title: Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial.
abstract: BACKGROUND
  Fixed-dose combination of isosorbide dinitrate and hydralazine (FDC-I/H) reduced mortality by 43% and death or first hospitalization for heart failure (HF) by 37% in the African-American Heart Failure Trial (A-HeFT). Reduction in mortality makes it difficult to determine the effect on hospitalizations unless the analysis adjusts for death as a competing risk.
  
  
  RESULTS
  In A-HeFT, 1050 self-identified black patients with moderate to severe HF were randomized to FDC-I/H or placebo. The effects of FDC-I/H on first and all hospitalizations and 30-day readmission rates were analyzed. Deaths as competing risks were adjusted using Fine-Gray regression and joint models of hospitalizations and mortality. There were 558 all-cause and 251 HF hospitalizations in placebo compared with 435 and 173 hospitalizations in the FDC-I/H group. Adjusting for deaths as a competing risk, the effect of FDC-I/H on the first hospitalization for HF, expressed in hazard ratio (95% confidence interval), was 0.61 (0.47-0.80; P<0.001) and 0.88 (0.72-1.06; P=0.18) on the first all-cause hospitalization. The effect of FDC-I/H on all recurrent hospitalizations for HF was 0.66 (0.52-0.83; P=0.0005), similar to the effect on the first hospitalizations for HF, whereas the effect on all hospitalizations for any cause was 0.75 (0.63-0.91; P=0.003). The 30-day all-cause readmission rate after the first hospitalization for HF was 23.6% (29 of 123) in placebo versus 14.8% (12 of 81) in the FDC-I/H group, but the effect (0.59; 0.30-1.16; P=0.12) in this small subgroup was not significant.
  
  
  CONCLUSIONS
  Treatment with FDC-I/H was associated with a substantial reduction in the first and recurrent HF hospitalizations, and in total all-cause hospitalizations, reducing the total burden of costly and distressing hospitalizations.
  
  
  BACKGROUND
  http://www.clinicaltrials.gov. Unique identifier: NCT00047775.
authors: From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.). anand001@umn.edu.
authors: Inder S
authors: IS
authors: Anand
authors: From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.).
authors: Sithu
authors: S
authors: Win
authors: From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.).
authors: Thomas S
authors: TS
authors: Rector
authors: From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.).
authors: Jay N
authors: JN
authors: Cohn
authors: From the Medicine Service Line (I.S.A., S.W., J.N.C., A.L.T.) and Research Service Line (T.S.R.), VA Medical Center, Minneapolis, MN (I.S.A., T.S.R.); Department of Medicine, University of Minnesota, Minneapolis (I.S.A., S.W., T.S.R., J.N.C.); and Department of Medicine, Columbia University Medical Center, College of Physicians and Surgeons, New York, NY (A.L.T.).
authors: Anne L
authors: AL
authors: Taylor
mesh_terms: D001741:Black or African American; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D006830:Hydralazine / Q000008:administration & dosage*; D007548:Isosorbide Dinitrate / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010359:Patient Readmission / Q000639:trends*; D012008:Recurrence; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D004338:Drug Combinations; C431665:isosorbide-hydralazine combination; D006830:Hydralazine; D007548:Isosorbide Dinitrate
keywords: heart failure; hospitalization; isosorbide dinitrate