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Isosorbide Dinitrate/Hydralazine Combination Improves Survival in African-Americans With Heart Failure and Atrial Fibrillation: Presented at HFSA

By Crina Frincu-Mallos, PhD

WASHINGTON, DC -- September 24, 2007 -- Fixed-dose combined isosorbide dinitrate/hydralazine (FDC I/H) was found to reduce mortality and morbidity in African-American patients at high risk of heart failure, with or without atrial fibrillation (AF), including in elderly patients, researchers reported here at the 11th Annual Scientific Meeting of the Heart Failure Society of America (HFSA).

African American patients with heart failure generally have a higher morbidity and mortality compared to the general heart-failure population. AF compounds the problem of worsening outcome.

Lead investigator Judith E. Mitchell, MD, Assistant Professor of Medicine, and Director, Heart Failure Center, SUNY Downstate Medical Center, New York, New York, United States, and colleagues sought to evaluate the effect of FDC I/H on outcome, with the intention of reducing mortality and increasing quality of life for African-American patients with heart failure. Her team examined patients receiving neurohormonal therapy in the African-American Heart Failure Trial (A-HeFT).

One of the co-investigators on this study, S. William Tam, PhD, Senior Director, Clinical Programs, Nitromed, Inc., Lexington, Massachusetts, United States, stated: "[Patients with AF] are different compared to patients without AF, looking at the baseline characteristics." Indeed, patients with AF are sicker, significantly older (61 years old vs. 56 years old), and generally have lower blood pressure. "In heart failure, lower blood pressure is actually an indication of poor cardiac performance, so it reflects a higher risk of poor outcome," commented Dr. Tam.

A retrospective analysis using standard Kaplan-Meier survival method was performed to compare two subgroups of patients: those with AF (n = 876) and those without AF (n = 174).

The results indicated that, in patients with AF, both systolic blood pressures (124 +- 18 mmHg vs. 127 +- 18 mmHg, P =.044), and diastolic blood pressures (74 +- 11 mmHg vs. 77 +- 10, P =.002) are significantly lower, and brain natriuretic peptide test results are significantly higher (431 +- 443 pg/mL vs. 283 +- 396 pg/mL [P <.001]).

"In this subgroup of subjects with AF, the baseline -- contemporary treatment -- is very good, [with] over 90% of these patients being treated with angiotensin-converting enzymes and/or angiotensin-receptor blockers (P =.055), 83% treated with beta blockers (P =.912), and approximately 40% treated with spironolactone (P =.089)," commented Dr. Tam. The only difference in medication between the two subgroups consisted in the higher use of digitalis by the AF patients (58 vs. 70%, P =.002).

The results of the trial indicated that AF patients had an increased risk of mortality (77% [P =.01]). When comparing the effect of FDC I/H treatment on these patients with AF, the analysis indicated significant benefit: There was a 79% reduction in mortality in this high-risk group (P =.002). "We were able to rescue patients that were at such high risk," said Dr. Tam.

Anne L. Taylor, MD, Professor of Medicine, Associate Dean for Faculty Affairs, Department of Medicine, University of Minnesota, Minneapolis, Minnesota, United States, presented the data obtained from analysing another subgroup of the African-American patient population in this trial: elderly patients (> 65 years). "If you look at the age-related incidences of heart failure, this is clearly a disease of the elderly, with peak incidence at age 75. In fact, each decade after age 50, the prevalence of the disease doubles," explained Dr. Taylor.

"The mortality benefit of the drug was very significant for this elderly subpopulation," concluded Dr. Taylor. "In addition, despite the fact that there were significant baseline characteristic differences between older and younger patients, including differences in the standard-of-care treatment, this therapy was effective in reducing the mortality and morbidity in all patients."

This study was intiated and funded by NitroMed, Inc.


[Presentation title: Atrial Fibrillation and Mortality in Patients Enrolled in the African American Heart Failure Trial. Abstract 208 and Fixed-Dose Combined Isosorbide Dinitrate/Hydralazine Improves Outcomes in Elderly Heart Failure Patients in the African-American Heart Failure Trial. Abstract 214]

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