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Long-Term Cardiovascular Effects of Mixed Amphetamine Salts Extended Release in Adults With ADHD

Published online by Cambridge University Press:  07 November 2014

Richard H. Weisler ,
Joseph Biederman ,
Thomas J. Spencer  and
Timothy E. Wilens
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Abstract

Objective: To assess long-term cardiovascular effects of mixed amphetamine salts extended release (MAS XR) in adults with attention-deficit/hyperactivity disorder (ADHD) combined subtype.

Methods: 223 otherwise healthy adults (≥18 years of age) with ADHD combined subtype were exposed to ≤24 months of MAS XR (20–60 mg/day). Resting sitting diastolic blood pressure (DBP) and systolic blood pressur (SBP) and pulse were measured at baseline and weekly, then monthly during long-term treatment. Twelve-lead electrocardiograms were obtained at screening/baseline, weekly, then at 3-and 6-month intervals up to 24 months.

Findings: With MAS XR 20–60 mg/day, mean changes in DBP (1.3±9.2 mm Hg; P=.O42), SBP (2.3±12.5 mmHg; P=.OO6), and pulse (2.1±13.4 bpm; P=.019) were small and not clinically significant. A clinically insignificant increase in QTcB (corrected by Bazett's formula) interval (7.2 msec; P<.001) was observed at 24 months. No subject exhibited QTcB interval >480 msec (QTcF [corrected by Fridericia's formula] >454 msec). Seven subjects discontinued due to a car-diovascular adverse event (hypertension, n=5, palpitation/tachycardia, n=2); none of these events was reported as serious. Few subjects with normal baseline vital signs (using approved parameters at the time of study initiation) exhibited clinically significant abnormalities at end point; several subjects with borderline baseline values exhibited shifts to abnormal values during MAS XR therapy.

Conclusion: Cardiovascular effects of long-term MAS XR (≤60 mg/day) were minimal in otherwise healthy adults with ADHD. Nevertheless, vital signs should be monitored prior to and during treatment with any stimulant.

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. 35 - 43
Copyright
Copyright © Cambridge University Press 2005

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References

REFERENCES

1. Rowland, AS, Lesesne, CA, Abramowitz, AJ. The epidemiology of attention-deficit/hyperactivity disorder (ADHD): a public health view. Ment Retard Dev Disabil Res Rev. 2002;8:162–17O.CrossRefGoogle ScholarPubMed
2. Wilens, TE, Faraone, SV, Biederman, J. Attention-deficit/hyperactivity disorder in adults. JAMA. 2004;292(5):619–623.CrossRefGoogle Scholar
3. Weiss, G, Hechtman, L, Milroy, T, Perlman, T. Psychiatric status of hyperactives as adults: a controlled prospective 15-year follow-up of 63 hyperactive children. J Am Acad Child Adolesc Psychiatry. 1985;24(2):211–220.CrossRefGoogle ScholarPubMed
4. Kessler, RC. Prevalence of adult ADHD in the United States: results from the National Comorbidity Survey Replication (NCS). Presentation at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
5. 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(suppl 10):85S–121S.CrossRefGoogle ScholarPubMed
6. Greenhill, LL, Pliszka, S, Dulcan, MK, et al. ; 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(suppl 2):26S–49S.CrossRefGoogle ScholarPubMed
7. Spencer, T, Wilens, T, Biederman, J, Faraone, SV, Ablon, S, Lapey, K. A double-blind cross-over comparison of methylphenidate and placebo in adults with childhood-onset attention-deficit hyperactivity disorder. Arch Gen Psychiatry. 1995;52(6):434–443.CrossRefGoogle ScholarPubMed
8. Wilens, TE, Hammemess, PG, Biederman, J, et al. Blood pressure changes associated with medication treatment of adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2005;66(2):253–259.CrossRefGoogle ScholarPubMed
9. 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
10. Weisler, RH, Biederman, J, Spencer, T, Wilens, TE, Chrisman, AK. Adderall XR dosed once daily in adult patients with ADHD. Presentation at: 156th American Psychiatric Association Annual Meeting; May 20, 2003; San Francisco, CA.Google Scholar
11. Findling, RL, Short, EJ, Manos, MJ. Short-term cardiovascular effects of methylphenidate and Adderall. J Am Acad Child Adolesc Psychiatry. 2001;40(5):525–529.CrossRefGoogle ScholarPubMed
12. Safer, DJ, Relative cardiovascular safety of psychostimulants used to treat attention-deficit hyperactivity disorder. J Child Adobe Psychopharmacol. 1992;2:279–290.CrossRefGoogle ScholarPubMed
13. Gutgesell, H, Atkins, D, Barst, R, et al. AHA Scientific Statement: cardiovascular monitoring of children and adolescents receiving psychotropic drugs. J Am Acad Child Adolesc Psychiatry. 1999;38(8): 1047–1050.CrossRefGoogle ScholarPubMed
14. Lampe, FC, Whincup, PH, Wannamethee, SG, et al. The natural history of prevalent ischaemic heart disease in middle-aged men. Eur Heart J. 2000;21(13):1052–lO62.CrossRefGoogle ScholarPubMed
15. Wilens, TE, Biederman, J, Lerner, M; 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(1):36–41.CrossRefGoogle Scholar
16. Tulloch, SJ, Zhang, Y, McLean, A, Wolf, KN. SLI381 (Adderall XR), a two-component, extended-release formulation of mixed amphetamine salts: bioavailability of three test formulations and comparison of fasted, fed, and sprinkled administration. Pharmacotherapy. 2002;22(11):1405–1415.CrossRefGoogle ScholarPubMed
17. 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
18. Diagnostic and Statistical Manual for Mental Disorders. 4th ed text rev. Washington, DC: American Psychiatric Association; 2000.Google Scholar
19. 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
20. Bazett, H. An analysis of time relations of electrocardiogram. Heart. 1920;7:353–370.Google Scholar
21. 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
22. Chronic Disease Management. Government of British Columbia, Ministry of Health Services. May 2003. Available at: http://www.healthservices.gov. Accessed November 22, 2005.Google Scholar
23. Wilens, TE, Spencer, T, Biederman, J. Short- and long-term cardiovascular effects of mixed amphetamine salts extended release in adolescents. CNS Spectr. 2005;10(10 suppl 15):22–30.CrossRefGoogle Scholar
24. Wilens, TE, Biederman, J, Podolski, A, et al. Amphetamine treatment of ADHD in adults with primary essential hypertension. Poster presented at: 158th American Psychiatric Association Annual Meeting; May 21–26, 2005; Atlanta, GA.Google Scholar