Institute for Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
Institute for Heart Diseases, University Hospital, Wroclaw, Poland.
Eur Heart J. 2023 Dec 21;44(48):5077-5091. doi: 10.1093/eurheartj/ehad586.
Whereas a beneficial effect of intravenous ferric carboxymaltose (FCM) on symptoms and exercise capacity among patients with iron deficiency and heart failure (HF) has been consistently demonstrated, the effects of treatment on clinical events remain the subject of research. This meta-analysis aimed to characterize the effects of FCM therapy on hospitalizations and mortality.
Patient-level data from randomized, placebo-controlled FCM trials including adults with HF and iron deficiency with ≥52 weeks follow-up were analysed. The co-primary efficacy endpoints were (i) composite of total/recurrent cardiovascular hospitalizations and cardiovascular death and (ii) composite of total HF hospitalizations and cardiovascular death, through 52 weeks. Key secondary endpoints included individual composite endpoint components. Event rates were analysed using a negative binomial model. Treatment-emergent adverse events were also examined.
Three FCM trials with a total of 4501 patients were included. Ferric carboxymaltose was associated with a significantly reduced risk of co-primary endpoint 1 (rate ratio 0.86; 95% confidence interval 0.75-0.98; P = .029; Cochran Q: 0.008), with a trend towards a reduction of co-primary endpoint 2 (rate ratio 0.87; 95% confidence interval 0.75-1.01; P = .076; Cochran Q: 0.024). Treatment effects appeared to result from reduced hospitalization rates, not improved survival. Treatment appeared to have a good safety profile and was well tolerated.
In iron-deficient patients with HF with reduced left ventricular ejection fraction, intravenous FCM was associated with significantly reduced risk of hospital admissions for HF and cardiovascular causes, with no apparent effect on mortality.
静脉注射羧基麦芽糖铁（FCM）已被证实对缺铁性心力衰竭（HF）患者的症状和运动能力有益，但治疗对临床事件的影响仍在研究中。本荟萃分析旨在描述 FCM 治疗对住院和死亡的影响。
对包括 HF 和缺铁性贫血且随访时间≥52 周的成年患者的随机、安慰剂对照 FCM 试验的患者水平数据进行分析。主要疗效终点为（i）全因/复发性心血管住院和心血管死亡的复合终点，（ii）全因 HF 住院和心血管死亡的复合终点，随访时间为 52 周。主要次要终点包括各复合终点组成部分。使用负二项式模型分析事件发生率。还检查了治疗中出现的不良事件。
共纳入 3 项 FCM 试验，共 4501 例患者。羧基麦芽糖铁与主要终点 1（发生率比 0.86；95%置信区间 0.75-0.98；P =.029；Cochran Q：0.008）的风险显著降低相关，主要终点 2（发生率比 0.87；95%置信区间 0.75-1.01；P =.076；Cochran Q：0.024）也呈降低趋势。治疗效果似乎是通过降低住院率而不是提高生存率来实现的。治疗效果似乎良好，且耐受性良好。
在射血分数降低的缺铁性 HF 患者中，静脉注射 FCM 与 HF 和心血管原因导致的住院风险显著降低相关，而对死亡率没有明显影响。
