A meta-analysis of the consistency of atomoxetine treatment effects in pediatric patients with attention-deficit/hyperactivity disorder from 15 clinical trials across four geographic regions

Journal of Child and Adolescent Psychopharmacology

Volumn 23, Issue 4, 2013, Pages 262-270

  Tanaka, Yoko ^a   Rohde, Luis A ^b   Jin, Ling ^a   Feldman, Peter D ^a   Upadhyaya, Himanshu P ^a  

^a ELI LILLY AND COMPANY   (United States)

^b HOSPITAL DE CLÍNICAS DE PORTO ALEGRE   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

ATOMOXETINE; PLACEBO;

ARTICLE; ASIA; ASIAN; ATTENTION DEFICIT DISORDER; CLINICAL TRIAL (TOPIC); DRUG DOSE SEQUENCE; DRUG EFFECT; EUROPE; GEOGRAPHY; HUMAN; META ANALYSIS; NORTH AMERICA; RUSSIAN FEDERATION;

ADOLESCENT; ADRENERGIC UPTAKE INHIBITORS; ATTENTION DEFICIT DISORDER WITH HYPERACTIVITY; CHILD; DOUBLE-BLIND METHOD; FEMALE; GEOGRAPHY; HUMANS; MALE; PROPYLAMINES; PSYCHIATRIC STATUS RATING SCALES; RANDOMIZED CONTROLLED TRIALS AS TOPIC; TREATMENT OUTCOME;

EID: 84878086431     PISSN: 10445463     EISSN: 15578992     Source Type: Journal    
DOI: 10.1089/cap.2012.0049     Document Type: Article

References (48)

1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th ed. Washington, DC: American Psychiatric Association; 1994.
2. Bitter I, Chou JCY, Ungvari GS, Tang WK, Xiang Z, Iwanami A, Gaszner P: Prescribing for inpatients with schizophrenia: An international multi-center comparative study. Pharmacopsychiatry 36:143-149, 2003.
3. Caldwell TM, Jorm AF, Knox S, Braddock D, Dear KBG, Britt H: General practice encounters for psychological problems in rural, remote and metropolitan areas in Australia. Aust N Z J Psychiatry 38:774-780, 2004.
4. Cardo E, Servera M, Vidal C, de Azua B, Redondo M, Riutort L: The influence of different diagnostic criteria and the culture on the prevalence of attention deficit hyperactivity disorder [in Spanish]. Rev Neurol 52 Suppl 1:S109-S117, 2011.
5. Chen J, Quan H, Binkowitz B, Ouyang SP, Tanaka Y, Li G, Menjoge S, Ibia E, Consistency Workstream of the PhRMA MRCT Key Issue Team: Assessing consistent treatment effect in a multi-regional clinical trial: a systematic review. Pharm Stat 9:242-253, 2010.
6. Cheuk DK, Li SY, Wong V: Exon 3 polymorphisms of dopamine D4 receptor (DRD4) gene and attention deficit hyperactivity disorder in Chinese children. Am J Med Genet B Neuropsychiatr Genet 141B:907-911, 2006.
7. Cox DR: Interaction. Int Stat Rev 52:1-25, 1984.
8. Cuffe SP, Waller JL, Cuccaro ML, Pumariega AJ, Garrison CZ: Race and gender differences in the treatment of psychiatric disorders in young adolescents. J Am Acad Child Adolesc Psychiatry 34:1536-1543, 1995.
9. Döpfner M, Breuer D, Wille N, Erhart M, Ravens-Sieberer U, the BELLA study group: How often do children meet ICD-10/DSM-IV criteria of attention deficit-/hyperactivity disorder and hyperkinetic disorder? Parent-based prevalence rates in a national sample-results of the BELLA study. Eur Child Adolesc Psychiatry 17 Suppl 1:59-70, 2008.
10. DuPaul GJ, Power TJ, Anastopoulos AD, Reid R: ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York: The Guilford Press; 1998.
11. Froehlich TE, McGough JJ, Stein MA: Progress and promise of attention-deficit hyperactivity disorder pharmacogenetics. CNS Drugs 24:99-117, 2010.
12. Gau SSF, Ni HC, Shang CY, Soong WT, Wu YY, Lin LY, Chiu YN: Psychiatric comorbidity among children and adolescents with and without persistent attention-deficit hyperactivity disorder. Aust N Z J Psychiatry 44:135-143, 2010.
13. Higgins JPT, Thompson SG, Deeks JJ, Altman DG: Measuring inconsistency in meta-analyses. BMJ 327:557-560, 2003.
14. Hinshaw SP, Scheffler RM, Fulton BD, Aase H, Banaschewski T, Cheng W, Mattos P, Holte A, Levy F, Sadeh A, Sergeant JA, Taylor E, Weiss MD: International variation in treatment procedures for ADHD: social context and recent trends. Psychiatr Serv 62:459-464, 2011.
15. Idle JR, Smith RL: Polymorphisms of oxidation at carbon centers of drugs and their clinical significance. Drug Metab Rev 9:301-317, 1979.
16. International Conference on Harmonization: ICH International Conference on Harmonization Tripartite Guidance E5: Ethnic Factor in the Acceptability of Foreign Data. Federal Register 83:31,790-31,796, 1998.
17. Lee SI, Schachar RJ, Chen SX, Ornstein TJ, Charach A, Barr C, Ickowicz A: Predictive validity of DSM-IV and ICD-10 criteria for ADHD and hyperkinetic disorder. J Child Psychol Psychiatry 49:70-78, 2008.
18. Leung PW, Lee CC, Hung SF, Ho TP, Tang CP, Kwong SL, Leung SY, Yuen ST, Lieh-Mak F, Oosterlaan J, Grady D, Harxhi A, Ding YC, Chi HC, Flodman P, Schuck S, Spence MA, Moyzis R, Swanson J: Dopamine receptor D4 (DRD4) gene in Han Chinese children with attention-deficit/hyperactivity disorder (ADHD): Increased prevalence of the 2-repeat allele. Am J Med Genet B Neuropsychiatr Genet 133B:54-56, 2005.
19. Leung PW, Luk SL, Ho TP, Taylor E, Mak FL, Bacon-Shone J: The diagnosis and prevalence of hyperactivity in Chinese schoolboys. Br J Psychiatry 168:486-496, 1996.
20. Martényi F, Zheng Y, Huang YS, Lee YS, Walton R, Harrison G, Treuer T: A prospective observational study of attention-deficit hyperactivity disorder in Asia: Baseline characteristics of symptom severity and treatment options in a paediatric population. East Asian Arch Psychiatry 20:76-86, 2010.
21. Michelson D, Faries D, Wernicke J, Kelsey D, Kendrick K, Sallee FR, Spencer T, the Atomoxetine ADHD Study Group: Atomoxetine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder: A randomized, placebo-controlled, doseresponse study. Pediatrics 108:e83, 2001.
22. Ministry of Health Labour and Welfare of Japan: Basic Principles on Global Clinical Trials. Tokyo: PMDA, 2007.
23. Moffitt TE, Melchior M: Why does the worldwide prevalence of childhood attention deficit hyperactivity disorder matter? Am J Psychiatry 164:856-858, 2007.
24. Newcorn JH, Sutton VK, Zhang S, Wilens T, Kratochvil C, Emslie GJ, D'souza DN, Schuh LM, Allen AJ: Characteristics of placebo responders in pediatric clinical trials of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 48:1165-1172, 2009.
25. Patil KD: Cochran's Q Test: Exact distribution. J Am Stat Assoc 70:186-189, 1975.
26. Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA: The worldwide prevalence of ADHD: A systematic review and metaregression analysis. Am J Psychiatry 164:942-948, 2007.
27. Rani S, Pargal A: Bioequivalence: An overview of statistical concepts. Indian J Pharmacol 36:209-216, 2004.
28. Rohde LA, Szobot C, Polanczyk G, Schmitz M, Martins S, Tramontina S: Attention-deficit/hyperactivity disorder in a diverse culture: Do research and clinical findings support the notion of a cultural construct for the disorder? Biol Psychiatry 57:1436-1441, 2005.
29. Rom DM, Hwang E: Testing for individual and population equivalence based on the proportion of similar responses. Stat Med 15:1489-1505, 1996.
30. Roman T, Rohde LA, Hutz MH: Polymorphisms of the dopamine transporter gene: Influence on response to methylphenidate in attention deficit- hyperactivity disorder.AmJ Pharmacogenomics 4:83-92, 2004.
31. Sauer JM, Ponsler GD, Mattiuz EL, Long AJ, Witcher JW, Thomasson HR, Desante KA: Disposition and metabolic fate of atomoxetine hydrochloride: The role of CYP2D6 in human disposition and metabolism. Drug Metab Dispos 31:98-107, 2003.
32. Snape D, Wang W, Wu J, Jacoby A, Baker GA: Knowledge gaps and uncertainties about epilepsy: Findings from an ethnographic study in China. Epilepsy Behav 14:172-178, 2009.
33. Snapinn SM: Noninferiority trials. Curr Control Trials Cardiovasc Med 1:19-21, 2000.
34. Spencer T, Biederman J, Wilens T, Harding M, O'Donnell D, Griffin S: Pharmacotherapy of attention-deficit hyperactivity disorder across the life cycle. J Am Acad Child Adolesc Psychiatry 35:409-432, 1996.
35. Spencer T, Heiligenstein JH, Biederman J, Faries DE, Kratochvil CJ, Conners CK, Potter WZ: Results from 2 proof-of-concept, placebocontrolled studies of atomoxetine in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry 63:1140-1147, 2002.
36. Student (Gosset WS): The probable error of a mean. Biometrika 6:1-25, 1908.
37. Svendsen SW: Regional variations in the incidence of manic-depressive psychoses in the Danish psychiatric hospital system 1977-1993 [in Danish]. Ugeskr Læger 158:598-602, 1996.
38. Swanson JM: 1992. Tahir E, Yazgan Y, Cirakoglu B, Ozbay F, Waldman I, Asherson PJ: Association and linkage of DRD4 and DRD5 with attention deficit hyperactivity disorder (ADHD) in a sample of Turkish children. Mol Psychiatry 5:396-404, 2000.
39. Tiainen A, Edman G, Flyckt L, Tomson G, Rehnberg C: Regional variations and determinants of direct psychiatric costs in Sweden. Scand J Public Health 36:483-492, 2008.
40. Tseng W, Chang SC, Nishizono M: Asian culture and psychotherapy: An overview. In: Asian Culture and Psychotherapy: Implications for East and West. Edited by W. Tseng, S.C. Chang, M. Nishizono. Honolulu: University of Hawai'i Press, 265-279, 2005.
41. U.S. Food and Drug Administration: Guidance for Industry. Statistical Approaches to Establishing Bioequivalence. Washington, D.C.: Government Printing Office, 2001.
42. Wang XS, Cleeland CS, Mendoza TR, Yun YH, Wang Y, Okuyama T, Johnson VE: Impact of cultural and linguistic factors on symptom reporting by patients with cancer. J Natl Cancer Inst 102:732-738, 2010.
43. Weiss M, Tannock R, Kratochvil C, Dunn D, Velez-Borras J, Thomason C, Tamura R, Kelsey D, Stevens L, Allen AJ: A randomized, placebo-controlled study of once-daily atomoxetine in the school setting in children with ADHD. J Am Acad Child Adolesc Psychiatry 44:647-655, 2005.
44. Wierdsma AI, Kamperman AM: Contact with the child and adolescent psychiatric services is determined by cultural and socio-economic differences [in Dutch]. Tijdschr Psychiatr 53:857-863, 2011.
45. Wilson JF, Weale ME, Smith AC, Gratrix F, Fletcher B, Thomas MG, Bradman N, Goldstein DB: Population genetic structure of variable drug response. Nat Genet 29:265-269, 2001.
46. World Medical Association: WMA Declaration of Helsinki-Ethical Principles for Medical Research Involving Human Subjects. Bull WHO 86:650-651, 2008.
47. Yang LK, Shang CY, Gau SSF: Psychiatric comorbidities in adolescents with attention-deficit hyperactivity disorder and their siblings. Can J Psychiatry 56:281-292, 2011.
48. Zullino D, Mayland G, Schmidt LG, Fähndrich E, Greil W, Horvath A, Rüther E, Engel R, Hippius H, Baumann P: Prescribing practices in German and Swiss psychiatric university and in non-university hospitals: National differences. Int J Clin Pharmacol Ther 43:339-349, 2005.