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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.
Circ Heart Fail. 2014 Sep; 7(5):759-65.CH

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.

METHODS AND 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.

CLINICAL TRIAL REGISTRATION URL

http://www.clinicaltrials.gov. Unique identifier: NCT00047775.

Authors+Show Affiliations

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.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.).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.).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.).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.).

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

24970468

Citation

Anand, Inder S., et al. "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." Circulation. Heart Failure, vol. 7, no. 5, 2014, pp. 759-65.
Anand IS, Win S, Rector TS, et al. 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. Circ Heart Fail. 2014;7(5):759-65.
Anand, I. S., Win, S., Rector, T. S., Cohn, J. N., & Taylor, A. L. (2014). 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. Circulation. Heart Failure, 7(5), 759-65. https://doi.org/10.1161/CIRCHEARTFAILURE.114.001360
Anand IS, et al. 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. Circ Heart Fail. 2014;7(5):759-65. PubMed PMID: 24970468.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Anand,Inder S, AU - Win,Sithu, AU - Rector,Thomas S, AU - Cohn,Jay N, AU - Taylor,Anne L, Y1 - 2014/06/26/ PY - 2014/6/28/entrez PY - 2014/6/28/pubmed PY - 2014/11/19/medline KW - heart failure KW - hospitalization KW - isosorbide dinitrate SP - 759 EP - 65 JF - Circulation. Heart failure JO - Circ Heart Fail VL - 7 IS - 5 N2 - 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. METHODS AND 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. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00047775. SN - 1941-3297 UR - https://www.unboundmedicine.com/medline/citation/24970468/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_ L2 - https://www.ahajournals.org/doi/10.1161/CIRCHEARTFAILURE.114.001360?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -