What is the effect of Hydralazine (Hydralazine) on African American patients?

From the Guidelines

Hydralazine is particularly beneficial for African American patients with heart failure, and the combination of hydralazine and isosorbide dinitrate (BiDil) is specifically recommended for self-identified Black patients with heart failure with reduced ejection fraction (HFrEF) who remain symptomatic despite optimal medical therapy. The standard dosing regimen is hydralazine 37.5 mg with isosorbide dinitrate 20 mg three times daily, titrated to a target dose of hydralazine 75 mg with isosorbide dinitrate 40 mg three times daily as tolerated 1. This combination should be added to standard heart failure therapy including ACE inhibitors/ARBs, beta-blockers, and aldosterone antagonists.

The benefit of this combination in African Americans was demonstrated in clinical trials showing a significant reduction in mortality, as seen in the African-American Heart Failure Trial (A-heFT), where the combination of isosorbide dinitrate and hydralazine reduced mortality by 43% and heart failure hospitalizations by 33% 1. The physiological basis for this benefit relates to differences in nitric oxide-mediated vasodilation pathways in African Americans compared to other populations. African Americans may have lower nitric oxide bioavailability, and the hydralazine-isosorbide dinitrate combination helps overcome this deficit by enhancing nitric oxide production and preventing its degradation.

Common side effects include headache, dizziness, and hypotension, so blood pressure should be monitored regularly 1. This therapy should be considered for symptomatic African American patients with NYHA class III-IV heart failure despite optimal medical therapy. The combination of hydralazine and isosorbide dinitrate is recommended for African Americans who remain symptomatic despite optimal medical therapy, including ACE inhibitors, beta-blockers, and aldosterone antagonists.

Key points to consider:

• The combination of hydralazine and isosorbide dinitrate is specifically recommended for African American patients with HFrEF who remain symptomatic despite optimal medical therapy.
• The standard dosing regimen is hydralazine 37.5 mg with isosorbide dinitrate 20 mg three times daily, titrated to a target dose of hydralazine 75 mg with isosorbide dinitrate 40 mg three times daily as tolerated.
• This combination should be added to standard heart failure therapy, including ACE inhibitors/ARBs, beta-blockers, and aldosterone antagonists.
• Common side effects include headache, dizziness, and hypotension, so blood pressure should be monitored regularly.

From the Research

Hydralazine in African American Studies

• The use of hydralazine in combination with isosorbide dinitrate has been shown to be effective in reducing mortality and morbidity in African American patients with heart failure 2, 3.
• The African-American Heart Failure Trial (A-HeFT) demonstrated that adding a fixed-dose combination of isosorbide dinitrate and hydralazine to modern guideline-based care improved outcomes, including all-cause mortality, in self-identified black patients with symptomatic heart failure 2.
• The combination of hydralazine and isosorbide dinitrate has been recommended for African American patients with moderate to severe heart failure with reduced ejection fraction (<40%) (HFrEF) 4.
• However, despite the recommendations, fewer than one-fourth of eligible African American patients receive guideline-recommended hydralazine-isosorbide dinitrate therapy 4.
• The US Food and Drug Administration (FDA) approved the fixed combination of hydralazine hydrochloride and isosorbide dinitrate for treating heart failure in black patients, citing a statistically significant 43% reduction in mortality compared to standard therapy alone 5.
• The use of hydralazine in African American patients with hypertension has also been discussed, with some guidelines recommending different treatment approaches based on patient race 6.

Key Findings

• Hydralazine-isosorbide dinitrate combination therapy is effective in reducing mortality and morbidity in African American patients with heart failure.
• The therapy is recommended for African American patients with moderate to severe heart failure with reduced ejection fraction.
• Despite recommendations, few eligible African American patients receive guideline-recommended hydralazine-isosorbide dinitrate therapy.
• The FDA has approved the fixed combination of hydralazine hydrochloride and isosorbide dinitrate for treating heart failure in black patients.
• Different treatment approaches may be recommended for African American patients with hypertension based on patient race.