Combination of isosorbide dinitrate and hydralazine in blacks with heart failure.
BACKGROUND
We examined whether a fixed dose of both isosorbide dinitrate and hydralazine provides additional benefit in blacks with advanced heart failure, a subgroup previously noted to have a favorable response to this therapy.


METHODS
A total of 1050 black patients who had New York Heart Association class III or IV heart failure with dilated ventricles were randomly assigned to receive a fixed dose of isosorbide dinitrate plus hydralazine or placebo in addition to standard therapy for heart failure. The primary end point was a composite score made up of weighted values for death from any cause, a first hospitalization for heart failure, and change in the quality of life.


RESULTS
The study was terminated early owing to a significantly higher mortality rate in the placebo group than in the group given isosorbide dinitrate plus hydralazine (10.2 percent vs. 6.2 percent, P=0.02). The mean primary composite score was significantly better in the group given isosorbide dinitrate plus hydralazine than in the placebo group (-0.1+/-1.9 vs. -0.5+/-2.0, P=0.01; range of possible values, -6 to +2), as were its individual components (43 percent reduction in the rate of death from any cause [hazard ratio, 0.57; P=0.01] 33 percent relative reduction in the rate of first hospitalization for heart failure [16.4 percent vs. 22.4 percent, P=0.001], and an improvement in the quality of life [change in score, -5.6+/-20.6 vs. -2.7+/-21.2, with lower scores indicating better quality of life; P=0.02; range of possible values, 0 to 105]).


CONCLUSIONS
The addition of a fixed dose of isosorbide dinitrate plus hydralazine to standard therapy for heart failure including neurohormonal blockers is efficacious and increases survival among black patients with advanced heart failure.
Taylor
Anne L
AL
Department of Medicine/Cardiology, University of Minnesota Medical School, Minneapolis 55455, USA. taylo135@umn.edu
Ziesche
Susan
S
Yancy
Clyde
C
Carson
Peter
P
D'Agostino
Ralph
R
Ferdinand
Keith
K
Taylor
Malcolm
M
Adams
Kirkwood
K
Sabolinski
Michael
M
Worcel
Manuel
M
Cohn
Jay N
JN
D000328:Adult; D000368:Aged; D044383:Black People; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology* / Q000401:mortality; D006801:Humans; D006830:Hydralazine / Q000009:adverse effects / Q000627:therapeutic use*; D007548:Isosorbide Dinitrate / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D020030:Nitric Oxide Donors / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
D004338:Drug Combinations; D020030:Nitric Oxide Donors; D014665:Vasodilator Agents; D006830:Hydralazine; D007548:Isosorbide Dinitrate