Comparing Pharmacotherapies for ADHD in Adults: Evidence from Outcome-Focused Analysis of Food and Drug Administration Drug Label Registration Trials

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  • Author(s): Craig B. H. Surman (ORCID Craig B. H. Surman (ORCID 0000-0003-1677-0686); Daniel M. Walsh; Joseph B. Bond
  • Language:
    English
  • Source:
    Journal of Attention Disorders. 2024 28(5):800-809.
  • Publication Date:
    2024
  • Document Type:
    Journal Articles
    Reports - Research
  • Additional Information
    • Availability:
      SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: [email protected]; Web site: https://sagepub.com
    • Peer Reviewed:
      Y
    • Source:
      10
    • Subject Terms:
      Drug Therapy; Attention Deficit Hyperactivity Disorder; Adults; Stimulants; Symptoms (Individual Disorders); Effect Size; Outcomes of Treatment; Intervention
    • Accession Number:
      10.1177/10870547231218041
    • ISSN:
      1087-0547
      1557-1246
    • Abstract:
      Objective: We appraised whether FDA registration trials for ADHD pharmacotherapy in adults provides comparable information to inform treatment expectations. Method: Comparison of ADHD outcome measure patterns in ADHD pharmacotherapy FDA drug label source studies. Results: Among stimulants, from fixed-dose titration data, amphetamine agents had numerically higher placebo-corrected symptom improvement and symptom effect sizes than methylphenidate agents. Symptom effect sizes were lower in the flexible dosing registration studies of atomoxetine and viloxazine. Varying responder definitions were analyzable, based on [greater than or equal to] 30% symptom improvement and/or CGI-I improvement of "much" or "very much improved." Number of exposures needed to create these responses were lower for stimulants than for viloxazine. Conclusion: Heterogeneity in the design and analysis of FDA drug label source trials restricts implications for clinical practice. Research conducted using replicated designs, direct comparison of available treatments, and outcome analyses that generalize to clinical care could better inform clinical decision making. "(J. of Att. Dis. 2024; 28(5) 800-809)"
    • Abstract:
      As Provided
    • Publication Date:
      2024
    • Accession Number:
      EJ1440938