TY - JOUR
T1 - Effect of oral digoxin in high-risk heart failure patients
T2 - 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
PY - 2013/5
Y1 - 2013/5
N2 - 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.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 IIIIV 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 IIIIV [hazard ratio (HR) 0.65; 95 confidence interval (CI) 0.570.75; P 0.001], LVEF 25 (HR 0.61; 95 CI 0.530.71; P 0.001), and CTR 55 (HR 0.65; 95 CI 0.570.75; P 0.001). Digoxin-associated HRs (95 CI) for 2-year all-cause mortality or all-cause hospitalization for subgroups with NYHA IIIIV, LVEF 25, and CTR 55 were 0.88 (0.800.97; P 0.012), 0.84 (0.760.93; P 0.001), and 0.85 (0.770.94; P 0.002), respectively.Digoxin improves outcomes in chronic HF patients with NYHA class IIIIV, LVEF 25, or CTR 55, and should be considered in these patients.
AB - 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.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 IIIIV 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 IIIIV [hazard ratio (HR) 0.65; 95 confidence interval (CI) 0.570.75; P 0.001], LVEF 25 (HR 0.61; 95 CI 0.530.71; P 0.001), and CTR 55 (HR 0.65; 95 CI 0.570.75; P 0.001). Digoxin-associated HRs (95 CI) for 2-year all-cause mortality or all-cause hospitalization for subgroups with NYHA IIIIV, LVEF 25, and CTR 55 were 0.88 (0.800.97; P 0.012), 0.84 (0.760.93; P 0.001), and 0.85 (0.770.94; P 0.002), respectively.Digoxin improves outcomes in chronic HF patients with NYHA class IIIIV, LVEF 25, or CTR 55, and should be considered in these patients.
KW - Digoxin
KW - Heart Failure
KW - High risk
KW - Morbidity
KW - Mortality
KW - CONVERTING-ENZYME-INHIBITORS
KW - LOW SERUM CONCENTRATIONS
KW - EJECTION FRACTION
KW - TASK-FORCE
KW - MORTALITY
KW - HOSPITALIZATION
KW - REDUCTION
KW - MORBIDITY
KW - DIGITALIS
KW - ASSOCIATION
U2 - 10.1093/eurjhf/hft010
DO - 10.1093/eurjhf/hft010
M3 - Article
SN - 1388-9842
VL - 15
SP - 551
EP - 559
JO - European Journal of Heart Failure
JF - European Journal of Heart Failure
IS - 5
ER -