25 June, 2005: The United States Food and Drug Administration (FDA) has cleared BiDil (bye-DILL), a medicine for treating heart failure in self-identified black patients, moving a step toward the promise of personalized medicine.
In heart failure, the heart is weakened and does not pump sufficient blood. It can be triggerd by a different kinds of damage to the heart, like heart attacks, high blood pressure and infections.
Some common side effects with the use of BiDil are headache and dizziness. BiDil is marketed by NitroMed, Inc. of Lexington, MA.
The green signal to BiDil was partly based on the results of the African-American Heart Failure Trial (A-HeFT). The study, with 1,050 self-identified black patients with severe heart failure who had already take treatment with the best therapy, was conducted because two earlier trials among severe heart failure patients found no benefit, but hinted at a benefit of BiDil in black patients. Patients using BiDil experienced a 43% decrease in death and a 39% reduction in hospitalization for heart failure as against placebo, and a decrease of their heart failure symptoms.
Said Dr Robert Temple, FDA Associate Director of Medical Policy: "The FDA's approval of a medicine for treating 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.”
"The information made available to the FDA clearly showed that blacks suffering from heart failure will now get an additional safe and effective option for treating their condition. In the future, we hope to discover characteristics that spot people of any race who might be helped by BiDil."
BiDil is a mix 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.
BY OUR PHARMA CORRESPONDENT