Relationship of Serum Digoxin Concentration to Mortality and Morbidity in Women in the Digitalis Investigation Group Trial
A Retrospective Analysis
Kirkwood F. Adams, Jr, MD, FACC*,*,
J. Herbert Patterson, PharmD ,
Wendy A. Gattis, PharmD ,
Christopher M. O’Connor, MD, FACC,
Craig R. Lee, PharmD,
Todd A. Schwartz, DrPH and
Mihai Gheorghiade, MD, FACC||
* Department of Medicine and Radiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Department of Biostatistics, School of Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina
Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina
|| Department of Medicine, Northwestern University Medical School, Chicago, Illinois.
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Figure 1 Diagram that shows the relationship between the original study population in the Digoxin Investigation Group (DIG) trial and the patients analyzed in the present study. LVEF = left ventricular ejection fraction.
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Figure 2 Plot of the adjusted point estimates and 95% confidence intervals of women and men for the hazard ratio for death on digoxin versus placebo at various serum digoxin concentrations (ng/ml) with concentration modeled as a continuous variable. The 95% confidence intervals for the women are offset to allow better depiction of results.
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Figure 3 Plot of adjusted survival curves in placebo and various digoxin serum concentration groups. Results from this categorical analysis demonstrated that women with serum concentrations from 0.5 to 0.9 ng/ml had similar survival compared with those receiving placebo (hazard ratio 0.81, with 95% confidence interval from 0.58 to 1.14, p = 0.229), whereas women with serum concentrations from 1.2 to 2.0 ng/ml seemed to have a worse outcome (hazard ratio 1.11, with 95% confidence interval from 0.78 to 1.60, p = 0.557). SDC = serum digoxin concentration.
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Figure 4 Plot of the adjusted point estimates and 95% confidence intervals of women and men for the hazard ratio for the combined study end point (of all-cause mortality or first hospitalization due to worsening heart failure) on digoxin versus placebo at various serum digoxin concentrations (ng/ml) with concentration modeled as a continuous variable. The 95% confidence intervals for the women are offset to allow better depiction of results.
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