Health

Drug Studied as Heart-Failure Treatment for African Americans

By Mike Sims

January 31, 2002 / 8:41 AM EST / CBS

Estimates suggest that African Americans are twice as likely to die from heart failure as whites. Now a drug manufacturer has announced plans to study a drug called Bidil (a combination of the drugs hydralazine HCl and isosorbide) which, if approved by the Food and Drug Administration (FDA), it would be the first drug specifically intended to treat heart failure in African-American patients. Doctor Anne Taylor, the study's principal investigator, who is also a professor and associate dean at the University of Minnesota School of Medicine, explains more.

How significant is this trial?

This is very significant. The rate of heart failure is much higher among African Americans. The mortality rate is higher, and we really don't know why. We hope that this trial will show that this medicine can be added to others to decrease mortality and improve quality of life.

What is Bidil?

It's actually a combination of two drugs. It works on people with congestive heart failure by decreasing the workload of the heart. We've found in earlier studies that it increases the heart's production of nitric oxide and that this helps to maintain the structural integrity of the heart.

Has this formula been used before?

It's the first time the two drugs that make up Bidil have been used together.

Can you xxplain why this drug seems to be especially helpful to African Americans?

The research suggests that the bodies of African Americans are not as good at producing nitric oxide as they might be. It's a substance that preserves cell structure. Less production means the heart has to work harder and that could ultimately be harmful. And boosting the production of nitric oxide dilates the blood vessels in the walls of the heart and that decreases the workload--thus preserving the structure of the heart. The structural changes are harmful.

Is this drug for use in only patients who've suffered congestive heart failure?

Yes, this is not a "preventive" drug.

Is this a drug that only works on African Americans?

We don't know. The research suggested that it could work better for African Americans. We hope to learn how much race or appearance predicts how well a particular medicine can be used for a specific genetic makeup.

Are you using any genetic testing to determine who by your definition is African American?

There's no real test. It's what the participants will identify themselves as and their appearance.

Is this a trend in medicine? Drugs designed for specific groups of people?

This is new ground and it's very exciting. We know that all humans are 99.9% alike, but that 0.1% can have important implications. We know that different people have different outcomes in treatments of disease. All drugs are not suitable for all patients.

(Hong: I've deleted the last sentence in the raph above because I don't really understand what Dr. Taylor is trying to say there, and it doesn't seem to quite make sense as written.--B.C.)

When do the trials get underway?

We're just beginning to identify study sites. As soon as we do, we'll be up and running around the country. We need 600 patients and the study will last for 1 year.

(Hong: Perhaps we can get a telephone number from Dr. Taylor later and put it up with this story?--In the sentence that I deleted in the preceding paragragh she mentions hoping to have a number by "Monday." I don't remember seeing a number on the screen in the Early Show interview either.--B.C.)

How can this change the way we test drugs?

For one thing, it can allow doctors to individualize therapy for patients.

Is NitroMed, the manufacturer of Bidil, sponsoring the trial?

Yes, in partnership with the Organization of Black Cardiologists.