Effects of ferric carboxymaltose on hospitalisations and mortality rates in iron-deficient heart failure patients: an individual patient data meta-analysis
Effects of ferric carboxymaltose on hospitalisations and mortality rates in iron-deficient heart failure patients: an individual patient data meta-analysis
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DOI：
10.1002/ejhf.823
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发表时间：
2018-01-01
影响因子：
18.2
通讯作者：
Ponikowski, Piotr
中科院分区：
文献类型：
--
作者：
Anker, Stefan D.;Kirwan, Bridget-Anne;Ponikowski, Piotr
铁缺乏是心力衰竭患者常见的合并症，并被认为与预后不良有关。最近完成的双盲随机对照试验（RCT）研究了患有ID的HF患者，结果显示，静脉注射羧基麦芽糖铁（FCM）治疗后，功能能力、症状和生活质量均有所改善。个体患者数据荟萃分析探讨了FCM与安慰剂对心衰患者ID.Methods和结果复发住院和死亡率的影响，个体患者数据提取自4个RCT，比较FCM与安慰剂对收缩期心衰和ID患者的影响。主要结局指标为复发心血管（CV）住院和CV死亡率。其他结局包括因特定原因住院和死亡。复发事件的主要分析得到了至首次事件时间分析的支持。共纳入839例患者，其中504例随机分配至FCM组。与服用安慰剂的患者相比，接受FCM治疗的患者的CV复发住院率和CV死亡率较低[率比0.59，95%置信区间（CI）0.40-0.88; P = 0.009]。FCM治疗还降低了复发性HF住院和CV死亡率（率比0.53，95% CI 0.33-0.86; P = 0.011）以及复发性CV住院和全因死亡率（率比0.60，95% CI 0.41-0.88; P = 0.009）。至首次事件发生时间分析显示了相似的结果，治疗效应略有减弱。FCM的管理与不良事件的风险增加无关。结论FCM治疗与静脉内与ID的收缩期HF患者的复发CV住院率降低相关。
Aims Iron deficiency (ID) is a common co-morbidity in patients with heart failure (HF) and has been suggested to be associated with poor prognosis. Recently completed double-blind randomised controlled trials (RCTs) studying HF patients with ID have shown improvements in functional capacity, symptoms and quality of life when treated with i.v. ferric carboxymaltose (FCM). This individual patient data meta-analysis investigates the effect of FCM vs. placebo on recurrent hospitalisations and mortality in HF patients with ID.Methods and results Individual patient data were extracted from four RCTs comparing FCM with placebo in patients with systolic HF and ID. The main outcome measures were recurrent cardiovascular (CV) hospitalisations and CV mortality. Other outcomes included cause-specific hospitalisations and death. The main analyses of recurrent events were backed up by time-to-first-event analyses. In total, 839 patients, of whom 504 were randomised to FCM, were included. Compared with those taking placebo, patients on FCM had lower rates of recurrent CV hospitalisations and CV mortality [rate ratio 0.59, 95% confidence interval (CI) 0.40-0.88; P = 0.009]. Treatment with FCM also reduced recurrent HF hospitalisations and CV mortality (rate ratio 0.53, 95% CI 0.33-0.86; P = 0.011) and recurrent CV hospitalisations and all-cause mortality (rate ratio 0.60, 95% CI 0.41-0.88; P = 0.009). Time-to-first-event analyses showed similar findings, with somewhat attenuated treatment effects. The administration of i.v. FCM was not associated with an increased risk for adverse events.Conclusions Treatment with i.v. FCM was associated with a reduction in recurrent CV hospitalisations in systolic HF patients with ID.