Abdul-Rahim Azmil H, MacIsaac Rachael L, Jhund Pardeep S, Petrie Mark C, Lees Kennedy R, McMurray John J V
Institute of Cardiovascular and Medical Sciences, University of Glasgow, UK.
Golden Jubilee National Hospital, Glasgow, UK.
Int J Cardiol. 2016 Apr 15;209:310-6. doi: 10.1016/j.ijcard.2016.02.074. Epub 2016 Feb 8.
Digoxin is recommended in symptomatic heart failure patients with reduced ejection fraction (HF-REF) in sinus rhythm and refractory to other evidence-based therapy. Although HF-REF patients with diabetes have worse functional status than those without, the effects of digoxin have not been specifically evaluated according to diabetes status.
We examined the efficacy and safety of digoxin in HF-REF patients with and without diabetes in the Digitalis Investigation Group trial. Mortality from all-cause, cardiovascular (CV) causes and heart failure (HF), along with HF hospitalisation and suspected digoxin toxicity were analyzed according to diabetes status and randomised treatment assignment.
Of the 6800 patients, those with diabetes (n=1933) were older, more often women, had worse clinical status and more co-morbidity than those without diabetes. All-cause and CV mortality were higher in patients with diabetes than in those without and digoxin did not reduce mortality in either sub-group. The rate of HF hospitalization (per 100 person-years) in patients with diabetes was higher than in those without and was reduced by digoxin in both patient groups: diabetes - placebo 20.5 and digoxin 16.0 (HR 0.79, 95% CI: 0.68-0.91); no diabetes - placebo 12.7 and digoxin 8.7 (HR 0.69, 0.62-0.77); interaction p=0.14. Suspected digoxin toxicity in patients randomised to digoxin was more common among patients with diabetes than without (6.5% versus 5.8%), as was hospitalisation for digoxin toxicity (1.4% versus 0.8%).
Added to an ACE inhibitor, digoxin reduced HF hospitalisation in HF-REF patients with and without diabetes without a substantial risk of toxicity.
对于射血分数降低的有症状心力衰竭患者（HF-REF），若为窦性心律且对其他循证治疗无效，推荐使用地高辛。尽管与无糖尿病的HF-REF患者相比，有糖尿病的患者功能状态更差，但尚未根据糖尿病状态对地高辛的效果进行专门评估。
我们在洋地黄研究组试验中研究了地高辛在有或无糖尿病的HF-REF患者中的疗效和安全性。根据糖尿病状态和随机治疗分配，分析了全因死亡率、心血管（CV）病因死亡率和心力衰竭（HF）死亡率，以及HF住院率和疑似地高辛毒性。
在6800例患者中，有糖尿病的患者（n = 1933）比无糖尿病的患者年龄更大，女性更多，临床状态更差且合并症更多。糖尿病患者的全因死亡率和CV死亡率高于无糖尿病的患者，地高辛在两个亚组中均未降低死亡率。糖尿病患者的HF住院率（每100人年）高于无糖尿病的患者，两组患者使用地高辛后住院率均降低：糖尿病 - 安慰剂组为20.5，地高辛组为16.0（风险比0.79，95%置信区间：0.68 - 0.91）；无糖尿病 - 安慰剂组为12.7，地高辛组为8.7（风险比0.69，0.62 - 0.77）；交互作用p = 0.14。随机分配到地高辛组的患者中，疑似地高辛毒性在糖尿病患者中比无糖尿病患者更常见（6.5%对5.8%），因地高辛毒性住院的情况也是如此（1.4%对0.8%）。
在ACE抑制剂基础上加用地高辛，可降低有或无糖尿病的HF-REF患者的HF住院率，且无明显毒性风险。
