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Efficacy of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder previously treated with amphetamines: analyses from a randomized, double-blind, multicenter, placebo-controlled titration study
Open accessAbstract
BACKGROUND: To examine the efficacy of lisdexamfetamine dimesylate (LDX) in adults with attention-deficit/hyperactivity disorder (ADHD) who remained symptomatic (ADHD Rating Scale IV [ADHD-RS-IV] total score >18) on amphetamine (AMPH) therapy (mixed AMPH salts and/or d-AMPH formulations) prior to enrollment in a 4-week placebo-controlled LDX trial vs the overall study population. In these post hoc analyses from a multicenter, randomized, double-blind, forced-dose titration study, clinical efficacy of LDX (30-70 mg/d) in adults with ADHD receiving AMPH treatment at screening vs the overall study population was evaluated. ADHD symptoms were assessed using the ADHD-RS-IV with adult prompts at screening, baseline (after prior treatment washout), and endpoint. Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, and electrocardiogram. RESULTS: Of 414 participants (62, placebo; 352, LDX) included in the overall study population, 41 were receiving AMPH therapy at screening (2, placebo; 39, LDX); mean AMPH dose was 35.0 and 34.1 mg/d for participants in placebo and all LDX groups, respectively. Of the 41 participants, 36 remained symptomatic (ADHD-RS-IV >18) at screening despite receiving AMPH. For the 36 participants in the placebo (n = 2) and LDX (n = 34) groups, respectively, at endpoint, mean change from screening ADHD-RS-IV total scores were -5.5 and -14.8 and from baseline scores were -13.5 and -17.8. For the overall study population, endpoint mean change from baseline ADHD-RS-IV total scores were -7.8 for placebo and -17.5 for LDX. In the prior AMPH subgroup, 2/2 (100.0%) in the placebo group and 22/39 (56.4%) participants in the LDX (all doses) group reported any TEAE. Events that occurred in ≥5% for LDX were dry mouth (5/39; 12.8%), headache (5/39; 12.8%), fatigue (3/39; 7.7%), insomnia (3/39; 7.7%), decreased appetite (2/39; 5.1%), and nausea (2/39; 5.1%). None of these events occurred in the 2 placebo patients with prior AMPH use. CONCLUSION: In these post hoc analyses, adults with significant baseline ADHD symptoms despite adequate AMPH treatment dose showed similar improvements in ADHD symptoms with LDX treatment as the overall study population. Prospective studies are needed to confirm these findings. The safety profile of LDX in the overall study population was consistent with long-acting psychostimulant use. TRIAL REGISTRY: Study to Assess the Safety and Efficacy of NRP104 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD). Clinicaltrials.gov Identifier: NCT00334880.
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In Waxmonsky et al, LDX was associated with significant reductions in children's negative behaviors and improvements in multiple parenting behaviors adversely affected by ADHD, and significant reductions in parental ADHD symptoms compared with placebo (P < .005).
“In addition to use of LDX being associated with significant reductions in children’s negative behaviors and improvements in multiple parenting behaviors adversely affected by ADHD, significant reductions in parental ADHD symptoms compared with placebo were also observed (P < .005).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [35]
Split into 2 atoms — 0 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 1 unverifiable. Expand the claim to see per-atom verdicts.
Experimental — accuracy not yet measuredIn Waxmonsky et al, reductions in parental verbalizations, moderate increases in parental responsiveness, and reductions in ratio of commands to verbalizations during the non-homework task were not significant.
“Although not significant, there were also reductions in parental verbalizations, moderate increases in parental responsiveness, and reductions in the ratio of commands to verbalizations during the non-homework task.”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [35]
The Results (Other efficacy measures; page unavailable) report ADHD response and remission in adults treated with lisdexamfetamine, not parent–child interactions. Searches for parental verbalizations, responsiveness, command ratios, non-homework tasks, and Waxmonsky found no passage addressing the claim. (LLM, conf=0.78)
Experimental — accuracy not yet measuredIn phase 1 of Waxmonsky et al, there were significant reductions in negative talk by parents (P = .0066) and in children's negative behaviors in the homework phase only (P = .0154).
“In phase 1, there were significant reductions in negative talk by parents (P = .0066) and in children’s negative behaviors in the homework phase only (P = .0154).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [35]
The Results (Primary efficacy measures and Other efficacy measures; page unavailable) report ADHD symptom scores and clinical response in adults treated with lisdexamfetamine. Searches for Waxmonsky, parental negative talk, children’s behavior during homework, and the stated P values found no passage addressing the claim. (LLM, conf=0.76)
Experimental — accuracy not yet measuredIn phase 2 of Waxmonsky et al, there was a statistically significant increase in praise by parents, and reductions in parental commands, and in children's inappropriate behaviors (P < .05 for all).
“In phase 2, there was a statically significant increase in praise by parents, and reductions in parental commands, and in children’s inappropriate behaviors (P < .05, for all).”
From Review of Lisdexamfetamine Dimesylate in Adults With Attention-Deficit/Hyperactivity Disorder (2017) · cites this paper as [35]
The Results (Primary efficacy measures; Other efficacy measures, pages unavailable) report ADHD symptom outcomes in adults treated with lisdexamfetamine, not a phase 2 study of parent–child behavior. Searches for Waxmonsky, parental praise and commands, and children’s inappropriate behavior found no passage reporting the claimed changes or P values. (LLM, conf=0.76)
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“The inactive prodrug is converted, primarily in the blood, to l-lysine and therapeutically active d-AMPH [12].”
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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
Metadata
- Authors
- Babcock, T., Dirks, B., Adeyi, B., & Scheckner, B.
- Affiliations
- Takeda (United States) (US)
- Corresponding author
- Babcock, Thomas
- ORCID
- Dirks, Bryan
- Venue
- BMC Pharmacology and Toxicology
- Published
- 2012-12
- Volume
- 13
- Issue
- 1
- Pages
- 18-18
- ISSN
- 2050-6511 (ISSN-L)
- PMC
- PMC3554536
- OpenAlex
- W2116799993
- Cited by
- 14
- References
- 7
- Citations by year
- 2026: 1 · 2023: 2 · 2022: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 2 · 2014: 4
- FWCI
- 1.37
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Pharmacology and Toxicology (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
- Health Sciences › Medicine › Pharmacology (medical) › Pharmacology and Obesity Treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- lisdexamfetamine dimesylate, adult ADHD, ADHD-RS-IV, treatment-emergent adverse events, xerostomia, headache, cardiovascular safety, electrocardiogram, stimulant efficacy, treatment-emergent mania
- MeSH terms
- Lisdexamfetamine Dimesylate, Adolescent, Adult, Central Nervous System Stimulants, Attention Deficit Disorder with Hyperactivity, Data Interpretation, Statistical, Dextroamphetamine, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Male, Middle Aged, Psychiatric Status Rating Scales, Surveys and Questionnaires, Treatment Outcome, Young Adult, Drug Substitution
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