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COPYRIGHT 2005 International Medical News Group
GAITHERSBURG, MD. -- The fixed-dose combination of isosorbide dinitrate and hydralazine is the first product approved specifically for treating patients in a specific racial group--a development that has been both lauded as a significant advance that could help save the lives of many African Americans with heart failure and criticized as scientifically unjustified and generating a racial stigma.
The Food and Drug Administration's approval is "for the treatment of heart failure as an adjunct to standard therapy in self-identified black patients to improve survival, to prolong time to hospitalization for heart failure, and to improve patient-reported functional status."
Those three outcomes were evaluated in the African American Heart Failure Trial (A-HeFT), which compared the combination with placebo in self-identified African American patients with moderate to severe heart failure (HF) who were on standard HF treatments and was the basis for this approval. The label points out that most patients were on a loop diuretic, an ACE inhibitor or an angiotensin receptor blocker, and a [beta]-blocker, and many were also on a cardiac glycoside or an aldosterone antagonist.
One week prior to the June 23 approval, the nine...
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