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Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial.
Circulation. 2007 Apr 03; 115(13):1747-53.Circ

Abstract

BACKGROUND

We previously reported that the fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride (FDC I/H) significantly decreased the risk of all-cause death and first hospitalization for heart failure (HF) and improved quality of life in patients with New York Heart Association class III or IV heart failure in the African-American Heart Failure Trial (A-HeFT). The current analyses further define the effect of FDC I/H on the timing of event-free survival (mortality or first hospitalization for HF) and time to first hospitalization for HF, as well as effects by subgroups and effects on cause-specific mortality.

METHODS AND RESULTS

Kaplan-Meier analyses of the 1050 A-HeFT patients on standard neurohormonal blockade demonstrated that FDC I/H produced a 37% improvement in event-free survival (P<0.001) and a 39% reduction in the risk for first hospitalization for HF (P<0.001). These benefits appeared to emerge early (at approximately 50 days of treatment) and were sustained through the duration of the trial. Subgroup analyses of treatment effect by age, sex, baseline blood pressure, history of chronic renal insufficiency, presence of diabetes mellitus, cause of HF, and baseline medication usage demonstrated consistent beneficial effect of FDC I/H on the primary composite score and event-free survival across all subgroups. Mortality from pump failure was reduced by 75% (P=0.012).

CONCLUSIONS

FDC I/H treatment of black patients with moderate to severe HF who were taking neurohormonal blockers produced early and sustained significant improvement in event-free survival and hospitalization for HF in the A-HeFT cohort, with significant reduction in mortality from cardiovascular and pump failure deaths. The treatment effects on the primary composite end point and event-free survival were consistent across subgroups.

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Authors+Show Affiliations

Taylor AL
Department of Medicine, University of Minnesota, Minneapolis, MN 55455, USA.
Ziesche S
No affiliation info available
Yancy CW
No affiliation info available
Carson P
No affiliation info available
Ferdinand K
No affiliation info available
Taylor M
No affiliation info available
Adams K
No affiliation info available
Olukotun AY
No affiliation info available
Ofili E
No affiliation info available
Tam SW
No affiliation info available
Sabolinski ML
No affiliation info available
Worcel M
No affiliation info available
Cohn JN
No affiliation info available
African-American Heart Failure Trial Investigators
No affiliation info available

MeSH

AdultAfrican AmericansAgedArthralgiaBiomarkersCardiovascular AgentsCause of DeathDisease-Free SurvivalDizzinessDouble-Blind MethodDrug CombinationsHeart FailureHeart TransplantationHospitalizationHumansHydralazineHypotensionIsosorbide DinitrateKaplan-Meier EstimateMiddle AgedMortalityNatriuretic Peptide, BrainNitric Oxide DonorsProportional Hazards ModelsQuality of LifeSurveys and QuestionnairesTreatment OutcomeVasodilator Agents

Pub Type(s)

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

Language

eng

PubMed ID

17372175

Citation

Taylor, Anne L., et al. "Early and Sustained Benefit On Event-free Survival and Heart Failure Hospitalization From Fixed-dose Combination of Isosorbide Dinitrate/hydralazine: Consistency Across Subgroups in the African-American Heart Failure Trial." Circulation, vol. 115, no. 13, 2007, pp. 1747-53.
Taylor AL, Ziesche S, Yancy CW, et al. Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial. Circulation. 2007;115(13):1747-53.
Taylor, A. L., Ziesche, S., Yancy, C. W., Carson, P., Ferdinand, K., Taylor, M., Adams, K., Olukotun, A. Y., Ofili, E., Tam, S. W., Sabolinski, M. L., Worcel, M., & Cohn, J. N. (2007). Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial. Circulation, 115(13), 1747-53.
Taylor AL, et al. Early and Sustained Benefit On Event-free Survival and Heart Failure Hospitalization From Fixed-dose Combination of Isosorbide Dinitrate/hydralazine: Consistency Across Subgroups in the African-American Heart Failure Trial. Circulation. 2007 Apr 3;115(13):1747-53. PubMed PMID: 17372175.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Early and sustained benefit on event-free survival and heart failure hospitalization from fixed-dose combination of isosorbide dinitrate/hydralazine: consistency across subgroups in the African-American Heart Failure Trial. AU - Taylor,Anne L, AU - Ziesche,Susan, AU - Yancy,Clyde W, AU - Carson,Peter, AU - Ferdinand,Keith, AU - Taylor,Malcolm, AU - Adams,Kirkwood, AU - Olukotun,Adeoye Y, AU - Ofili,Elizabeth, AU - Tam,S William, AU - Sabolinski,Michael L, AU - Worcel,Manuel, AU - Cohn,Jay N, AU - ,, Y1 - 2007/03/19/ PY - 2007/3/21/pubmed PY - 2007/4/24/medline PY - 2007/3/21/entrez SP - 1747 EP - 53 JF - Circulation JO - Circulation VL - 115 IS - 13 N2 - BACKGROUND: We previously reported that the fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride (FDC I/H) significantly decreased the risk of all-cause death and first hospitalization for heart failure (HF) and improved quality of life in patients with New York Heart Association class III or IV heart failure in the African-American Heart Failure Trial (A-HeFT). The current analyses further define the effect of FDC I/H on the timing of event-free survival (mortality or first hospitalization for HF) and time to first hospitalization for HF, as well as effects by subgroups and effects on cause-specific mortality. METHODS AND RESULTS: Kaplan-Meier analyses of the 1050 A-HeFT patients on standard neurohormonal blockade demonstrated that FDC I/H produced a 37% improvement in event-free survival (P<0.001) and a 39% reduction in the risk for first hospitalization for HF (P<0.001). These benefits appeared to emerge early (at approximately 50 days of treatment) and were sustained through the duration of the trial. Subgroup analyses of treatment effect by age, sex, baseline blood pressure, history of chronic renal insufficiency, presence of diabetes mellitus, cause of HF, and baseline medication usage demonstrated consistent beneficial effect of FDC I/H on the primary composite score and event-free survival across all subgroups. Mortality from pump failure was reduced by 75% (P=0.012). CONCLUSIONS: FDC I/H treatment of black patients with moderate to severe HF who were taking neurohormonal blockers produced early and sustained significant improvement in event-free survival and hospitalization for HF in the A-HeFT cohort, with significant reduction in mortality from cardiovascular and pump failure deaths. The treatment effects on the primary composite end point and event-free survival were consistent across subgroups. SN - 1524-4539 UR - https://www.unboundmedicine.com/medline/citation/17372175/Early_and_sustained_benefit_on_event_free_survival_and_heart_failure_hospitalization_from_fixed_dose_combination_of_isosorbide_dinitrate/hydralazine:_consistency_across_subgroups_in_the_African_American_Heart_Failure_Trial_ L2 - http://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.106.644013?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -