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Heart-Disease Research Focuses on Drug for African-Americans Shands Jacksonville Was Part of a Clinical Trial of BiDil, Which is Being Marketed for One Race.

Posted on: Tuesday, 23 August 2005, 18:00 CDT

After Jacksonville resident Johnnie Cherry suffered three heart attacks, his physician put him on a low-salt diet and inserted a pacemaker into his chest. The 49-year-old widower also was enrolled in a clinical trial in 2001 to determine whether a heart medicine targeted specifically for African-Americans actually worked.

The U.S. Food and Drug Administration recently approved the drug, called BiDil, marking one of the only times a drug has been marketed exclusively for one race.

BiDil is a combination of two generic drugs used to treat chest pain and high blood pressure.

The drug enhances the benefits of nitric oxide in heart patients. Nitric oxide is a substance produced by cells that protects the heart and arteries from damage. Research has shown African- Americans who suffer heart failure are more likely to have lower levels of nitric oxide. That is why BiDil worked more effectively in a study involving 1,050 African-American heart disease patients than it did for the general population. In that study, BiDil reduced mortality in African-Americans by 43 percent.

Those results led researchers to conduct a clinical trial aimed specifically at African-Americans.

The results of the three-year study, which was conducted at 170 sites across the country including Shands Jacksonville, showed the patients who took the new drug along with other heart treatments had a higher survival rate.

The trial was expected to be completed early this year, but the results were so impressive it was continued until July.

"African-Americans between the ages of 45 and 64 are 2.5 times more likely to die prematurely from heart failure than their non- black counterparts," said Anne Taylor, the trial's lead investigator from the University of Minnesota Medical School.

They also die earlier, she said.

"FDA approval of BiDil represents an important leap forward in addressing this health disparity," she said.

In Jacksonville the drug will be available to patients within the next couple of months, said Alan Miller, a University of Florida cardiologist and professor of medicine who led the clinical trial at Shands. Area physicians are undergoing training to better understand the drug and its effects.

"We can't just give the drug to African-Americans and say, 'You'll feel better,' " Miller said. "This is not replacement therapy; this is added therapy."

Some physicians say approving a drug specifically for African- Americans fuels the idea that there are biological differences between the races, which historically has been used to justify discrimination. Others counter by saying that studies based solely on science and advancements in medicine and specific to gender or race is the next step in medical research.

Cherry, who said he was successful while a part of the clinical trial, is optimistic about BiDil for the general public.

"It helped me," he said. "I hope it helps a lot of other people like me with bad hearts live longer."cherie.black@jacksonville.com, (904) 359-4504HEART-DISEASE FACTS

Cardiovascular disease is the leading cause of death in African- Americans in the United States. An estimated 750,000 African- Americans were diagnosed with heart disease in 2004. This number is expected to grow to nearly 900,000 new cases by 2010. There is no cure and more than half of those with heart disease die within five years of diagnosis.

A little more than 40 percent of African-American men suffer from cardiovascular disease, compared to 30 percent of white men.

Nearly 40 percent of African-American women suffer from cardiovascular disease, compared to nearly 24 percent of white women.

Sources: The American Heart Association, The Census Bureau, The Centers for Disease Control and Prevention

Source: Florida Times Union

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