FDA may approve new heart drug for blacks

The medication would become the first to target cardiac disease in a minority population.

By Victoria Stagg Elliott, AMNews staff. March 26, 2001.

The Food and Drug Administration is prepared to approve a drug for heart failure specifically in African-American patients if it proves effective in a clinical trial focused on this population.

BiDil, a combination of hydral-azine hydrochloride and isosorbide, has demonstrated some increased effectiveness in black vs. white congestive heart failure patients in retrospective studies.

"African-Americans appear underserved with respect to currently available drugs for the treatment of heart failure," said Anne L. Taylor, MD, a professor of medicine at the University of Minnesota in Minneapolis. She will be organizing the study for the drug's manufacturer, NitroMed Inc. "The FDA's support of the continued development of a therapy for black heart failure patients represents a significant medical milestone. Once approved, BiDil will provide cardiologists with a critically needed pharmacologic treatment option."

Heart failure is twice as common and much more deadly in blacks than in whites, something experts ascribe to numerous factors, including reduced access to health care, increased rates of hypertension and differences in response to treatment.

"We've known for some years that African-Americans fare less well with heart failure than do whites. There are many reasons for that," said Jay N. Cohn, MD, a professor of medicine at the University of Minnesota in Minneapolis and co-author of "Racial differences in response to therapy for heart failure: Analysis of the vasodilator-heart failure trials," published in the September 1999 Journal of Cardiac Failure. "We've now found that one of the reasons may well be that they don't respond as well to the drug. This will provide an opportunity to at least bridge the therapeutic gap," said Dr. Cohn. [...]