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November 12, 2004 Newsletter
| Did
You Know?
Only two TV shows are on the
top ten lists for both White viewers and African American viewer.
The two shows are 60 Minutes and Monday Night Football.
Below are the two lists for the week of October 25th to
October 31st.
|
As the lead product for NitroMed, BiDil,
is an orally-administered nitric oxide-enhancing medicine that is
being investigated for its potential to reduce mortality and hospitalization
and improve the quality of life of African Americans diagnosed with
heart failure. BiDil is a combination of two drugs, isosorbide dinitrate
and hydralzine. Isosorbide dinitrate is a nitric oxide donor. Hydralzine
is an antioxidant and vasodilator agent, which means it dilates blood
vessels and protects the nitric oxide formed by isosorbide dinitrate
from deactivating. Through these properties, BiDil is intended to
provide a number of beneficial effects for African-American heart
failure patients, including increasing levels of nitric oxide in the
body. Because heart failure is a chronic disease, if approved, BiDil,
like other medicines taken for chronic heart disease, will be taken
for the duration of the patient's life. African Americans and Heart Failure Heart failure-or end-stage cardiovascular
disease-affects approximately five million Americans. There is no
cure for this disease and more than 50% of patients die within five
years of diagnosis. African Americans suffer a disproportionate incidence
of cardiovascular disease. With respect to heart failure, they are
affected at a rate almost twice the rate of the corresponding white
population and are more likely to die from it. This dramatic ethnic
difference in health outcomes has been attributed to a variety of
factors, including access to medical care, management of heart failure
and socioeconomic factors. Recent analyses of heart failure clinical
trials, however, show that the mortality rate and the hospitalization
rate for African Americans is significantly higher than for non-African
Americans, even after adjustment for such factors. Based on data from
the United States census bureau and the Centers for Disease Control,
we estimate that 750,000 African Americans have been diagnosed with
heart failure, and we expect this number to grow to approximately
900,000 persons by 2010. African Americans may also be more vulnerable
to heart failure because some medicines approved for use in heart
failure appear in certain clinical studies to be less effective in
African-American patients. These ethnic differences are documented
in FDA-required product package inserts. While BiDil may be of benefit
to the general heart failure population, several factors lead us to
believe BiDil has the potential to be particularly successful in African-American
heart failure patients. Specifically: 2. existing therapies for heart
failure may not work as effectively in African Americans 3. BiDil's mechanism of action is intended to address the nitric oxide deficiency we believe to be associated with heart failure in African Americans; and 4. a retrospective analysis of
a completed heart failure study in the general population using the
components of BiDil suggests that BiDil's components may have efficacy
in African-American patients. Confirmatory Clinical
Study We amended BiDil's previously submitted
new drug application, which had been filed by a prior sponsor of the
drug who was investigating BiDil for use in the general heart failure
population. In early 2001, we received a letter from the FDA stating
that, in addition to the data already submitted to the Agency, a clearly
positive confirmatory trial in African Americans with heart failure
would, together with the satisfaction of other conditions, including
the FDA's approval of our manufacturing processes and marketing materials,
provide a basis for approval of BiDil. In May 2001, we commenced our
phase III confirmatory trial for BiDil, the African American Heart
Failure Trial (A-Heft). |
PERSPECTIVE Are we moving into a new era of race-based
therapeutics? The publication, in this issue of the Journal,of the
African-American Heart Failure Trial (A-Heft) (pages 20492057),
a clinical trial of a medication intended for a single racial group,
poses this awkward question. The studys most striking finding
that the addition of isosorbide dinitrate and hydralazine to
conventional therapy for heart failure reduced relative one-year mortality
by 43 percent among blacks will provoke wide discussion. The
trials sponsor, NitroMed, which holds a patent on the fixed-dose
combination of isosorbide dinitrate and hydralazine that was used,
posits that heart failure has a different pathophysiology in blacks
than in whites, necessitating different treatment strategies. |
| Coming Events | ||
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Click
here to RSVP NAACP ANNUAL FREEDOM FUND BANQUET
Harvard announces new initiative aimed at economic barriers to college 'Harvard is open to talented students from all economic backgrounds,' says President Summers' Financial aid: Recruiting: Admissions: For More information go to |
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![]() Starring
Raena White, Ashley White, Laban King, Alexis Sims, Jihan Woods, Alex Ubokudom, Diviin Huff, Mary Patillo, Tony Smith, Lamar Davidson, Jillian Walker, Jamie Flaherty, Stephanie Brown DREAMGIRLS is the glittery story of Motown-era girl group, The Dreams, who skyrocket from singing backup to superstardom, but not without being torn apart by ambition, greed, frayed friendships and disillusionment. R & B, soul and gospel music combine for showstopper after showstopper. The musical originally opened on Broadway in 1981, won 6 Tony Awards and ran for 1,521 performances. November 19th - November 21st Tickets are $8 for UM Student $13 for Non-UM Student |
Charles G. Ransom
Multicultural Studies Librarian
209
(734) 764-7522 Office Phone
(734) 764-0259 FAX