM-A scores with treatment of LDX compared with placebo in subscales of Performance and Daily Functioning, Impact of Symptoms: Daily Interference, Impact of Symptoms: Bother/Concern, and Relationships/Communications, Living with ADHD, and General Well-Being (P ≤ .0302).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [33]
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Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder
Najib, J., Wimer, D., Zeng, J., Lam, K. W., Romanyak, N., Paige Morgan, E., & Thadavila, A. (2017) · Journal of Central Nervous System Disease · doi:10.1177/1179573517728090 · Cited by 17 · see citing works
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Self-citation
- Authors
- Ginsberg, L., Katic, A., Adeyi, B., Dirks, B., Babcock, T., Lasser, R., Scheckner, B., & Adler, L. A.
- Affiliations
- Red Oak Psychiatry Associates, PA, Houston, TX, USA
- Claghorn Lesem Research Clinic (US)
- Shire Development Inc., Wayne, PA, USA
- VA NY Harbor Healthcare System (US)
- Corresponding author
- Ginsberg, Lawrence
- Venue
- Current Medical Research and Opinion
- Publisher
- Informa Healthcare
- Published
- 2011-03-28
- Volume
- 27
- Issue
- 6
- Pages
- 1097-1107
- ISSN
- 0300-7995 (ISSN-L)
- 1473-4877
- OpenAlex
- W2056601230
- Cited by
- 26
- References
- 12
- Citations by year
- 2025: 1 · 2024: 1 · 2023: 2 · 2022: 3 · 2021: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 2 · 2015: 1 · 2014: 4 · 2013: 3 · 2012: 3
- FWCI
- 2.64
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Current Medical Research and Opinion (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Keywords
- lisdexamfetamine dimesylate, adult ADHD, baseline severity, long-term treatment outcomes, symptom remission, clinical response, dose optimization, treatment-emergent adverse events, stimulant efficacy, ADHD-RS-IV, ADHD medication, safety and tolerability, open-label extension, treatment discontinuation
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adult, Attention Deficit Disorder with Hyperactivity, Dextroamphetamine, Female, Humans, Male, Middle Aged, Severity of Illness Index, Treatment Outcome, Young Adult
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