FDA Approves BiDil(R) for Treatment of Heart Failure in Black Patients

[steve2470]

http://biz.yahoo.com/prnews/050623/dcth067.html?.v=10

Thursday June 23, 7:22 pm ET
Improvement in Survival and Patient-Reported Functional Status, and Prolonged Time to Hospitalization for Heart Failure Seen With BiDil

LEXINGTON, Mass., June 23 /PRNewswire-FirstCall/ -- NitroMed, Inc. (Nasdaq: NTMD - News) announced today that the U.S. Food and Drug Administration (FDA) approved BiDil® (isosorbide dinitrate/hydralazine hydrochloride) for the treatment of heart failure in black patients.

BiDil is indicated to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status, as an adjunct to current standard heart failure therapy in self-identified black patients. There is little experience in patients with New York Heart Association (NYHA) class IV heart failure. Most patients in the clinical trial supporting effectiveness, referred to as the African American Heart Failure Trial (A-HeFT), received, in addition to BiDil or placebo, a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies experienced a significant 43 percent decrease in the risk of mortality (P=.012) (absolute mortality rate: BiDil, 6.2% vs. placebo, 10.2%), a 39 percent reduction in the risk of first hospitalization for heart failure (P<.001) (absolute first hospitalization rate: BiDil, 16.4% vs. placebo, 24.4%) and a statistically significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire, which is a self-report of the patient's functional status, versus patients taking placebo in addition to current standard therapies.

"In BiDil, we now have a new treatment that has been shown to save the lives of black heart failure patients, helping a population that is disproportionately burdened by cardiovascular disease," said Anne Taylor, M.D., associate dean for faculty affairs, professor of medicine, University of Minnesota Medical School and lead A-HeFT investigator. "African Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non-black counterparts, and they also present with and die from the disease at an earlier age. FDA approval of BiDil represents an important leap forward in addressing this health disparity," said Dr. Taylor.

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[The Sushi Bandit]

1. Old News... highlighted on PBS News hour last Monday

[AspenRose]

2. Two words: REMEMBER TUSKEEGEE

I wouldn't put ANYTHING past the pharmaceutical industry, especially during this administration's tenure.
:tinfoilhat:


You want to improve the health of blacks and others in this country? UNIVERSAL HEALTH CARE!