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Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial.

Publication ,  Journal Article
Gheorghiade, M; Patel, K; Filippatos, G; Anker, SD; van Veldhuisen, DJ; Cleland, JGF; Metra, M; Aban, IB; Greene, SJ; Adams, KF; McMurray, JJV ...
Published in: Eur J Heart Fail
May 2013

AIMS: In the Digitalis Investigation Group (DIG) trial, digoxin reduced mortality or hospitalization due to heart failure (HF) in several pre-specified high-risk subgroups of HF patients, but data on protocol-specified 2-year outcomes were not presented. In the current study, we examined the effect of digoxin on HF death or HF hospitalization and all-cause death or all-cause hospitalization in high-risk subgroups during the protocol-specified 2 years of post-randomization follow-up. METHODS AND RESULTS: In the DIG trial, 6800 ambulatory patients with chronic HF, normal sinus rhythm, and LVEF ≤45% (mean age 64 years, 26% women, 17% non-whites) were randomized to receive digoxin or placebo. The three high-risk groups were defined as NYHA class III-IV symptoms (n = 2223), LVEF <25% (n = 2256), and cardiothoracic ratio (CTR) >55% (n = 2345). In all three high-risk subgroups, compared with patients in the placebo group, those in the digoxin group had a significant reduction in the risk of the 2-year composite endpoint of HF mortality or HF hospitalization: NYHA III-IV [hazard ratio (HR) 0.65; 95% confidence interval (CI) 0.57-0.75; P < 0.001], LVEF <25% (HR 0.61; 95% CI 0.53-0.71; P < 0.001), and CTR >55% (HR 0.65; 95% CI 0.57-0.75; P < 0.001). Digoxin-associated HRs (95% CI) for 2-year all-cause mortality or all-cause hospitalization for subgroups with NYHA III-IV, LVEF <25%, and CTR >55% were 0.88 (0.80-0.97; P = 0.012), 0.84 (0.76-0.93; P = 0.001), and 0.85 (0.77-0.94; P = 0.002), respectively. CONCLUSIONS: Digoxin improves outcomes in chronic HF patients with NYHA class III-IV, LVEF <25%, or CTR >55%, and should be considered in these patients.

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Published In

Eur J Heart Fail

DOI

EISSN

1879-0844

Publication Date

May 2013

Volume

15

Issue

5

Start / End Page

551 / 559

Location

England

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Heart Failure
  • Follow-Up Studies
  • Female
  • Double-Blind Method
 

Citation

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Gheorghiade, M., Patel, K., Filippatos, G., Anker, S. D., van Veldhuisen, D. J., Cleland, J. G. F., … Ahmed, A. (2013). Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial. Eur J Heart Fail, 15(5), 551–559. https://doi.org/10.1093/eurjhf/hft010
Gheorghiade, Mihai, Kanan Patel, Gerasimos Filippatos, Stefan D. Anker, Dirk J. van Veldhuisen, John G. F. Cleland, Marco Metra, et al. “Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial.Eur J Heart Fail 15, no. 5 (May 2013): 551–59. https://doi.org/10.1093/eurjhf/hft010.
Gheorghiade M, Patel K, Filippatos G, Anker SD, van Veldhuisen DJ, Cleland JGF, et al. Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial. Eur J Heart Fail. 2013 May;15(5):551–9.
Gheorghiade, Mihai, et al. “Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial.Eur J Heart Fail, vol. 15, no. 5, May 2013, pp. 551–59. Pubmed, doi:10.1093/eurjhf/hft010.
Gheorghiade M, Patel K, Filippatos G, Anker SD, van Veldhuisen DJ, Cleland JGF, Metra M, Aban IB, Greene SJ, Adams KF, McMurray JJV, Ahmed A. Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial. Eur J Heart Fail. 2013 May;15(5):551–559.
Journal cover image

Published In

Eur J Heart Fail

DOI

EISSN

1879-0844

Publication Date

May 2013

Volume

15

Issue

5

Start / End Page

551 / 559

Location

England

Related Subject Headings

  • Treatment Outcome
  • Risk Factors
  • Middle Aged
  • Male
  • Humans
  • Hospitalization
  • Heart Failure
  • Follow-Up Studies
  • Female
  • Double-Blind Method