The EvidenceAlthough heart failure disparities exist for many ethnic subgroups of Americans, in the special case of African Americans, there is a scientifically proven treatment that is today, grossly underutilized.
The 2013 American College of Cardiology Foundation/American Heart Association Guideline for the Management of Heart Failure recommends a fixed-dose combination of isosorbide dinitrate and hydralazine (F-ISDN/HYN) as adjunctive therapy for self-identified African Americans with heart failure (HF) who remain symptomatic despite concomitant use of angiotensin-converting-enzyme inhibitors (ACEIs), beta blockers (ARB), and aldosterone antagonists. |
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In 2004, Taylor et al. reported results from the African-American Heart Failure Trial (A‑HeFT), which compared the fixed-dose combination (F-H/ISDN) of isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD) versus placebo in self-identified blacks with heart failure (HF). The trial was terminated early, at a mean follow-up of 12 months, primarily because in the in the F-H/ISDN treated group there was a 43% reduction in all-cause mortality, a 39% reduction in the risk of a first hospitalization for HF, and a statistically significant improvement in response to the Minnesota Living with Heart Failure questionnaire, a self-report of the patient’s functional status. Based upon these findings, in June 2005, the Food and Drug Administration (FDA) approved F-H/ISDN as a new drug (brand name BiDil) for the treatment of heart failure in African Americans.
Since 2005 the standard of care for the treatment of HF in African Americans is an ACEI or an ARB for left-ventricular systolic dysfunction with F–H/ISDN as adjunctive therapy. This standard of care should prevail for clinicians, administrators of health systems, designers of clinical trials, insurers, writers of clinical guidelines or performance measures, legislators, regulators, caregivers, and patients.
Published studies estimates that there are 555,408 African Americans living with HF and 150,754 should be F-ISDN/HYN, which is proven to reduce mortality in blacks by 43% and first-time hospitalizations for HF by 38% while improving the quality of life. Unfortunately, research is showing only 7% (11,005) of African Americans who are clinical eligible for the therapy are receiving it. As a consequence annually 6,655 blacks are dying prematurely because they are not receiving or adhering to standard of care.
Each year, there are more deaths occurring from this failure to follow standard of care than occurred as a result of 9/11 and Katrina combined. It signals a clear systemic failure in health systems to provide appropriate care to blacks living with the disease. There is a clear need for a quality improvement initiative to increase the percentage of African Americans who are receiving standard of care.
Since 2005 the standard of care for the treatment of HF in African Americans is an ACEI or an ARB for left-ventricular systolic dysfunction with F–H/ISDN as adjunctive therapy. This standard of care should prevail for clinicians, administrators of health systems, designers of clinical trials, insurers, writers of clinical guidelines or performance measures, legislators, regulators, caregivers, and patients.
Published studies estimates that there are 555,408 African Americans living with HF and 150,754 should be F-ISDN/HYN, which is proven to reduce mortality in blacks by 43% and first-time hospitalizations for HF by 38% while improving the quality of life. Unfortunately, research is showing only 7% (11,005) of African Americans who are clinical eligible for the therapy are receiving it. As a consequence annually 6,655 blacks are dying prematurely because they are not receiving or adhering to standard of care.
Each year, there are more deaths occurring from this failure to follow standard of care than occurred as a result of 9/11 and Katrina combined. It signals a clear systemic failure in health systems to provide appropriate care to blacks living with the disease. There is a clear need for a quality improvement initiative to increase the percentage of African Americans who are receiving standard of care.
Footnotes
Clyde W. Yancy, Mariell Jessup, Biykem Bozkurt, Javed Butler, Donald E. Casey, Mark H. Drazner, Gregg C. Fonarow, et al., “2013 ACCF/AHA Guideline for the Management of Heart Failure A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” Circulation 128, no. 16 (15 October 2013): e240–327. doi:10.1161/CIR.0b013e31829e8776.
Anne L. Taylor, Susan Ziesche, Clyde Yancy, Peter Carson, Ralph D’Agostino, Keith Ferdinand, Malcolm Taylor, et al. for the African-American Heart Failure Trial Investigators, “Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure,” New England Journal of Medicine 351, no. 20 (November 11, 2004): 2049–2057, doi:10.1056/NEJMoa042934.
Gregg C. Fonarow, Clyde W. Yancy, Adrian F. Hernandez, Eric D. Peterson, John A. Spertus, and Paul A. Heidenreich, “Potential impact of optimal implementation of evidence-based heart failure therapies on mortality”, American Heart Journal, June 2011, Volume 161, Number 6, pp. 1025-1026.
Anne L. Taylor, Susan Ziesche, Clyde Yancy, Peter Carson, Ralph D’Agostino, Keith Ferdinand, Malcolm Taylor, et al. for the African-American Heart Failure Trial Investigators, “Combination of Isosorbide Dinitrate and Hydralazine in Blacks with Heart Failure,” New England Journal of Medicine 351, no. 20 (November 11, 2004): 2049–2057, doi:10.1056/NEJMoa042934.
Gregg C. Fonarow, Clyde W. Yancy, Adrian F. Hernandez, Eric D. Peterson, John A. Spertus, and Paul A. Heidenreich, “Potential impact of optimal implementation of evidence-based heart failure therapies on mortality”, American Heart Journal, June 2011, Volume 161, Number 6, pp. 1025-1026.
