Textbook of Personalized Medicine - Second Edition [2015]

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research on the effi cacy of therapies for heart failure in black patients. This analysis,
combined with other recent data from clinical trials, suggests that the overall popu-
lation of black patients with heart failure may be underserved by current therapeutic
recommendations. The fact that large-scale trials of therapy for heart failure have
been performed in preponderantly white populations has limited the ability of the
medical community to assess the effi cacy of current therapies in black patients.
The relatively high level of heart failure in the black population has been attrib-
uted, in part, to a lack of nitric oxide (NO). BiDil (NitroMed), made of isosorbide
dinitrate and hydralazine, is thought to reduce mortality in this population by restor-
ing depleted NO levels, and by protecting NO that is formed naturally in vascular
endothelial cells. A randomized trial has examined whether a fi xed dose of Bidil
provides additional benefi t in blacks with advanced heart failure, a subgroup previ-
ously noted to have a favorable response to this therapy (Taylor et al. 2004 ).
Hydralazine is an antioxidant and vasodilator, which means that it protects NO
formed by isosorbide dinitrate and dilates blood vessels. Neither drug is indicated
separately for heart failure. The addition of a fi xed dose of isosorbide dinitrate plus
hydralazine to standard therapy for heart failure including neurohormonal blockers
was shown to be effi cacious and increased survival among black patients with
advanced heart failure. The study was terminated early owing to a signifi cantly
higher mortality rate in the placebo group than in the group treated with the drug
combination. NitroMed Inc has submitted the African American Heart Failure Trial
(A-HeFT) clinical dataset to the FDA. The product was approved by the FDA in



  1. BiDil became the fi rst drug to be developed and marketed on the basis of a
    demonstrated effi cacy in black subjects and could pave the way for a generation of
    individualized medicines for ethnic groups.
    The African American Heart Failure Trial (A-HeFT) and the FDA approval of
    BiDil for race-specifi c prescription stirred the debate about the scientifi c and medi-
    cal status of race. An analysis has been published of the factors infl uencing physi-
    cians’ prescription of BiDil and whether exposure to the controversy has an impact
    on their therapeutic judgments about the drug (Maglo et al. 2014 ). Overall, physi-
    cians prescribe and are willing to prescribe BiDil more to black patients than to
    white patients. However, physicians’ lack of awareness about the controversial sci-
    entifi c status of A-HeFT suggests the need for more effi cient ways to convey scien-
    tifi c information about BiDil to clinicians. Furthermore, the uncertainties about the
    determination of clinical utility of BiDil for the individual patient raise questions
    about whether this specifi c race-based therapy is in patients’ best interest.


Management of Hypertension


Hypertension (HPN) is a common disorder affecting ~20 % of the US population.
Care of hypertensive patients vary a lot. Ideally, individual risks must be assessed
in order for the best decision to be made as to which patients with hypertension to
treat and how. Assessment identifi es important cardiovascular risk factors that may


14 Personalized Management of Cardiovascular Disorders
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