Effect of oral digoxin in high-risk heart failure patients: a pre-specified subgroup analysis of the DIG trial.
Pubmed ID: 23355060
Pubmed Central ID: PMC3707428
Journal: European journal of heart failure
Publication Date: 05/01/2013
Affiliation: Center for Cardiovascular Innovation, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
MeSH Terms: Humans, Male, Female, Aged, Risk Factors, Middle Aged, Heart Failure, Hospitalization, Treatment Outcome, Follow-Up Studies, Cardiotonic Agents, Double-Blind Method, Digoxin, Administration, Oral
Authors: Ahmed A, Gheorghiade M, Anker SD, Aban IB, Filippatos G, Adams KF, Patel K, McMurray JJ, Cleland JG, van Veldhuisen DJ, Metra M, Greene SJ
Cite As: Gheorghiade M, Patel K, Filippatos G, Anker SD, van Veldhuisen DJ, Cleland JG, Metra M, Aban IB, Greene SJ, Adams KF, McMurray JJ, 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):551-9. Epub 2013 Jan 25.
- Digitalis Investigation Group (DIG)
- Systolic Blood Pressure Intervention Trial (SPRINT)
- Systolic Blood Pressure Intervention Trial Primary Outcome Paper (SPRINT-POP) Data
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.