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Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience.
BMC Nephrology ( IF 2.3 ) Pub Date : 2020-06-03 , DOI: 10.1186/s12882-020-01866-x
Jorge A Jesus-Silva 1 , Archie Lamplugh 2 , Sameera Dhada 1 , James O Burton 1, 3 , Sunil Bhandari 2
Affiliation  

Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials. This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation. A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P < 0.01). The weekly iron dose was similar after adjustment (P = 0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM. This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events.

中文翻译:

血液透析患者从蔗糖铁转化为异麦芽糖苷铁:真实世界的经验。

贫血在血液透析 (HD) 患者中很常见,并且与显着的发病率和死亡率相关。静脉注射 (IV) 铁联合红细胞生成刺激剂 (ESA) 是这些患者贫血的主要治疗方法。仅在少数试验中评估了 IV 铁制剂的比较疗效和不良事件风险。这是一项在 2 个中心进行的回顾性观察研究,旨在比较蔗糖铁 (IS-Venofer®) 与异麦芽糖苷铁 (IIM-Diafer®) 在血液透析患者中​​的安全性和有效性。该研究包括目前正在透析并接受 Venofer 的患者,这些患者改用 Diafer® 并监测每种铁制剂的至少 12 个月。总共包括 190 名患者,平均年龄为 65.8 岁 (SD ± 15.5)。在 12 个月内每毫克铁的平均血红蛋白没有变化,这证实了非劣效性。在研究期间,总共有 41,295 份异麦芽糖苷铁和 14,685 份蔗糖铁处方,报告的不良事件数量没有差异(每份 7 份,无一例严重)。转换后随着时间的推移,Hb 具有统计学上显着的影响,包括对多重比较的调整。随着时间的推移,铁蛋白有显着改善,保持在 6 个月(P <0.01)。调整后每周铁剂量相似(P = 0.02)。在转为 IIM 的患者中,EPO 剂量在第 0 个月后没有显着差异。该研究证明了异麦芽糖苷铁与蔗糖铁的安全性和有效性比较,透析患者的给药方案相似。
更新日期:2020-06-03
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