FDA Approves Heart Failure Drug for Black Patients

The Food and Drug Administration (FDA) approved BiDil (bye-DILL), a drug for the treatment of heart failure in self-identified black patients, representing a step toward the promise of personalized medicine.

Heart failure is a condition in which the heart is weakened and does not pump enough blood. It can be caused by a variety of damage to the heart, including heart attacks, high blood pressure, and infections.

The approval of BiDil was based in part on the results of the African-American Heart Failure Trial (A-HeFT). The study, which involved 1,050 self-identified black patients with severe heart failure who had already been treated with the best available therapy, was conducted because two previous trials in the general population of severe heart failure patients found no benefit, but suggested a benefit of BiDil in black patients. Patients on BiDil experienced a 43% reduction in death and a 39% decrease in hospitalization for heart failure compared to placebo, and a decrease of their symptoms of heart failure.

“Today’s approval of a drug to treat severe heart failure in self-identified black population is a striking example of how a treatment can benefit some patients even if it does not help all patients,” said Dr. Robert Temple, FDA Associate Director of Medical Policy. “The information presented to the FDA clearly showed that blacks suffering from heart failure will now have an additional safe and effective option for treating their condition. In the future, we hope to discover characteristics that identify people of any race who might be helped by Bidil.”

BiDil is a combination of two older drugs, neither approved for heart failure–hydralazine and isosorbide dinitrate.

As an anti-hypertensive agent, hydralazine relaxes the arteries, and decreases the work of the heart. The anti-anginal agent, isosorbide dinitrate, relaxes the veins as well as the arteries. Isosorbide seems to work by releasing nitric oxide at the blood vessel wall, but its effect usually wears off after half a day. Hydralazine may prevent this loss of effect. But how the two drugs work together is not fully known.

Some common side effects with the use of BiDil are headache and dizziness.

BiDil is marketed by NitroMed, Inc. of Lexington, MA.

From U.S. FDA

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