Serum digoxin concentration and outcomes in women with heart failure: A bi-directional effect and a possible effect modification by ejection fraction

Ali Ahmed, Inmaculada B. Aban, Michael T. Weaver, Wilbert S. Aronow, Jerome L. Fleg

Research output: Contribution to journalArticle

24 Citations (Scopus)

Abstract

Background: The association between serum digoxin concentration (SDC) and outcomes in women with heart failure (HF) has not been well studied. Aims: To test the hypothesis that the effect of digoxin on outcomes in women with HF is bi-directional and dependent on SDC, as in men, and is modified by ejection fraction (EF). Methods: We studied 1366 female participants of the Digitalis Investigation Group trial in whom data on SDC (ng/ml) were available. We calculated adjusted odds ratios (AOR) and Bonferroni-adjusted 97.5% confidence intervals (CI) for various outcomes at a median follow up of 41 months, in all women and stratified by EF 35%. Results: Compared with placebo (26.9%), 40.3% with SDC ≥ 1.2 (AOR = 1.80; CI = 1.14-2.86; p = 0.004) and 26.6% with SDC 0.5-1.1 (AOR = 1.05; CI = 0.73-1.51; p = 0.762) died. Respective rates for HF-hospitalizations were: placebo (32.8%), SDC ≥ 1.2 (38.0%) and SDC 0.5-1.1 (25.5%). For women with EF <35% (N = 677), SDC 0.5-1.1 lowered odds for HF-hospitalizations (AOR = 0.63; CI = 0.39-1.00; p = 0.026) without increasing odds for death (AOR = 0.77; CI = 0.47-1.26; p = 0.233). In women with EF ≥ 35% (N = 689), SDC 0.5-1.1 had a borderline association with death (AOR = 1.58; CI = 0.92-2.72; p = 0.058) but not with HF-hospitalization (AOR = 0.95; CI = 0.54-1.66; p = 0.826). Conclusions: As in men, in women with HF, digoxin has a bi-directional effect based on SDC, and the beneficial effects were significant only among women with EF <35%.

Original languageEnglish (US)
Pages (from-to)409-419
Number of pages11
JournalEuropean Journal of Heart Failure
Volume8
Issue number4
DOIs
StatePublished - Jun 2006
Externally publishedYes

Fingerprint

Digoxin
Heart Failure
Serum
Odds Ratio
Confidence Intervals
Hospitalization
Placebos
Digitalis

Keywords

  • Ejection fraction
  • Heart failure
  • Outcomes
  • Serum digoxin concentration
  • Women

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

Serum digoxin concentration and outcomes in women with heart failure : A bi-directional effect and a possible effect modification by ejection fraction. / Ahmed, Ali; Aban, Inmaculada B.; Weaver, Michael T.; Aronow, Wilbert S.; Fleg, Jerome L.

In: European Journal of Heart Failure, Vol. 8, No. 4, 06.2006, p. 409-419.

Research output: Contribution to journalArticle

Ahmed, Ali ; Aban, Inmaculada B. ; Weaver, Michael T. ; Aronow, Wilbert S. ; Fleg, Jerome L. / Serum digoxin concentration and outcomes in women with heart failure : A bi-directional effect and a possible effect modification by ejection fraction. In: European Journal of Heart Failure. 2006 ; Vol. 8, No. 4. pp. 409-419.
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abstract = "Background: The association between serum digoxin concentration (SDC) and outcomes in women with heart failure (HF) has not been well studied. Aims: To test the hypothesis that the effect of digoxin on outcomes in women with HF is bi-directional and dependent on SDC, as in men, and is modified by ejection fraction (EF). Methods: We studied 1366 female participants of the Digitalis Investigation Group trial in whom data on SDC (ng/ml) were available. We calculated adjusted odds ratios (AOR) and Bonferroni-adjusted 97.5{\%} confidence intervals (CI) for various outcomes at a median follow up of 41 months, in all women and stratified by EF 35{\%}. Results: Compared with placebo (26.9{\%}), 40.3{\%} with SDC ≥ 1.2 (AOR = 1.80; CI = 1.14-2.86; p = 0.004) and 26.6{\%} with SDC 0.5-1.1 (AOR = 1.05; CI = 0.73-1.51; p = 0.762) died. Respective rates for HF-hospitalizations were: placebo (32.8{\%}), SDC ≥ 1.2 (38.0{\%}) and SDC 0.5-1.1 (25.5{\%}). For women with EF <35{\%} (N = 677), SDC 0.5-1.1 lowered odds for HF-hospitalizations (AOR = 0.63; CI = 0.39-1.00; p = 0.026) without increasing odds for death (AOR = 0.77; CI = 0.47-1.26; p = 0.233). In women with EF ≥ 35{\%} (N = 689), SDC 0.5-1.1 had a borderline association with death (AOR = 1.58; CI = 0.92-2.72; p = 0.058) but not with HF-hospitalization (AOR = 0.95; CI = 0.54-1.66; p = 0.826). Conclusions: As in men, in women with HF, digoxin has a bi-directional effect based on SDC, and the beneficial effects were significant only among women with EF <35{\%}.",
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T1 - Serum digoxin concentration and outcomes in women with heart failure

T2 - A bi-directional effect and a possible effect modification by ejection fraction

AU - Ahmed, Ali

AU - Aban, Inmaculada B.

AU - Weaver, Michael T.

AU - Aronow, Wilbert S.

AU - Fleg, Jerome L.

PY - 2006/6

Y1 - 2006/6

N2 - Background: The association between serum digoxin concentration (SDC) and outcomes in women with heart failure (HF) has not been well studied. Aims: To test the hypothesis that the effect of digoxin on outcomes in women with HF is bi-directional and dependent on SDC, as in men, and is modified by ejection fraction (EF). Methods: We studied 1366 female participants of the Digitalis Investigation Group trial in whom data on SDC (ng/ml) were available. We calculated adjusted odds ratios (AOR) and Bonferroni-adjusted 97.5% confidence intervals (CI) for various outcomes at a median follow up of 41 months, in all women and stratified by EF 35%. Results: Compared with placebo (26.9%), 40.3% with SDC ≥ 1.2 (AOR = 1.80; CI = 1.14-2.86; p = 0.004) and 26.6% with SDC 0.5-1.1 (AOR = 1.05; CI = 0.73-1.51; p = 0.762) died. Respective rates for HF-hospitalizations were: placebo (32.8%), SDC ≥ 1.2 (38.0%) and SDC 0.5-1.1 (25.5%). For women with EF <35% (N = 677), SDC 0.5-1.1 lowered odds for HF-hospitalizations (AOR = 0.63; CI = 0.39-1.00; p = 0.026) without increasing odds for death (AOR = 0.77; CI = 0.47-1.26; p = 0.233). In women with EF ≥ 35% (N = 689), SDC 0.5-1.1 had a borderline association with death (AOR = 1.58; CI = 0.92-2.72; p = 0.058) but not with HF-hospitalization (AOR = 0.95; CI = 0.54-1.66; p = 0.826). Conclusions: As in men, in women with HF, digoxin has a bi-directional effect based on SDC, and the beneficial effects were significant only among women with EF <35%.

AB - Background: The association between serum digoxin concentration (SDC) and outcomes in women with heart failure (HF) has not been well studied. Aims: To test the hypothesis that the effect of digoxin on outcomes in women with HF is bi-directional and dependent on SDC, as in men, and is modified by ejection fraction (EF). Methods: We studied 1366 female participants of the Digitalis Investigation Group trial in whom data on SDC (ng/ml) were available. We calculated adjusted odds ratios (AOR) and Bonferroni-adjusted 97.5% confidence intervals (CI) for various outcomes at a median follow up of 41 months, in all women and stratified by EF 35%. Results: Compared with placebo (26.9%), 40.3% with SDC ≥ 1.2 (AOR = 1.80; CI = 1.14-2.86; p = 0.004) and 26.6% with SDC 0.5-1.1 (AOR = 1.05; CI = 0.73-1.51; p = 0.762) died. Respective rates for HF-hospitalizations were: placebo (32.8%), SDC ≥ 1.2 (38.0%) and SDC 0.5-1.1 (25.5%). For women with EF <35% (N = 677), SDC 0.5-1.1 lowered odds for HF-hospitalizations (AOR = 0.63; CI = 0.39-1.00; p = 0.026) without increasing odds for death (AOR = 0.77; CI = 0.47-1.26; p = 0.233). In women with EF ≥ 35% (N = 689), SDC 0.5-1.1 had a borderline association with death (AOR = 1.58; CI = 0.92-2.72; p = 0.058) but not with HF-hospitalization (AOR = 0.95; CI = 0.54-1.66; p = 0.826). Conclusions: As in men, in women with HF, digoxin has a bi-directional effect based on SDC, and the beneficial effects were significant only among women with EF <35%.

KW - Ejection fraction

KW - Heart failure

KW - Outcomes

KW - Serum digoxin concentration

KW - Women

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