Heart Disease Medication Specifically Benefits African-American Patients, Study Finds

The heart disease medication BiDil, manufactured by NitroMed, reduced deaths among African Americans with heart failure by 43%, according to a University of Minnesota study presented on Monday at the American Heart Association annual conference in New Orleans, the Wall Street Journal reports. The study, led by University of Minnesota professor of medicine Anne Taylor, involved 1,050 African Americans with moderate to advanced heart failure. Half of participants received BiDil, a combination of the heart disease medications isosorbide dinitrate and hydralazine, and half received a placebo. After three years, 32 participants who took BiDil died, compared with 54 who took a placebo, the study found. In addition, the study found that the number of first hospital admissions for heart failure among participants who took BiDil was 33% less than the number among those who took a placebo (Winslow, Wall Street Journal, 11/9). Taylor said that researchers also found "a very significant improvement in the quality of life" among participants who took BiDil (Sternberg, USA Today, 11/9). However, according to the study, almost half of participants who took BiDil reported headaches, and 30% reported dizziness, compared with 20% and 12%, respectively, among those who took a placebo. Researchers ended the study, which began in June 2001, in July after an independent board found that participants received a "substantial benefit" from BiDil, the Journal reports. NitroMed and the Association of Black Cardiologists sponsored the study, which will appear in a future issue of the New England Journal of Medicine.

FDA Approval Likely?
The results of the study could prompt FDA by the middle of next year to approve BiDil specifically for African Americans, a move that would represent the "first time the agency approved a drug specifically developed for black patients with a disease that is common in the general population," the Journal reports. In previous studies among African-American and white heart failure patients conducted in the 1980s, BiDil appeared to provide only a small benefit to participants (Wall Street Journal, 11/9). However, according to Jay Cohn, a University of Minnesota professor of medicine who developed BiDil, a later analysis of the studies indicated that the medication appeared to benefit African Americans more than whites. Cohn said that BiDil increases the level of nitric oxide, a substance that protects arteries and is "more absent in blacks than in whites" (Majeski, St. Paul Pioneer Press, 11/9). Michael Loberg, president and CEO of NitroMed, said that the company likely will complete the FDA application process by the end of the year (Wall Street Journal, 11/9).

Reaction
Cohn said, "For African-American patients who have heart failure, this suggests they should all be taking this drug. There seems to be no downside and a remarkable upside" (Lerner, Minneapolis Star Tribune, 11/9). Taylor said, "We followed a trail of evidence suggesting there may be a response. We need to see what else is responsible" for how the medication works. Keith Ferdinand, a New Orleans cardiologist and an author of the study, said that he was "surprised at the mortality benefit" but that race is "a pretty nonspecific marker." He added that factors such as socioeconomic status, culture and diet also could affect the development of heart problems (Pope, New Orleans Times-Picayune, 11/9). In a NEJM commentary that will accompany the study, M. Gregg Bloche of the Georgetown University Law Center wrote that the study should have included all racial groups. Bloche also questioned whether medicine was "moving into an era of race-based therapeutics." Researchers said that some patients from other racial groups likely would benefit from the BiDil (Wall Street Journal, 11/9). Some critics also raised concerns that physicians will prescribe BiDil to African-American patients, regardless of whether the medication is the most effective treatment for them, and others said that the "drug also may help whites and should have been tested on them, but wasn't for business reasons," the AP/Washington Times reports (AP/Washington Times, 11/9). African-American cardiologists "hailed the research," the Pioneer Press reports. However, Augustus Grant, past president of the Association of Black Cardiologists, said, "Here we have a wonderful trial that shows a clear result and the issue is raised, 'Why was this trial only done in African Americans?'" (St. Paul Pioneer Press, 11/9).

Broadcast Coverage

• ABCNews' "World News Tonight": The segment includes comments from Jonathan Kahn, assistant professor of law and bioethicist at Hamline University; Loberg; Clyde Yancy, a heart specialist at University of Texas Southwestern Medical Center; and patients involved in the study (McKenzie, "World News Tonight," ABCNews, 11/8).
  
  
• CBS' "Evening News": The segment includes comments from Patricia King, a law professor at Georgetown University; Taylor; and patients involved in the study (Andrews, "Evening News," CBS, 11/8). The complete segment is available online in RealPlayer.
  
  
• NPR's "Morning Edition": The segment includes comments from Bloche; Georgia Dunston, director of molecular genetics at the National Genome Center at Howard University; Taylor; and Loberg (Prakash, "Morning Edition," NPR, 11/9). The complete segment is available online in RealPlayer.