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Effect of oral digoxin in high‐risk heart failure patients: a pre‐specified subgroup analysis of the DIG trial
Author(s) -
Gheorghiade Mihai,
Patel Kanan,
Filippatos Gerasimos,
Anker Stefan D.,
Veldhuisen Dirk J.,
Cleland John G.F.,
Metra Marco,
Aban Inmaculada B.,
Greene Stephen J.,
Adams Kirkwood F.,
McMurray John J.V.,
Ahmed Ali
Publication year - 2013
Publication title -
european journal of heart failure
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 5.149
H-Index - 133
eISSN - 1879-0844
pISSN - 1388-9842
DOI - 10.1093/eurjhf/hft010
Subject(s) - medicine , digoxin , heart failure , dig , subgroup analysis , cardiology , meta analysis , world wide web , computer science
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.