Heart failure disproportionately affects African Americans
Heart failure (HF) is significantly more prevalent in African Americans than in any other population group. By 2030, The American Heart Association estimates that there will be a 29% increase in the number of African Americans diagnosed with HF.1
Age-adjusted incidence rate of HF per 1000 person-years2
African Americans are disproportionately burdened by HF and its associated costs. The Atherosclerosis Risk in Communities study showed that the annual incidence of newly diagnosed HF is the highest among African Americans vs all other ethnicities studied. Heart failure also occurs at an earlier age in African Americans, with functional and structural cardiac changes strongly associated with the development of HF appearing at an average of 10 years before symptom onset. Overall, African Americans develop HF more often, at earlier ages, and are more negatively impacted than other ethnicities.3
African Americans are also predisposed to diastolic impairment, with endothelial dysfunction evidenced by impaired digital and brachial artery vasomotion. Physiologically, African Americans have higher left ventricular mass and wall thickness, and a higher incidence of left ventricular hypertrophy (LVH). Modifiable risk factors also play a part. African Americans are more prone to diabetes, hypertension, and obesity than their white counterparts, which contribute to a higher percentage of HF cases in this population.3
Risks for HF in the African American population3
|Modifiable risk factors||Hypertension, hyperglycemia, LVH, smoking|
|Neurohormonal imbalances and endothelial dysfunction||Dysfunctions in the renin-angiotensin-aldosterone and adrenergic axes as well as impaired endothelial function are more common|
|Genetic polymorphisms||Racial disparity may be the result of several polymorphisms associated with the risk of HF (beta 1 adrenergic receptor, alpha 2c receptor, aldosterone synthase, G protein, transforming growth factor beta, nitric oxide synthase, and transthyrectin)|
|Socioeconomic factors and quality of care||Low socioeconomic status and discrimination from healthcare providers serve as barriers to attaining treatment goals in African Americans|
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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. Heidenreich PA, Albert NM, Allen LA, et al. Forecasting the impact of heart failure in the United States: a policy statement from the American Heart Association. Circ Heart Fail. 2013;6(3):606-619. 2. Mozaffarian D, Benjamin EJ, Arnett KD, et al. AHA statistical update: Heart disease and stroke statistics—2015 update. A report from the American Heart Association. Circulation. 2014:e1-e295. circ.ahajournals.org. 3. 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.