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Fixed-Dose Isosorbide Dinitrate-Hydralazine: Race-Based Cardiovascular Medicine Benefit or Mirage?

Published online by Cambridge University Press:  01 January 2021

Extract

The goal of this paper is to present a succinct overview, from a clinician’s perspective, of the importance and implications of research on heart failure in African Americans. It first gives a brief outline of the rationale and results of the African-American Heart Failure Trial (A-HeFT), which showed evidence for the effectiveness of fixed-dose combination of isosorbide dinitrate and hydralazine (ISDN/Hyd), marketed as BiDil (NitroMed Inc.), in this population. Finally, it underscores the necessity of treating African Americans with evidence-based medicine given that humanistic physicians and other clinicians strive to provide holistic treatment to their patients.

Most researchers and clinicians recognize the difficulty with utilizing race as a category for inclusion in trials. While race lacks any true biologic definition, it is potentially beneficial as a consideration in clinical studies, based on prior evidence of certain potential differences across self-identified racial/ethnic groups in morbidity and mortality and responses to medicine. Even though use of race as a classification is a problematic distinction, it should not be ignored. If clinical trials demonstrate significant improvement with targeted treatment in African Americans, clinicians should not withhold life-saving drugs that result from such studies.

Type
Symposium
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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References

Hypertension Prevalence of the 1984 Joint National Committee the United States, “Final Report of the Subcommittee on Definition and prevalence and the Status of Awareness, Treatment, and Control,” Hypertension 7, no. 3 (1985): 457468.Google Scholar
American Heart Association, “Heart Failure,” available at <http://www.americanheart.org/presenter.jhtml?identifier=1486> (last visited May 12, 2008).+(last+visited+May+12,+2008).>Google Scholar
Thom, T., Haase, N., and Rosamond, W. et al., “Heart Disease and Stroke Statistics — 2006 Update: A Report from the American Heart Association Statistics Committee and Stroke Statistics Subcommittee,” Circulation 113, no. 6 (February 2006): e85e151.Google Scholar
Centers for Disease Control and Prevention, National Vital Statistics Deaths, Percent of Total Deaths, and Death Rates for the 15 Leading Causes of Death in 10-Year Age Groups, by Race and Sex: US, 2003, available at <http://www.cdc.gov/nchs/data/dvs/lcwk2_2003.pdf> (last visited May 12, 2008).+(last+visited+May+12,+2008).>Google Scholar
See Thom, , Haase, , and Rosamond, et al., supra note 3.Google Scholar
Krumholz, H. M., Parent, E. M., Tu, N., Vaccarino, V., Wang, Y., Radford, M. J., and Hennen, J., “Readmission After Hospitalization for Congestive Heart Failure among Medicare Beneficiaries,” Archives of Internal Medicine 157, no. 1 (1997): 99104.CrossRefGoogle Scholar
Lillie-Blanton, M., Maddox, T. M., and Rushing, O. et al., “Disparities in Cardiac Care: Rising to the Challenge of Healthy People 2010,” Journal of the American College of Cardiology 44, no. 3 (August 4, 2004): 503508.CrossRefGoogle Scholar
Yancy, C. W., “Heart Failure in African Americans,” American Journal of Cardiology 96, no. 7 (2005): 312.CrossRefGoogle Scholar
See Thom, , Haase, , and Rosamond, et al., supra note 3.Google Scholar
See Yancy, , supra note 9.Google Scholar
Exner, D. V., Dries, D. L., and Domanski, M. J. et al., “Lesser Response to Angiotensin-Converting-Enzyme Inhibitor Therapy in Black as Compared with White Patients with Left Ventricular Dysfunction,” New England Journal of Medicine 344, no. 18 (May 3, 2001): 13511357.CrossRefGoogle Scholar
See Yancy, , supra note 9.Google Scholar
Julius, S., Alderman, M. H., and Beevers, G. et al., “Cardiovascular Risk Reduction in Hypertensive Black Patients with Left Ventricular Hypertrophy: The LIFE Study,” Journal American College Cardiology 43, no. 6 (2004): 10471055.CrossRefGoogle Scholar
Although existing data were imperfect, it suggested a tantalizing lead. See Yancy, , supra note 9.Google Scholar
Taylor, A. L., Ziesche, S., and Yancy, C. et al., “Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure,” New England Journal of Medicine 351, no. 20 (2004): 20492057.CrossRefGoogle Scholar
Tam, S. W., Sbolinski, M. L., Worcel, M., Packer, M., and Cohn, J. N., “Lack of Bioequivalence between Different Formulations of Isosorbide Dinitrate and Hydralazine and the Fixed-Dose Combination of Isosorbide Dinitrate/Hydralazine:Google Scholar
Ferdinand, K. C., “African American Heart Failure Trial: Role of Endothelial Dysfunction and Heart Failure in African Americans,” American Journal of Cardiology 99, no. 6 (2007): S3DS6; Small, K. M., Wagoner, L. E., and Levin, A. M. et al., “Synergistic Polymorphisms of b1- and a2c-Adrenergic Receptors and the Risk of Congestive Heart Failure,” New England Journal of Medcine 347, no. 15 (2002): 1135–1142; McNamara, D. M., Tam, W., and Sabolinski, M. L. et al., “Aldosterone Synthase Promoter Polymorphism Predicts Outcome in African Americans with Heart Failure: Results from the A-HeFT Trial,” Journal of American College of Cardiology 48, no. 6 (2006): 1277–1282.CrossRefGoogle Scholar
Id. (McNamara et al.)Google Scholar
See Taylor, , Ziesche, , and Yancy, et al., supra note 16.Google Scholar
Hunt, S., Abraham, W. T., and Chin, M. H. et al., “ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines,” Circulation 112, no. 12 (September 20, 2005): e154e235.Google Scholar
Carey, L. A., Perou, C. M., and Livasy, C. A. et al., “Race, Breast Cancer Subtypes, and Survival in the Carolina Breast Cancer Study,” JAMA 295, no. 21 (June 7, 2006): 24922502.CrossRefGoogle Scholar
Centers for Disease Control and Prevention, “Healthy People 2010 Focus Area 3 Cancer Progress Review,” PowerPoint presentation available at <http://www.cdc.gov/nchs/ppt/hpdata2010/focusareas/fa03_charts.ppt> (last visited May 12, 2008).+(last+visited+May+12,+2008).>Google Scholar
Saul, S., “U.S. to Review Heart Drug Intended for One Race,” New York Times, June 13, 2005, available at <http://www.nytimes.com/2005/06/13/business/13cardio.html> (last visited May 27, 2008).+(last+visited+May+27,+2008).>Google Scholar