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J Am Coll Cardiol, 2007; 49:32-39, doi:10.1016/j.jacc.2006.04.109 (Published online 13 December 2006).
© 2007 by the American College of Cardiology Foundation
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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

Inder S. Anand, MD, FACC, FRCP, DPhil (Oxon)*,{dagger},*, S. William Tam, PhD{ddagger},1, Thomas S. Rector, PhD*,3, Anne L. Taylor, MD, FACC{dagger}, Michael L. Sabolinski, MD{ddagger},1, W. Tad Archambault, PhD§, Kirkwood F. Adams, MD||, Adeoye Y. Olukotun, MD§, Manuel Worcel, MD{ddagger},1 and Jay N. Cohn, MD, FACC{dagger},2

* VA Medical Center, Minneapolis, Minnesota
{dagger} University of Minnesota, Minneapolis, Minnesota
{ddagger} NitroMed, Inc., Lexington, Massachusetts
§ Virtu Stat, Ltd., North Wales, Pennsylvania
|| University of North Carolina, Chapel Hill, North Carolina
CR Strategies, LLC, Princeton, New Jersey.


Figure 1
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Figure 1 Effect of Baseline SBP on Mortality and Morbidity

Kaplan-Meier curves for mortality (left) and for mortality or the first hospitalization for heart failure (right), by quartiles of baseline systolic blood pressure (SBP).

 

Figure 2
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Figure 2 Effect of FDC I/H Treatment on Mortality and Morbidity by Median Baseline SBP

Effectiveness of fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) treatment on mortality and morbidity in patients above or below the median baseline systolic blood pressure (SBP) shown as point estimates of the hazard ratios (HR) with 95% confidence intervals (CI). HF = heart failure.

 

Figure 3
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Figure 3 Time Course of Mean SBP and DBP Change in the Placebo and FDC I/H Groups

Note that blood pressure decreased in the active treatment group soon after starting treatment, with no further change in blood pressure over time. The p values compare changes between treatment groups: *p < 0.05; **p < 0.01. DBP = diastolic blood pressure; FDC I/H = fixed-dose combination of isosorbide dinitrate and hydralazine; SBP = systolic blood pressure.

 

Figure 4
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Figure 4 Change in Mean SBP in Baseline SBP Quartiles and in Baseline SBP ≤100 mm Hg

In the fixed-dose combination of isosorbide dinitrate and hydralazine (FDC I/H) group, blood pressure (BP) decreased in the 2 highest systolic blood pressure (SBP) quartiles and increased in the lowest SBP quartile and in subjects with baseline systolic BP ≤100 mm Hg, but did not change in the second lowest SBP quartile. There were 79 subjects with baseline systolic BP ≤100 mm Hg (mean SBP in FDC I/H group 95.0 ± 5.0 mm Hg, n = 31, and in placebo group 95 ± 5.4 mm Hg, n = 48). The p values compare changes between treatment groups: *p < 0.05; **p < 0.01.

 




 
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