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

Autor:	Surman CBH; Massachusetts General Hospital, Boston, USA.; Harvard Medical School, Boston, MA, USA., Walsh DM; Massachusetts General Hospital, Boston, USA., Bond JB; Massachusetts General Hospital, Boston, USA.; Harvard Medical School, Boston, MA, USA.; Mass General Brigham Integrated Care, Somerville, MA, USA.
Jazyk:	angličtina
Zdroj:	Journal of attention disorders [J Atten Disord] 2024 Mar; Vol. 28 (5), pp. 800-809. Date of Electronic Publication: 2024 Jan 16.
DOI:	10.1177/10870547231218041
Abstrakt:	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 ≥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. Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Daniel Walsh reports no conflicts of interest. Dr. Bond reports no conflicts of interest. Dr. Surman has received, in his lifetime, consulting fees from Eisai, Ironshore, Kaylon, Mcneil, NLS Pharma, Neurocentria, Nutricia, Otsuka, Pfizer, Adlon/Purdue, Rhodes, Shire, Somaxon, Sunovion, Supernus, Takeda, and Teva. He has also received payments for lectures for Alcobra, Arbor, McNeil, Janssen, Janssen-Ortho, Novartis, Shire, and Reed/MGH Academy (funded by multiple companies) as well as GME CME (funded by multiple companies). Royalties have been given to Dr. Surman from Berkeley/Penguin for “FASTMINDS: How to Thrive if You have ADHD (or think you might)” and from Humana/Springer for “ADHD in Adults: A Practical Guide to Evaluation and Management.” Additionally, Dr. Surman has conducted clinical research at Massachusetts General Hospital supported by Abbot, Cephalon, Hilda and Preston Davis Foundation, Eli Lilly, Magceutics/Neurocentria, Jazz, Johnson & Johnson/McNeil, Lundbeck, Merck, The National Institutes of Health, Nordic Naturals, Shire, and Takeda.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu