title: Combination of isosorbide dinitrate and hydralazine in blacks with heart failure.
abstract: 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.
authors.affiliation: Department of Medicine/Cardiology, University of Minnesota Medical School, Minneapolis 55455, USA. taylo135@umn.edu
authors.forename: Anne L
authors.initials: AL
authors.lastname: Taylor
authors.forename: Susan
authors.initials: S
authors.lastname: Ziesche
authors.forename: Clyde
authors.initials: C
authors.lastname: Yancy
authors.forename: Peter
authors.initials: P
authors.lastname: Carson
authors.forename: Ralph
authors.initials: R
authors.lastname: D'Agostino
authors.forename: Keith
authors.initials: K
authors.lastname: Ferdinand
authors.forename: Malcolm
authors.initials: M
authors.lastname: Taylor
authors.forename: Kirkwood
authors.initials: K
authors.lastname: Adams
authors.forename: Michael
authors.initials: M
authors.lastname: Sabolinski
authors.forename: Manuel
authors.initials: M
authors.lastname: Worcel
authors.forename: Jay N
authors.initials: JN
authors.lastname: Cohn
mesh_terms: 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*
chemical_list: D004338:Drug Combinations; D020030:Nitric Oxide Donors; D014665:Vasodilator Agents; D006830:Hydralazine; D007548:Isosorbide Dinitrate