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Efficacy and Tolerability of Long-Term, Open-Label, Mixed Amphetamine Salts Extended Release in Adolescents With ADHD

Published online by Cambridge University Press:  07 November 2014

Abstract

Objective

Assess long-term tolerability and efficacy of once-daily mixed amphetamine salts extended release (MAS XR) for attention-deficit/hyperactivity disorder (ADHD) in adolescents (13–17 years of age).

Methods

Efficacy of MAS XR (10–60 mg/day) in 138 adolescents with ADHD was assessed in a 6-month, openlabel, extension study following participation in a 4-week, randomized, placebo-controlled trial of MAS XR. Efficacy was based on ADHD Rating Scale-IV (ADHD-RS-IV) scores and Clinical Global Impressions-Improvement (CGI-I) ratings at end point. Tolerability was based on reported adverse events, physical and laboratory examintions, vital signs, and electrocardiographic measures.

Findings

Patients exhibited sustained improvement in ADHD symptoms in this 6-month, open-label study of MAS XR 10–60 mg/day. End point ADHD-RS-IV total score was significantly decreased from baseline (-7.9; P<.0001); similar decreases were seen for hyperactivity/impulsivity (-4.0; P<.0001) and indttentiveness (-3.8; P<.0001). Based on CGI-I ratings, 60.9% of patients were very much/much improved, 33.3% were unchanged, 5.8% were much worse, and 0% were very much worse. The most common adverse events related to MAS XR were anorexia (24.6%), weight loss (24.6%), headache (14.5%), and nervousness (13.0%).

Conclusion

Long-term MAS XR therapy is generally well tolerated and exerts sustained control of ADHD symptoms in otherwise healthy adolescents.

Type
Academic Supplement
Copyright
Copyright © Cambridge University Press 2005

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References

REFERENCES

1. Academy of Pediatrics, Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: diagnosis and evaluation of the child with attention-deficit/hyperacttvity disorder. Pediatrics. 2000;105:11581170.Google Scholar
2. Barkley, RA, Fischer, M, Edelbrook, C, et al.The adolescent outcome of hyperacrive children diagnosed by research criteria, I: an 8-year prospective follow-up study. J Am Acad Child Adolesc Psychiatry. 1990;29:546557.Google Scholar
3. Biederman, J, Faraone, S, Milberger, S, et al.Predictors of persistence and remission of ADHD into adolescence: results from a four-year prospective follow-up study. J Am Acad Child Adolesc Psychiatry. 1996;35:343351.Google Scholar
4. Hechtman, L, Greenfield, B. Lung-term use of stimulants in children with attention deficit hyperactivity disorder: safety, efficacy, and long-term outcome. Paediatr Drugs. 2003;5:787794.Google Scholar
5. Barkley, RA, Fischer, M, Smallish, L, Fletcher, K. Young adult follow-up of hyperactive children: antisocial activities and drug use. J Child Psychol Psychiatry. 2004;45:195211.Google Scholar
6. Zito, JM, Safer, DJ, DosReis, S, et al.Psychotropic practice patterns for youth. A 10-year perspective. Arch Pediatr Adolesc Med. 2003;157:1725.CrossRefGoogle ScholarPubMed
7. American Academy of Pediatrics. Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: treatment of the school-age child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:10331044.CrossRefGoogle Scholar
8. 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 Child Adolesc Psychiatry. 2002;41:26S49S.Google Scholar
9. Findling, RL, Dogin, JW. Psychopharmacology of ADHD: children and adolescents. J Clin Psychiatry. 1998;59:4249.Google ScholarPubMed
10. Connors, CK. Forty years of methylphenidate treatment in attention-deficit/hyperactivity disorder. J Atten Disord. 2002;6(suppl 1):S17S30.CrossRefGoogle Scholar
11. MTA Cooperative Group. National Institute of Mental Health multimodal treatment study of ADHD follow-up: 24-month outcomes of treatment strategies for attention-deficit/hyperactivity disorder. Pediatrics. 2004;113:754761.Google Scholar
12. Ahmann, PA, Theye, FW, Berg, R, Linquist, AJ, Van Erem, AJ, Campbell, LR. Placebo-controlled evaluation of amphetamine mixture-dextroamphetamine salts and amphetamine salts (Adderall): efficacy rate and side effects. Pediatrics. 2001;107:e10.Google Scholar
13. Stein, MA, Sarampote, CS, Waldman, ID, et al.A dose-response study of OROS methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2003;112:e404.Google Scholar
14. Greenhill, LL, Findling, RL, Swanson, JM, for the ADHD Study Group. A double-blind, placebo-controlled study of modified release methylphenidate in children with attention-deficit/hyperactivity disorder. Pediatrics. 2002;109:e39.Google Scholar
15. Klorman, R, Brumaghim, JT, Fitzpatrick, PA, Borgstedt, AD. Clinical effects of a controlled trial of methylphenidate on adolescents with attention deficit disorder. J Am Acad Child Adolesc Psychiatry. 1990;29:702709.CrossRefGoogle ScholarPubMed
16. Wilens, T, McBurnett, K, Bukstein, O, et al.A multisite, controlled trial of OROS methylphenidate in the treatment of adolescents with ADHD. Arch Pediatr Adolesc Med. 2005. In press.Google Scholar
17. Spencer, TJ, Wilens, TE, Biederman, J, Weisier, RH, Read, SC, Pratt, R. Efficacy and safety of Adderall XR in the management of attention-deficit/hyperactivity disorder in adolescent patients: a randomized, double-blind, placebo-controlled, parallel-group study. Clin Ther. 2005. In press.Google Scholar
18. Diagnostic and Statistical Manual of Mental Disorders. 4th ed text rev. Washington, DC: American Psychiatric Association; 2000.Google Scholar
19. Kaufman, J, Birmaher, B, Brent, D, et al.Schedule for Affective Disorders and Schizophrenia for School-aged Children-Present and Lifetime version (K-SADS-PL). J Am Acad Child Adolesc Psychiatry. 1997;36:980988.Google Scholar
20. DuPaul, GJ, Power, T, Anastopoulos, A, Reed, R. The ADHD Rating Scale-IV: Checklist, Norms, and Clinical Interpretation, New York, NY: Guilford Press; 1998.Google Scholar
21. SAS Institute. SAS/STAT Software; Changes and Enhancements Through Release 6.12, 1997. Cary, NC: SAS Institute.Google Scholar
22. Wilens, TE, Spencer, TJ, Biederman, J. Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in adolescents with ADHD. CNS Spectr. 2005;10(10 suppl 15):2230.Google Scholar
23. 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(6):530538.CrossRefGoogle ScholarPubMed
24. Spencer, T, Biederman, J, Wilens, T, et al.Efficacy of a mixed amphetamine salts compound in adults with attcntion-deficit/hyperactivity disorder. Arch Gen Psychiatry. 2001;58:775782.CrossRefGoogle ScholarPubMed
25. Abikoff, H, Hechtman, L, Klein, RG, et al.Symptomatic improvement in children with ADHD treated with long-term methylphenidate and multimodal psychosocial treatment. J Am Acad Child Adolesc Psychiatry. 2004;43:802811.Google Scholar