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Effect of oral digoxin in high-risk heart failure patients: A pre-specified subgroup analysis of the DIG trial
Gheorghiade, Mihai Patel, Kanan Filippatos, Gerasimos S. Anker, Stefan D. van Veldhuisen, Dirk J. Cleland, John G. F. Metra, Marco Aban, Inmaculada B. Greene, Stephen J. Adams, Kirkwood F.
Gheorghiade, Mihai
Patel, Kanan
Filippatos, Gerasimos S.
Anker, Stefan D.
van Veldhuisen, Dirk J.
Cleland, John G. F.
Metra, Marco
Aban, Inmaculada B.
Greene, Stephen J.
Adams, Kirkwood F.
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.
Keywords
digoxin, heart failure, high risk, morbidity, mortality
Date
2013
Type
Journal article
Journal
European Journal of Heart Failure
Book
Volume
15
Issue
5
Page Range
551-559
Article Number
ACU Department
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Relation URI
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Event URL
Open Access Status
License
File Access
Controlled