Document Detail

Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis.
MedLine Citation:
PMID:  16053964     Owner:  NLM     Status:  MEDLINE    
OBJECTIVES: The purpose of this study was to investigate the relationship of serum digoxin concentration (SDC) and outcomes in women with heart failure (HF). BACKGROUND: Controversy continues concerning the clinical utility of digoxin in women with HF. METHODS: Our analysis was retrospective with data from the Digitalis Investigation Group (DIG) trial. The principal study analysis reviewed 4,944 patients with HF due to systolic dysfunction who survived for at least 4 weeks (all 3,366 patients randomized to placebo and the 1,578 of 3,372 patients randomized to digoxin who had serum concentration measured 6 to 30 h [inclusive] after the last dose of study drug at 4 weeks). RESULTS: Continuous multivariable analysis demonstrated a significant linear relationship between SDC and mortality in women (p = 0.008) and men (p = 0.002, p = 0.766 for gender interaction). Averaging hazard ratios (HRs) across serum concentrations from 0.5 to 0.9 ng/ml in women produced a HR for death of 0.8 (95% confidence interval [CI] 0.62 to 1.13, p = 0.245) and for death or hospital stay for worsening HF of 0.73 (95% CI 0.58 to 0.93, p = 0.011). In contrast, SDCs from 1.2 to 2.0 ng/ml were associated with a HR for death for women of 1.33 (95% CI 1.001 to 1.76, p = 0.049). CONCLUSIONS: Retrospective analysis of data from the DIG trial indicates a beneficial effect of digoxin on morbidity and no excess mortality in women at serum concentrations from 0.5 to 0.9 ng/ml, whereas serum concentrations > or =1.2 ng/ml seem harmful.
Kirkwood F Adams; J Herbert Patterson; Wendy A Gattis; Christopher M O'Connor; Craig R Lee; Todd A Schwartz; Mihai Gheorghiade
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Publication Detail:
Type:  Comparative Study; Journal Article; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  Journal of the American College of Cardiology     Volume:  46     ISSN:  0735-1097     ISO Abbreviation:  J. Am. Coll. Cardiol.     Publication Date:  2005 Aug 
Date Detail:
Created Date:  2005-08-01     Completed Date:  2005-08-30     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  8301365     Medline TA:  J Am Coll Cardiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  497-504     Citation Subset:  AIM; IM    
Department of Medicine and Radiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27517, USA.
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MeSH Terms
Age Factors
Biological Availability
Cardiotonic Agents / pharmacokinetics,  therapeutic use*
Confidence Intervals
Digoxin / pharmacokinetics*,  therapeutic use*
Dose-Response Relationship, Drug
Drug Administration Schedule
Heart Failure / diagnosis,  drug therapy*,  mortality*
Maximum Tolerated Dose
Middle Aged
Multivariate Analysis
Proportional Hazards Models
Retrospective Studies
Risk Assessment
Severity of Illness Index
Survival Analysis
Treatment Outcome
Reg. No./Substance:
0/Cardiotonic Agents; 20830-75-5/Digoxin
Comment In:
J Am Coll Cardiol. 2005 Aug 2;46(3):505-7   [PMID:  16053965 ]

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