Hostname: page-component-78c5997874-dh8gc Total loading time: 0 Render date: 2024-11-04T21:39:54.687Z Has data issue: false hasContentIssue false
  • English
  • Français

Long-Term Safety and Effectiveness of Mixed Amphetamine Salts Extended Release in Adults With ADHD

Published online by Cambridge University Press:  07 November 2014

Joseph Biederman ,
Thomas J. Spencer ,
Timothy E. Wilens ,
Richard H. Weisler ,
Stephanie C. Read  and
Simon J. Tulloch
Get access Rights & Permissions [Opens in a new window]

Abstract

Objective: Assess the long-term safety and effectiveness of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype.

Methods: A 24-month, open-label extension of a 4-week, multicenter, double-blind, placebo-controlled, parallel-group, forced–dose-escalation study of MAS XR in adults (≥ 18 years of age) with ADHD. The 223 enrolled subjects started treatment at 20 mgl day for 1 week, with subsequent titration up to 60 mgl day for optimal therapeutic effects. At monthly visits, efficacy was assessed based on the ADHD Rating Scale IV (ADHD-RS-N). Safety assessments included spontaneously reported adverse events, laboratory assessments, and monitoring of vital signs.

Findings: ADHD symptoms significantly improved for all subjects as measured by change from baseline in mean ADHD-RS-IV total scores (-7.2±13.04 unit points; P<.001); this was sustained for up to 24 months. The most common treatment-related adverse events were dry mouth (43% of subjects reporting at least one occurrence), infection (33%), insomnia (32%), anorexia/decreased appetite (32%), headache (30%), and nervousness (26%). Most adverse events were mild to moderate in intensity.

Conclusion: Treatment with MAS XR 20–60 mgl day for adult ADHD was generally well tolerated and was associated with sustained symptomatic improvement for up to 24 months.

Type
Academic Supplement
Information
CNS Spectrums , Volume 10 , Issue S20: Mixed Amphetamine Salts Extended Release for the Treatment of ADHD in Adults: Current Evidence , December 2005 , pp. 16 - 25
Copyright
Copyright © Cambridge University Press 2005

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Wilens, TE, Faraone, SV, Biederman, J.Attention-deficit/hyperactivity disorder in adults. JAMA. 2004;292(5):619–623.CrossRefGoogle ScholarPubMed
2. Rowland, AS, Lesesne, CA, Abramowitz, AJ.The epidemiology of attention-deficit/hyperactivity disorder (ADHD): a public health view. Merit Retard Dev Disabil Res Rev.2002;8:162–170.Google ScholarPubMed
3. Dulcan, M.Practice parameters for the assessment and treatment of children, adolescents, and adults with attention-deficit/hyperactivity disorder. American Academy of Child and Adolescent Psychiatry. J Am Acad Child Adolesc Psychiatry. 1997;36(10 suppl):85S–121S.CrossRefGoogle ScholarPubMed
4. Kessler, RC.Prevalence of adult, ADHD in the United States: results from the National Comorbidity Survey Replication (NCS). Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
5. Faraone, SV, Biederman, J.Prevalence of adult, ADHD in the United States. Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
6. United States Census Bureau: Census 2000 Summary File 4- Available at: http://factfinder.census.gov. Accessed August 16, 2004.Google Scholar
7. Faraone, SV, Biederman, J, Spencer, T, et al. Attention-deficit/hyperactivity disorder in adults: an overview. Biol Psychiatry. 2000:48(1):9–20.CrossRefGoogle ScholarPubMed
8. Spencer, T, Biederman, J, Wilens, T, Faraone, SV.Is attention-deficit hyperactivity disorder in adults a valid disorder? Harv Rev Psychiatry. 1994;1(6):326–335.CrossRefGoogle ScholarPubMed
9. Biederman, J.Impact of comorbidity in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2004;65(suppl 3):3–7.Google ScholarPubMed
10. Biederman, J, Mick, E, Faraone, SV.Age dependent decline of, ADHD symptoms revisited: impact of remission definition and symptom type. Am J Psychiatry. 2000;157(5):816–818.CrossRefGoogle Scholar
11. Biederman, J, Faraone, SV, Monuteaux, MC, Bober, M, Cadogen, E.Gender effects on attention-deficit/hyperactivity disorder in adults, revisited. Biol Psychiatry. 2004;55(7):692–700.CrossRefGoogle Scholar
12. Barkley, RA. Major life activity and health outcomes associated with attentiondeficit/ hyperactivity disorder. J Clin Psychiatry. 2002;63(suppl 12):10–15.Google Scholar
13. Faraone, SV, Biederman, J.A controlled study of functional impairments in 500 ADHD adults. Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
14. Lage, MJ, Secnik, K, Swensen, AR. The costs associated with attention-deficit/hyperactivity disorder in adults. Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
15. Spencer, T, Wilens, T, Biederman, J, Faraone, SV, Ablon, S, Lapey, K.A double-blind, crossover comparison of methylphenidate and placebo in adults with childhood-onset attention-deficit hyperactivity disorder. Arch Gen Psychiatry. 1995;52(6):434–443.CrossRefGoogle ScholarPubMed
16. Wilens, TE, Biederman, J, Spencer, TJ, et al. Controlled trial of high doses of pemoline for adults with attention-deficit/hyperactivity disorder. J Clin Psychopharmacol. 1999;19(3):257–264.CrossRefGoogle ScholarPubMed
17. Spencer, T, Biederman, J, Wilens, T, et al. Efficacy of a mixed amphetamine salts compound in adults with attention-deficit/hyperactivity disorder. Arch Gen Psychiatry. 2001;58(8):775–782.CrossRefGoogle ScholarPubMed
18. Wilens, T, Pelham, W, Stein, M, et al. , ADHD treatment with once-daily, OROS methylphenidate: interim 12-month results from a long-term open-label study. J Am Acad Child Adolesc Psychiatry. 2003;42(4):424–433.CrossRefGoogle ScholarPubMed
19. 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):530–538.CrossRefGoogle ScholarPubMed
20. McCracken, JT, Biederman, J, Greenhill, LL, et al. Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall, XR), in children with, ADHD. J Am Acad Child Adolesc Psychiatry. 2003;42(6):673–683.CrossRefGoogle ScholarPubMed
21. Biederman, J, Lopez, FA, Boellner, SW, Chandler, MC.A randomized, double-blind, placebo-controlled, parallel-group study of, SL1381 (Adderall, XR) in children with attention-deficit/hyperactivity disorder. Pediatrics. 2002;110(2 Pt 1):258–266.CrossRefGoogle ScholarPubMed
22. Adler, LA, McGough, J, Muniz, R, et al. Long-term efficacy of extended-release dexmethylphenidate in adult, ADHD. Poster presented at: American Academy of Child and Adolescent Psychiatry 51st Annual Meeting; October 19-24, 2004; Washington, DC.Google Scholar
23. Biederman, J, Spencer, T, Surman, C, et al. Open-label study of, OROS methylphenidate in the treatment of adults with, ADHD not otherwise specified (NOS). Poster presented at: 158th Annual Meeting of the American Psychiatric Association; May 20, 2005; Washington, DC.Google Scholar
24. Weisler, RH, Biederman, J, Spencer, T, Wilens, TE, Chrisman, AK. Adderall, XR dosed once daily in adult patients with, ADHD. Poster presented at: 156th Annual Meeting of the American Psychiatric Association; May 20,2003; San Francisco, CA.Google Scholar
25. Diagnostic and Statistical Manual of Mental Disorders. 4th ed text rev. Washington, DC: American Psychiatric Association; 2000.Google Scholar
26. DuPaul, G, Power, T, Anastopoulos, A, Ried, R.ADHD Rating Scale, IV: Checklists, Norms, and Clinical Interpretation. New York, NY: Guilford Press; 1998.Google Scholar
27. Chobanian, AV, Bakris, GL, Black, HR, et al. ; Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure, National Heart, Lung, and Blood Institute; National High Blood Pressure Education Program Coordinating Committee. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206–1252.CrossRefGoogle ScholarPubMed
28. Committee for Proprietary Medicinal Products. The Assessment of the Potential for, QT Interval Prolongation by Non-cardiovascular Medicinal Products. London, UK: The European Agency for the Evaluation of Medicinal Products, Human Medicines Evaluation Unit; December 17, 1997. Report, CPMP/986/96.Google Scholar
29. Biederman, J, Spencer, T, Wilens, T.Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in adolescents with, ADHD. CNS Spectr. 2005;10(10 suppl 15):22–30.Google Scholar
30. Adler, L, Spencer, T, Sutton, V, Sumner, CR.Dose and time response of atomoxetine use in adult, ADHD. Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar