BiDil for Heart Failure in Black Patients
Authors: Kirsten Bibbins-Domingo, Alicia Fernandez
Journal: Annals of Internal Medicine (2007)

Letters7 August 2007BiDil for Heart Failure in Black PatientsKirsten Bibbins-Domingo, PhD, MD and Alicia Fernandez, MDKirsten Bibbins-Domingo, PhD, MDFrom the University of California, San Francisco, San Francisco, CA 94143-1364.Search for more papers by this author and Alicia Fernandez, MDFrom the University of California, San Francisco, San Francisco, CA 94143-1364.Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-147-3-200708070-00018 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail 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 ...References1. 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 Scholar2. 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 Scholar3. 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 Scholar4. Heart Failure Society of America. Heart failure in patients with left ventricular systolic dysfunction. J Card Fail. 2006;12:38-57. [PMID: 16500571] CrossrefMedlineGoogle Scholar5. Payne JW. A cure for race? The Washington Post. 16 November 2004:HE01. Google Scholar6. 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 InformationAuthors: Kirsten Bibbins-Domingo, PhD, MD; Alicia Fernandez, MDAffiliations: From the University of California, San Francisco, San Francisco, CA 94143-1364.Disclosures: None disclosed. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoBiDil for Heart Failure in Black Patients: The U.S. Food and Drug Administration Perspective Robert Temple and Norman L. Stockbridge BiDil for Heart Failure in Black Patients: Implications of the U.S. Food and Drug Administration Approval Kirsten Bibbins-Domingo and Alicia Fernandez BiDil for Heart Failure in Black Patients Jonathan D. Kahn BiDil for Heart Failure in Black Patients Robert Temple and Norman L. Stockbridge Metrics Cited byMedicine, anti-realism and ideology: Variation in medical genetics does not show that race is biologically realSelf-reported race/ethnicity in the age of genomic research: its potential impact on understanding health disparities 7 August 2007Volume 147, Issue 3Page: 214-215KeywordsClinical trialsConflicts of interestDrugsFood and Drug AdministrationForecastingHeart diseasesHeart failureLongitudinal studiesRacial and ethnic issues ePublished: 7 August 2007 Issue Published: 7 August 2007 Copyright & PermissionsCopyright © 2007 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...