AFRICAN AMERICANS AND HEART FAILURE

Heart failure-or end-stage cardiovascular disease-affects approximately five million Americans. There is no cure for this disease and more than 50% of patients die within five years of diagnosis. African Americans suffer a disproportionate incidence of cardiovascular disease. With respect to heart failure, they are affected at a rate almost twice the rate of the corresponding white population and are more likely to die from it. This dramatic ethnic difference in health outcomes has been attributed to a variety of factors, including access to medical care, management of heart failure and socioeconomic factors. Recent analyses of heart failure clinical trials, however, show that the mortality rate and the hospitalization rate for African Americans is significantly higher than for non-African Americans, even after adjustment for such factors. Based on data from the United States census bureau and the Centers for Disease Control, we estimate that 750,000 African Americans have been diagnosed with heart failure, and we expect this number to grow to approximately 900,000 persons by 2010.

African Americans may also be more vulnerable to heart failure because some medicines approved for use in heart failure appear in certain clinical studies to be less effective in African-American patients. These ethnic differences are documented in FDA-required product package inserts, including:

• the package insert for enalapril, known commercially as Vasotec, an angiotensin converting enzyme inhibitor, or ACE inhibitor, which states ''it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to non-blacks.''
   
• the package insert for losartan, known commercially as Cozaar, an angiotensin receptor blocker, which states ''...the LIFE study provides no evidence that the benefits of Cozaar on reducing the risk of cardiovascular events in hypertensive patients with left ventricular hypertrophy apply to Black patients'' and also notes ''this finding could not be explained on the basis of differences in the populations other than race.''

While BiDil® may be of benefit to the general heart failure population, several factors lead us to believe BiDil has the potential to be particularly successful in African-American heart failure patients. Specifically:

• African-American heart failure patients are disproportionately over-represented in the North American heart failure population
   
• existing therapies for heart failure may not work as effectively in African Americans
   
• BiDil's mechanism of action is intended to address the nitric oxide deficiency we believe to be associated with heart failure in African Americans; and
   
• a retrospective analysis of a completed heart failure study in the general population using the components of BiDil suggests that BiDil's components may have efficacy in African-American patients.