BiDil (isosorbide dinitrate/hydralazine hydrochloride) is indicated as an adjunct to current standard heart-failure therapy in self-identified black patients to increase survival, delay hospitalization and improve a patient's ability to function.

Blacks More at Risk for Heart Failure

"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.

43% Decrease in Risk of Death

In addition to BiDil or a placebo, most patients in the clinical trial supporting BiDil's effectiveness -- called the African American Heart Failure Trial (A-HeFT) -- received a loop diuretic; an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker; and a beta blocker. Many also received a cardiac glycoside or an aldosterone antagonist.

Clinical trial participants taking BiDil in addition to current standard heart failure therapies experienced a significant 43 percent decrease in the risk of mortality, a 39 percent reduction in the risk of first hospitalization for heart failure, and a statistically significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire (a self-report of the patient's functional status) versus patients taking placebo in addition to current standard therapies.

Trial Halted Early

The FDA based the approval of BiDil primarily on results from the recent A-HeFT trial, which was halted early, in July 2004, due to the significant survival benefit seen with the drug.

Co-sponsored by NitroMed and the Association of Black Cardiologists (ABC), A-HeFT was the first clinical trial conducted in a heart-failure population in which all of the participants identified themselves as black.

A retrospective analysis of an earlier study with a combination of isosorbide dinitrate and hydralazine hydrochloride had suggested a trend for improved survival in the subset of patients with mild to moderate heart failure who self-identified as black.

"BiDil has the ability to significantly extend and enhance the lives of black patients with heart failure," said Michael D. Loberg, Ph.D., president and chief executive officer, NitroMed, Inc. "NitroMed looks forward to bringing this important medicine to the patients and physicians who need it."