Department of Medicine I and Christian Doppler Laboratory on Iron and Phosphate Biology, Medical University of Innsbruck, Innsbruck, Austria
Division of Nephrology, Department of Medicine, and Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Gut. 2023 Apr;72(4):644-653. doi: 10.1136/gutjnl-2022-327897. Epub 2022 Sep 9.
Intravenous iron-a common treatment for anaemia and iron deficiency due to inflammatory bowel disease (IBD)-can cause hypophosphataemia. This trial compared the incidence of hypophosphataemia after treatment with ferric carboxymaltose (FCM) or ferric derisomaltose (FDI).
This randomised, double-blind, clinical trial was conducted at 20 outpatient hospital clinics in Europe (Austria, Denmark, Germany, Sweden, UK). Adults with IBD and iron deficiency anaemia (IDA) were randomised 1:1 to receive FCM or FDI at baseline and at Day 35 using identical haemoglobin- and weight-based dosing regimens. The primary outcome was the incidence of hypophosphataemia (serum phosphate <2.0 mg/dL) at any time from baseline to Day 35 in the safety analysis set (all patients who received ≥1 dose of study drug). Markers of mineral and bone homeostasis, and patient-reported fatigue scores, were measured.
A total of 156 patients were screened; 97 (49 FDI, 48 FCM) were included and treated. Incident hypophosphataemia occurred in 8.3% (4/48) FDI-treated patients and in 51.0% (25/49) FCM-treated patients (adjusted risk difference: -42.8% (95% CI -57.1% to -24.6%) p<0.0001). Both iron formulations corrected IDA. Patient-reported fatigue scores improved in both groups, but more slowly and to a lesser extent with FCM than FDI; slower improvement in fatigue was associated with greater decrease in phosphate concentration.
Despite comparably effective treatment of IDA, FCM caused a significantly higher rate of hypophosphataemia than FDI. Further studies are needed to address the longer-term clinical consequences of hypophosphataemia and to investigate mechanisms underpinning the differential effects of FCM and FDI on patient-reported fatigue.
静脉铁剂常用于治疗炎症性肠病（IBD）引起的贫血和缺铁，可导致低磷血症。本试验比较了羧基麦芽糖铁（FCM）和去铁胺麦芽糖铁（FDI）治疗后低磷血症的发生率。
这是一项在欧洲 20 家门诊医院（奥地利、丹麦、德国、瑞典、英国）进行的随机、双盲、临床试验。患有 IBD 和缺铁性贫血（IDA）的成年人按 1:1 随机分组，在基线时和第 35 天分别接受 FCM 或 FDI 治疗，采用相同的基于血红蛋白和体重的剂量方案。主要结局是安全性分析集中从基线到第 35 天任何时间的低磷血症（血清磷<2.0mg/dL）发生率（接受至少 1 剂研究药物的所有患者）。检测了矿物质和骨代谢的标志物以及患者报告的疲劳评分。
共筛选了 156 例患者；97 例（49 例 FDI，48 例 FCM）被纳入并接受治疗。在 FDI 治疗组中，有 8.3%（4/48）的患者发生低磷血症，而在 FCM 治疗组中，有 51.0%（25/49）的患者发生低磷血症（调整后的风险差异：-42.8%（95%CI-57.1%至-24.6%），p<0.0001）。两种铁制剂均纠正了 IDA。两组患者的报告的疲劳评分均有所改善，但 FCM 组改善速度较慢，幅度较小；疲劳改善较慢与磷酸盐浓度下降幅度较大相关。
尽管 IDA 的治疗效果相当，但 FCM 引起低磷血症的发生率明显高于 FDI。需要进一步研究来解决低磷血症的长期临床后果，并研究 FCM 和 FDI 对患者报告的疲劳的不同影响的潜在机制。
