Influence of Blood Pressure on the Effectiveness of a Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine in the African-American Heart Failure Trial

Inder Anand, S. William Tam, Thomas S. Rector, Anne L. Taylor, Michael L. Sabolinski, W. Tad Archambault, Kirkwood F. Adams, Adeoye Y. Olukotun, Manuel Worcel, Jay N Cohn

Research output: Contribution to journalArticle

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Abstract

Objectives: This study sought to assess the effect of baseline systolic blood pressure (SBP) and changes in SBP on the effectiveness of treatment with fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) in patients with heart failure (HF). Background: Low SBP is a risk factor for adverse outcomes in patients with HF. However, FDC I/H lowered SBP in the A-HeFT (African-American Heart Failure Trial) and yet prolonged survival. Whether blood pressure (BP) lowering is critical to the efficacy of FDC I/H and whether a low BP limits its effectiveness is unclear. Methods: The effects of FDC I/H on SBP and on mortality and hospitalization were compared in patients with a low or high baseline SBP using multivariable Cox regression models. The interaction between the effect of treatment and baseline SBP was examined. Results: Mean ± SD baseline SBP in all of the patients was 126 ± 18 mm Hg. Patients with baseline SBP equal to or below the median (126 mm Hg) had features of more severe HF. Baseline SBP equal to or below the median was an independent risk factor for death (hazard ratio [HR] 2.09; 95% confidence interval [CI] 1.02 to 4.29) or first hospitalization for HF (HR 1.66; 95% CI 1.18 to 2.34). The FDC I/H treatment reduced BP in patients with SBP above the median but not in patients with SBP below 126 mm Hg. The FDC I/H treatment was associated with a similar decrease in mortality or hospitalization for HF in patients with SBP below the median and above the median. The effects of FDC I/H on mortality alone were also similar. Conclusions: In A-HeFT, patients with lower SBP had a greater risk but a similar relative benefit from the use of FDC I/H as those with higher SBP. The FDC I/H treatment did not reduce SBP in patients with low SBP. An asymptomatic low SBP should not be considered a contraindication to use of FDC I/H in patients with HF.

Original languageEnglish (US)
Pages (from-to)32-39
Number of pages8
JournalJournal of the American College of Cardiology
Volume49
Issue number1
DOIs
StatePublished - Jan 2 2007

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African Americans
Heart Failure
Blood Pressure
isosorbide-hydralazine combination
Hypotension
Hospitalization
Mortality

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Influence of Blood Pressure on the Effectiveness of a Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine in the African-American Heart Failure Trial. / Anand, Inder; Tam, S. William; Rector, Thomas S.; Taylor, Anne L.; Sabolinski, Michael L.; Archambault, W. Tad; Adams, Kirkwood F.; Olukotun, Adeoye Y.; Worcel, Manuel; Cohn, Jay N.

In: Journal of the American College of Cardiology, Vol. 49, No. 1, 02.01.2007, p. 32-39.

Research output: Contribution to journalArticle

Anand, Inder ; Tam, S. William ; Rector, Thomas S. ; Taylor, Anne L. ; Sabolinski, Michael L. ; Archambault, W. Tad ; Adams, Kirkwood F. ; Olukotun, Adeoye Y. ; Worcel, Manuel ; Cohn, Jay N. / Influence of Blood Pressure on the Effectiveness of a Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine in the African-American Heart Failure Trial. In: Journal of the American College of Cardiology. 2007 ; Vol. 49, No. 1. pp. 32-39.
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abstract = "Objectives: This study sought to assess the effect of baseline systolic blood pressure (SBP) and changes in SBP on the effectiveness of treatment with fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) in patients with heart failure (HF). Background: Low SBP is a risk factor for adverse outcomes in patients with HF. However, FDC I/H lowered SBP in the A-HeFT (African-American Heart Failure Trial) and yet prolonged survival. Whether blood pressure (BP) lowering is critical to the efficacy of FDC I/H and whether a low BP limits its effectiveness is unclear. Methods: The effects of FDC I/H on SBP and on mortality and hospitalization were compared in patients with a low or high baseline SBP using multivariable Cox regression models. The interaction between the effect of treatment and baseline SBP was examined. Results: Mean ± SD baseline SBP in all of the patients was 126 ± 18 mm Hg. Patients with baseline SBP equal to or below the median (126 mm Hg) had features of more severe HF. Baseline SBP equal to or below the median was an independent risk factor for death (hazard ratio [HR] 2.09; 95{\%} confidence interval [CI] 1.02 to 4.29) or first hospitalization for HF (HR 1.66; 95{\%} CI 1.18 to 2.34). The FDC I/H treatment reduced BP in patients with SBP above the median but not in patients with SBP below 126 mm Hg. The FDC I/H treatment was associated with a similar decrease in mortality or hospitalization for HF in patients with SBP below the median and above the median. The effects of FDC I/H on mortality alone were also similar. Conclusions: In A-HeFT, patients with lower SBP had a greater risk but a similar relative benefit from the use of FDC I/H as those with higher SBP. The FDC I/H treatment did not reduce SBP in patients with low SBP. An asymptomatic low SBP should not be considered a contraindication to use of FDC I/H in patients with HF.",
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T1 - Influence of Blood Pressure on the Effectiveness of a Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine in the African-American Heart Failure Trial

AU - Anand, Inder

AU - Tam, S. William

AU - Rector, Thomas S.

AU - Taylor, Anne L.

AU - Sabolinski, Michael L.

AU - Archambault, W. Tad

AU - Adams, Kirkwood F.

AU - Olukotun, Adeoye Y.

AU - Worcel, Manuel

AU - Cohn, Jay N

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N2 - Objectives: This study sought to assess the effect of baseline systolic blood pressure (SBP) and changes in SBP on the effectiveness of treatment with fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) in patients with heart failure (HF). Background: Low SBP is a risk factor for adverse outcomes in patients with HF. However, FDC I/H lowered SBP in the A-HeFT (African-American Heart Failure Trial) and yet prolonged survival. Whether blood pressure (BP) lowering is critical to the efficacy of FDC I/H and whether a low BP limits its effectiveness is unclear. Methods: The effects of FDC I/H on SBP and on mortality and hospitalization were compared in patients with a low or high baseline SBP using multivariable Cox regression models. The interaction between the effect of treatment and baseline SBP was examined. Results: Mean ± SD baseline SBP in all of the patients was 126 ± 18 mm Hg. Patients with baseline SBP equal to or below the median (126 mm Hg) had features of more severe HF. Baseline SBP equal to or below the median was an independent risk factor for death (hazard ratio [HR] 2.09; 95% confidence interval [CI] 1.02 to 4.29) or first hospitalization for HF (HR 1.66; 95% CI 1.18 to 2.34). The FDC I/H treatment reduced BP in patients with SBP above the median but not in patients with SBP below 126 mm Hg. The FDC I/H treatment was associated with a similar decrease in mortality or hospitalization for HF in patients with SBP below the median and above the median. The effects of FDC I/H on mortality alone were also similar. Conclusions: In A-HeFT, patients with lower SBP had a greater risk but a similar relative benefit from the use of FDC I/H as those with higher SBP. The FDC I/H treatment did not reduce SBP in patients with low SBP. An asymptomatic low SBP should not be considered a contraindication to use of FDC I/H in patients with HF.

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