"We now know that hydralazine not only acts to lower blood pressure, but it is an antioxidant . . . [and] protects arteries in the heart," Cohn said.
Isosorbide dinitrate is still commonly prescribed to treat chest pain, doctors said. The drug relaxes the arteries and veins, helping to deliver nitric oxide to the body, Cohn said.
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More Heart News
Previous trials suggest that some black people may have a nitric oxide deficiency that BiDil helps to correct. Black patients have also been found to be less responsive to ACE inhibitor therapy for hypertension and heart failure, the study's authors said in telephone interviews.
NitroMed plans to conduct further research to see if other patients might also benefit from BiDil, according to Worcel, a cardiologist.
"Do we believe that only blacks have nitric oxide deficiency? Absolutely not," Worcel said. "The issue here is how to identify those patients that are going to be helped by drugs like [BiDil.]" The drug company hopes to identify other, less "crude" biomarkers, he said, to help them identify other patients who would respond well to BiDil.
Cohn said he has prescribed the two components of BiDil individually for many of his own patients with heart failure since 1980, when an earlier study showed benefits for patients of all races. "Many of my colleagues who have been around a long time are using the combination and have been for many years," he said.
New Route to Approval
The study that touched off the controversy began in June 2001, said lead author Anne Taylor, a professor of medicine and cardiology at the University of Minnesota. The 1,050 black patients who were randomly assigned to take BiDil or a placebo had an average age of 56. The BiDil group was about 55 percent male, and the placebo group was 63 percent male.
The trial, co-sponsored by the Association of Black Cardiologists, was supposed to end in 2005. But researchers stopped it in July, when benefits to the BiDil group were so great that the researchers could not defend withholding the drug from the placebo group. When the trial was stopped, 54 of the 532 patients in the placebo group had died, compared with 32 of the 518 patients in the BiDil group. That translated to a 43 percent improvement in survival among patients taking BiDil, according to the study.
Researchers also found a 33 percent reduction in the rate of first hospitalizations for heart failure among patients taking BiDil compared with those taking placebo. Patients taking the new drug also reported improved quality of life. BiDil also helped lower some patients' blood pressure, the authors wrote.
The trial, dubbed the African American Heart Failure Trial, followed an unsuccessful 1980s attempt to get the FDA to approve BiDil for all racial groups.