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

Published online by Cambridge University Press:  07 November 2014

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

Type
Original Research
Information
CNS Spectrums , Volume 13 , Issue 7 , July 2008 , pp. 614 - 620
Copyright
Copyright © Cambridge University Press 2008

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References

REFERENCES

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):85S–121S.CrossRefGoogle ScholarPubMed
2.Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperactivity disorder. American Academy of Pediatrics. Pediatrics. 2000;105:1158–1170.CrossRefGoogle Scholar
3.Faraone, SV, Sergeant, J, Gillberg, C, Biederman, J. The worldwide prevalence of ADHD: is it an American condition? World Psychiatry. 2003;2:104–113.Google ScholarPubMed
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;45:642–657.CrossRefGoogle ScholarPubMed
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;108:1033–1044.CrossRefGoogle Scholar
6.Connor, DF, Steingard, RJ. New formulations of stimulants for attention-deficit hyperactivity disorder: therapeutic potential. CNS Drugs. 2004;18:1011–1030.CrossRefGoogle ScholarPubMed
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;62:970–976.CrossRefGoogle ScholarPubMed
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;42:684–691.CrossRefGoogle ScholarPubMed
9.Volkow, ND, Swanson, JM. Variables that affect the clinical use and abuse of methylphenidate in the treatment of ADHD. Am J Psychiatry. 2003;160:1909–1918.CrossRefGoogle ScholarPubMed
10.Vyvanse [package insert]. Wayne, Penn: Shire US Inc.; 2008.Google Scholar
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;29:450–463.CrossRefGoogle ScholarPubMed
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.Google Scholar
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.CrossRefGoogle Scholar
14.DuPaul, GJ, Power, TJ, Anastopoulos, AD, Reid, R. ADHD Rating Scale-IV: Checklists, Norms, and Clinical Interpretation. New York, NY: Goilford Press; 1998.Google Scholar
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; 1976:218–222.Google Scholar
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;45:919–927.CrossRefGoogle ScholarPubMed
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;44:530–538.CrossRefGoogle ScholarPubMed
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;14:305–309.CrossRefGoogle ScholarPubMed
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;15:191–202.CrossRefGoogle ScholarPubMed