Toblli Jorge Eduardo, Angerosa Margarita
Nephrology Section, Department of Internal Medicine, Hospital Alemán, School of Medicine, University of Buenos Aires, Argentina.
Drug Des Devel Ther. 2014 Dec 11;8:2475-91. doi: 10.2147/DDDT.S55499. eCollection 2014.
With the challenge of optimizing iron delivery, new intravenous (iv) iron-carbohydrate complexes have been developed in the last few years. A good example of these new compounds is ferric carboxymaltose (FCM), which has recently been approved by the US Food and Drug Administration for the treatment of iron deficiency anemia in adult patients who are intolerant to oral iron or present an unsatisfactory response to oral iron, and in adult patients with non-dialysis-dependent chronic kidney disease (NDD-CKD). FCM is a robust and stable complex similar to ferritin, which minimizes the release of labile iron during administration, allowing higher doses to be administered in a single application and with a favorable cost-effective rate. Cumulative information from randomized, controlled, multicenter trials on a diverse range of indications, including patients with chronic heart failure, postpartum anemia/abnormal uterine bleeding, inflammatory bowel disease, NDD-CKD, and those undergoing hemodialysis, supports the efficacy of FCM for iron replacement in patients with iron deficiency and iron-deficiency anemia. Furthermore, as FCM is a dextran-free iron-carbohydrate complex (which has a very low risk for hypersensitivity reactions) with a small proportion of the reported adverse effects in a large number of subjects who received FCM, it may be considered a safe drug. Therefore, FCM appears as an interesting option to apply high doses of iron as a single infusion in a few minutes in order to obtain the quick replacement of iron stores. The present review on FCM summarizes diverse aspects such as pharmacology characteristics and analyzes trials on the efficacy/safety of FCM versus oral iron and different iv iron compounds in multiple clinical scenarios. Additionally, the information on cost effectiveness and data on change in quality of life are also discussed.
面对优化铁剂输送的挑战，过去几年中已研发出新型静脉注射（IV）铁 - 碳水化合物复合物。这些新化合物的一个典型例子是羧基麦芽糖铁（FCM），它最近已获得美国食品药品监督管理局的批准，用于治疗对口服铁剂不耐受或对口服铁剂反应不佳的成年缺铁性贫血患者，以及非透析依赖性慢性肾脏病（NDD - CKD）成年患者。FCM是一种类似于铁蛋白的强大且稳定的复合物，在给药过程中可将不稳定铁的释放降至最低，使得在单次应用中能够给予更高剂量，且具有良好的性价比。来自随机、对照、多中心试验的累积信息涉及多种适应症，包括慢性心力衰竭患者、产后贫血/异常子宫出血患者、炎症性肠病患者、NDD - CKD患者以及接受血液透析的患者，这些信息支持了FCM在缺铁和缺铁性贫血患者中进行铁替代治疗的有效性。此外，由于FCM是一种不含右旋糖酐的铁 - 碳水化合物复合物（过敏反应风险极低），在大量接受FCM治疗的受试者中报告的不良反应比例较小，因此它可被视为一种安全的药物。所以，FCM似乎是一种很有吸引力的选择，能够在几分钟内单次输注高剂量铁剂，从而快速补充铁储备。本综述对FCM的药理学特性等多个方面进行了总结，并分析了在多种临床场景中FCM与口服铁剂及不同静脉铁化合物相比的疗效/安全性试验。此外，还讨论了成本效益信息以及生活质量变化数据。
