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Long-Term Effectiveness and Safety of Lisdexamfetamine Dimesylate in School-Aged Children with Attention-Deficit/Hyperactivity Disorder

  • Robert L. Findling, Ann C. Childress, Suma Krishnan and James J. McGough

Abstract

Introduction:

Lisdexamfetamine dimesylate (LDX), a prodrug stimulant, is indicated for attention-deficit/hyperactivity disorder (ADHD) in children 6–12 years of age and in adults. In shortterm studies, once-daily LDX provided efficacy throughout the day. This study presented here was conducted to assess the long-term safety, tolerability, and effectiveness of LDX in 6- to 12-year-olds with ADHD.

Methods:

This open-label, multicenter, singlearm study enrolled children with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision criteria for ADHD. Following 1-week screening and washout periods, subjects were titrated to LDX 30, 50, or 70 mg/day over 4 weeks and placed on maintenance treatment for 11 months. The ADHD Rating Scale and Clinical Global Impression-Improvement scale measured effectiveness.

Results:

Of 272 subjects receiving LDX, 147 completed the study. Most adverse events were mild to moderate and occurred during the first 4 weeks. There were no clinically meaningful changes in blood pressure or electrocardiographic parameters. From baseline to endpoint, mean ADHD Rating Scale scores improved by 27.2 points (P<.0001). Improvements occurred during each of the first 4 weeks, and were maintained throughout. Based on Clinical Global Impression-Improvement scale scores, >80% of subjects at endpoint and >95% of completers at 12 months were rated “improved.”

Conclusion:

Long-term 30, 50, and 70 mg/day LDX was generally well tolerated and effective in children with ADHD.

Copyright

Corresponding author

Please direct all correspondence to: Robert L. Findling, MD, Director, Child and Adolescent Psychiatry, University Hospitals Case Medical Center, 11100 Euclid Ave., Cleveland, OH 44106; Tel: 216-844-1717, Fax: 216-844-5883; E-mail: robert.findling@uhhospitals.org.

References

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1.Dulcan, M. Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 1997;36(10 suppl):85S121S.
2.Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. American Academy of Pediatrics. Pediatrics. 2000;105:11581170.
3.Faraone, SV, Sergeant, J, Gillberg, C, Biederman, J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003;2:104113.
4.Pliszka, SR, Crismon, ML, Hughes, CW, et al.The Texas Children's Medication Algorithm Project: revision of the algorithm for pharmacotherapy of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45:642657.
5.American Academy of Pediatrics. Subcommittee on Attention-Deficit/Hyperactivity Disorder and Committee on Quality Improvement. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:10331044.
6.Connor, DF, Steingard, RJ. New formulations of stimulants for attention-deficit hyperactivity disorder: therapeutic potential. CNS Drugs. 2004;18:10111030.
7.Biederman, J, Boellner, SW, Childress, A, Lopez, FA, Krishnan, S, Zhang, Y. Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study. Biol Psychiatry. 2007;62:970976.
8.McGough, JJ, Biederman, J, Greenhill, LL, et al.Pharmacokinetics of SLI381 (ADDERALL XR), an extended-release formulation of Adderall. J Am Acad Child Adolesc Psychiatry. 2003;42:684691.
9.Volkow, ND, Swanson, JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry. 2003;160:19091918.
10.Vyvanse [package insert]. Wayne, Penn: Shire US Inc.; 2008.
11.Biederman, J, Krishnan, S, Zhang, Y, McGough, JJ, Findling, RL. Efficacy and tolerability of lisdexamfetamine dimesylate (NRP-104) in children with attention-deficit/hyperactivity disorder: a phase III, multicenter, randomized, double-blind, forced-dose, parallel-group study. Clin Ther. 2007;29:450463.
12.World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Available at: www.wma.net/e/policy/b3.htm. Accessed June 6, 2008.
13.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). Available at: www.ich.org/LOB/media/MEDIA482.pdf. Accessed June 6, 2008.
14.DuPaul, GJ, Power, TJ, Anastopoulos, AD, Reid, R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York, NY: Goilford Press; 1998.
15.Guy, W. Clinical global impressions. In: ECDEU Assessment Manual for Psychopharmacology. Rockville, Md: US Department of Health, Education, and Welfare; Public Health Service, Alcohol, Drug Abuse and Mental Health Administration, NIMH Psychopharmacology Research Branch; 1976:218222.
16.Kratochvil, CJ, Wilens, TE, Greenhill, LL, et al.Effects of long-term atomoxetine treatment for young children with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2006;45:919927.
17.McGough, JJ, Biederman, J, Wigal, SB, et al.Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD. J Am Acad Child Adolesc Psychiatry. 2005;44:530538.
18.Hoare, P, Remschmidt, H, Medori, R, et al.12-month efficacy and safety of OROS MPH in children and adolescents with attention-deficit/hyperactivity disorder switched from MPH. Eur Child Adolesc Psychiatry. 2005;14:305309.
19.Faraone, SV, Biederman, J, Monuteaux, M, Spencer, T. Long-term effects of extended-release mixed amphetamine salts treatment of attention-deficit/hyperactivity disorder on growth. J Child Adolesc Psychopharmacol. 2005;15:191202.

Long-Term Effectiveness and Safety of Lisdexamfetamine Dimesylate in School-Aged Children with Attention-Deficit/Hyperactivity Disorder

  • Robert L. Findling, Ann C. Childress, Suma Krishnan and James J. McGough

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