Heart failure burdens the African American community
- Heart failure (HF) has a more aggressive natural history in African Americans—people are younger and sicker at diagnosis compared with whites1
- African Americans are 20 times more likely to develop HF before the age of 50 than whites1
- African Americans are approximately twice as likely to die of HF than whites2
- African Americans are hospitalized for HF more frequently than whites3
- African Americans between the ages of 55 and 64 are almost 3X more likely to have a first acute decompensated HF annual event than whites4
Depression and socioeconomic factors in HF
In addition to the physical burden of HF and the negative outcomes experienced by African Americans with HF, there is an emotional component. In the larger population of patients with HF, multiple studies have found5-7:
- Depression in HF patients is associated with increased mortality, a higher rate of hospitalization, a decline in activities of daily living, and worse NYHA functional scores6,7
- Extent of depression has been associated with decline in functional ability6
Incidence of depressive symptoms by number of risk factors7
Living alone, economic pressures, alcohol abuse, and overall Kansas City Cardiomyopathy Questionnaire score of <50 were independent predictors of depression in HF patients7
No patient had all 4 risk factors in this sudy7
Socioeconomic factors may also play a role in making the burden of HF heavier for African Americans. A study of more than 40,000 patients with HF showed that low income was a significant predictor of hospital readmission.8 Even after adjustment for baseline differences and process of care, lower levels of income were independently associated with a higher rate of rehospitalization.9 Once hospitalized for HF, African Americans are at a 45% greater risk of death or decline in functional status than white patients.8
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INDICATIONS AND USAGE
BiDil is indicated for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status. There is little experience in patients with NYHA class IV heart failure. Most patients in the clinical trial supporting effectiveness (A-HeFT) received a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.
IMPORTANT SAFETY INFORMATION
BiDil is contraindicated in patients who are allergic to organic nitrates, or who take phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulator (riociguat). Concomitant use can cause hypotension.
WARNINGS AND PRECAUTIONS
Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome. Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.
Symptomatic hypotension, particularly with upright posture, may occur with even small doses of BiDil. Hypotension is most likely to occur in patients who have been volume or salt depleted; correct prior to initiation of BiDil. Hydralazine hydrochloride can cause tachycardia and hypotension potentially leading to myocardial ischemia and angina, particularly in patients with hypertrophic cardiomyopathy.
Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness, and tingling, which may be related to an antipyridoxine effect. Pyridoxine should be added to BiDil therapy if such symptoms develop.
Most common adverse reactions (> 5% more on BiDil than on placebo) were headache and dizziness.
The full Prescribing Information for BiDil is available here.
References: 1. Bibbins-Domingo K, Pletcher MJ, Lin F, et al. Racial differences in incident heart failure among young adults. N Engl J Med. 2009;360(12):1179-1190. 2. Yancy CW. Heart failure in African-Americans. US Cardiol. 2006;2005:2(1):196-200. 3. Exner DV, Dries DL, Domanski MJ, Cohn JN. Lesser response to angiotensin-converting-enzyme inhibitor therapy in black as compared with white patients with left ventricular dysfunction. N Engl J Med. 2001;344(18):1351-1357. 4. Go AS, Mozaffarian D, Roger VL, et al. Heart disease and stroke statistics—2014 update: a report from the American Heart Association. Circulation. 2014;129(3):e28-e292. 5. Rumsfeld JS, Havranek E, Masoudi FA, et al. Depressive symptoms are the strongest predictors of short-term declines in health status in patients with heart failure. J Am Coll Cardiol. 2003;42(10):1811-1817. 6. Gottlieb SS, Khatta M, Friedmann E, et al. The influence of age, gender, and race on the prevalence of depression in heart failure patients. J Am Coll Cardiol. 2004;43(9):1542-1549. 7. Havranek EP, Spertus JA, Masoudi FA. Predictors of the onset of depressive symptoms in patients with heart failure. J Am Coll Cardiol. 2004;44(12):2333-2338. 8. Sharma A, Colvin-Adams M, Yancy CW. Heart failure in African Americans: disparities can be overcome. Cleve Clin J Med. 2014;81(5):301-311. 9. Philbin EF, Dec GW, Jenkins PL, DiSalvo TG. Socioeconomic status as an independent risk factor for hospital readmission for heart failure. Am J Cardiol. 2001;87(12):1367-1371.