Drug for Only Blacks Stirs Hope, Concern

Thomas H. Maugh II, Los Angeles Times, Nov. 9

A new heart drug that targets African Americans reduced deaths from advanced heart failure by 43% and reduced hospitalizations by a third, setting the stage for it to become the first drug approved for only one racial group.

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The drug in question is BiDil, manufactured by NitroMed Inc. of Lexington, Mass. BiDil is a combination of two heart drugs now distributed generically, isosorbide dinitrate and hydralazine. Isosorbide dinitrate is thought to stimulate the production of nitric oxide, which has a variety of beneficial effects on the heart. Hydralazine is used for treating high blood pressure.

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When Cohn reanalyzed the data and stratified the results by race, however, it appeared that the drug provided greater benefits for blacks. That was an intriguing finding because, even though heart failure affects 5 million Americans, blacks are 2 1/2 times more likely to suffer from it. The disease occurs when heart muscles weaken, interfering with pumping and allowing fluids to back up into the lungs, causing shortness of breath.

Spurred by these findings, Cohn and his colleagues organized a new study of the two drugs in 1,050 patients self-identified as black. Half received the drugs in conjunction with normal therapy for heart failure, and half received only conventional therapy. In both cases, subjects were given an ACE inhibitor.

The results were so striking that the study was terminated prematurely in July. Over the two years of the study, 6.2% of the patients given BiDil died, compared with 10.2% of those given the standard treatment. First hospitalizations for heart failure were observed in 16.4% of those receiving BiDil, compared with 24.4% of those receiving conventional therapy.

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