This is billed as "the first ethnic drug" - a heart drug for African Americans - is about to be tested clinical trials. NitroMed, a company in New Bedford, Massachusetts, announced earlier this month it won Food and Drug Administration (FDA) clinical trial authorization in black.
in the United States, blacks are more likely than whites to develop congestive heart failure and are nearly twice as likely to die of the disease. They do not benefit as much from the drug treatment of first line, known for ACE inhibitors. These drugs interfere with a metabolic process that causes constriction of blood vessels, increase blood pressure. However, the drug is more effective when patients respond with a sharp increase in the flow of nitric oxide (NO ). Black patients may have inherited a physiological difference that causes them to respond to ACE inhibitors with lower NO levels than whites, limiting the effect, said Jay Cohn, a heart researcher at the University Minnesota, Twin Cities.
--which BiDil combines two vasodilators with a source of NO - can help, said Cohn, who invented the drug and licensed the rights to NitroMed in 1999. Although BiDil had little effect on the overall mortality in a study conducted in the 1980s, Cohn analysis of a subset of black patients suggests that they have benefited. On this basis, the FDA accepted a 2-year trial that will compare BiDil and other drugs with placebo in 0 black patients at 100 sites.
Other researchers are intrigued but wary. "I'm skeptical of the approach," because it substitutes the color of the skin for genetic analysis, said Marc Pfeffer of Brigham Harvard and Women's Hospital in Boston. Conceding the point, an official NitroMed said "we are looking for better diagnosis" to target therapy.
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