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Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial.
Eur J Heart Fail 2013; 15(5):551-9EJ

Abstract

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.

Authors+Show Affiliations

Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23355060

Citation

Gheorghiade, Mihai, et al. "Effect of Oral Digoxin in High-risk Heart Failure Patients: a Pre-specified Subgroup Analysis of the DIG Trial." European Journal of Heart Failure, vol. 15, no. 5, 2013, pp. 551-9.
Gheorghiade M, Patel K, Filippatos G, 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;15(5):551-9.
Gheorghiade, M., Patel, K., Filippatos, G., Anker, S. D., van Veldhuisen, D. J., Cleland, J. G., ... Ahmed, A. (2013). Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial. European Journal of Heart Failure, 15(5), pp. 551-9. doi:10.1093/eurjhf/hft010.
Gheorghiade M, 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;15(5):551-9. PubMed PMID: 23355060.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial. AU - Gheorghiade,Mihai, AU - Patel,Kanan, AU - Filippatos,Gerasimos, AU - Anker,Stefan D, AU - van Veldhuisen,Dirk J, AU - Cleland,John G F, AU - Metra,Marco, AU - Aban,Inmaculada B, AU - Greene,Stephen J, AU - Adams,Kirkwood F, AU - McMurray,John J V, AU - Ahmed,Ali, Y1 - 2013/01/25/ PY - 2013/1/29/entrez PY - 2013/1/29/pubmed PY - 2013/12/16/medline SP - 551 EP - 9 JF - European journal of heart failure JO - Eur. J. Heart Fail. VL - 15 IS - 5 N2 - 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. SN - 1879-0844 UR - https://www.unboundmedicine.com/medline/citation/23355060/Effect_of_oral_digoxin_in_high_risk_heart_failure_patients:_a_pre_specified_subgroup_analysis_of_the_DIG_trial_ L2 - https://doi.org/10.1093/eurjhf/hft010 DB - PRIME DP - Unbound Medicine ER -