메뉴 건너뛰기




Volumn 32, Issue 2, 2010, Pages 252-264

Pharmacokinetics of lisdexamfetamine dimesylate and its active metabolite, d-amphetamine, with increasing oral doses of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: A single-dose, randomized, open-label, crossover study

Author keywords

ADHD; LDX; pharmacokinetics; stimulant; Vyvanse

Indexed keywords

CEFPROZIL; CENTRAL STIMULANT AGENT; CETIRIZINE; DECONGESTIVE AGENT; DEXAMPHETAMINE; LISDEXAMFETAMINE; PARACETAMOL;

EID: 77649101889     PISSN: 01492918     EISSN: 1879114X     Source Type: Journal    
DOI: 10.1016/j.clinthera.2010.02.011     Document Type: Article
Times cited : (69)

References (43)
  • 1
    • 34250832736 scopus 로고    scopus 로고
    • The worldwide prevalence of ADHD: A systematic review and metaregression analysis
    • Polanczyk G., de Lima M.S., Horta B.L., et al. The worldwide prevalence of ADHD: A systematic review and metaregression analysis. Am J Psychiatry 164 (2007) 942-948
    • (2007) Am J Psychiatry , vol.164 , pp. 942-948
    • Polanczyk, G.1    de Lima, M.S.2    Horta, B.L.3
  • 2
    • 22144455050 scopus 로고    scopus 로고
    • Attention-deficit hyperactivity disorder [published correction appears in Lancet. 2006;367:210]
    • Biederman J., and Faraone S.V. Attention-deficit hyperactivity disorder [published correction appears in Lancet. 2006;367:210]. Lancet 366 (2005) 237-248
    • (2005) Lancet , vol.366 , pp. 237-248
    • Biederman, J.1    Faraone, S.V.2
  • 4
    • 0032495853 scopus 로고    scopus 로고
    • Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents
    • Council on Scientific Affairs, American Medical Association
    • Goldman L.S., Genel M., Bezman R.J., Slanetz P.J., Council on Scientific Affairs, and American Medical Association. Diagnosis and treatment of attention-deficit/hyperactivity disorder in children and adolescents. JAMA 279 (1998) 1100-1107
    • (1998) JAMA , vol.279 , pp. 1100-1107
    • Goldman, L.S.1    Genel, M.2    Bezman, R.J.3    Slanetz, P.J.4
  • 5
    • 0029790434 scopus 로고    scopus 로고
    • Attention deficit disorder: A review of the past 10 years
    • Cantwell D.P. Attention deficit disorder: A review of the past 10 years. J Am Acad Child Adolesc Psychiatry 35 (1996) 978-987
    • (1996) J Am Acad Child Adolesc Psychiatry , vol.35 , pp. 978-987
    • Cantwell, D.P.1
  • 6
    • 0036483615 scopus 로고    scopus 로고
    • Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults
    • American Academy of Child and Adolescent Psychiatry
    • Greenhill L.L., Pliszka S., Dulcan M.K., et al., American Academy of Child and Adolescent Psychiatry. Practice parameter for the use of stimulant medications in the treatment of children, adolescents, and adults. J Am Acad ChildAdolesc Psychiatry 41 Suppl 2 (2002) 26S-49S
    • (2002) J Am Acad ChildAdolesc Psychiatry , vol.41 , Issue.SUPPL. 2
    • Greenhill, L.L.1    Pliszka, S.2    Dulcan, M.K.3
  • 7
    • 33744827954 scopus 로고    scopus 로고
    • The Texas Children's Medication Algorithm Project: Revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder
    • Texas Consensus Conference Panel on Pharmacotherapy of Childhood Attention Deficit Hyperactivity Disorder
    • Pliszka S.R., Crismon M.L., Hughes C.W., et al., Texas Consensus Conference Panel on Pharmacotherapy of Childhood Attention Deficit Hyperactivity Disorder. The Texas Children's Medication Algorithm Project: Revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry 45 (2006) 642-657
    • (2006) J Am Acad Child Adolesc Psychiatry , vol.45 , pp. 642-657
    • Pliszka, S.R.1    Crismon, M.L.2    Hughes, C.W.3
  • 10
    • 85012548055 scopus 로고
    • Relative cardiovascular safety of psychostimulants used to treat attention-deficit hyperactivity disorder
    • Safer D.J. Relative cardiovascular safety of psychostimulants used to treat attention-deficit hyperactivity disorder. J Child Adolesc Psychopharmacol. 2 (1992) 279-290
    • (1992) J Child Adolesc Psychopharmacol. , vol.2 , pp. 279-290
    • Safer, D.J.1
  • 12
    • 25144476583 scopus 로고    scopus 로고
    • Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children
    • SLI381.301 and.302 Study Groups
    • Findling R.L., Biederman J., Wilens T.E., et al., SLI381.301 and.302 Study Groups. Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children. J Pediatr. 147 (2005) 348-354
    • (2005) J Pediatr. , vol.147 , pp. 348-354
    • Findling, R.L.1    Biederman, J.2    Wilens, T.E.3
  • 13
    • 49349084791 scopus 로고    scopus 로고
    • ADHD, substance use disorders, and psychostimulant treatment: Current literature and treatment guidelines
    • Kollins S.H. ADHD, substance use disorders, and psychostimulant treatment: Current literature and treatment guidelines. J Atten Disord. 12 (2008) 115-125
    • (2008) J Atten Disord. , vol.12 , pp. 115-125
    • Kollins, S.H.1
  • 14
    • 46749142537 scopus 로고    scopus 로고
    • Lisdexamfetamine dimesylate: The first longacting prodrug stimulant treatment for attention deficit/hyperactivity disorder
    • Faraone S.V. Lisdexamfetamine dimesylate: The first longacting prodrug stimulant treatment for attention deficit/hyperactivity disorder. Expert Opin Pharmacother 9 (2008) 1565-1574
    • (2008) Expert Opin Pharmacother , vol.9 , pp. 1565-1574
    • Faraone, S.V.1
  • 15
    • 0043190430 scopus 로고    scopus 로고
    • Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall
    • McGough J.J., Biederman J., Greenhill L.L., et al. Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall. J Am Acad Child Adolesc Psychiatry 42 (2003) 684-691
    • (2003) J Am Acad Child Adolesc Psychiatry , vol.42 , pp. 684-691
    • McGough, J.J.1    Biederman, J.2    Greenhill, L.L.3
  • 17
    • 77049120157 scopus 로고    scopus 로고
    • Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: An open-label, dose-optimization study
    • Findling R.L., Ginsberg L.D., Jain R., and Gao J. Effectiveness, safety, and tolerability of lisdexamfetamine dimesylate in children with attention-deficit/hyperactivity disorder: An open-label, dose-optimization study. J Child Adolesc Psychopharmacol. 19 (2009) 649-662
    • (2009) J Child Adolesc Psychopharmacol. , vol.19 , pp. 649-662
    • Findling, R.L.1    Ginsberg, L.D.2    Jain, R.3    Gao, J.4
  • 19
    • 77949731782 scopus 로고    scopus 로고
    • Absorption of lisdexamfetamine dimesylate and hydrolysis to form the active moiety, d-amphetamine
    • Hollywood, Fla
    • Pennick M. Absorption of lisdexamfetamine dimesylate and hydrolysis to form the active moiety, d-amphetamine. Presented at: 49th Annual Meeting of the New Clinical Drug Evaluation Unit. Hollywood, Fla (June 29-July 2, 2009)
    • (2009) Presented at: 49th Annual Meeting of the New Clinical Drug Evaluation Unit
    • Pennick, M.1
  • 21
    • 39149138093 scopus 로고    scopus 로고
    • Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: A single-dose, crossover pharmacokinetic study
    • Krishnan S., and Zhang Y. Relative bioavailability of lisdexamfetamine 70-mg capsules in fasted and fed healthy adult volunteers and in solution: A single-dose, crossover pharmacokinetic study. J Clin Pharmacol. 48 (2008) 293-302
    • (2008) J Clin Pharmacol. , vol.48 , pp. 293-302
    • Krishnan, S.1    Zhang, Y.2
  • 22
    • 77649144040 scopus 로고    scopus 로고
    • Effects of omeprazole on the pharmacokinetic profiles of lisdexamfetamine dimesylate and extended-release mixed amphetamine salts in adults
    • Haffey M.B., Buckwalter M., Zhang P., et al. Effects of omeprazole on the pharmacokinetic profiles of lisdexamfetamine dimesylate and extended-release mixed amphetamine salts in adults. Postgrad Med. 121 (2009) 11-19
    • (2009) Postgrad Med. , vol.121 , pp. 11-19
    • Haffey, M.B.1    Buckwalter, M.2    Zhang, P.3
  • 23
    • 34948906993 scopus 로고    scopus 로고
    • Lisdexamfetamine dimesylate and mixed amphetamine salts extendedrelease in children with ADHD: A double-blind, placebocontrolled, crossover analog classroom study
    • Biederman J., Boellner S.W., Childress A., et al. Lisdexamfetamine dimesylate and mixed amphetamine salts extendedrelease in children with ADHD: A double-blind, placebocontrolled, crossover analog classroom study. Biol Psychiatry 62 (2007) 970-976
    • (2007) Biol Psychiatry , vol.62 , pp. 970-976
    • Biederman, J.1    Boellner, S.W.2    Childress, A.3
  • 24
    • 85060774811 scopus 로고    scopus 로고
    • Lisdexamfetamine dimesylate: Linear dose-proportionality, low intersubject and intrasubject variability, and safety in an open-label single-dose pharmacokinetic study in healthy adult volunteers
    • In press
    • Ermer J, Homolka R, Martin P, et al. Lisdexamfetamine dimesylate: Linear dose-proportionality, low intersubject and intrasubject variability, and safety in an open-label single-dose pharmacokinetic study in healthy adult volunteers. J Clin Pharmacol. In press.
    • J Clin Pharmacol
    • Ermer, J.1    Homolka, R.2    Martin, P.3
  • 25
    • 67650225546 scopus 로고    scopus 로고
    • A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder
    • 311 Study Group
    • Wigal S.B., Kollins S.H., Childress A.C., Squires L., and 311 Study Group. A 13-hour laboratory school study of lisdexamfetamine dimesylate in school-aged children with attention-deficit/hyperactivity disorder. Child Adolesc Psychiatry Ment Health 3 (2009) 17
    • (2009) Child Adolesc Psychiatry Ment Health , vol.3 , pp. 17
    • Wigal, S.B.1    Kollins, S.H.2    Childress, A.C.3    Squires, L.4
  • 26
    • 34247257281 scopus 로고    scopus 로고
    • Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: A phase III, multicenter, randomized, doubleblind, forced-dose, parallel-group study
    • Biederman J., Krishnan S., Zhang Y., et al. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: A phase III, multicenter, randomized, doubleblind, forced-dose, parallel-group study. Clin Ther. 29 (2007) 450-463
    • (2007) Clin Ther. , vol.29 , pp. 450-463
    • Biederman, J.1    Krishnan, S.2    Zhang, Y.3
  • 27
    • 52649161328 scopus 로고    scopus 로고
    • Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder
    • 303 Study Group
    • Adler L.A., Goodman D.W., Kollins S.H., et al., 303 Study Group. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry 69 (2008) 1364-1373
    • (2008) J Clin Psychiatry , vol.69 , pp. 1364-1373
    • Adler, L.A.1    Goodman, D.W.2    Kollins, S.H.3
  • 29
    • 77649120575 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Accessed January 19, 2010
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R1). http://www.ich.org/LOB/media/MEDIA482.pdf Accessed January 19, 2010
    • ICH Harmonised Tripartite Guideline. Guideline for Good Clinical Practice E6(R1)
  • 30
    • 0003484310 scopus 로고    scopus 로고
    • US Food and Drug Administration Accessed January 19, 2010
    • US Food and Drug Administration. Guidance for Industry: Bioanalytical Method Validation. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070107.pdf Accessed January 19, 2010
    • Guidance for Industry: Bioanalytical Method Validation
  • 32
    • 55849092101 scopus 로고    scopus 로고
    • Metabolism, distribution and elimination of lisdexamfetamine dimesylate: Open-label, single-centre, phase I study in healthy adult volunteers
    • Krishnan S.M., Pennick M., and Stark J.G. Metabolism, distribution and elimination of lisdexamfetamine dimesylate: Open-label, single-centre, phase I study in healthy adult volunteers. Clin Drug Investig. 28 (2008) 745-755
    • (2008) Clin Drug Investig. , vol.28 , pp. 745-755
    • Krishnan, S.M.1    Pennick, M.2    Stark, J.G.3
  • 33
    • 38549118950 scopus 로고    scopus 로고
    • Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers
    • Krishnan S.M., and Stark J.G. Multiple daily-dose pharmacokinetics of lisdexamfetamine dimesylate in healthy adult volunteers. Curr Med Res Opin. 24 (2008) 33-40
    • (2008) Curr Med Res Opin. , vol.24 , pp. 33-40
    • Krishnan, S.M.1    Stark, J.G.2
  • 34
    • 0242668432 scopus 로고    scopus 로고
    • Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults
    • Markowitz J.S., Straughn A.B., Patrick K.S., et al. Pharmacokinetics of methylphenidate after oral administration of two modified-release formulations in healthy adults. Clin Pharmacokinet 42 (2003) 393-401
    • (2003) Clin Pharmacokinet , vol.42 , pp. 393-401
    • Markowitz, J.S.1    Straughn, A.B.2    Patrick, K.S.3
  • 35
    • 33845723090 scopus 로고    scopus 로고
    • Doseproportional pharmacokinetics of d-threo-methylphenidate after a repeated-action release dosage form
    • Tuerck D., Appel-Dingemanse S., Maboudian M., et al. Doseproportional pharmacokinetics of d-threo-methylphenidate after a repeated-action release dosage form. J Clin Pharmacol. 47 (2007) 64-69
    • (2007) J Clin Pharmacol. , vol.47 , pp. 64-69
    • Tuerck, D.1    Appel-Dingemanse, S.2    Maboudian, M.3
  • 36
    • 0141865635 scopus 로고    scopus 로고
    • Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: Focus on methylphenidate formulations
    • Markowitz J.S., Straughn A.B., and Patrick K.S. Advances in the pharmacotherapy of attention-deficit-hyperactivity disorder: Focus on methylphenidate formulations. Pharmacotherapy 23 (2003) 1281-1299
    • (2003) Pharmacotherapy , vol.23 , pp. 1281-1299
    • Markowitz, J.S.1    Straughn, A.B.2    Patrick, K.S.3
  • 40
    • 0021684532 scopus 로고
    • Clinical correlates of methylphenidate blood levels
    • Gualtieri C.T., Hicks R.E., Patrick K., et al. Clinical correlates of methylphenidate blood levels. Ther Drug Monit. 6 (1984) 379-392
    • (1984) Ther Drug Monit. , vol.6 , pp. 379-392
    • Gualtieri, C.T.1    Hicks, R.E.2    Patrick, K.3
  • 41
    • 67651111966 scopus 로고    scopus 로고
    • Pharmacokinetics and therapeutic drug monitoring of psychotropic drugs in pediatrics
    • Pichini S., Papaseit E., Joya X., et al. Pharmacokinetics and therapeutic drug monitoring of psychotropic drugs in pediatrics. Ther Drug Monit. 31 (2009) 283-318
    • (2009) Ther Drug Monit. , vol.31 , pp. 283-318
    • Pichini, S.1    Papaseit, E.2    Joya, X.3
  • 42
    • 10044221884 scopus 로고    scopus 로고
    • New formulations of stimulants for attention-deficit hyperactivity disorder: Therapeutic potential
    • Connor D.F., and Steingard R.J. New formulations of stimulants for attention-deficit hyperactivity disorder: Therapeutic potential. CNS Drugs. 18 (2004) 1011-1130
    • (2004) CNS Drugs. , vol.18 , pp. 1011-1130
    • Connor, D.F.1    Steingard, R.J.2
  • 43
    • 0030882054 scopus 로고    scopus 로고
    • Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms. A randomized, doubleblind, placebo-controlled trial
    • Gillberg C., Melander H., von Knorring A.L., et al. Long-term stimulant treatment of children with attention-deficit hyperactivity disorder symptoms. A randomized, doubleblind, placebo-controlled trial. Arch Gen Psychiatry 54 (1997) 857-864
    • (1997) Arch Gen Psychiatry , vol.54 , pp. 857-864
    • Gillberg, C.1    Melander, H.2    von Knorring, A.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.