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Short-Term Cardiovascular Effects of Mixed Amphetamine Salts Extended Release in Children and Adolescents With Oppositional Defiant Disorder

Published online by Cambridge University Press:  07 November 2014

Daniel F. Connor  and
Thomas J. Spencer
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Abstract

Objective

Assess cardiovascular effects of mixed amphetamine salts extended release (MAS XR) in children and adolescents (6–17 years of age) with oppositional defiant disorder (ODD).

Methods

A 4-week, double-blind, randomized, placebo-controlled, forced dose-titration study of once-daily 10-, 20-, 30-, or 40-mg MAS XR (n=308). Resting/sitting systolic blood pressure (SBP) and diastolic blood pressure (DBP) and pulse were measured at baseline and weekly thereafter. Electrocardiograms (ECGs) were obtained at screening and study end point.

Findings

At study end point, mean changes in SBP and DBP were minimal with MAS XR (SBP: -0.2 to 1.1 mm Hg; DBP: -1.0 to 2.1 mm Hg) and comparable to placebo (SBP: -0.6 mm Hg; DBP: -0.4 mm Hg). Mean end point pulse was similar with MAS XR (80.6–84.7 bpm) and placebo (81.8 bpm). No dose-related trends in blood pressure and pulse changes were observed. No clinically significant changes in ECG parameters were seen with MAS XR. Changes in QTcB (Bazett's formula) interval with MAS XR were small (0.5 to 3.9 msec). No patient discontinued due to a cardiovascular adverse event.

Conclusion

Cardiovascular effects of MAS XR (10–40 mg) were minimal and comparable to those with placebo in children and adolescents with ODD.

Type
Academic Supplement
Information
CNS Spectrums , Volume 10 , Issue S15: Mixed Amphetamine Salts Extended Release for the Treatment of ADHD in Adolescents: Current Evidence , October 2005 , pp. 31 - 38
Copyright
Copyright © Cambridge University Press 2005

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References

REFERENCES

1.American Association for Child and Adolescent Psychiatry. Children with oppositional defiant disorder. Facts for families. No. 72. Available at: http://www.aacap.org/pubtications3/factsFam/72.htm. Accessed April 7, 2005.Google Scholar
2.Bird, HR, Canino, G, Rubio-Stipec, M, et al.Estimates of the prevalence of childhood maladjustment in a community survey in Puerto Rico: the use of combined measures. Arch Gen Psychiatry. 1988;45:1120–1126.CrossRefGoogle Scholar
3.Bird, HR, Madelyn, SG, Staghezza, BM. Patterns of diagnostic comorbidity in a community sample of children aged 9 through 16 years. J Am Acad Child Adolesc Psychiatry. 1993;32:361–368.Google Scholar
4.Szatmari, P, Boyle, M, Offord, DR. ADHD and conduct disorder: degree of diagnostic overlap and differences among correlates. J Am Acad Child Adolesc Psychiatry. 1989;28:865–872.Google Scholar
5.Greene, RW, Biederman, J, Zerwas, S, et al.Psychiatric comorbidity, family dysfunction, and social impairment in referred youth with oppositional defiant disorder. Am j Psychiatry. 2002;159:1214–1224.Google Scholar
6.Mannuzza, S, Klein, RG, Abikoff, H, et al.Significance of childhood conduct problems to later development of conduct disorder among children with ADHD: a prospective follow-up study. J Abnorm Child Psychol. 2004;32:565–573.Google Scholar
7.Abikoff, HA, 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;43:802–811.CrossRefGoogle ScholarPubMed
8.Greene, RW, Ablon, JS, Goring, JC, et al.Effectiveness of collaborative problem solving in affectively dysregulated children with oppositional-defiant disorder: initial findings. J Consult Clin Psychol. 2004;72:1157–1164.Google Scholar
9.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;41:26S–49S.Google Scholar
10.American Academy of Pediatrics, Committee on Quality Improvement and Subcommittee on Attention-Deficit/Hyperactivity Disorder. Clinical practice guideline: treatment of the school-aged child with attention-deficit/hyperactivity disorder. Pediatrics. 2001;108:1033–1044.Google Scholar
11.Jensen, PS, Hinshaw, SP, Kraemer, HC, et al.ADHD comorbidity findings from the MTA study: comparing comorbid subgroups. J Am Acad Child Adolesc Psychiatry. 2001;40:147–158.Google Scholar
12.Gutgesell, H, Atkins, D, Barst, R, et al.Cardiovascular monitoring of children and adolescents receiving psychotropic drugs: a statement for healthcare professionals from the Committee on Congenital Cardiac Defects, Council on Cardiovascular Disease in the Young, American Heart Association. Circulation. 1999;99:979–982.Google Scholar
13.Findling, RL, Short, EJ, Manos, MJ. Short-term cardiovascular effects of methylphenidate and Adderall. J Am Acad Child Adolesc Psychiatry. 2001;40:525–529.Google Scholar
14.Spencer, T, Biederman, J, Wilens, T, et al.Pharmacotherapy of attention-deficit/hyperactivity disorder across the life cycle. J Am Acad Child Adolesc Psychiatry. 1996;35:409–432.Google Scholar
15.Safer, DJ. Relative cardiovascular safety of psychostimulants used to treat attention-deficit hyperactivity disorder. J Child Adolesc Psychopharmacol. 1992;2:279–290.Google Scholar
16.Rapport, MD, Moffitt, C. Attention deficit/hyperactivity disorder and methylphenidate. A review of height/weight, cardiovascular, and somatic complaint side effects. Clin Psychol Rev. 2002;22:1107–1131.Google Scholar
17.Wilens, TE, Biederman, J, Lerner, M, and the Concerta® Study Group. Effects of once'daily osmotic-release methylphenidate on blood pressure and heart rate in children with attention-deficit/hyperactivity disorder. Results from a one-year follow-up study. J Clin Psychopharmacol. 2004;24:36–41.Google Scholar
18.Findling, RL, Biederman, J, Wilens, TE, et al.Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in children. J Pediatr. 2005;147. In press.Google Scholar
19.Spencer, TJ, Abikoff, HB, Connor, DF, et al.The safety and efficacy of Adderall XR (mixed amphetamine salts extended release) in the management of oppositional defiant disorder (ODD) in school-age children and adolescents. Clin Ther. 2005. In press.Google Scholar
20.Diagnostic and Statistical Manual of Mental Disorders. 4th ed text rev. Washington, DC: American Psychiatric Association; 2000.Google Scholar
21.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;36:980–988.Google Scholar
22.Bazett, H. An analysis of time relations of electrocardiogram. Heart. 1920;7:353–370.Google Scholar
23.SAS Institute. SAS/STAT Software: Changes and Enhancements Through Release 6.12. 1997. Cary, NC: SAS Institute.Google Scholar
24.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 No. CPMP/986/96.Google Scholar
25.Swanson, JM, Wigal, SB, Wigal, T, et al.A comparison of once-daily extended-release methylphenidate formulations in children with attention-deficit/hyperactivity disorder in the laboratory school (the Comacs Study). Pediatrics. 2004;113:e206–e216.Google Scholar
26.Adderall, XR (package insert). Shire US Inc.: Wayne, PA; 2004.Google Scholar