title: Functional outcomes from a head-to-head, randomized, double-blind trial of lisdexamfetamine dimesylate and atomoxetine in children and adolescents with attention-deficit/hyperactivity disorder and an inadequate response to methylphenidate.
abstract: Attention-deficit/hyperactivity disorder (ADHD) is associated with functional impairments in multiple domains of patients' lives. A secondary objective of this randomized, active-controlled, head-to-head, double-blind, dose-optimized clinical trial was to compare the effects of lisdexamfetamine dimesylate (LDX) and atomoxetine (ATX) on functional impairment in children and adolescents with ADHD. Patients aged 6-17 years with an ADHD Rating Scale IV total score ≥ 28 and an inadequate response to methylphenidate treatment (judged by investigators) were randomized (1:1) to once-daily LDX or ATX for 9 weeks. Parents/guardians completed the Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) at baseline and at week 9 or early termination. p values were nominal and not corrected for multiple comparisons. Of 267 randomized patients, 200 completed the study (LDX 99, ATX 101). At baseline, mean WFIRS-P total score in the LDX group was 0.95 [standard deviation (SD) 0.474; 95% confidence interval (CI) 0.87, 1.03] and in the ATX group was 0.91 (0.513; 0.82, 1.00). Scores in all WFIRS-P domains improved from baseline to endpoint in both groups, with least-squares mean changes in total score of -0.35 (95% CI -0.42, -0.29) for LDX and -0.27 (-0.33, -0.20) for ATX. The difference between LDX and ATX was statistically significant (p < 0.05) for the Learning and School (effect size of LDX vs ATX, 0.43) and Social Activities (0.34) domains and for total score (0.27). Both treatments reduced functional impairment in children and adolescents with ADHD; LDX was statistically significantly more effective than ATX in two of six domains and in total score.
authors.affiliation: Vadaskert Child and Adolescent Psychiatry Hospital and Outpatient Clinic, Budapest, Hungary.
authors.forename: Peter
authors.initials: P
authors.lastname: Nagy
authors.affiliation: Paediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany.
authors.forename: Alexander
authors.initials: A
authors.lastname: Häge
authors.affiliation: Division of Neuroscience, University of Dundee, Dundee, UK.
authors.forename: David R
authors.initials: DR
authors.lastname: Coghill
authors.affiliation: Shire, Eysins, Switzerland.
authors.forename: Beatriz
authors.initials: B
authors.lastname: Caballero
authors.affiliation: Shire, Wayne, PA, USA.
authors.forename: Ben
authors.initials: B
authors.lastname: Adeyi
authors.affiliation: Shire, Wayne, PA, USA.
authors.forename: Colleen S
authors.initials: CS
authors.lastname: Anderson
authors.affiliation: Shire, Wayne, PA, USA.
authors.forename: Vanja
authors.initials: V
authors.lastname: Sikirica
authors.affiliation: Neuropaediatric Unit, Son Llàtzer Hospital and Research Institute on Health Sciences, University of the Balearic Islands, Palma De Mallorca, Spain. ecardojalon@gmail.com.
authors.forename: Esther
authors.initials: E
authors.lastname: Cardo
mesh_terms: D000293:Adolescent; D000069445:Atomoxetine Hydrochloride / Q000627:therapeutic use*; D001288:Attention; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy* / Q000523:psychology; D000697:Central Nervous System Stimulants / Q000627:therapeutic use*; D002648:Child; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000069478:Lisdexamfetamine Dimesylate / Q000627:therapeutic use*; D008297:Male; D008774:Methylphenidate / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride; D000069478:Lisdexamfetamine Dimesylate
keywords: Atomoxetine; Attention-deficit/hyperactivity disorder; Functional impairment; Lisdexamfetamine dimesylate; Weiss Functional Impairment Rating Scale-Parent Report