title: Prognostic factors of improvement in health-related quality of life in atomoxetine-treated children and adolescents with attention-deficit/hyperactivity disorder, based on a pooled analysis.
abstract: The objective of this study is to identify prognostic factors of treatment response to atomoxetine in improvement of health-related quality of life (HR-QoL), measured by the Child Health and Illness Profile-Child Edition Parent Report Form (CHIP-CE PRF) Achievement and Risk Avoidance domains, in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). Pooled data from 3 placebo-controlled trials and separate data from 3 open-label trials of atomoxetine in children and adolescents with ADHD were analyzed using logistic regression methods. Based on baseline impairment in the Achievement and/or Risk Avoidance domains (CHIP-CE PRF < 40 points), 2 subsamples of subjects were included. Treatment outcome was categorized as <5 points or ≥5 points increase in the CHIP-CE PRF Achievement and Risk Avoidance domains. Data of 190 and 183 subjects from the pooled sample, and 422 and 355 subjects from the open-label trials were included in the analysis of Achievement and Risk Avoidance domains. Baseline CHIP-CE subdomain scores proved to be the most robust prognostic factors for treatment outcome in both domains, based on data from the pooled sample of double-blind studies and from the individual open-label studies (odds ratios [OR] 0.74-1.56, p < 0.05; OR < 1, indicating a worse baseline score associated with worse odds of responding). Initial treatment response (≥25 % reduction in ADHD Rating Scale scores in the first 4-6 weeks) was another robust prognostic factor, based on data from the open-label studies (OR 2.99-6.19, p < 0.05). Baseline impairment in HR-QoL and initial treatment response can be early prognostic factors of atomoxetine treatment outcome in HR-QoL in children and adolescents with ADHD.
authors.affiliation: Medical Neuroscience, Eli Lilly Canada Inc., 3650 Danforth Avenue, Toronto, ON, M1N 2E8, Canada, montoya_alonso@lilly.com.
authors.forename: Alonso
authors.initials: A
authors.lastname: Montoya
authors.forename: Deborah
authors.initials: D
authors.lastname: Quail
authors.forename: Ernie
authors.initials: E
authors.lastname: Anand
authors.forename: Esther
authors.initials: E
authors.lastname: Cardo
authors.forename: José A
authors.initials: JA
authors.lastname: Alda
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Escobar
mesh_terms: D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis* / Q000188:drug therapy / Q000523:psychology*; D002648:Child; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004522:Educational Status; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D011379:Prognosis; D011437:Propylamines / Q000627:therapeutic use; D011788:Quality of Life / Q000523:psychology*; D040242:Risk Reduction Behavior; D016896:Treatment Outcome
chemical_list: D011437:Propylamines; D000069445:Atomoxetine Hydrochloride