Results from the African American Heart Failure Trial (A-HeFT) indicate that African-American patients with heart failure, or end-stage cardiovascular disease, experienced a 43% improvement in survival after taking a new drug combination in addition to standard heart failure therapy, compared with patients receiving standard heart failure therapy plus a placebo. The product, called BiDil® (NitroMed), is a nitric oxide-enhancing, fixed-dose combination of isosorbide dinitrate and hydralazine.
The primary endpoints were a composite score made up of weighted values for death from any cause, a first hospi-talization for heart failure, and a change in quality of life. NitroMed submitted these clinical data to the FDA on November 1, 2004, and plans to file an amended New Drug Application for BiDil® by the end of 2004.
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The mortality rate for the placebo patients was 10.2%; the rate for the treated patients was 6.2%. The treated patients experienced a 33% reduction in first-time hospitalization for heart failure and an improved quality of life.
African-Americans experience a disproportionate incidence of cardiovascular disease, and their rates of heart failure are greater than those of the corresponding non-African-Americans. They also die as a result of the disease at an earlier age.
As reported in the September issue of P&T, the 18-month study enrolled more than 1,000 self-identified African-American patients with New York Heart Association class III and IV heart failure. No patients were lost to follow-up during the study.