Acute atomoxetine treatment of younger and older children with ADHD: A meta-analysis of tolerability and efficacy

被引：41
作者：
Kratochvil C.J. [1 ]
Milton D.R. [2 ]
Vaughan B.S. [1 ]
Greenhill L.L. [3 ]
机构：
[1] University of Nebraska Medical Center, 985581 Nebraska Medical Center, Omaha
[2] Eli Lilly and Company, Lilly Corporate Center, Indianapolis
[3] New York State Psychiatric Institute, New York, NY 10032
来源：
Child and Adolescent Psychiatry and Mental Health | / 2卷 / 1期
关键词：
Subscale Score; Oppositional Defiant Disorder; ADHD Symptom; Atomoxetine; Oppositional Defiant Disorder;
D O I：
10.1186/1753-2000-2-25
中图分类号：
学科分类号：
摘要：
Background: Atomoxetine is FDA-approved as a treatment of attention-deficit/hyperactivity disorder (ADHD) in patients aged 6 years to adult. Among pediatric clinical trials of atomoxetine to date, six with a randomized, double-blind, placebo-controlled design were used in this meta-analysis. The purpose of this article is to describe and compare the treatment response and tolerability of atomoxetine between younger children (6-7 years) and older children (8-12 years) with ADHD, as reported in these six acute treatment trials. Methods: Data from six clinical trials of 6-9 weeks duration were pooled, yielding 280 subjects, ages 6-7 years, and 860 subjects, ages 8-12 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)-diagnosed ADHD. Efficacy was analyzed using the ADHD Rating Scale-IV (ADHD-RS), Conners' Parent Rating Scale-revised (CPRS-R:S), and the Clinical Global Impression of ADHD Severity (CGI-ADHD-S). Results: Atomoxetine was superior to placebo in both age categories for mean (SD) change in ADHD-RS total, total T, and subscale scores; 3 CPRS-R:S subscales; and CGI-ADHD-S from baseline. Although there were no significant treatment differentials between the age groups for these efficacy measures, the age groups themselves, regardless of treatment, were significantly different for ADHD-RS total (younger: ATX = -14.2 [13.8], PBO = -4.6 [10.4]; older: ATX = -15.4 [13.2], PBO = -7.3 [12.0]; p = .001), total T (younger: ATX = -15.2 [14.8], PBO = -4.9 [11.2]; older: ATX = -16.4 [14.6], PBO = -7.9 [13.1]; p = .003), and subscale scores (Inattentive: younger: ATX = -7.2 [7.5], PBO = -2.4 [5.7]; older: ATX = -8.0 [7.4], PBO = -3.9 [6.7]; p = .043; Hyperactive/Impulsive: younger: ATX = -7.0 [7.2], PBO = -2.1 [5.4]; older: ATX = -7.3 [7.0], PBO = -3.4 [6.3]; p < .001), as well as the CGI-ADHD-S score (younger: ATX = -1.2 [1.3], PBO = -0.5 [0.9]; older: ATX = -1.4 [1.3], PBO = -0.7 [1.1]; p = .010). Although few subjects discontinued from either age group due to adverse events, a significant treatment-by-age-group interaction was observed for abdominal pain (younger: ATX = 19%, PBO = 6%; older: ATX = 15%, PBO = 13%; p = .044), vomiting (younger: ATX = 14%, PBO = 2%; older: ATX = 9%, PBO = 6%; p = .053), cough (younger: ATX = 10%, PBO = 6%; older: ATX = 3%, PBO = 9%; p = .007), and pyrexia (younger: ATX = 5%, PBO = 2%; older: ATX = 3%, PBO = 5%; p = .058). Conclusion: Atomoxetine is an effective and generally well-tolerated treatment of ADHD in both younger and older children as assessed by three recognized measures of symptoms in six controlled clinical trials. © 2008 Kratochvil et al; licensee BioMed Central Ltd.
引用
收藏
相关论文
共 25 条
  • [1] Diagnostic and Statistical Manual of Mental Disorders: DSM-IV-TR, Text Revision, (2000)
  • [2] Lavigne J.V., Gibbons R.D., Christoffel K.K., Arend R., Rosenbaum D., Binns H., Dawson N., Sobel H., Isaacs C., Prevalence rates and correlates of psychiatric disorders among preschool children, J Am Acad Child Psychiatry, 35, pp. 204-214, (1996)
  • [3] DuPaul G.J., McGoey K.E., Eckert T.L., VanBrakle J., Preschool children with attention-deficit/hyperactivity disorder: Impairments in behavioral, social, and school functioning, J Am Acad Child Adolesc Psychiatry, 40, pp. 508-515, (2001)
  • [4] Lahey B.B., Pelham W.E., Stein M.A., Loney J., Trapani C., Nugent K., Kipp H., Schmith E., Lee S., Cale M., Gold E., Hartung C.M., Willcutt E., Baumann B., Validity of DSM-IV attention-deficit/hyperactivity disorder for younger children, J Am Acad Child Adolesc Psychiatry, 37, pp. 695-702, (1998)
  • [5] Mariani M.A., Barkley R.A., Neuropsychological and academic functioning in preschool boys with attention deficit hyperactivity disorder, Dev Neuropsychol, 13, pp. 111-129, (1997)
  • [6] Shelton T.L., Barkley R.A., Crosswait C., Moorehouse M., Fletcher K., Barrett S., Jenkins L., Metevia L., Psychiatric and psychological morbidity as a function of adaptive disability in preschool children with aggressive and hyperactive-impulsive-inattentive behavior, J Abnorm Child Psychol, 26, pp. 475-494, (1998)
  • [7] A 14-month randomized clinical trial of treatment strategies for attention-deficit/hyperactivity disorder, Arch Gen Psychiatry, 56, pp. 1073-1086, (1999)
  • [8] Greenhill L., Kollins S., Abikoff H., McCracken J., Riddle M., Swanson J., McGough J., Wigal S., Wigal T., Vitiello B., Skrobala A., Posner K., Ghuman J., Cunnigham C., Davies M., Chuang S., Cooper T., Efficacy and Safety of Immediate-Release Methylphenidate Treatment for Preschoolers With ADHD, J Am Acad Child Adolesc Psychiatry, 45, pp. 1284-1293, (2006)
  • [9] Pliszka S., Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder, J Am Acad Child Adolesc Psychiatry, 46, pp. 894-921, (2007)
  • [10] Kratochvil C.J., Vaughan B.S., Mayfield-Jorgensen M.L., March J.S., Kollins S.H., Murray D.W., Ravi H., Greenhill L.L., Kotler L.A., Paykina N., Biggins P., Stoner J., A pilot study of atomoxetine in young children with attention-deficit/ hyperactivity disorder, J Child Adolesc Psychopharmacol, 17, pp. 175-185, (2007)
123