Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder

doi:10.1016/j.jaac.2011.01.007

Journal of the American Academy of Child & Adolescent Psychiatry

Volume 50, Issue 4, April 2011, Pages 395-405

https://doi.org/10.1016/j.jaac.2011.01.007 Get rights and content

Objective

To examine lisdexamfetamine dimesylate (LDX) efficacy and safety versus placebo in adolescents with attention-deficit/hyperactivity disorder (ADHD).

Method

Adolescents (13 through 17) with at least moderately symptomatic ADHD (ADHD Rating Scale IV: Clinician Version [ADHD-RS-IV] score ≥28) were randomized to placebo or LDX (30, 50, or 70 mg/d) in a 4-week, forced-dose titration, double-blind study. Primary and secondary efficacy measures were the ADHD-RS-IV, Clinical Global Impressions–Improvement (CGI-I), and Youth QOL–Research Version (YQOL-R). Safety assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical examinations, and ECG.

Results

Overall, 314 participants were randomized; 309 were in efficacy analyses and 49 withdrew (11 due to TEAEs). Least squares mean (SE) change from baseline at endpoint in ADHD-RS-IV total scores were −18.3 (1.25), −21.1 (1.28), −20.7 (1.25) for 30, 50, and 70 mg/d LDX, respectively; −12.8 (1.25) for placebo (p ≤ .0056 versus placebo for each). Differences in ADHD-RS-IV total scores favored all LDX doses versus placebo at all weeks (p ≤ .0076). On the CGI-I, 69.1% of participants were rated very much/much improved at endpoint with LDX all doses versus placebo (39.5%) (p < .0001). YQOL-R changes at endpoint scores for LDX groups versus placebo were not significant. Commonly reported LDX (all doses combined) TEAEs (≥5%) were decreased appetite, headache, insomnia, decreased weight, and irritability. Small mean increases in pulse and blood pressure and no clinically meaningful trends in ECG changes were noted with LDX.

Conclusions

LDX at all doses was effective versus placebo in treating adolescent ADHD and demonstrated a safety profile consistent with previous LDX studies.

Clinical trials registry information

Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD); http://www.clinicaltrials.gov; NCT00735371.

Section snippets

Study Design

This was a 4-week, randomized, double-blind, multicenter (45 US sites), parallel-group, placebo-controlled, forced-dose titration efficacy and safety study in adolescents (13 through 17 years) with an ADHD primary diagnosis by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria.²¹ The study was initiated on October 8, 2008 and completed on April 6, 2009 and conducted in accordance with the Declaration of Helsinki and Good Clinical Practice

Participant Disposition

Overall, 314 participants were enrolled and randomized, 309 were included in the efficacy analyses (FAS), and 310 received at least one dose of study medication and were included in the safety population. The modal number of participants per study site for the 45 sites was 8; the range in number of participants per site was one to 16. A total of 49 participants (15.6%) were discontinued from all treatment groups (Figure 1). Five participants with pretreatment ECG abnormalities were discontinued

Discussion

In this large, randomized, double-blind, multicenter, parallel-group, 4-week, placebo-controlled, forced-dose titration study, LDX was effective versus placebo in reducing ADHD-RS-IV total and subscale scores in adolescents with ADHD, indicative of clinical improvement. At endpoint, mean changes for each LDX dose in the ADHD-RS-IV total score (primary efficacy result) and CGI-I were statistically significant versus placebo. Symptoms were significantly improved in each LDX dose group versus

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Though behavior therapy (BT) for ADHD in adolescence is evidence-based, almost no work examines its implementation and effectiveness in community settings. A recent randomized community-based trial of an evidence-based BT for adolescent ADHD (Supporting Teens’ Autonomy Daily; STAND; N = 278) reported high clinician, parent, and youth acceptability but variable implementation fidelity. Primary outcome analyses suggested no significant differences between STAND and usual care (UC) unless the clinician delivering STAND was licensed. The present study reports secondary outcomes for this trial on indices of comorbidity (anxiety, depression, oppositional defiant disorder, conduct disorder) and ADHD outcomes not targeted by the active treatment (social skills, sluggish cognitive tempo). We also examine whether therapist licensure moderated treatment effects (as in primary outcome analyses). Using intent-to-treat and per protocol linear mixed models, patients randomized to STAND were compared to those randomized to UC over approximately 10 months of follow-up. Group × Time effects revealed that, overall, STAND did not outperform usual care when implemented by community clinicians. However, a Group × Time × Licensure interaction revealed a significant effect on conduct problems when STAND was delivered by licensed clinicians (d = .19–.47). When delivered in community settings, behavior therapy for adolescent ADHD can outperform UC with respect to conduct problems reduction. Community mental health clinics should consider: (1) assigning adolescent ADHD cases to licensed professionals to maximize impact and (2) choosing psychosocial approaches when ADHD presents with comorbid conduct problems. There is also a need to reduce implementation barriers for unlicensed clinicians in community settings.
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Childhood attention-deficit/hyperactivity disorder (ADHD) is a risk factor for substance misuse and substance use disorder (SUD) in adolescence and (early) adulthood. ADHD and SUD also frequently co-occur in treatment-seeking adolescents, which complicates diagnosis and treatment and is associated with poor treatment outcomes. Research on the effect of treatment of childhood ADHD on the prevention of adolescent SUD is inconclusive, and studies on the diagnosis and treatment of adolescents with ADHD and SUD are scarce. Thus, the available evidence is generally not sufficient to justify robust treatment recommendations.
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Efficacy and Safety of Lisdexamfetamine in Preschool Children With Attention-Deficit/Hyperactivity Disorder
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Citation Excerpt :
The most consistent vital sign change observed in this study and across other LDX pediatric studies is increased pulse22-25; however, in the phase 2, open-label LDX study in children aged 4 to 5 years, a small decrease in pulse was observed.15 Regarding BP, greater mean increases from baseline were observed with LDX vs PBO in some studies24,25 (as in the current study), but no meaningful differences between LDX and PBO were observed in other studies.22,23 Despite this variability, the possibility of adverse effects of LDX on vital signs in pediatric populations warrants regular monitoring.
To evaluate the acute efficacy, safety, and tolerability of lisdexamfetamine dimesylate (LDX) vs placebo (PBO) in preschool-aged children with attention-deficit/hyperactivity disorder (ADHD).
This phase 3, double-blind, fixed-dose study randomly assigned children (aged 4-5 years) with ADHD to 6 weeks of LDX (5, 10, 20, 30 mg) or PBO. The prespecified primary (change from baseline at week 6 in ADHD Rating Scale IV, Preschool version, total score [ADHD-RS-IV-PS-TS]) and key secondary (Clinical Global Impression–Improvement [CGI-I] score at week 6) efficacy endpoints were assessed using linear mixed-effects models for repeated measures. Safety and tolerability assessments included treatment-emergent adverse events (TEAEs) and changes in pulse and blood pressure (BP).
The study comprised 199 participants randomly asigned 5:5:5:5:6 to receive 5, 10, 20, 30 mg LDX or PBO, respectively. Least squares (LS) mean (95% CI) treatment difference at week 6 between pooled LDX (10, 20, 30 mg) and PBO was statistically significant for ADHD-RS-IV-PS-TS change (–5.9 [–11.01, –0.78], p = .0242; effect size [ES], –0.43). CGI-I scores improved (ie, 1-2 on CGI-I) in 41.7% for pooled LDX and 24.3% for PBO (p = .0857). The LS mean (95% CI) treatment difference between pooled LDX and PBO for CGI-I score at week 6 was –0.6 (–1.03, –0.16; p = .0074; ES, –0.52). Frequency of TEAEs was 46.6% across all 4 LDX doses vs 42.2% with PBO; the most frequent TEAEs were decreased appetite (13.7% vs 8.9%, respectively) and irritability (9.6% vs 0%). Discontinuations because of TEAEs were 5.5% for all LDX doses and 4.4% for PBO. Mean ± SD pulse/BP changes from baseline at week 6/early termination were numerically greater with LDX vs PBO (pulse beats/min: 2.7 ± 10.79 vs 1.2 ± 9.90; systolic BP, mm Hg: 1.0 ± 7.51 vs 0.3 ± 6.06; diastolic BP, mm Hg: 1.7 ± 5.90 vs 0.0 ± 6.88).
In children aged 4 to 5 years with ADHD, LDX was more efficacious than PBO in reducing symptoms. The observed ES for change in ADHD-RS-IV-PS-TS appears to be smaller in magnitude than has been reported for studies of LDX conducted in older children and adolescents. LDX was generally well tolerated, and no new safety signals were identified.
Safety and Efficacy Study in Preschool Children Aged 4–5 Years With Attention-Deficit/Hyperactivity Disorder; http://www.clinicaltrials.gov; NCT03260205.
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The most common top problems reported in the sample were social isolation (parent-report: 26.7%; self-report: 41.5%), difficulties engaging in online learning (parent-report: 23.3%, self-report: 20.3%), motivation problems (parent-report: 27.9%), and boredom (self-report: 21.3%). According to parent (d = 0.98) and self-report (d = 1.33), these top problems were more severe during the pandemic than in prior months. Contrary to previous speculation, there was no evidence that pandemic-related changes mitigated ADHD severity. Multi-level models indicated that A/YAs with higher IQs experienced severer top problems exacerbations at the transition to the COVID-19 pandemic.
For A/YAs with ADHD, several risk factors for depression and school dropout were incurred during the early months of the COVID-19 pandemic. A/YAs with ADHD should be monitored for school disengagement and depressive symptoms during the COVID-19 pandemic. Recommended interventions attend to reducing risk factors such as increasing social interaction, academic motivation, and behavioral activation among A/YAs with ADHD.
Effects of lisdexamfetamine on plasma steroid concentrations compared with D-amphetamine in healthy subjects: A randomized, double-blind, placebo-controlled study
2019, Journal of Steroid Biochemistry and Molecular Biology
The novel d-amphetamine prodrug lisdexamfetamine is applied to treat attention-deficit/hyperactivity disorder (ADHD). d-Amphetamine releases dopamine and norepinephrine and stimulates the hypothalamic-pituitary-adrenal (HPA) axis, which may contribute to its reinforcing effects and risk of abuse. However, no data is currently available on the effects of lisdexamfetamine on circulating steroids. This randomized, double-blind, placebo-controlled, cross-over study evaluated the effects of equimolar doses of d-amphetamine (40 mg) and lisdexamfetamine (100 mg) and placebo on circulating steroids in 24 healthy subjects. Plasma steroid and d-amphetamine levels were determined up to 24 h. Delayed increase and peak levels of plasma d-amphetamine concentrations were observed following lisdexamfetamine treatment compared with d-amphetamine administration, however the maximal concentrations and total exposure (area under the curve [AUC]) were similar. Lisdexamfetamine and d-amphetamine significantly enhanced plasma levels of adrenocorticotropic hormone, glucocorticoids (cortisol, cortisone, corticosterone, 11-dehydrocorticosterone, and 11-deoxycortisol), androgens (dehydroepiandrosterone, dehydroepiandrosterone sulfate, and Δ4-androstene-3,17-dione [androstenedione]), and progesterone (only in men) compared with placebo. Steroid concentration-time curves were shifted to later time points due to a non-significantly later onset following lisdexamfetamine administration than after d-amphetamine, however maximal plasma steroid concentrations and AUCs did not differ between the active treatments. None of the active treatments altered plasma levels of the mineralocorticoids aldosterone and 11-deoxycorticosterone or the androgen testosterone compared with placebo. The effects of the amphetamines on glucocorticoid production were similar to those that were previously reported for methylphenidate (60 mg) but weaker than those for the serotonin releaser 3,4-methylenedioxymethamphetamine (MDMA; 125 mg) or direct serotonin receptor agonist lysergic acid diethylamide (LSD; 0.2 mg). Lisdexamfetamine produced comparable HPA axis activation and had similar pharmacokinetics than d-amphetamine, except for a delayed time of onset. Thus, serotonin (MDMA, LSD) may more effectively stimulate the HPA axis than dopamine and norepinephrine (D-amphetamine).

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: Clinical research was funded by the sponsor, Shire Development Inc.

: Shire Development Inc. provided funding to Ogilvy CommonHealth Scientific Communications (OCHSC) for support in writing and editing this manuscript. Michael McKay, M.B.A., from Shire Development Inc. coordinated the management of the study. Under the direction of the authors, Huda Ismail Abdullah, Ph.D., and Michael Pucci, Ph.D., employees of OCHSC provided writing assistance for this publication. Editorial assistance in formatting, proofreading, copy editing, and fact checking was provided by Mary Ann McAdams, an employee of OCHSC. Brian Scheckner, Pharm.D., Thomas Babcock, D.O., and Bryan Dirks, M.D., from Shire Development Inc. also reviewed and edited the manuscript for scientific accuracy. Although the sponsor was involved in the design, collection, analysis, interpretation, and fact checking of information, the content of this manuscript, the ultimate interpretation, and the decision to submit it for publication in Journal of the American Academy of Child & Adolescent Psychiatry were made by the authors independently.

: Disclosure: Dr. Findling has received research support, served as a consultant and/or served on a speaker's bureau for Abbott, Addrenex, AstraZeneca, Biovail, Bristol-Myers Squibb, Eli Lilly and Co., Forest, GlaxoSmithKline, Johnson and Johnson, KemPharm, Lundbeck, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer, Rhodes Pharmaceuticals, Sanofi-Aventis, Schering-Plough, Seaside Therapeutics, Sepracor, Shire, Solvay, Sunovion, Supernus Pharmaceuticals, Validus, and Wyeth. Dr. Childress has received research support and served as a consultant and/or on the speakers' bureau for Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Johnson and Johnson Pharmaceutical Research and Development, LLC, Lilly USA, LLC, NextWave, Novartis, Ortho-McNeill Janssen Scientific Affairs, Sepracor, Shire, and Somerset. Dr. Cutler has received research support, served as a consultant and/or on the speakers' bureau, and participated in a CME advisory board for Abbott, Addrenex, AstraZeneca, Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Janssen, Jazz Pharmaceuticals, Johnson and Johnson PRD, Eli Lilly and Co., McNeil Pharmaceuticals, Memory Pharmaceuticals, Merck, Neuroscience Education Institute, Novartis, Ortho-McNeil, Otsuka, Pfizer, Sanofi (including Sanofi-Synthelabo, Sanofi-Aventis), Shionogi, Sepracor, Shire, Solvay, Supernus, and Targacept. Dr. Gasior is an employee of Shire and holds stock and/or stock options in Shire. Mr. Hamdani is an employee of Shire and holds stock and/or stock options in Shire. Dr. Ferreira-Cornwell is an employee of Shire and holds stock and/or stock options in Shire. Dr. Squires is an employee of Shire and holds stock and/or stock options in Johnson and Johnson, Pfizer, and Shire.

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New researchEfficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder

Objective

Method

Results

Conclusions

Clinical trials registry information

Section snippets

Study Design

Participant Disposition

Discussion

Pediatr Clin North Am

J Am Acad Child Adolesc Psychiatry

Prim Care

J Am Acad Child Adolesc Psychiatry

J Am Acad Child Adolesc Psychiatry

Clin Ther

Biol Psychiatry

J Adolesc

J Adolesc

J Am Acad Child Adolesc Psychiatry

J Am Acad Child Adolesc Psychiatry

Diagnosis of attention deficit/hyperactivity disorderTechnical review 3

Safety, efficacy and extended duration of action of mixed amphetamine salts extended-release capsules for the treatment of ADHD

Expert Opin Pharmacother

Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder

Pediatrics

The worldwide prevalence of ADHD: a systematic review and metaregression analysis

Am J Psychiatry

Overview of epidemiology, clinical features, genetics, neurobiology, and prognosis of adolescent attention-deficit/hyperactivity disorder

Adolesc Med State Art Rev

The effect of ADHD on the life of an individual, their family, and community from preschool to adult life

Arch Dis Child

Absorption of lisdexamfetamine dimesylate and its enzymatic conversion to d-amphetamine

Neuropsychiatr Dis Treat

Long-term effectiveness and safety of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder

CNS Spectr

New research
Efficacy and Safety of Lisdexamfetamine Dimesylate in Adolescents With Attention-Deficit/Hyperactivity Disorder