Drug Trial to Study Blacks Only

March 21 -- If you're black and suffer from heart failure, you've probably heard the bad news. Blacks are twice as likely as whites to suffer from the disease and twice as likely to die from it.

Particularly confounding for doctors, blacks don't respond as well to popular heart drugs that are more effective in white patients.

Soon, though, that could all change. The Food and Drug Administration has given the go-ahead for Massachusetts-based NitroMed to begin final testing of a drug designed to treat black patients with heart failure, a disorder in which the organ loses its ability to pump blood efficiently.

The drug, BiDil, is believed to be the first government-approved medication that will be developed and marketed specifically for a racial group.

In a field generally characterized by a one-drug-fits-all approach, BiDil marks the beginning of what scientists say is a new era: tailoring medications to individuals. (see sidebar)

The upcoming clinical trial to test BiDil, which will include only African-Americans, is a milestone. Historically, prescription drugs have been developed based on research on white males. Doctors have only started including women in clinical research in the last decade.

The Nitric Oxide Connection

"This whole area of medicine has blossomed with the understanding that not everyone benefits the same way — either to the same degree, or benefits at all — to the drugs we give," says Dr. James Young, medical director of the Kaufman Center for Heart Failure at the Cleveland Clinic Foundation.

Researchers don't completely understand why blacks don't respond as well to widely successful heart failure drugs, such as beta-blockers or ACE inhibitors.

One popular theory is that blacks may produce less nitric oxide in their bodies than Caucasians, explains cardiologist Dr. Jay Cohn of the University of Minnesota. Since the effectiveness of ACE inhibitors hinges on the production of nitric oxide, this could explain why blacks aren't responding as well to the drugs, Cohn said.