Why the study?
Does the fixed combination of hydralazine hydrochloride and isosorbide dinitrate reduce mortality in black patients with heart failure?
Population
Self-identified black patients with heart failure
Comparison
Fixed combination of hydralazine hydrochloride… vs Standard therapy alone
Design
Editorial
Authors
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The FDA perspective defends the race-based approval of hydralazine/isosorbide dinitrate for black patients with heart failure, citing a 43% mortality reduction and the urgency of providing a proven survival benefit without unreasonable delay.
Does the fixed combination of hydralazine hydrochloride and isosorbide dinitrate reduce mortality in black patients with heart failure?
The FDA perspective defends the race-based approval of hydralazine/isosorbide dinitrate for black patients with heart failure, citing a 43% mortality reduction and the urgency of providing a proven survival benefit without unreasonable delay.
Temple et al. (2007) studied this question.
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