title: Efficacy and Safety Extrapolation Analyses for Atomoxetine in Young Children with Attention-Deficit/Hyperactivity Disorder.
abstract: OBJECTIVE
  This extrapolation analysis qualitatively compared the efficacy and safety profile of atomoxetine from Lilly clinical trial data in 6-7-year-old patients with attention-deficit/hyperactivity disorder (ADHD) with that of published literature in 4-5-year-old patients with ADHD (two open-label [4-5-year-old patients] and one placebo-controlled study [5-year-old patients]).
  
  
  METHODS
  The main efficacy analyses included placebo-controlled Lilly data and the placebo-controlled external study (5-year-old patients) data. The primary efficacy variables used in these studies were the ADHD Rating Scale-IV Parent Version, Investigator Administered (ADHD-RS-IV-Parent:Inv) total score, or the Swanson, Nolan and Pelham (SNAP-IV) scale score. Safety analyses included treatment-emergent adverse events (TEAEs) and vital signs. Descriptive statistics (means, percentages) are presented.
  
  
  RESULTS
  Acute atomoxetine treatment improved core ADHD symptoms in both 6-7-year-old patients (n=565) and 5-year-old patients (n=37) (treatment effect: -10.16 and -7.42). In an analysis of placebo-controlled groups, the mean duration of exposure to atomoxetine was ∼ 7 weeks for 6-7-year-old patients and 9 weeks for 5-year-old patients. Decreased appetite was the most common TEAE in atomoxetine-treated patients. The TEAEs observed at a higher rate in 5-year-old versus 6-7-year-old patients were irritability (36.8% vs. 3.6%) and other mood-related events (6.9% each vs. <3.0%). Blood pressure and pulse increased in both 4-5-year-old patients and 6-7-year-old patients, whereas a weight increase was seen only in the 6-7-year-old patients.
  
  
  CONCLUSIONS
  Although limited by the small sample size of the external studies, these analyses suggest that in 5-year-old patients with ADHD, atomoxetine may improve ADHD symptoms, but possibly to a lesser extent than in older children, with some adverse events occurring at a higher rate in 5-year-old patients.
authors.affiliation: 1 Lilly Research Laboratories , Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Himanshu
authors.initials: H
authors.lastname: Upadhyaya
authors.affiliation: 2 Clinical Research, Department of Psychiatry, University of Nebraska Medical Center , Omaha, Nebraska.
authors.forename: Christopher
authors.initials: C
authors.lastname: Kratochvil
authors.affiliation: 3 Child and Adolescent Psychiatry, The University of Arizona , Tucson, Arizona.
authors.forename: Jaswinder
authors.initials: J
authors.lastname: Ghuman
authors.affiliation: 4 Eli Lilly Italia S.p.A. , Sesto Fiorentino, Firenze, Italy .
authors.forename: Angelo
authors.initials: A
authors.lastname: Camporeale
authors.affiliation: 5 inVentiv Health Clinical , Blue Bell, Pennsylvania.
authors.forename: Sarah
authors.initials: S
authors.lastname: Lipsius
authors.affiliation: 5 inVentiv Health Clinical , Blue Bell, Pennsylvania.
authors.forename: Deborah
authors.initials: D
authors.lastname: D'Souza
authors.affiliation: 1 Lilly Research Laboratories , Eli Lilly and Company, Indianapolis, Indiana.
authors.forename: Yoko
authors.initials: Y
authors.lastname: Tanaka
mesh_terms: D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000367:Age Factors; D000069445:Atomoxetine Hydrochloride / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D012449:Safety
chemical_list: D018759:Adrenergic Uptake Inhibitors; D000069445:Atomoxetine Hydrochloride