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European Heart Journal Advance Access published online on December 8, 2005
European Heart Journal, doi:10.1093/eurheartj/ehi687
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received October 17, 2005
Revised November 14, 2005
Accepted November 25, 2005

Clinical research

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

Ali Ahmed 1 *, Michael W. Rich 2, Thomas E. Love 3, Donald M. Lloyd-Jones 4, Inmaculada B. Aban 5, Wilson S. Colucci 6, Kirkwood F. Adams 7, and Mihai Gheorghiade 4

1 University of Alabama at Birmingham, VA Medical Center, 1530 3rd Avenue South, CH-19, Ste-219, Birmingham, AL35294-2041, USA
2 Washington University, St Louis, MO, USA
3 Case Western Reserve University, Cleveland, OH, USA
4 Northwestern University, Chicago, IL, USA
5 University of Alabama at Birmingham, Birmingham, AL, USA
6 Boston University, Boston, MA, USA
7 University of North Carolina, Chapel Hill, NC, USA

* To whom correspondence should be addressed.
Ali Ahmed, E-mail: aahmed{at}uab.edu


  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 ≥ 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.

Keywords: Digoxin; Heart failure; Preserved systolic function; Diastolic heart failure; Mortality; Hospitalization.
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