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 ...
References
- 1.
Temple R ,Stockbridge NL . BiDil for heart failure in black patients: The U.S. Food and Drug Administration perspective. Ann Intern Med. 2007;146:57-62. [PMID:17200223 ] LinkGoogle Scholar - 2.
Yusuf S ,Wittes J ,Probstfield J ,Tyroler HA . Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA. 1991;266:93-8. [PMID:2046134 ] CrossrefMedlineGoogle Scholar - 3.
Hunt SA ,Abraham WT ,Chin MH ,Feldman AM ,Francis GS ,Ganiats TG ,et al . ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005;112:154-235. [PMID:16160202 ] MedlineGoogle Scholar - 4.
Heart Failure Society of America . Heart failure in patients with left ventricular systolic dysfunction. J Card Fail. 2006;12:38-57. [PMID:16500571 ] CrossrefMedlineGoogle Scholar - 5. Payne JW. A cure for race? The Washington Post. 16 November 2004:HE01. Google Scholar
- 6. Saul S. U.S. to review heart drug intended for one race. The New York Times. 13 June 2005. Google Scholar
Author, Article, and Disclosure Information
From the University of California, San Francisco, San Francisco, CA 94143-1364.
Disclosures: None disclosed.
Submit a Comment
Contributors must reveal any conflict of interest. Comments are moderated. Please see our information for authorsregarding comments on an Annals publication.
*All comments submitted after October 1, 2021 and selected for publication will be published online only.