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Cited by 23Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Comparative efficacy, acceptability, and tolerability of lisdexamfetamine in child and adolescent ADHD: a meta-analysis of randomized, controlled trials

Open access
Maneeton, Narong, Maneeton, Benchalak, Likhitsatian, Surinporn, Suttajit, Sirijit, Narkpongphun, Assawin, Srisurapanont, Manit, Woottiluk, Pakapan·2015·Drug Design, Development and Therapy
DOI 10.2147/dddt.s79071PMC PMC4389815
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Abstract

BACKGROUND: Several studies have shown that lisdexamfetamine (LDX) is efficacious in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). OBJECTIVES: Aims of this study were to systematically review the efficacy, acceptability, and tolerability of LDX in child and adolescent ADHD. Any randomized controlled trials (RCTs) of LDX versus placebo carried out in children and adolescents with ADHD were included. DATA SOURCES: The searches of the SCOPUS, MEDLINE, CINAHL and Cochrane Controlled Trials Register were performed in September 2014. Additional searches in the ClinicalTrials. gov and EU Clinical Trials Register database were conducted. STUDY ELIGIBILITY CRITERIA PARTICIPANTS AND INTERVENTIONS: This review included all RCTs of LDX versus placebo which were carried out in children and adolescents up to 18 years old. Additionally, the included studies must have reported the final outcomes of: i) severity of ADHD symptoms with standardized scales, ii) rates of improvement, iii) rates of discontinuation. To be more thorough, the languages of such RCTs were not limited. STUDY APPRAISAL AND SYNTHESIS METHODS: The abstracts from databases were inspected and the full text versions of relevant trials were examined and extracted for important outcomes. The efficacious measurements included either the pooled mean end-point or changed scores of ADHD rating scales, and the rate of improvement. Acceptability and tolerability were measured by the pooled overall discontinuation rate and the pooled discontinuation rate due to adverse events, respectively. A random effect model technique was utilized to synthesize the mean differences (either standardized mean differences or weighted mean differences) and relative risks (RRs) with 95% confidence intervals (CIs). RESULTS: A total of 1,016 children and adolescents with ADHD were included. The dosage of LDX was 30 to 70 mg/day. The pooled mean change scores of LDX-treated group was significantly greater than that of the placebo (weighted mean difference [95% CI] of -15.20 [-19.95, -10.46], I (2)=94%). The pooled improvement rate of the LDX-treated group was also significantly higher than that of the placebo (RR [95% CI] of 0.34 [0.24, 0.47], I (2)=80%). The pooled overall discontinuation rate between the two groups was not significantly different (RR [95% CI] of 0.78 [0.46, 1.31], I (2)=63%). Similarly, the pooled discontinuation rate due to adverse events between the two groups showed no significant difference (RR [95% CI] of 1.99 [0.70, 5.64], I (2)=0%). LIMITATIONS: The number of included studies was limited (five RCTs). CONCLUSION: According to the present review, LDX was effective and well-tolerated in the treatment of child and adolescent ADHD. Unfortunately, the acceptability of LDX was not better than the placebo. Since the number of included studies was limited, the outcome from this review should be carefully interpreted and considered as preliminary. Further studies, therefore, should be conducted to confirm these findings. IMPLICATION OF KEY FINDINGS: Lisdexamfetamine is an efficacious stimulant for treating child and adolescent ADHD.

AI snapshot

Written from the paper’s full text.

TL;DR

In a meta-analysis of five RCTs including 1,016 children and adolescents with ADHD, lisdexamfetamine (LDX) 30–70 mg/day was more efficacious than placebo on ADHD symptom change and improvement rates. Acceptability and tolerability, measured by overall discontinuation and discontinuation due to adverse events, did not differ significantly from placebo, though pulse rate increased with LDX.

Key findings

  • LDX produced greater pooled mean change on ADHD-RS-IV than placebo: WMD −15.20 (95% CI −19.95 to −10.46), I²=94%.
  • Pooled improvement rate favored LDX: RR 0.34 (95% CI 0.24 to 0.47), I²=80%; pooled improvement was 72% with LDX versus 21% with placebo, with number needing treatment 1.97 (95% CI 1.80 to 2.21).
  • Overall discontinuation (acceptability) did not differ significantly: RR 0.78 (95% CI 0.46 to 1.31), I²=63%; discontinuation due to adverse events (tolerability) also did not differ significantly: RR 1.99 (95% CI 0.70 to 5.64), reported as I²=0% in the abstract and I²=16% in the results.
  • Vital signs showed no significant pooled differences for systolic blood pressure (WMD −0.95, 95% CI −2.71 to 0.81, I²=0%) or diastolic blood pressure (WMD 0.16, 95% CI −1.75 to 1.43, I²=0%), but pulse rate was significantly higher with LDX (WMD 4.96, 95% CI 2.77 to 7.15, I²=0%).

Methods

  • Systematic review and meta-analysis of randomized, placebo-controlled trials of LDX in children and adolescents up to 18 years old with ADHD; searches of SCOPUS, MEDLINE, CINAHL, Cochrane Controlled Trials Register, ClinicalTrials.gov, and EU Clinical Trials Register were performed in September 2014.
  • From 369 citations, five RCTs were eligible, including 1,016 children and adolescents; trial duration was 4–11 weeks, LDX dosage was 30–70 mg/day, and two trials were crossover studies.
  • A random-effects model was used; continuous outcomes were pooled as weighted mean differences or standardized mean differences, dichotomous outcomes as relative risks with 95% CIs using the Mantel-Haenszel technique in RevMan 5.1; heterogeneity was considered significant at I²≥50%.

Limitations

  • The paper states that the number of included studies was limited (five RCTs), that all five included studies were financially supported by a pharmaceutical company holding the LDX patent, and that publication bias could not be calculated because too few trials were included.
  • The text makes evident high heterogeneity for the ADHD-RS-IV mean change (I²=94%), improvement rate (I²=80%), and overall discontinuation rate (I²=63%), as well as unclear risk of bias in two studies for sequence generation and allocation concealment and unclear risk in two or more domains in two studies.
  • The abstract and results section report inconsistent I² values for discontinuation due to adverse events (0% versus 16%), which the text does not reconcile.

Model-written summary. Check it against the paper before relying on it.

Integrity signals

Registry

Crossref · 10.2147/dddt.s79071

Cites

43 of 43 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

7 of 15 cited sources checked · 5 supported · 0 flagged · accuracy not yet measured

  • Interpretationcitation

    Efficacy of LDX is explained by its active metabolite, dextroamphetamine.

    “The efficacy of LDX in such patients is explained by its active metabolite, dextroamphetamine.”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [9] Madaan V Kolli V Bestha DP Shah MJ Update on optimal use of lisdexamfetamine in the treatment of ADHD Neuropsychiatr Dis Treat 2013 9 977 983 23901276 PMC3726586 source
  • Findingown data

    The pooled overall discontinuation rate did not differ significantly between LDX-treated and placebo-treated children and adolescents with ADHD (RR 0.78, 95% CI 0.46 to 1.31, I2=63%).

    “The pooled overall discontinuation rate between the two groups was not significantly different (RR [95% CI] of 0.78 [0.46, 1.31], I2=63%).”
    • Also stated in: § Discontinuation rates (acceptability and tolerability) · plain
      “The pooled overall discontinuation rate (acceptability) and discontinuation rate due to adverse events (tolerability) in child and adolescent ADHD between the LDX- and placebo-treated groups had no significant differences with RR (95% CI) of 0.78 (0.46, 1.31), I2=63% and RR (95% CI) of 1.99 (0.70, 5.64), I2=16%, respectively.”
    Quote in the paperSubstantial claim
  • Findingown data

    The pooled mean change score on the ADHD-RS-IV was significantly greater in LDX-treated children and adolescents with ADHD than in placebo-treated children and adolescents (WMD -15.20, 95% CI -19.95 to -10.46, I2=94%).

    “The pooled mean change scores of LDX-treated group was significantly greater than that of the placebo (weighted mean difference [95% CI] of −15.20 [−19.95, −10.46], I2=94%).”
    • Also stated in: § Synthesis of results · plain
      “Based on synthesis of four studies,11,12,33,34 the pooled mean-changed ADHD-RS-IV score of child and adolescent ADHD in the LDX-treated group was significantly greater than that of the placebo-treated group (WMD [95% CI] of −15.20 [−19.95, −10.46], I2=94%) (see Figure 2).”
    Quote in the paperSubstantial claim
  • Findingown data

    There was not significant heterogeneity in the mean-changed vital sign scores.

    “Based on the mean-changed vital sign scores, there was not significant heterogeneity.”
    Quote in the paperNot a substantial claim
  • Findingown data

    Five RCTs were eligible and included in the review.

    “The number of included studies was limited (five RCTs).”
    • Also stated in: § Study selection · plain
      “Therefore, only five studies10–12,33,34 were eligible in the present review.”
    Quote in the paperSubstantial claim
  • Classified as probably not a substantial claim. 16
  • May combine two claims. 10

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    LDX requires an enzyme in red blood cells to be converted to active amphetamine, so it tends to have less potential for drug abuse and diversion and has a relatively long-acting property.

    “Since LDX requires an enzyme in red blood cells to be converted to the active form of amphetamine, it tends to have less potential for drug abuse and diversion, and has a relatively long-acting property.8,9”
    Quote in the paperNot a substantial claim1 of 2 sources checked
    • cites [8] Elbe D Macbride A Reddy D Focus on Lisdexamfetamine: A Review of its use in Child and Adolescent Psychiatry J Can Acad Child Adolesc Psychiatry 2010 19 4 303 314 21037922 PMC2962544
    • cites [9] Madaan V Kolli V Bestha DP Shah MJ Update on optimal use of lisdexamfetamine in the treatment of ADHD Neuropsychiatr Dis Treat 2013 9 977 983 23901276 PMC3726586 source

  • May combine two claims.

    Premisecitation

    RCTs showed efficacy and tolerability of LDX in child and adolescent ADHD, but each trial had a limited sample size.

    “Although randomized controlled trials (RCTs) showed the efficacy and tolerability of LDX in child and adolescent ADHD,10–13 each trial had a limited sample size.”
    Quote in the paperSubstantial claim2 of 4 sources checked
    • cites [10] Biederman J Boellner SW Childress A Lopez FA Krishnan S Zhang Y Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study Biol Psychiatry 2007 62 9 970 976 17631866 source
    • cites [11] Findling RL Childress AC Cutler AJ Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder J Am Acad Child Adolesc Psychiatry 2011 50 4 395 405 21421179 source
    • cites [12] Coghill D Banaschewski T Lecendreux M European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder Eur Neuropsychopharmaco 2013 23 10 1208 1218 23332456 source

      The Discussion reports that this randomized trial found LDX more effective than placebo and well tolerated in children and adolescents with ADHD. The Patient disposition section reports 336 randomized patients, but the paper does not characterize its sample as limited or establish that each of the other cited trials had a limited sample size. Page numbers were not available in our copy. (LLM, conf=0.83)

      Experimental — accuracy not yet measured
    • cites [13] Coghill DR Banaschewski T Lecendreux M Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial Eur Child Adolesce Psychiatry 2014 23 2 61 68 PMC3918120 23708466 source

      The Introduction reports that this randomized trial found LDX effective and well tolerated in children and adolescents with ADHD. The Results (Patient disposition and baseline demographics; page unavailable) give 317 patients in the full analysis set, including 104 receiving LDX. The paper does not characterize its sample size as limited or establish that each of the other cited trials had a limited sample size. (LLM, conf=0.84)

      Experimental — accuracy not yet measured

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    Dextroamphetamine blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and directly increases the release of these monoamines extraneuronally.

    “Like other stimulants, dextroamphetamine blocks the reuptake of norepinephrine and dopamine into the presynaptic neuron and directly increases the release of these monoamines extraneuronally.9”
    Quote in the paperNot a substantial claim1 of 1 sources checked
    • cites [9] Madaan V Kolli V Bestha DP Shah MJ Update on optimal use of lisdexamfetamine in the treatment of ADHD Neuropsychiatr Dis Treat 2013 9 977 983 23901276 PMC3726586 source

  • May combine two claims.

    Premisecitation

    Previous studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.

    “Previous studies documented that LDX was an effective, safe, and well-tolerated stimulant in the treatment of ADHD in children and adolescents.10–13”
    Quote in the paperSubstantial claim2 of 4 sources checked
    • cites [10] Biederman J Boellner SW Childress A Lopez FA Krishnan S Zhang Y Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study Biol Psychiatry 2007 62 9 970 976 17631866 source
    • cites [11] Findling RL Childress AC Cutler AJ Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder J Am Acad Child Adolesc Psychiatry 2011 50 4 395 405 21421179 source
    • cites [12] Coghill D Banaschewski T Lecendreux M European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder Eur Neuropsychopharmaco 2013 23 10 1208 1218 23332456 source
    • cites [13] Coghill DR Banaschewski T Lecendreux M Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial Eur Child Adolesce Psychiatry 2014 23 2 61 68 PMC3918120 23708466 source

  • May combine two claims.

    Interpretationown data

    LDX did not increase systolic or diastolic blood pressure but did increase pulse rate in children and adolescents with ADHD.

    “Although LDX as compared with placebo did not increase SBP and DBP, it did increase the pulse rates in children and adolescents with ADHD.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Interpretationreasoning

    LDX has efficacy, acceptability, and tolerability in treatment of child and adolescent ADHD.

    “Considering these findings, LDX has efficacy, acceptability, and tolerability in treatment of child and adolescent ADHD.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductcitation

    An intention-to-treat population was applied for four clinical trials.

    “An intention-to-treat population was applied for four clinical trials.10,11,33,34”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Interpretationreasoning

    Acceptability of LDX may be explained by its metabolite dextroamphetamine, which is efficacious for ADHD treatment.

    “Good tolerability of LDX may be explained by the prodrug formulation which may reduce the adverse events noted in other psychostimulants while its acceptability may be explained by its metabolite, dextroamphetamine, which is efficacious for ADHD treatment.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Intent-to-treat results were included if possible.

    “If possible, the intent-to-treat results were included.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    The abstracts of articles were independently examined by two authors (NM and BM) to determine suitability according to the eligibility criteria.

    “The abstracts of articles, established from the databases, were independently examined by the authors (NM and BM) for determining whether they were suitable according to the eligibility criteria defined previously.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Internal validity assessments were carried out by the authors (NM and BM).

    “The internal validity (quality) assessments were carried out by the authors (NM and BM).”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Study design and conductcitation

    Risk of bias for each trial was evaluated according to the Cochrane Handbook domains.

    “As stated in the Handbook of Cochrane Collaboration, risks of bias for each trial were evaluated as follows: 1) the generation of randomized sequences, 2) concealment of allocation, 3) blinding, 4) incomplete outcomes, 5) selective reporting, 6) other sources of bias, and 7) baseline similarity.15”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [15] Higgins JPT Altman DG Assessing risk of bias in included studies Higgins JPT Green S Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 (Updated March 2011) The Cochrane Collaboration 2009

      Couldn’t be matched to a paper in Crossref, so it can’t be checked.

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductown data

    Freedom of selective reporting was determined in three studies.

    “However, freedom of selective reporting was determined in three studies (see Table 2).11,12,34”
    Quote in the paperNot a substantial claim

  • Classified as probably not a substantial claim.

    Interpretationown data

    The outcome from this review should be carefully interpreted and considered preliminary because the number of included studies was limited.

    “Since the number of included studies was limited, the outcome from this review should be carefully interpreted and considered as preliminary.”
    Quote in the paperSubstantial claim

  • Classified as probably not a substantial claim.

    Study design and conductreasoning

    A funnel plot was not applied because only five RCTs were included.

    “In this review, only five RCTs were included. Accordingly, the real chance asymmetry was difficult to distinguish,22 therefore, this meta-analysis did not apply the funnel plot.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Disagreements were resolved by consensus.

    “In cases of disagreement, the authors discussed and resolved them by means of consensus.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing).

    Study design and conductnone given

    Full-text versions of relevant articles were independently examined by the authors.

    “After the full-text versions of relevant articles were provided, the authors then independently examined them.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Interpretationown data

    LDX is effective and well-tolerated in the treatment of child and adolescent ADHD.

    “According to the present review, LDX was effective and well-tolerated in the treatment of child and adolescent ADHD.”
    • Also stated in: § Conclusion · plain
      “According to the findings of this review, LDX is effective, and well-tolerated in the treatment of child and adolescent ADHD.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Study design and conductreasoning

    All mean change scores were assessed by using similar rating scales across the included trials, so WMD were used to synthesize the continuous data.

    “All mean change scores were assessed by using similar rating scales across the included trials, therefore, the WMD were considered in calculating and synthesizing those continuous data.”
    Quote in the paperSubstantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Premisecitation

    LDX is an inactive and water-soluble prodrug that after absorption is converted to l-lysine and dextroamphetamine.

    “Known as a stimulant, lisdexamfetamine (LDX), an inactive and water-soluble prodrug, after it is absorbed from the gastrointestinal tract, is converted to l-lysine, an essential amino acid, and dextroamphetamine, which has a therapeutic effect in the reduction of ADHD symptoms.7”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [7] Blick SK Keating GM Lisdexamfetamine Paediatr Drugs 2007 9 2 129 135 discussion 136–138 17407369 source

  • Probably not a substantial claim: may not pass S2 (checkable), S4 (based).

    Premisenone given

    A meta-analysis is typically more effective in determining the true effect size.

    “A meta-analysis, typically more effective in determining the true effect size, was the method used to assess the efficacy, acceptability, and tolerability of LDX for child and adolescent ADHD.”
    Quote in the paperNot a substantial claim

  • Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

    Study design and conductown data

    NM extracted important outcomes and BM reviewed the extracted results.

    “NM extracted the important outcomes into the data extraction form. Then BM reviewed those extracted results, again.”
    Quote in the paperNot a substantial claim
22 of 22

  • The authors state this as an assumption.

    Each eligible trial outcome was not the same effect caused by the quality of methodology in individual study.

    “Our hypothesis assumed that each eligible trial outcome was not the same effect caused by the quality of methodology in individual study.”

  • The paper relies on this without support.

    The included trials were not exactly identical.

    “Therefore, it was impossible to presume that those trials were exactly identical.”
2 of 2

Self-check

Percentages, sums and reported differences re-computed from the paper’s own numbers.

Each contradiction between two passages listed here was confirmed by an independent check.

  • Improvement risk ratio contradicts the stated direction of effect

    Major

    The paper says improvement was more likely with LDX but reports a relative risk below one. By its own definition, an RR below one means the outcome is less likely in the experimental group.

  • DBP estimate is not centered in its reported confidence interval

    Minor

    The midpoint of the reported DBP confidence interval is −0.16, not the stated WMD of 0.16. The interval appears to have been calculated for an estimate with the opposite sign.

    Reported 0.16 · recomputed -0.16

  • Conflicting heterogeneity values for adverse-event discontinuation

    Minor

    The abstract reports I2=0% for discontinuation due to adverse events, while the Results section reports I2=16% for the same pooled outcome.

3 of 3

Cites

Flagged first, then by citations

Research works printed but not linked: 1

  1. [19]Papakostas GI Tolerability of modern antidepressants J Clin Psychiatry 2008 69 Suppl E1 8 13 18494538

Cited by

Sorted by citations

Related

Authors
Maneeton, N., Maneeton, B., Likhitsatian, S., Suttajit, S., Narkpongphun, A., Srisurapanont, M., & Woottiluk, P.
Affiliations
Chiang Mai University (TH)
ORCID
Venue
Drug Design, Development and Therapy
Publisher
Informa UK Limited
Published
2015-04
Volume
9
Pages
1927
ISSN
1177-8881 (ISSN-L)
DOI
10.2147/dddt.s79071
PMC
PMC4389815
OpenAlex
W2029320399
Semantic Scholar
19389fdf7214e20bb35224c138f533bce6c410e1
Cited by
23
References
43
Citations by year
2025: 1 · 2024: 4 · 2023: 1 · 2022: 3 · 2021: 2 · 2020: 1 · 2019: 1 · 2018: 3 · 2017: 5 · 2016: 1 · 2015: 1
FWCI
0.44
Type
journal article
Language
en
Open access
Licence
Locations
  • Drug Design Development and Therapy (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
  • Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Attention Deficit Hyperactivity Disorder
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Medicine › Pharmacology › Pharmacology and Obesity Treatment
Keywords
lisdexamfetamine, attention deficit hyperactivity disorder, children and adolescents, ADHD symptom severity, treatment efficacy, treatment acceptability, tolerability, discontinuation rate, adverse events, stimulant medication, placebo comparison, dose-response relationship
MeSH terms
Lisdexamfetamine Dimesylate, Adolescent, Attention Deficit Disorder with Hyperactivity, Child, Drug Tolerance, Humans, Randomized Controlled Trials as Topic

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