Monday, April 23, 2012
Comment from Susan Graham: We at Project RACE are often told that there is no basis for classifications for multiracial people because there are no differences between races. That’s when I bring out BiDil information, which you can read for yourself below. If a multiracial person who has African American heritage has congestive heart failure, should a doctor prescribe BiDil? We don’t know because most pharmaceutical clinical trials still use “check one” on their forms. It’s a matter of life and death.
Isosorbide dinitrate/hydralazine is a fixed dose combination drug treatment specifically indicated for African Americans with congestive heart failure. It is a combination of hydralazine (an antihypertensive) and isosorbide dinitrate (a vasodilator). It is the first race-based prescription drug in the United States.The combination preparation is marketed in the United States by Arbor Pharmaceuticals, Inc. (who purchased the rights to market the drug in December of 2011 from NitroMed) under the trade name BiDil.
Originally rejected by the Food and Drug Administration (FDA) in 1997, the combination preparation was approved by the FDA in June 2005 for use in African Americans. It was already known that African American individuals with congestive heart failure (CHF) respond less effectively to conventional CHF treatments (particularly ACE inhibitors) than Caucasians. The study by Taylor et al., based on which the FDA approved the medication demonstrated that isosorbide dinitrate with hydralazine reduced mortality by 43%, reduced hospitalizations by 39%, and quality of life markers in African-American patients with CHF.
Posted by Susan at 7:23 AM