Heart drug to target ethnic group

Emily Kaiser

A University professor’s idea to combine two drugs to fight heart failure might finally become reality.

After reviewing data from trials he had done in the 1980s, Jay Cohn, a University medicine professor, realized the drug he tested had been particularly effective for black patients. He began retesting BiDil, a nitric oxide enhancing medicine used in addition to regular treatment, on black patients in 2001.

Researchers halted the trial on July 19 after they saw the drug had significant survival benefits for the patients in the trial.

“There was a big benefit for the group that was receiving the treatment, so the Data Safety and Monitoring Committee recommended that we stop, and all patients be given the active drug,” said Anne L. Taylor, a University professor of medicine and chairwoman of the study.

If approved, the drug will be the first drug marketed to a specific ethnic group.

“It was well known that there is some difference in response to drugs in African Americans, and there is evidence for a difference in nitric oxide in black versus white patients,” Cohn said.

Nitric oxide is a gas released from blood vessels and the heart to protect artery walls, Cohn said.

“Nitric oxide is a molecule that is normally secreted by the body, but is also rapidly broken down,” Taylor said. “The drug donates and stabilizes nitric oxide.”

The company testing the drug, NitroMed Inc., “embarked on new ground” by creating a drug geared toward black heart failure patients, said Kathleen O’Donnell, NitroMed director of public affairs and investor relations.

“NitroMed took what would be called a risk, to look at prospectively studying an ethnic population that had a predisposition to heart failure and suffered a disproportionate burden of the disease,” O’Donnell said.

According to data from the Census Bureau and the Centers for Disease Control and Prevention, 750,000 black U.S. citizens are diagnosed with heart failure each year. The disease affects a total of about 5 million Americans.

Taylor said the study was meant to discover differences among patients. Biologically, all humans are 99.9 percent alike, but the medical field needs to look at small differences to see when they do matter, she said.

“We know that in those incidents when they do matter, we need to have clinical trials that are inclusive in the kinds of patients that are recruited in sufficient numbers so we can see when there is a difference,” Taylor said.

NitroMed is prepared to launch the drug during the first quarter of 2005, one year earlier than the company originally planned, O’Donnell said.

Although the drug was tested only with black patients, Cohn said it will still be effective in other patients.

“What we wanted to show was that this drug was effective in treating heart failure and we chose a specific population to study,” Cohn said. “Now this therapy can be used in anyone.”

Cohn said it does not matter to him whether patients use NitroMed’s drug or get the two generic drugs used to make the treatment.