Division of Cardiology and Metabolism-Heart Failure, Cachexia & Sarcopenia; Department of Internal Medicine & Cardiology; DZHK (German Center for Cardiovascular Research); and Berlin-Brandenburg Center for Regenerative Therapies (BCRT), at Charité University Medicine, Berlin, Germany.
Department of Clinical Research, SOCAR Research SA, Nyon, Switzerland.
Eur J Heart Fail. 2018 Jan;20(1):125-133. doi: 10.1002/ejhf.823. Epub 2017 Apr 24.
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.
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.
Treatment with i.v. FCM was associated with a reduction in recurrent CV hospitalisations in systolic HF patients with ID.
缺铁（ID）是心力衰竭（HF）患者的常见合并症，并已被认为与预后不良有关。最近完成的针对 ID 心力衰竭患者的双盲随机对照试验（RCT）表明，用静脉注射铁羧基麦芽糖（FCM）治疗可改善患者的功能能力、症状和生活质量。这项个体患者数据荟萃分析研究了 FCM 与安慰剂在 ID 心力衰竭患者中的再住院率和死亡率的影响。
从四项 RCT 中提取了比较 FCM 与安慰剂在射血分数降低的 HF 和 ID 患者中的个体患者数据。主要结局测量是再发心血管（CV）住院和 CV 死亡率。其他结局包括特定原因的住院和死亡。再发事件的主要分析结果得到了首次事件时间分析的支持。共有 839 例患者，其中 504 例随机分配至 FCM 组，包括在内。与安慰剂组相比，FCM 组患者的再发 CV 住院率和 CV 死亡率较低[风险比 0.59，95%置信区间（CI）0.40-0.88；P=0.009]。FCM 治疗还降低了再发 HF 住院率和 CV 死亡率（风险比 0.53，95%CI 0.33-0.86；P=0.011）和再发 CV 住院率和全因死亡率（风险比 0.60，95%CI 0.41-0.88；P=0.009）。首次事件时间分析显示了类似的发现，但治疗效果略有减弱。静脉注射 FCM 的使用与不良事件风险的增加无关。
静脉注射 FCM 治疗与 ID 的射血分数降低的 HF 患者再发 CV 住院率降低有关。
