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.
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.


CONCLUSIONS
This model predicts that LDX may have a large treatment effect size in European adults with ADHD.
Statistics and Epidemiology, AMF Consulting, 846 S. Citrus Avenue, Los Angeles, CA 90036, USA.
M
M
Fridman
Global Health Economics & Outcomes Research, Shire, 725 Chesterbrook Boulevard, Wayne, PA 19087, USA.
P S
PS
Hodgkins
Research, BPS International, 3830 Valley Centre #705 PMB503, San Diego, CA 92130, USA. Electronic address: jkahle@bpsintl.com.
J S
JS
Kahle
Health Economics and Epidemiology, Shire, 725 Chesterbrook Boulevard, Wayne, PA 19087, USA.
M H
MH
Erder
D000328:Adult; D001288:Attention / Q000187:drug effects; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000008:administration & dosage*; D018765:Dopamine Uptake Inhibitors / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate / Q000008:administration & dosage*; D008297:Male; D008774:Methylphenidate / Q000008:administration & dosage; D012044:Regression Analysis; D016896:Treatment Outcome
D000697:Central Nervous System Stimulants; D018765:Dopamine Uptake Inhibitors; D008774:Methylphenidate; D000069478:Lisdexamfetamine Dimesylate
Attention deficit hyperactivity disorder (ADHD); Efficacy; Lisdexamfetamine; Psychiatry in Europe; Psychopharmacology others; Vyvanse