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BOSTON - NitroMed Inc. has gotten the green light to begin final testing of a drug to treat congestive heart failure in African-Americans, the Bedford, Mass. company said Friday.
If the drug, called BiDil, gains US Food and Drug Administration approval, it will be the first time the agency has recognized medical differences between blacks and whites in such a broad category of disease and approved a drug specifically for a racial group.
Heart failure is the single biggest medical problem that blacks face. They are twice as likely to suffer from it as are whites.
Nearly five million Americans experience heart failure - usually a weakness in the heart muscle that reduces the pumping of blood to the rest of body. About 20 percent of them are African-American.
The lack of proper circulation results in a buildup of fluid in organs, triggering severe congestion in tissues and swelling, most often in arms and legs. Heart disease causes patients to become extremely tired and short of breath.
``In our discussions with the FDA,'' said Michael D. Loberg, chief executive of NitroMed, ``we came to the conclusion that heart failure presents itself differently in African-Americans, and that existing drugs to treat it give a survival benefit that works less in blacks than in the general population.
``Not all drugs are for all patients.''
Details about the clinical trial, involving 600 African-Americans, will be announced next Saturday by the Association of Black Cardiologists in Orlando, Fla., just before the American College of Cardiology's annual meeting.
The trial will mark ``the first time that a racial difference in responsiveness to a drug is examined in a focused way,'' said Dr. Ann Taylor, a cardiologist at the University of Minnesota. She will be NitroMed's clinical investigator.
The trial will, for the first time, include a significant number of African-American women, she said. Participants will use either BiDil or a placebo with their current medications. The goal is to measure quality of life, reduced need for hospitalization, and improvement of heart function.
During the 1980s and early 1990s, two clinical trials were conducted using BiDil's components: isosorbide dinitrate, an angina treatment, and hydralazine, a diuretic used to treat high blood pressure.
The combination replaces depleted levels of nitric oxide in blacks far better than it does in whites - a distinction that may be based on genetics, Loberg said. Nitric oxide is known to help the heart by relaxing blood vessels.
Developing the two drugs as a medical treatement has been the goal of Dr. Jay N. Cohn, a cardiologist and a professor at the University of Minnesota. In September 1999, he licensed BiDil to NitroMed.
He said the two previous trials invovled 640 male volunteers, of which 30 percent were black - many of them recruited through Veterans Administration hospitals.
``We were fortunate that we got as many African-Americans, because ultimately it became the turning point in our studies,'' Cohn said.
For the total population, BiDil was found to be not very effective. However, a closer look showed it was significantly more effective among blacks than whites. Those findings led NitroMed to ask the FDA for permission to conduct a ``confirmatory trial'' to assure regulators the earlier results were valid.
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(The Boston Globe web site is at http://www.boston.com/globe/ )
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