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Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis.
J Am Coll Cardiol 2005; 46(3):497-504JACC

Abstract

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.

Authors+Show Affiliations

Department of Medicine and Radiology, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27517, USA. kfa@med.unc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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.

Language

eng

PubMed ID

16053964

Citation

Adams, Kirkwood F., et al. "Relationship of Serum Digoxin Concentration to Mortality and Morbidity in Women in the Digitalis Investigation Group Trial: a Retrospective Analysis." Journal of the American College of Cardiology, vol. 46, no. 3, 2005, pp. 497-504.
Adams KF, Patterson JH, Gattis WA, et al. Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. J Am Coll Cardiol. 2005;46(3):497-504.
Adams, K. F., Patterson, J. H., Gattis, W. A., O'Connor, C. M., Lee, C. R., Schwartz, T. A., & Gheorghiade, M. (2005). Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. Journal of the American College of Cardiology, 46(3), pp. 497-504.
Adams KF, et al. Relationship of Serum Digoxin Concentration to Mortality and Morbidity in Women in the Digitalis Investigation Group Trial: a Retrospective Analysis. J Am Coll Cardiol. 2005 Aug 2;46(3):497-504. PubMed PMID: 16053964.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Relationship of serum digoxin concentration to mortality and morbidity in women in the digitalis investigation group trial: a retrospective analysis. AU - Adams,Kirkwood F,Jr AU - Patterson,J Herbert, AU - Gattis,Wendy A, AU - O'Connor,Christopher M, AU - Lee,Craig R, AU - Schwartz,Todd A, AU - Gheorghiade,Mihai, PY - 2004/11/12/received PY - 2005/02/08/revised PY - 2005/02/14/accepted PY - 2005/8/2/pubmed PY - 2005/9/1/medline PY - 2005/8/2/entrez SP - 497 EP - 504 JF - Journal of the American College of Cardiology JO - J. Am. Coll. Cardiol. VL - 46 IS - 3 N2 - 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. SN - 0735-1097 UR - https://www.unboundmedicine.com/medline/citation/16053964/Relationship_of_serum_digoxin_concentration_to_mortality_and_morbidity_in_women_in_the_digitalis_investigation_group_trial:_a_retrospective_analysis_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0735-1097(05)01049-1 DB - PRIME DP - Unbound Medicine ER -