Minutolo Roberto, Berto Patrizia, Liberti Maria Elena, Peruzzu Nicola, Borrelli Silvio, Netti Antonella, Garofalo Carlo, Conte Giuseppe, De Nicola Luca, Del Vecchio Lucia, Locatelli Francesco
Division of Nephrology, University of Campania, Luigi Vanvitelli, 80138 Naples, Italy.
Certara Italy, 20124 Milan, Italy.
J Clin Med. 2021 Mar 23;10(6):1322. doi: 10.3390/jcm10061322.
No information is available on the efficacy of ferric carboxymaltose (FCM) in real-world CKD patients outside the hemodialysis setting. We prospectively followed 59 non-hemodialysis CKD patients with iron deficient anemia (IDA: hemoglobin <12.0/<13.5 g/dL in women/men and TSAT < 20% and/or ferritin < 100 ng/mL) who were intolerant or non-responders to oral iron. Patients received ferric carboxymaltose (FCM) (single dose of 500 mg) followed by additional doses if iron deficiency persisted. We evaluated efficacy of FCM in terms of increase of hemoglobin, ferritin, and TSAT levels. Direct and indirect costs of FCM were also analyzed in comparison with a hypothetical scenario where same amount of iron as ferric gluconate (FG) was administered intravenously. During the 24 weeks of study, 847 ± 428 mg of FCM per patient were administered. IDA improved after four weeks of FCM and remained stable thereafter. At week-24, mean change (95%CI) from baseline of hemoglobin, ferritin and TSAT were +1.16 g/dL (0.55-1.77), +104 ng/mL (40-168) and +9.5% (5.8-13.2), respectively. These changes were independent from ESA use and clinical setting (non-dialysis CKD, peritoneal dialysis and kidney transplant). Among ESA-treated patients ( = 24), ESA doses significantly decreased by 26% with treatment and stopped either temporarily or persistently in nine patients. FCM, compared to a FG-based scenario, was associated with a cost saving of 288 euros/patient/24 weeks. Saving was the same in ESA users/non-users. Therefore, in non-hemodialysis CKD patients, FCM effectively corrects IDA and allows remarkable cost savings in terms of societal, healthcare and patient perspective.
关于羧基麦芽糖铁（FCM）在血液透析环境之外的真实世界慢性肾脏病（CKD）患者中的疗效尚无可用信息。我们前瞻性地随访了59例非血液透析的CKD缺铁性贫血（IDA：女性/男性血红蛋白<12.0/<13.5 g/dL且转铁蛋白饱和度<20%和/或铁蛋白<100 ng/mL）患者，这些患者对口服铁剂不耐受或无反应。患者接受羧基麦芽糖铁（FCM）（单次剂量500 mg），如果缺铁持续则给予额外剂量。我们根据血红蛋白、铁蛋白和转铁蛋白饱和度水平的升高来评估FCM的疗效。还将FCM的直接和间接成本与静脉注射等量葡萄糖酸铁（FG）的假设情况进行了比较分析。在24周的研究期间，每位患者给予847±428 mg的FCM。FCM治疗四周后IDA得到改善，此后保持稳定。在第24周时，血红蛋白、铁蛋白和转铁蛋白饱和度相对于基线的平均变化（95%CI）分别为+1.16 g/dL（0.55 - 1.77）、+104 ng/mL（40 - 168）和+9.5%（5.8 - 13.2）。这些变化与促红细胞生成素（ESA）的使用和临床环境（非透析CKD、腹膜透析和肾移植）无关。在接受ESA治疗的患者（n = 24）中，治疗后ESA剂量显著降低了26%，9例患者暂时或持续停用。与基于FG的情况相比，FCM使每位患者在24周内节省成本288欧元。ESA使用者/非使用者的节省情况相同。因此，在非血液透析的CKD患者中，FCM可有效纠正IDA，并从社会、医疗保健和患者角度实现显著的成本节约。
