Drug Approved for Heart Failure in Black Patients
By ANDREW POLLACK

A drug aimed at treating heart failure specifically in black patients has proved so effective that the clinical trial in which it was being tested has been halted early, the company sponsoring the trial said yesterday.

The results are expected to lead to approval of the first drug specifically for a single ethnic group. They seem to validate the gamble by the company, NitroMed, to take a drug that had failed to win approval for general use and test it only on African-Americans, an approach that ignited controversy on the relevance of race to medicine. The company's stock soared on yesterday's announcement.

Michael D. Loberg, the president and chief executive, said the company had been expecting the drug to be approved in early 2006 but would now be ready to introduce the drug in early 2005, if the Food and Drug Administration approves it that soon for use by blacks.

NitroMed has argued that blacks have a higher rate of heart failure than the American population as a whole and that they tend not to respond to some existing heart failure drugs as well as other groups. For NitroMed executives, those factors, and some earlier evidence that blacks respond better to the drug, which is called BiDil, justified a test of the drug just in that ethnic group.

Yesterday, NitroMed said that an independent committee of medical researchers overseeing patient safety in the trial decided it would be unethical to continue giving some patients a placebo because those getting the drug were living significantly longer. The trial, which began in 2001 and had enrolled about 1,050 of the 1,100 patients eventually intended to take part, was halted immediately and all the participating patients will be offered BiDil.

"It is a spectacular result," said Anne L. Taylor, a professor of medicine at the University of Minnesota and the chairwoman of the study. "It offers an additional treatment for a group of patients who traditionally, with standard medications, have not done as well."