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First all African-American cholesterol lowering trial in U.S. at Methodist

Houston, TX - 5/8/2002

The nation’s first all African-American trial studying cholesterol lowering therapy is now underway at the Methodist DeBakey Heart Center and Baylor College of Medicine, in an effort to discover how effective these drugs are in this high risk ethnic group.

More African-Americans die from heart disease than any other ethnic group in the United States but there has been no significant research that has determined why.

Cholesterol is known to increase the risk of heart disease and

death related to heart disease, and lowering cholesterol is proven to reduce these risks. Statins, powerful drugs that lower cholesterol, are commonly used to treat people with these risk factors. However, no clinical trials have focused on lipid lowering therapy in high risk ethnic groups, such as African-Americans.

"Historically, this ethnic group has been extremely reluctant to participate in clinical trials and, as a result, there is very little data about how these life-saving medications can help African-Americans, said Dr. Ryan Neal, director of cardiac rehabilitation at the Methodist DeBakey Heart Center and principal investigator of the trial. Eventually, 70 centers will participate in the trial, with more than 700 patients.

In the largest cholesterol trials focusing on mortality, more than 30,000 people have been studied, with less than 900 being minorities.

"Although African-Americans are at a far greater risk, and have more additional risk factors for heart disease, less than half with high cholesterol are treated with lipid lowering medications. These medications have proven to save lives, but awareness in the African-American community is still low," Neal said.

Neal, who is African-American, said the reluctance to join clinical trials dates as far back as the Tuskegee Study of Untreated Syphilis in the Negro Male. From 1932 through 1972, the U.S. Public Health Service allowed more than 400 black men to go untreated for syphilis after offering them free medical care. The men received treatment only after the experiment became public in 1972. To help overcome this mistrust of clinical trials, Neal is working closely with the African-American community through churches and community groups to explain the benefits of the trial and the benefits of cholesterol drugs.

Even if they do not join the trial, Neal said awareness has to be elevated so African-Americans do not go untreated for heart disease. The trial will hopefully give researchers clues as to how well the therapy works in this population, he said.

In the study, participants who meet the criteria will either be given Lipitor or the new drug Crestor, which has not been FDA approved yet. AstraZeneca is the sponsor of this national trial. By better understanding the patient response to cholesterol lowering therapy, researchers can try to determine the proper course of treatment for African- Americans. In the research that is available on cholesterol, there appears to be subtle differences in cholesterol characteristics of African-Americans and whites.