Blacks With Congestive Heart Failure
Blacks with congestive heart failure may find that a new drug (BiDil) helps relieve their symptoms. In a clinical study, black patients on BiDil experienced a 43 percent reduction in death and a 39 percent decrease in hospitalization; there was no evidence of benefit for whites. The release of this drug marks the first time the FDA has approved a drug specifically for blacks with congestive heart failure.
Congestive heart failure (CHF) affects about 5 million Americans, including about 750,000 blacks. There is no cure, and more than half of patients die within five years of diagnosis.
Blacks between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than whites in the same age range. Blacks also tend to develop heart failure and die from the disease at an earlier age than whites.
In June 2005, the U.S. Food and Drug Administration (FDA) approved a heart failure drug aimed specifically at blacks with congestive heart failure. This marked the first time that the agency has approved a drug for a specific racial group. When added to standard heart failure therapy, this drug (known as BiDil®) dramatically reduces death and hospitalization in blacks.
BiDil is a combination of two older drugs: hydralazine and isosorbide dinitrate. Hydralazine relaxes the arteries so that the heart doesn't have to work as hard to push blood through them. Isosorbide dinitrate relaxes both the veins and the arteries. Experts say isosorbide dinitrate may work by releasing nitric oxide at the blood vessel wall, but its effect usually wears off after half a day. Hydralazine may prevent the loss of this effect, but it's not fully known how the two drugs work together. BiDil is taken by mouth and started at a dose of one tablet three times a day, which may be adjusted based on patient tolerance. Adverse side effects may include headaches and dizziness.
The approval of BiDil was based mainly on the results of the African American Heart Failure Trial (A-HeFT), a study of 1,050 self-identified black patients with severe heart failure who were already being treated with the best available therapy. This study was conducted because two previous studies suggested a benefit of BiDil in black patients, with no evidence of benefit in the white population.
Patients on BiDil experienced a 43 percent reduction in death and a 39 percent decrease in hospitalization for heart failure, compared with patients who took a placebo. Patients taking BiDil also experienced a decrease of their heart failure symptoms, notably shortness of breath and extreme fatigue. The results were so favorable that the trial was stopped early so that all the participants could take BiDil.