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Randomized Controlled Trial
. 2006 Jan;27(2):178-86.
doi: 10.1093/eurheartj/ehi687. Epub 2005 Dec 8.

Digoxin and reduction in mortality and hospitalization in heart failure: a comprehensive post hoc analysis of the DIG trial

Ali Ahmed  1 , Michael W Rich, Thomas E Love, Donald M Lloyd-Jones, Inmaculada B Aban, Wilson S Colucci, Kirkwood F Adams, Mihai Gheorghiade
Affiliations
Randomized Controlled Trial

Digoxin and reduction in mortality and hospitalization in heart failure: a comprehensive post hoc analysis of the DIG trial

Ali Ahmed et al. Eur Heart J. 2006 Jan.

Abstract

Aims: To determine the effects of digoxin on all-cause mortality and heart failure (HF) hospitalizations, regardless of ejection fraction, accounting for serum digoxin concentration (SDC).

Methods and results: This comprehensive post-hoc analysis of the randomized controlled Digitalis Investigation Group trial (n=7788) focuses on 5548 patients: 1687 with SDC, drawn randomly at 1 month, and 3861 placebo patients, alive at 1 month. Overall, 33% died and 31% had HF hospitalizations during a 40-month median follow-up. Compared with placebo, SDC 0.5-0.9 ng/mL was associated with lower mortality [29 vs. 33% placebo; adjusted hazard ratio (AHR), 0.77; 95% confidence interval (CI), 0.67-0.89], all-cause hospitalizations (64 vs. 67% placebo; AHR, 0.85; 95% CI, 0.78-0.92) and HF hospitalizations (23 vs. 33% placebo; AHR, 0.62; 95% CI, 0.54-0.72). SDC> or =1.0 ng/mL was associated with lower HF hospitalizations (29 vs. 33% placebo; AHR, 0.68; 95% CI, 0.59-0.79), without any effect on mortality. SDC 0.5-0.9 reduced mortality in a wide spectrum of HF patients and had no interaction with ejection fraction >45% (P=0.834) or sex (P=0.917).

Conclusions: Digoxin at SDC 0.5-0.9 ng/mL reduces mortality and hospitalizations in all HF patients, including those with preserved systolic function. At higher SDC, digoxin reduces HF hospitalization but has no effect on mortality or all-cause hospitalizations.

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Figures

Figure 1
Figure 1
Kaplan-Meier plots for cumulative risk of death due to all causes by serum digoxin concentration (SDC)
Figure 2
Figure 2
Kaplan-Meier plots for cumulative risk of death due to all causes among patients matched by propensity to develop serum digoxin concentrations (SDC) 0.5-0.9 ng/ml and ≥1.0 ng/ml
Figure 3
Figure 3
Kaplan-Meier plots for cumulative risk of hospitalization due to worsening heart failure (HF) by serum digoxin concentration (SDC)
Figure 4
Figure 4
Hazard ratio (95% confidence interval) for all-cause mortality in subgroups of patients with heart failure with serum digoxin concentration 0.5-0.9 ng/dL and placebo (ACE= angiotensin-converting enzyme, CKD= chronic kidney disease, EF= ejection fraction, NYHA= New York Heart Association)
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