Hostname: page-component-cd9895bd7-7cvxr Total loading time: 0 Render date: 2024-12-25T17:01:07.843Z Has data issue: false hasContentIssue false
  • English
  • Français

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

Published online by Cambridge University Press:  15 April 2020

M. Fridman ,
P.S. Hodgkins ,
J.S. Kahle  and
M.H. Erder
M. Fridman
Affiliation:
Statistics and Epidemiology, AMF Consulting, 846 S. Citrus Avenue, Los Angeles, CA90036, USA
P.S. Hodgkins
Affiliation:
Global Health Economics & Outcomes Research, Shire, 725 Chesterbrook Boulevard, Wayne, PA19087, USA
J.S. Kahle*
Affiliation:
Research, BPS International, 3830 Valley Centre #705 PMB503, San Diego, CA92130, USA
M.H. Erder
Affiliation:
Health Economics and Epidemiology, Shire, 725 Chesterbrook Boulevard, Wayne, PA19087, USA
*
*Corresponding author at: BPS International, 3830 Valley Centre #705 PMB503, San Diego, CA 92130 USA. Tel.: +1 858 509 2711; fax: +1 858 509 2711. E-mail address:jkahle@bpsintl.com (J.S. Kahle).
Get access

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.

Keywords

Attention deficit hyperactivity disorder (ADHD)Psychopharmacology othersPsychiatry in EuropeEfficacyLisdexamfetamineVyvanse
Type
Review
Information
European Psychiatry , Volume 30 , Issue 4 , June 2015 , pp. 521 - 527
Copyright
Copyright © Elsevier Masson SAS 2015

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

Footnotes

1

Tel.: +1 323 857 6618; fax: +1 323 857 6656.

2

Currently: Vertex Pharmaceuticals, 50 Northern Avenue, Boston, MA 02210 USA. Tel.: +1 617 961 7003; fax: +1 617 366 3967.

3

Tel.: +1 484 595 8346; fax: +1 484 595 8178.

References

Adler, LA, Goodman, DW, Kollins, SH, Weisler, RH, Krishnan, S, Zhang, Yet al.Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2008;69(9):1364–1373.CrossRefGoogle ScholarPubMed
Adler, LA, Zimmerman, B, Starr, HL, Silber, S, Palumbo, J, Orman, Cet al.Efficacy and safety of OROS methylphenidate in adults with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, double-blind, parallel group, dose-escalation study. J Clin Psychopharmacol 2009;29(3):239–247.CrossRefGoogle ScholarPubMed
Adler, LA, Spencer, T, Brown, TE, Holdnack, J, Saylor, K, Schuh, Ket al.Once-daily atomoxetine for adult attention-deficit/hyperactivity disorder: a 6-month, double-blind trial. J Clin Psychopharmacol 2009;29(1):44–50.CrossRefGoogle ScholarPubMed
American Psychiatric Association. Diagnostic and statistical manual of mental disorders, 5th ed. Arlington, VA: American Psychiatric Association; 2013.Google Scholar
Biederman, J, Krishnan, S, Zhang, Y, McGough, JJ, Findling, RLEfficacy 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(3):450–463.CrossRefGoogle ScholarPubMed
Biederman, J, Mick, E, Surman, C, Doyle, R, Hammerness, P, Kotarski, Met al.A randomized, 3-phase, 34-week, double-blind, long-term efficacy study of osmotic-release oral system-methylphenidate in adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol 2010;30(5):549–553.CrossRefGoogle ScholarPubMed
Block, SL, Kelsey, D, Coury, D, Lewis, D, Quintana, H, Sutton, Vet al.Once-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosing. Clin Pediatr (Phila) 2009;48(7):723–733.CrossRefGoogle ScholarPubMed
Brod, M, Pohlman, B, Lasser, R, Hodgkins, PComparison of the burden of illness for adults with ADHD across seven countries: a qualitative study. Health Qual Life Outcomes 2012;10:47.CrossRefGoogle ScholarPubMed
Casas, M, Rosler, M, Sandra Kooij, JJ, Ginsberg, Y, Ramos-Quiroga, JA, Heger, Set al.Efficacy and safety of prolonged-release OROS methylphenidate in adults with attention deficit/hyperactivity disorder: a 13-week, randomized, double-blind, placebo-controlled, fixed-dose study. World J Biol Psychiatry 2013;14(4):268–281.CrossRefGoogle ScholarPubMed
Cochran, WThe combination of estimates from different experiments. Biometrics 1954;10:110–129.CrossRefGoogle Scholar
Coghill, D, Banaschewski, T, Lecendreux, M, Soutullo, C, Johnson, M, Zuddas, Aet al.European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol 2013;23(10):1208–1218.CrossRefGoogle ScholarPubMed
Cohen, JStatistical power analysis for the behavioral sciences, 2nd ed. Hillsdale, N.J.: L. Erlbaum Associates; 1988 [xxi, 567 p.].Google Scholar
Cunill, R, Castells, X, Tobias, A, Capellà, DAtomoxetine for attention deficit hyperactivity disorder in the adulthood: a meta-analysis and meta-regression. Pharmacoepidemiol Drug Saf 2013;22(9):961–969.Google ScholarPubMed
Dittmann, R, Cardo, E, Nagy, P, Anderson, C, Bloomfield, R, Caballero, Bet al.Efficacy and safety of lisdexamfetamine dimesylate and atomoxetine in the treatment of attention-deficit/hyperactivity disorder: a head-to-head, randomized, double-blind, phase IIIb study. CNS Drugs 2013;27(12):1081–1092.CrossRefGoogle ScholarPubMed
Durell, TM, Adler, LA, Williams, DW, Deldar, A, McGough, JJ, Glaser, PEet al.Atomoxetine treatment of attention-deficit/hyperactivity disorder in young adults with assessment of functional outcomes: a randomized, double-blind, placebo-controlled clinical trial. J Clin Psychopharmacol 2013;33(1):45–54.CrossRefGoogle ScholarPubMed
Faraone, S, Buitelaar, JComparing the efficacy of stimulants for ADHD in children and adolescents using meta-analysis. Eur Child Adolesc Psychiatry 2010;19(4):353–364.CrossRefGoogle ScholarPubMed
Faraone, S, Biederman, J, Spencer, T, Aleardi, MComparing the efficacy of medications for ADHD using meta-analysis. MedGenMed 2006;8(4):4.Google ScholarPubMed
Findling, RL, Bukstein, OG, Melmed, RD, Lopez, FA, Sallee, FR, Arnold, LEet al.A randomized, double-blind, placebo-controlled, parallel-group study of methylphenidate transdermal system in pediatric patients with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2008;69(1):149–159.CrossRefGoogle ScholarPubMed
Findling, RL, Childress, AC, Cutler, AJ, Gasior, M, Hamdani, M, Ferreira-Cornwell, MCet al.Efficacy and safety of lisdexamfetamine dimesylate in adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 2011;50(4):395–405.CrossRefGoogle ScholarPubMed
Higgins, J, Green, SCochrane handbook for systematic reviews of interventions Version 5.1.0. Available from http://www.cochrane-handbook.org.2011 [updated March 2011].Google Scholar
Higgins, J, Thompson, SQuantifying heterogeneity in a meta-analysis. Stat Med 2002;21:1539–1558.CrossRefGoogle ScholarPubMed
Kelsey, DK, Sumner, CR, Casat, CD, Coury, DL, Quintana, H, Saylor, KEet al.Once-daily atomoxetine treatment for children with attention-deficit/hyperactivity disorder, including an assessment of evening and morning behavior: a double-blind, placebo-controlled trial. Pediatrics 2004;114(1):e1–e8.CrossRefGoogle ScholarPubMed
Medori, R, Ramos-Quiroga, JA, Casas, M, Kooij, JJ, Niemela, A, Trott, GEet al.A randomized, placebo-controlled trial of three fixed dosages of prolonged-release OROS methylphenidate in adults with attention-deficit/hyperactivity disorder. Biol Psychiatry 2008;63(10):981–989.CrossRefGoogle ScholarPubMed
Michelson, D, Faries, D, Wernicke, J, Kelsey, D, Kendrick, K, Sallee, FRet al.Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: a randomized, placebo-controlled, dose-response study. Pediatrics 2001;108(5):E83.CrossRefGoogle ScholarPubMed
Michelson, D, Allen, AJ, Busner, J, Casat, C, Dunn, D, Kratochvil, Cet al.Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study. Am J Psychiatry 2002;159(11):1896–1901.CrossRefGoogle ScholarPubMed
Michelson, D, Adler, L, Spencer, T, Reimherr, FW, West, SA, Allen, AJet al.Atomoxetine in adults with ADHD: two randomized, placebo-controlled studies. Biol Psychiatry 2003;53(2):112–120.CrossRefGoogle ScholarPubMed
Montoya, A, Hervas, A, Cardo, E, Artigas, J, Mardomingo, MJ, Alda, JAet al.Evaluation of atomoxetine for first-line treatment of newly diagnosed, treatment-naive children and adolescents with attention deficit/hyperactivity disorder. Curr Med Res Opin 2009;25(11):2745–2754.CrossRefGoogle ScholarPubMed
Newcorn, JH, Kratochvil, CJ, Allen, AJ, Casat, CD, Ruff, DD, Moore, RJet al.Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder: acute comparison and differential response. Am J Psychiatry 2008;165(6):721–730.CrossRefGoogle ScholarPubMed
Polanczyk, G, de Lima, MS, Horta, BL, Biederman, J, Rohde, LAThe worldwide prevalence of ADHD: a systematic review and metaregression analysis. Am J Psychiatry 2007;164(6):942–948.CrossRefGoogle ScholarPubMed
Polanczyk, G, Willcutt, E, Salum, G, Kieling, C, Rohde, LADHD prevalence estimates across three decades: an updated systematic review and meta-regression analysis. Int J Epidemiol 2014;43(2):434–442.CrossRefGoogle ScholarPubMed
Sobanski, E, Sabljic, D, Alm, B, Baehr, C, Dittmann, RW, Skopp, Get al.A randomized, waiting list-controlled 12-week trial of atomoxetine in adults with ADHD. Pharmacopsychiatry 2012;45(3):100–107.Google ScholarPubMed
Spencer, T, Heiligenstein, JH, Biederman, J, Faries, DE, Kratochvil, CJ, Conners, CKet al.Results from 2 proof-of-concept, placebo-controlled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry 2002;63(12):1140–1147.CrossRefGoogle ScholarPubMed
Sutherland, SM, Adler, LA, Chen, C, Smith, MD, Feltner, DEAn 8-week, randomized controlled trial of atomoxetine, atomoxetine plus buspirone, or placebo in adults with ADHD. J Clin Psychiatry 2012;73(4):445–450.CrossRefGoogle ScholarPubMed
Wehmeier, PM, Schacht, A, Ulberstad, F, Lehmann, M, Schneider-Fresenius, C, Lehmkuhl, Get al.Does atomoxetine improve executive function, inhibitory control, and hyperactivity? Results from a placebo-controlled trial using quantitative measurement technology. J Clin Psychopharmacol 2012;32(5):653–660.CrossRefGoogle ScholarPubMed
Weisler, RH, Pandina, GJ, Daly, EJ, Cooper, K, Gassmann-Mayer, CRandomized clinical study of a histamine H3 receptor antagonist for the treatment of adults with attention-deficit hyperactivity disorder. CNS Drugs 2012;26(5):421–434.CrossRefGoogle ScholarPubMed
Wigal, SB, Kollins, SH, Childress, AC, Adeyi, BEfficacy and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: sex and age effects and effect size across the day. Child Adolesc Psychiatry Ment Health 2010;4:32.CrossRefGoogle ScholarPubMed
Wigal, T, Brams, M, Gasior, M, Gao, J, Giblin, JEffect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Postgrad Med 2011;123(2):169–176.CrossRefGoogle ScholarPubMed
Wilens, TE, McBurnett, K, Bukstein, O, McGough, J, Greenhill, L, Lerner, Met al.Multisite controlled study of OROS methylphenidate in the treatment of adolescents with attention-deficit/hyperactivity disorder. Arch Pediatr Adolesc Med 2006;160(1):82–90.CrossRefGoogle ScholarPubMed
Wilens, TE, Gault, LM, Childress, A, Kratochvil, CJ, Bensman, L, Hall, CMet al.Safety and efficacy of ABT-089 in pediatric attention-deficit/hyperactivity disorder: results from two randomized placebo-controlled clinical trials. J Am Acad Child Adolesc Psychiatry 2011;50(1):73-84 e1.CrossRefGoogle ScholarPubMed
Young, JL, Sarkis, E, Qiao, M, Wietecha, LOnce-daily treatment with atomoxetine in adults with attention-deficit/hyperactivity disorder: a 24-week, randomized, double-blind, placebo-controlled trial. Clin Neuropharmacol 2011;34(2):51–60.Google ScholarPubMed
Supplementary material: File

Fridman et al. supplementary material

Supplementary materials

Download Fridman et al. supplementary material(File)
File 389.8 KB
Submit a response

Comments

No Comments have been published for this article.