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Cited by 26Attention Deficit Hyperactivity DisorderPharmaceutical studies and practicesPharmacology and Obesity Treatment

Efficacy of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder previously treated with methylphenidate: a post hoc analysis

Open access
Jain, Rakesh, Babcock, Thomas, Burtea, Teodor, Dirks, Bryan, Adeyi, Ben, Scheckner, Brian, Lasser, Robert·2011·Child and Adolescent Psychiatry and Mental Health
DOI 10.1186/1753-2000-5-35PMC PMC3225298
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Abstract

BACKGROUND: Attention-deficit/hyperactivity disorder (ADHD) is a common neurobehavioral psychiatric disorder that afflicts children, with a reported prevalence of 2.4% to 19.8% worldwide. Stimulants (methylphenidate [MPH] and amphetamine) are considered first-line ADHD pharmacotherapy. MPH is a catecholamine reuptake inhibitor, whereas amphetamines have additional presynaptic activity. Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many still fail to respond optimally to either. After administration, the prodrug stimulant lisdexamfetamine dimesylate (LDX) is converted to l-lysine and therapeutically active d-amphetamine in the blood. The objective of this study was to evaluate the clinical efficacy of LDX in children with ADHD who remained symptomatic (ie, nonremitters; ADHD Rating Scale IV [ADHD-RS-IV] total score > 18) on MPH therapy prior to enrollment in a 4-week placebo-controlled LDX trial, compared with the overall population. METHODS: In this post hoc analysis of data from a multicenter, randomized, double-blind, forced-dose titration study, we evaluated the clinical efficacy of LDX in children aged 6-12 years with and without prior MPH treatment at screening. ADHD symptoms were assessed using the ADHD-RS-IV scale, Conners' Parent Rating Scale-Revised short form (CPRS-R), and Clinical Global Impressions-Improvement scale, at screening, baseline, and endpoint. ADHD-RS-IV total and CPRS-R ADHD Index scores were summarized as mean (SD). Clinical response for the subgroup analysis was defined as a ≥ 30% reduction from baseline in ADHD-RS-IV score and a CGI-I score of 1 or 2. Dunnett test was used to compare change from baseline in all groups. Number needed to treat to achieve one clinical responder or one symptomatic remitter was calculated as the reciprocal of the difference in their proportions on active treatment and placebo at endpoint. RESULTS: Of 290 randomized participants enrolled, 28 received MPH therapy at screening, of which 26 remained symptomatic (ADHD-RS-IV > 18). ADHD-RS-IV total scores, changes from baseline, clinical responsiveness, and rates of symptomatic remission in this subgroup were comparable to the overall population. The safety and tolerability profiles for LDX were comparable to other stimulants currently available. CONCLUSION: In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX and experienced similar improvements in their symptoms as the overall study population. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00556296.

AI snapshot

Written from the paper’s full text.

TL;DR

In a post hoc analysis of a 4-week randomized placebo-controlled trial, lisdexamfetamine dimesylate (LDX) improved ADHD symptoms in children who remained symptomatic despite prior methylphenidate (MPH) treatment. Improvements in this subgroup were comparable to those in the overall study population.

Key findings

  • Among 26 children classified as nonremitters on prior MPH (ADHD-RS-IV total score > 18 at screening), LDX produced a mean (SD) ADHD-RS-IV total score change from baseline of -24.0 (12.56), a mean (SD) reduction of 57% (29.9%); the placebo-adjusted reduction was -17.6 (95% CI -29.65 to -5.49; P = .0063).
  • Symptomatic remission (ADHD-RS-IV ≤ 18) occurred in 12/19 (63.2%) LDX-treated vs 1/7 (14.3%) placebo-treated nonremitters; NNT was 2.0 (95% CI 1.21–6.63) in nonremitters vs 2.1 (95% CI 1.74–2.72) in the overall study population.
  • Clinical response (≥ 30% ADHD-RS-IV reduction plus CGI-I score of 1 or 2) occurred in 15/19 (78.9%) LDX-treated vs 3/7 (42.9%) placebo-treated nonremitters; NNT was 2.0 (95% CI 1.21–6.63) in nonremitters vs 1.8 (95% CI 1.51–2.22) in the overall population. In the overall efficacy population, 169 (79.3%) LDX-treated and 21 (29.2%) placebo-treated participants achieved clinical response.
  • CPRS-R ADHD Index mean changes from baseline for morning, afternoon, and evening were -14.7 (10.90), -12.2 (12.89), and -13.4 (11.69) for LDX, respectively, and -1.3 (14.92), -0.1 (9.01), and 0.4 (11.25) for placebo. Safety/tolerability were comparable to other stimulants; 196/290 (68%) reported ≥ 1 TEAE, 21/290 (7.2%) discontinued due to TEAE, and no serious AEs were observed.

Methods

  • Post hoc analysis of a multicenter, randomized, double-blind, forced-dose titration, parallel-group 4-week trial (ClinicalTrials.gov NCT00556296) in children aged 6–12 years with DSM-IV-TR ADHD and ADHD-RS-IV score ≥ 28 after washout. Participants were randomized 1:1:1:1 to LDX 30 mg/day, 50 mg/day, 70 mg/day, or placebo.
  • Of 290 randomized participants, 28 received MPH at screening and 26 were nonremitters on prior MPH (ADHD-RS-IV > 18) before randomization; efficacy analyses used available screening data and compared this subgroup with the overall efficacy population (285 participants with postrandomization symptom assessment).
  • Outcomes included ADHD-RS-IV total score, CPRS-R Short Form, and CGI-I. Clinical response was defined as ≥ 30% reduction in ADHD-RS-IV total score from baseline plus CGI-I score of 1 or 2; symptomatic remission was defined as ADHD-RS-IV total score ≤ 18. NNT was calculated as the reciprocal of the difference in proportions on active treatment vs placebo at endpoint; Dunnett test and ANCOVA were used for comparisons.

Limitations

  • The paper states that classification of participants as nonremitters on prior MPH considered only the screening ADHD-RS-IV total score and may not reflect overall clinical response to MPH; switching from MPH to LDX was protocol-driven rather than a clinical practice decision; the 4-week duration limits extrapolation to long-term ADHD treatment; and the study was not prospectively designed or powered to detect differences between treatment groups, so a prospective study would be needed to confirm findings.
  • The text also notes no separate safety assessments were performed in nonremitters on prior MPH due to low sample numbers.
  • Evident from the text: the key subgroup was very small (26 nonremitters; 19 LDX-treated and 7 placebo-treated in responder/remitter analyses), and prior MPH treatment was provided according to community standards, with some participants possibly receiving suboptimal doses, while LDX was given as forced-dose titration.

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

Integrity signals

Registry

Crossref · 10.1186/1753-2000-5-35

Cites

32 of 32 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Claims the paper makes

0 of 12 cited sources checked · 0 supported · 0 flagged

  • Findingown data

    The mean percentage reduction in ADHD-RS-IV total score was 57% (SD 29.9%) in the 19 nonremitters on prior methylphenidate.

    “corresponding to a mean (SD) percentage reduction of 57 (29.9%) in the 19 nonremitters on prior MPH treatment.”
    Quote in the paperSubstantial claim
  • Findingown data

    Of the 26 nonremitters on prior methylphenidate at screening, 12 (63.2%) receiving lisdexamfetamine dimesylate and 1 (14.3%) receiving placebo were classified as remitters during the study.

    “Of the 26 nonremitters on prior MPH at screening, 12 (63.2%) participants receiving LDX and 1 (14.3%) receiving placebo were classified as remitters during the study (Figure 3).”
    Quote in the paperSubstantial claim
  • Findingcitation

    CPRS-R ADHD index score data in nonremitters on prior methylphenidate were similar to those observed in the overall population.

    “These data were similar to the CPRS-R ADHD index scores observed in the overall population [17].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL: Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007, 29: 450-463. 10.1016/S0149-2918(07)80083-X. source

      Not checked in the free run.

  • Findingown data

    No serious adverse events were observed during the study.

    “No serious AEs were observed during the study.”
    Quote in the paperNot a substantial claim
  • Findingown data

    In the overall efficacy population, 169 (79.3%) treated with lisdexamfetamine dimesylate and 21 (29.2%) treated with placebo achieved clinical response.

    “In the overall efficacy population, 169 (79.3%) treated with LDX and 21 (29.2%) treated with placebo achieved clinical response (Figure 4).”
    Quote in the paperSubstantial claim
  • The quote only partly states this claim. 2
  • May combine two claims. 18
  • Classified as probably not a substantial claim. 6

  • The quote only partly states this claim.

    Findingown data

    The mean change in ADHD-RS-IV total score from baseline with lisdexamfetamine dimesylate treatment was -24.0 (SD 12.56) in the 19 nonremitters on prior methylphenidate.

    “The mean (SD) change in ADHD-RS-IV total score from baseline with LDX treatment was -24.0 (12.56) (Figure 2)”
    Quote in the paperSubstantial claim

  • May combine two claims. The quote only partly states this claim.

    Findingown data

    Of 290 randomized participants, 28 received methylphenidate at screening, and 26 of these remained symptomatic (ADHD-RS-IV total score > 18).

    “Of the 290 randomized participants, 28 were receiving MPH treatment at screening and 26 of these were classified as nonremitters on prior MPH at the screening visit, prior to randomization (Table 1).”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    For diastolic blood pressure, the change ranged from 0.6 (SE 0.93) to 2.3 (SE 0.91) mm Hg for all lisdexamfetamine dimesylate groups and was 0.6 (SE 0.91) mm Hg for the placebo group.

    “For diastolic BP the change ranged from 0.6 (0.93) to 2.3 (0.91) mm Hg for all LDX groups and was 0.6 (0.91) mm Hg for the placebo group.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The systolic blood pressure change for all lisdexamfetamine dimesylate groups ranged from 0.4 (SE 1.08) to 2.6 (SE 1.05) mm Hg, and for placebo was 1.3 (SE 1.05) mm Hg.

    “The systolic BP change for all LDX groups ranged from 0.4 (1.08) to 2.6 (1.05) mm Hg and for placebo was 1.3 (1.05) mm Hg.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The number needed to treat to achieve clinical response with lisdexamfetamine dimesylate at treatment endpoint was 2.0 (95% CI 1.21, 6.63) in nonremitters on prior methylphenidate versus 1.8 (1.51, 2.22) in the overall population.

    “NNT (95% CI) to achieve clinical response with LDX at treatment endpoint was 2.0 (1.21, 6.63) in nonremitters on prior MPH, versus 1.8 (1.51, 2.22) in the overall population.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    The number needed to treat to achieve symptomatic remission with lisdexamfetamine dimesylate at treatment endpoint was 2.0 (95% CI 1.21, 6.63) in nonremitters and 2.1 (1.74, 2.72) in the overall study population.

    “The NNT (95% CI) to achieve symptomatic remission with LDX at treatment endpoint was 2.0 (1.21, 6.63) in nonremitters and 2.1 (1.74, 2.72) in the overall study population.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Lisdexamfetamine dimesylate treatment was not associated with any significant changes in mean blood pressure, electrocardiogram parameters, and laboratory values.

    “LDX treatment was not associated with any significant changes in mean BP, ECG parameters, and laboratory values.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    The mean changes from baseline in morning, afternoon, and evening CPRS-R ADHD index scores were -14.7 (SD 10.90), -12.2 (SD 12.89), and -13.4 (SD 11.69) for the lisdexamfetamine dimesylate groups, respectively, and -1.3 (SD 14.92), -0.1 (SD 9.01), and 0.4 (SD 11.25) for the placebo group, respectively.

    “The mean changes from baseline morning, afternoon, and evening CPRS-R ADHD index scores were -14.7 (10.90), -12.2 (12.89), and -13.4 (11.69) for the LDX groups, respectively, and -1.3 (14.92), -0.1 (9.01), and 0.4 (11.25) for the placebo group, respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingcitation

    More than 95% of treatment-emergent adverse events were mild or moderate in intensity, and most began during the first week of treatment and abated over time.

    “More than 95% of TEAEs were mild or moderate in intensity and most began during the first week of treatment and abated over time [17].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [17] Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL: Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007, 29: 450-463. 10.1016/S0149-2918(07)80083-X. source

      Not checked in the free run.

  • May combine two claims.

    Findingown data

    Clinical response was achieved in 15 (78.9%) nonremitters on prior methylphenidate treated with lisdexamfetamine dimesylate and 3 (42.9%) treated with placebo.

    “Of nonremitters on prior MPH, clinical response was achieved in 15 (78.9%) treated with LDX and 3 (42.9%) treated with placebo, respectively.”
    Quote in the paperSubstantial claim

  • May combine two claims.

    Findingown data

    Treatment-emergent adverse events with an incidence ≥ 5% in the combined lisdexamfetamine dimesylate group were decreased appetite, insomnia, headache, upper abdominal pain, irritability, weight loss, vomiting, nausea, dizziness, and nasopharyngitis; in the placebo group they were headache, cough, nasal congestion, nasopharyngitis, and upper abdominal pain.

    “TEAEs with an incidence ≥ 5% in the combined LDX group were decreased appetite, insomnia, headache, upper abdominal pain, irritability, weight loss, vomiting, nausea, dizziness, and nasopharyngitis and, in the placebo group, were headache, cough, nasal congestion, nasopharyngitis, and upper abdominal pain.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Findingown data

    In the safety population, 196/290 (68%) participants reported one or more treatment-emergent adverse events, and 21/290 (7.2%) discontinued due to a treatment-emergent adverse event.

    “In the safety population, 196/290 (68%) participants reported one or more TEAEs; 21/290 (7.2%) discontinued due to TEAE.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Premisecitation

    Although methylphenidate and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many patients still fail to respond optimally to either.

    “Although MPH and amphetamine can effectively manage ADHD symptoms in most pediatric patients, many patients still fail to respond optimally to either.”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [11] Arnold LE: Methylphenidate vs. amphetamine: comparative review. J Atten Disord. 2000, 3: 200-211. 10.1177/108705470000300403. source

      Not checked in the free run.

  • May combine two claims.

    Premisecitation

    In a randomized controlled trial, lisdexamfetamine dimesylate was associated with improvements in clinical symptoms of ADHD in children while maintaining a safety profile similar to other stimulant medications.

    “In a randomized controlled trial (RCT), LDX was associated with improvements in clinical symptoms of ADHD in children while maintaining a safety profile similar to other stimulant medications [17].”
    Quote in the paperSubstantial claim0 of 1 sources checked
    • cites [17] Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL: Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007, 29: 450-463. 10.1016/S0149-2918(07)80083-X. source

      Not checked in the free run.

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

    Premisecitation

    Steele et al. suggested that treatment response be considered as an improvement in symptom scores from baseline of 25% to 30%.

    “Steele et al [23] suggested that treatment response be considered as an improvement in symptom scores from baseline of 25% to 30%.”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [23] Steele M, Jensen PS, Quinn DMP: Remission versus response as the goal of therapy in ADHD: a new standard for the field?. Clin Ther. 2006, 28: 1892-908. 10.1016/j.clinthera.2006.11.006. source

      Not checked in the free run.

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

    Study design and conductreasoning

    No separate safety assessments were performed in nonremitters on prior methylphenidate due to low sample numbers and no reason to expect differences in safety/tolerability in these participants.

    “No separate assessments were performed in nonremitters on prior MPH due to low sample numbers and no reason to expect differences in safety/tolerability in these participants.”
    Quote in the paperNot a substantial claim
    • The authors state this as an assumption: Safety and tolerability of lisdexamfetamine dimesylate in nonremitters on prior methylphenidate do not differ from the overall population.

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

    Study design and conductown data

    Participants were randomized in a 1:1:1:1 ratio using a block-randomization schedule.

    “Participants were randomized in a 1:1:1:1 ratio (using a block-randomization schedule)”
    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

    The study was a multicenter, randomized, double-blind, forced-dose titration, parallel-group study, conducted in accordance with Good Clinical Practice and the Declaration of Helsinki.

    “This was a multicenter, randomized, double-blind, forced-dose titration, parallel-group study, conducted in accordance with the Guideline for Good Clinical Practice from the World Health Organization and the Declaration of Helsinki and its amendments.”
    Quote in the paperNot a substantial claim

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

    Premisecitation

    A bimodal pattern of clinical response to atomoxetine has been described, with no obvious demographic or clinical predictors of clinical response.

    “A bimodal pattern of clinical response to atomoxetine has been described, with no obvious demographic or clinical predictors of clinical response [33].”
    Quote in the paperNot a substantial claim0 of 1 sources checked
    • cites [33] Newcorn JH, Sutton VK, Weiss MD, Sumner CR: Clinical responses to atomoxetine in attention-deficit/hyperactivity disorder: the Integrated Data Exploratory Analysis (IDEA) study. J Am Acad Child Adolesc Psychiatry. 2009, 48: 511-18. 10.1097/CHI.0b013e31819c55b2. source

      Not checked in the free run.

  • May combine two claims.

    Interpretationown data

    Lisdexamfetamine dimesylate demonstrated efficacy and clinical response in children with significant clinical ADHD symptoms despite previous methylphenidate treatment.

    “In this post hoc analysis of children who had significant clinical ADHD symptoms despite previous MPH treatment, LDX demonstrated efficacy and clinical response in the subpopulation assessed.”
    • Also stated in: § Discussion · plain
      “In this post hoc analysis, LDX showed efficacy when given to children with significant clinical ADHD symptoms despite prior MPH treatment.”
    • Also stated in: § Conclusion · plain
      “In this analysis, children with significant clinical ADHD symptoms despite MPH treatment improved during treatment with LDX”
    Quote in the paperSubstantial claim
    • Rests on an assumption: The 26 nonremitters on prior methylphenidate in this trial are representative of children with ADHD who remain symptomatic despite methylphenidate treatment.

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

    Interpretationreasoning

    Use of different definitions of therapeutic response may have altered the rates observed.

    “Use of different definitions of therapeutic response may have altered the rates observed.”
    Quote in the paperNot a substantial claim

  • May combine two claims.

    Study design and conductnone given

    The classification of participants as nonremitters on prior methylphenidate considers only the ADHD-RS-IV total score at screening and may not reflect the participants' overall clinical response to methylphenidate.

    “The classification of participants as nonremitters on prior MPH considers only the ADHD-RS-IV total score at screening and may not reflect the participants' overall clinical response to MPH.”
    Quote in the paperNot a substantial claim
22 of 22

  • The authors state this as an assumption.

    Safety and tolerability of lisdexamfetamine dimesylate in nonremitters on prior methylphenidate do not differ from the overall population.

    “No separate assessments were performed in nonremitters on prior MPH due to low sample numbers and no reason to expect differences in safety/tolerability in these participants.”

  • The paper relies on this without support.

    The 26 nonremitters on prior methylphenidate in this trial are representative of children with ADHD who remain symptomatic despite methylphenidate treatment.

    “In this post hoc analysis of children who had significant clinical ADHD symptoms despite previous MPH treatment, LDX demonstrated efficacy and clinical response in the subpopulation assessed.”
2 of 2

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

Self-check

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

  • Percentage receiving immediate-release MPH is too low

    Minor

    Three of the 26 prior-MPH nonremitters received IR MPH, which is 11.5%, not 7.7%.

    Reported 7.7 · recomputed 11.538462

1 of 1

Cites

Flagged first, then by citations

1 of the 33 references couldn’t be matched to a known paper.

Research works printed but not linked: 2

  1. Faraone SV, Sergeant J, Gillberg C, Biederman J: The worldwide prevalence of ADHD: is it an American condition?. World Psychiatry. 2003, 2: 104-13.
  2. Goodman D, Faraone SV, Adler LA, Dirks B, Hamdani M, Weisler R: Interpreting ADHD rating scale scores: linking ADHD rating scale scores and CGI levels in two randomized controlled trials of lisdexamfetamine dimesylate in ADHD. Primary Psychiatry. 2010, 17: 44-52.

Cited by

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Related

Authors
Jain, R., Babcock, T., Burtea, T., Dirks, B., Adeyi, B., Scheckner, B., & Lasser, R.
Affiliations
  • The University of Texas Health Science Center at Houston (US)
  • Shire (Canada) (CA)
Corresponding author
Jain, Rakesh
ORCID
Venue
Child and Adolescent Psychiatry and Mental Health
Publisher
Springer Science and Business Media LLC
Published
2011-11-04
Volume
5
Issue
1
Pages
35-35
ISSN
1753-2000 (ISSN-L)
DOI
10.1186/1753-2000-5-35
PMC
PMC3225298
OpenAlex
W2120173188
Semantic Scholar
e82f9d0f2ffbb5644f75c0a685941ac86ecac5e7
Cited by
26
References
33
Citations by year
2025: 1 · 2023: 1 · 2020: 3 · 2019: 2 · 2016: 2 · 2015: 1 · 2014: 6 · 2013: 5 · 2012: 5
FWCI
3.52
Type
journal article
Language
en
Open access
Licence
Locations
  • Child and Adolescent Psychiatry and Mental Health (publishedVersion, cc-by)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
Funders
Shire Canada
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 dimesylate, attention deficit hyperactivity disorder, methylphenidate, children with ADHD, symptom remission, clinical response, ADHD-RS-IV, stimulant efficacy, number needed to treat, safety and tolerability

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