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Effects of ACE inhibitors or beta-blockers in patients treated with the fixed-dose combination of isosorbide dinitrate/hydralazine in the African-American Heart Failure Trial.
Am J Cardiovasc Drugs. 2007; 7(5):373-80.AJ

Abstract

BACKGROUND

In the A-HeFT (African-American Heart Failure Trial), treatment of African-American patients with New York Heart Association (NYHA) class III/IV heart failure (HF) with fixed-dose combination (FDC) of isosorbide dinitrate/hydralazine (I/H) reduced mortality and morbidity and improved patient reported functional status compared with standard therapy alone.

OBJECTIVE

To examine the benefit of FDC I/H in subgroups based on baseline drug therapy and to investigate whether ACE inhibitors and/or angiotensin receptor antagonists (angiotensin receptor blockers) [ARBs] or beta-adrenoceptor antagonists (beta-blockers) provided additional benefit in FDC I/H-treated African-American patients with HF.

STUDY DESIGN

The A-HeFT was a double-blind, placebo-controlled study enrolling 1050 patients stabilized on optimal HF therapies and with NYHA class III/IV HF with systolic dysfunction conducted during the years 2001-4 with up to 18 months follow-up. The primary endpoint was a composite of mortality, first HF hospitalization, and improvement of quality of life at 6 months. Secondary endpoints included mortality, hospitalizations, and change in quality of life. Prospective Kaplan-Meier survival analyses were used for differences between FDC I/H and placebo groups and retrospective analyses were conducted within FDC I/H-treated and placebo groups.

RESULTS

Subgroup analysis for mortality, event-free survival (death or first HF hospitalization), and HF hospitalization showed that FDC I/H, compared with placebo, was effective with or without ACE inhibitors or beta-blockers or other standard medications with all-point estimates favoring the FDC I/H group. Within the placebo-treated group, beta-blockers or ACE inhibitors and/or ARBs were efficacious in improving survival (hazard ratio [HR] 0.33; p<0.0001 for [beta]-blocker use and HR 0.39; p=0.01 for ACE inhibitor and/or ARB use). However, within the FDC I/H-treated group, use of beta-blockers, but not ACE inhibitors and/or ARBs, provided additional significant benefit for survival (HR 0.44; p=0.029 and HR 0.60; p=0.34, respectively), event-free survival (HR 0.62; p=0.034 and HR 0.72; p=0.29, respectively) and the composite score of death, HF hospitalization and change in quality of life (p=0.016 and p=0.13, respectively).

CONCLUSION

Based on the analysis of baseline medication use in the A-HeFT, FDC I/H was superior to placebo with or without beta-blockers or ACE inhibitor. However, beta-blockers but not ACE inhibitors and/or ARBs provided additional significant benefit in African-Americans with HF treated with FDC I/H. These analyses are hypotheses generating and their confirmation in clinical trials needs to be considered.

Authors+Show Affiliations

University Health Center, Wayne State University, Detroit, MI 48201, USA. jghali@med.wayne.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18041162

Citation

Ghali, Jalal K., et al. "Effects of ACE Inhibitors or Beta-blockers in Patients Treated With the Fixed-dose Combination of Isosorbide Dinitrate/hydralazine in the African-American Heart Failure Trial." American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions, vol. 7, no. 5, 2007, pp. 373-80.
Ghali JK, Tam SW, Ferdinand KC, et al. Effects of ACE inhibitors or beta-blockers in patients treated with the fixed-dose combination of isosorbide dinitrate/hydralazine in the African-American Heart Failure Trial. Am J Cardiovasc Drugs. 2007;7(5):373-80.
Ghali, J. K., Tam, S. W., Ferdinand, K. C., Lindenfeld, J., Sabolinski, M. L., Taylor, A. L., Worcel, M., Curry, C. L., & Cohn, J. N. (2007). Effects of ACE inhibitors or beta-blockers in patients treated with the fixed-dose combination of isosorbide dinitrate/hydralazine in the African-American Heart Failure Trial. American Journal of Cardiovascular Drugs : Drugs, Devices, and Other Interventions, 7(5), 373-80.
Ghali JK, et al. Effects of ACE Inhibitors or Beta-blockers in Patients Treated With the Fixed-dose Combination of Isosorbide Dinitrate/hydralazine in the African-American Heart Failure Trial. Am J Cardiovasc Drugs. 2007;7(5):373-80. PubMed PMID: 18041162.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of ACE inhibitors or beta-blockers in patients treated with the fixed-dose combination of isosorbide dinitrate/hydralazine in the African-American Heart Failure Trial. AU - Ghali,Jalal K, AU - Tam,S William, AU - Ferdinand,Keith C, AU - Lindenfeld,JoAnn, AU - Sabolinski,Michael L, AU - Taylor,Anne L, AU - Worcel,Manuel, AU - Curry,Charles L, AU - Cohn,Jay N, AU - ,, PY - 2007/11/29/pubmed PY - 2008/4/2/medline PY - 2007/11/29/entrez SP - 373 EP - 80 JF - American journal of cardiovascular drugs : drugs, devices, and other interventions JO - Am J Cardiovasc Drugs VL - 7 IS - 5 N2 - BACKGROUND: In the A-HeFT (African-American Heart Failure Trial), treatment of African-American patients with New York Heart Association (NYHA) class III/IV heart failure (HF) with fixed-dose combination (FDC) of isosorbide dinitrate/hydralazine (I/H) reduced mortality and morbidity and improved patient reported functional status compared with standard therapy alone. OBJECTIVE: To examine the benefit of FDC I/H in subgroups based on baseline drug therapy and to investigate whether ACE inhibitors and/or angiotensin receptor antagonists (angiotensin receptor blockers) [ARBs] or beta-adrenoceptor antagonists (beta-blockers) provided additional benefit in FDC I/H-treated African-American patients with HF. STUDY DESIGN: The A-HeFT was a double-blind, placebo-controlled study enrolling 1050 patients stabilized on optimal HF therapies and with NYHA class III/IV HF with systolic dysfunction conducted during the years 2001-4 with up to 18 months follow-up. The primary endpoint was a composite of mortality, first HF hospitalization, and improvement of quality of life at 6 months. Secondary endpoints included mortality, hospitalizations, and change in quality of life. Prospective Kaplan-Meier survival analyses were used for differences between FDC I/H and placebo groups and retrospective analyses were conducted within FDC I/H-treated and placebo groups. RESULTS: Subgroup analysis for mortality, event-free survival (death or first HF hospitalization), and HF hospitalization showed that FDC I/H, compared with placebo, was effective with or without ACE inhibitors or beta-blockers or other standard medications with all-point estimates favoring the FDC I/H group. Within the placebo-treated group, beta-blockers or ACE inhibitors and/or ARBs were efficacious in improving survival (hazard ratio [HR] 0.33; p<0.0001 for [beta]-blocker use and HR 0.39; p=0.01 for ACE inhibitor and/or ARB use). However, within the FDC I/H-treated group, use of beta-blockers, but not ACE inhibitors and/or ARBs, provided additional significant benefit for survival (HR 0.44; p=0.029 and HR 0.60; p=0.34, respectively), event-free survival (HR 0.62; p=0.034 and HR 0.72; p=0.29, respectively) and the composite score of death, HF hospitalization and change in quality of life (p=0.016 and p=0.13, respectively). CONCLUSION: Based on the analysis of baseline medication use in the A-HeFT, FDC I/H was superior to placebo with or without beta-blockers or ACE inhibitor. However, beta-blockers but not ACE inhibitors and/or ARBs provided additional significant benefit in African-Americans with HF treated with FDC I/H. These analyses are hypotheses generating and their confirmation in clinical trials needs to be considered. SN - 1175-3277 UR - https://www.unboundmedicine.com/medline/citation/18041162/Effects_of_ACE_inhibitors_or_beta_blockers_in_patients_treated_with_the_fixed_dose_combination_of_isosorbide_dinitrate/hydralazine_in_the_African_American_Heart_Failure_Trial_ L2 - https://dx.doi.org/10.2165/00129784-200707050-00007 DB - PRIME DP - Unbound Medicine ER -