The African-American heart failure trial: a new look at old drugs.
Evaluation of: Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. Taylor AL, Zieche S, Yancy C et al.: N. Engl. J. Med. 351, 2049-2057 (2004). The African-American Heart Failure Trial (AHeFT) evaluated the efficacy of a fixed dose combination of isosorbide dinitrate and hyrdalazine compared with placebo in black patients with advanced self-identified heart failure. The study was stopped early by the Data Safety Monitoring Board, after a highly significant mortality benefit (43% reduction in all-cause mortality) was seen in the active treatment arm. Similar improvements were seen in other end points, including hospitalizations for heart failure and quality of life. These data represent a significant advance in the medical management of African-American patients with advanced systolic heart failure. Additionally, the design of the AHeFT study represents a novel approach to the design of clinical trials in heart failure, based on an understanding of the mechanism of action of drugs and the underlying pathophysiology of the disease state in specific patients groups. Future research will be required to assess whether benefits of this drug combination seen in AHeFT can be extended to the wider population of patients with advanced heart failure.
Felker
G Michael
GM
Duke Clinical Research Institute, 2400 Pratt St, Room 0311 Terrace Level, Durham, NC 27705, USA. Michael.felker@duke.edu