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BiDil for Heart Failure in Black Patients
- Kirsten Bibbins-Domingo, PhD, MD; and
- Alicia Fernandez, MD
- From the University of California, San Francisco, San Francisco, CA 94143-1364.
TO THE EDITOR:
We are surprised that the U.S. Food and Drug Administration's (FDA) defense of their position to approve BiDil for black patients with heart failure (1) extended beyond the evidence that this combination pill works in black patients to the assertion that this therapy does not work in white patients. While the efficacy of hydralazine hydrochloride–isosorbide dinitrate in black patients is clearly established given the results of A-HeFT (African-American Heart Failure Trial), the lack of efficacy in white patients is not. The FDA's contention is based on post hoc subgroup analyses of 2 older, smaller trials that studied this combination as primary treatment for heart failure only and did not address the contemporary question of whether the combination is effective as an adjunct to standard therapy in patients with refractory disease. In general, post hoc subgroup analyses should be interpreted …
