Relationship of serum digoxin concentration to mortality and morbidity heart failure in women in the digitalis investigation group trial - A retrospective analysis
Relationship of serum digoxin concentration to mortality and morbidity heart failure in women in the digitalis investigation group trial - A retrospective analysis
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DOI：
10.1016/j.jacc.2005.02.091
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发表时间：
2005-08-02
影响因子：
24
通讯作者：
Gheorghiade, M
中科院分区：
文献类型：
--
作者：
Adams, KF;Patterson, JH;Gheorghiade, M
目的探讨地高辛血药浓度(SDC)与心力衰竭(HF)患者预后的关系。背景：关于地高辛在心力衰竭(HF)患者中的临床应用仍存在争议。主要研究分析回顾了4,944名存活至少4周的心功能不全患者(全部3,366名患者随机服用安慰剂，3,372名随机服用地高辛的患者中有1,578人在最后一次研究药物4周后6-30小时[包括]测量了血药浓度)。结果连续多变量分析显示，女性(p=0.008)和男性(p=0.002，p=0.766)的SDC与死亡率之间存在显著的线性关系。女性平均风险比(HR)为0.80(95%可信区间为0.62-1.13，p=0.245)，死亡或住院期间心力衰竭恶化为0.73(95%可信区间为0.58-0.93，p=0.011)。相反，SDC1.2~2.0 ng/ml与妇女死亡比为1.33(95%CI 1.001~1.76，p=0.049)相关。结论对DIG试验数据的回顾分析表明，血清浓度在0.5~0.9 ng/ml时，地高辛对妇女的发病率和死亡率无明显影响，而血清浓度=1.2 ng/ml似乎有害。
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 >= 1.2 ng/ml seem harmful.