Abstract：
Intravenous (IV) iron is the preferred treatment for patients with iron deficiency anemia (IDA) who require rapid replenishment of iron stores or in whom oral iron is not tolerated or effective. Data from two large-scale randomized controlled trials (RCTs) have recently been published reporting the incidence of adjudicated cardiovascular events after ferric derisomaltose (FDI) and iron sucrose (IS). The objective was to calculate the relative incidence of cardiovascular events with FDI and IS, and to conduct an indirect comparison with ferric carboxymaltose (FCM) based on previously published studies of cardiovascular risk.
RCTs reporting the incidence of blindly adjudicated cardiovascular events in IDA patients treated with IV iron were identified by systematic literature review (SLR). Pairwise random effects meta-analyses of FDI versus IS, and FCM versus IS were conducted for the pre-specified adjudicated composite cardiovascular endpoint of: death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure, arrhythmia, and protocol-defined hypertensive and hypotensive events. Analyses were also conducted for the composite endpoint excluding blood pressure events. Meta-analysis results were combined in an adjusted indirect comparison to provide an indirect estimate of cardiovascular risk with FDI versus FCM.
The SLR retrieved 694 unique articles, of which four were RCTs reporting the incidence of the composite cardiovascular endpoint; two studies comparing FCM (N = 1529) with IS (N = 1505), and two studies comparing FDI (N = 2008) with IS (N = 1000). The odds ratios of the composite CV endpoint were 0.59 (95% confidence interval: 0.39-0.90) for FDI versus IS, 1.12 (95% CI 0.90-1.40) for FCM versus IS, and the indirect OR for FDI versus FCM was 0.53 (95% CI 0.33-0.85).
Pooling data from four large-scale RCTs suggested that FDI was associated with significantly lower incidence of cardiovascular adverse events compared to both FCM and IS.
RCTs reporting the incidence of blindly adjudicated cardiovascular events in IDA patients treated with IV iron were identified by systematic literature review (SLR). Pairwise random effects meta-analyses of FDI versus IS, and FCM versus IS were conducted for the pre-specified adjudicated composite cardiovascular endpoint of: death due to any cause, nonfatal myocardial infarction, nonfatal stroke, unstable angina requiring hospitalization, congestive heart failure, arrhythmia, and protocol-defined hypertensive and hypotensive events. Analyses were also conducted for the composite endpoint excluding blood pressure events. Meta-analysis results were combined in an adjusted indirect comparison to provide an indirect estimate of cardiovascular risk with FDI versus FCM.
The SLR retrieved 694 unique articles, of which four were RCTs reporting the incidence of the composite cardiovascular endpoint; two studies comparing FCM (N = 1529) with IS (N = 1505), and two studies comparing FDI (N = 2008) with IS (N = 1000). The odds ratios of the composite CV endpoint were 0.59 (95% confidence interval: 0.39-0.90) for FDI versus IS, 1.12 (95% CI 0.90-1.40) for FCM versus IS, and the indirect OR for FDI versus FCM was 0.53 (95% CI 0.33-0.85).
Pooling data from four large-scale RCTs suggested that FDI was associated with significantly lower incidence of cardiovascular adverse events compared to both FCM and IS.
摘要：
静脉（IV）铁是缺铁性贫血（IDA）患者的首选治疗方法，这些患者需要快速补充铁储备或口服铁不能耐受或有效。最近发表了两项大规模随机对照试验（RCT）的数据，报告了在铁麦芽糖（FDI）和蔗糖铁（IS）之后裁定的心血管事件的发生率。目的是用FDI和IS计算心血管事件的相对发生率，并根据先前发表的心血管风险研究，与羧基麦芽糖铁（FCM）进行间接比较。
通过系统文献综述（SLR）确定了报告使用IV铁治疗的IDA患者盲目裁定心血管事件发生率的RCT。FDI与IS的成对随机效应荟萃分析，和FCM与IS进行了预先指定的裁定复合心血管终点：任何原因导致的死亡，非致死性心肌梗死,非致命性中风,不稳定型心绞痛需要住院治疗，充血性心力衰竭,心律失常,和方案定义的高血压和低血压事件。还对不包括血压事件的复合终点进行了分析。将荟萃分析结果与调整后的间接比较相结合，以提供FDI与FCM对心血管风险的间接估计。
SLR检索到694篇独特文章，其中四项是报告复合心血管终点发生率的随机对照试验；两项研究比较了FCM(N=1529)和IS(N=1505)，以及两项比较FDI(N=2008)和IS(N=1000)的研究。FDI与IS的复合CV终点的比值比为0.59（95％置信区间：0.39-0.90），FCM与IS的1.12（95%CI0.90-1.40），FDI与FCM的间接OR为0.53（95%CI0.33-0.85）。
来自四个大规模随机对照试验的汇总数据表明，与FCM和IS相比，FDI与心血管不良事件发生率显著降低相关。
通过系统文献综述（SLR）确定了报告使用IV铁治疗的IDA患者盲目裁定心血管事件发生率的RCT。FDI与IS的成对随机效应荟萃分析，和FCM与IS进行了预先指定的裁定复合心血管终点：任何原因导致的死亡，非致死性心肌梗死,非致命性中风,不稳定型心绞痛需要住院治疗，充血性心力衰竭,心律失常,和方案定义的高血压和低血压事件。还对不包括血压事件的复合终点进行了分析。将荟萃分析结果与调整后的间接比较相结合，以提供FDI与FCM对心血管风险的间接估计。
SLR检索到694篇独特文章，其中四项是报告复合心血管终点发生率的随机对照试验；两项研究比较了FCM(N=1529)和IS(N=1505)，以及两项比较FDI(N=2008)和IS(N=1000)的研究。FDI与IS的复合CV终点的比值比为0.59（95％置信区间：0.39-0.90），FCM与IS的1.12（95%CI0.90-1.40），FDI与FCM的间接OR为0.53（95%CI0.33-0.85）。
来自四个大规模随机对照试验的汇总数据表明，与FCM和IS相比，FDI与心血管不良事件发生率显著降低相关。
