Cited by 16Attention Deficit Hyperactivity DisorderPharmacology and Obesity TreatmentSchizophrenia research and treatment

Predicted effect size of lisdexamfetamine treatment of attention deficit/hyperactivity disorder (ADHD) in European adults: Estimates based on indirect analysis using a systematic review and meta-regression analysis

Fridman, M., Hodgkins, P.S., Kahle, J.S., Erder, M.H.·2015·European Psychiatry

Abstract

Background There are few approved therapies for adults with attention-deficit/hyperactivity disorder (ADHD) in Europe. Lisdexamfetamine (LDX) is an effective treatment for ADHD; however, no clinical trials examining the efficacy of LDX specifically in European adults have been conducted. Therefore, to estimate the efficacy of LDX in European adults we performed a meta-regression of existing clinical data. Methods A systematic review identified US- and Europe-based randomized efficacy trials of LDX, atomoxetine (ATX), or osmotic-release oral system methylphenidate (OROS-MPH) in children/adolescents and adults. A meta-regression model was then fitted to the published/calculated effect sizes (Cohen's d) using medication, geographical location, and age group as predictors. The LDX effect size in European adults was extrapolated from the fitted model. Sensitivity analyses performed included using adult-only studies and adding studies with placebo designs other than a standard pill-placebo design. Results Twenty-two of 2832 identified articles met inclusion criteria. The model-estimated effect size of LDX for European adults was 1.070 (95% confidence interval: 0.738, 1.401), larger than the 0.8 threshold for large effect sizes. The overall model fit was adequate (80%) and stable in the sensitivity analyses. Conclusion This model predicts that LDX may have a large treatment effect size in European adults with ADHD.

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Crossref · 10.1016/j.eurpsy.2015.01.001

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  • Both effect sizes were larger than the 0.8 threshold for large effect sizes.

    “Both effect sizes were larger than the 0.8 threshold for large effect sizes”
  • Effect sizes for OROS-MPH and atomoxetine were also reported higher in adult patients in European versus US studies: 0.627 vs 0.384 and 0.616 vs 0.372, respectively.

    “however, the effect sizes noted for osmotic-release oral system methylphenidate (OROS-MPH) and atomoxetine, 2 other alternative therapies for ADHD, were also reported higher in adult patients in European vs US studies: 0.627 vs 0.384 and 0.616 vs 0.372, respectively.”
  • The pooled European location effect size was larger compared with the United States, which may explain the higher effect size, as can changes in study design regarding placebo, and clinical and methodological diversity among studies which may influence estimated effect sizes.

    “The pooled European location effect size was larger compared with the United States which may explain the higher effect size, as can changes in study design regarding placebo, and clinical and methodological diversity among studies which may influence estimated effect sizes.”
  • A recent systematic review and meta-analysis estimated the efficacy of LDX in adult patients with ADHD to be 1.07 (95% CI: 0.74-1.40) in European patients compared with 0.83 (95% CI: 0.58-1.08) in US patients.

    “A recent systemic review and meta-analysis estimated the efficacy of LDX in adult patients with ADHD to be 1.07 (95% confidence interval [CI]: 0.74-1.40) in European patients compared with 0.83 (95% CI: 0.58-1.08) in US patients.53”
  • Pharmacokinetic profiles following oral and intranasal administration of LDX in healthy adults demonstrated similar systemic exposures of d-amphetamine concentrations.

    “Pharmacokinetic profiles following oral and intranasal administration of LDX in healthy adults demonstrated similar systemic exposures of d-amphetamine concentrations.51”

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Authors
Fridman, M., Hodgkins, P. S., Kahle, J. S., & Erder, M. H.
Affiliations
BPS Bioscience (United States) (US)
Corresponding author
Kahle, J.S.
Venue
European Psychiatry
Published
2015-06
Volume
30
Issue
4
Pages
521-527
ISSN
  • 0924-9338 (ISSN-L)
  • 1778-3585
OpenAlex
W1966204370
Cited by
16
References
11
Citations by year
2025: 1 · 2022: 3 · 2021: 3 · 2020: 1 · 2018: 1 · 2017: 2 · 2016: 3 · 2015: 2
FWCI
0.37
Type
journal article
Language
en
Open access
closed
Locations
  • European Psychiatry (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, adult ADHD, treatment effect size, atomoxetine, European adults, meta-regression
MeSH terms
Lisdexamfetamine Dimesylate, Adult, Central Nervous System Stimulants, Attention, Attention Deficit Disorder with Hyperactivity, Dose-Response Relationship, Drug, Europe, Female, Follow-Up Studies, Humans, Male, Methylphenidate, Regression Analysis, Treatment Outcome, Dopamine Uptake Inhibitors

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