SO073IRON-RELATED PARAMETERS AND ANTI-ANAEMIC THERAPY IN HAEMODIALYSIS PATIENTS TREATED WITH SUCROFERRIC OXYHYDROXIDE: A 1-YEAR RETROSPECTIVE EUROPEAN CLINICAL DATABASE (EUCLID) ANALYSIS

NEPHROLOGY DIALYSIS TRANSPLANTATION(2020)

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Abstract Background and Aims This retrospective analysis of data from the European Clinical Database (EuCliD®) evaluated changes in iron-related parameters and use of concomitant anti-anaemic therapies in European haemodialysis (HD) patients treated with sucroferric oxyhydroxide (SFOH). Previous Phase 3 clinical studies and non-clinical studies have indicated that there is minimal iron absorption from SFOH. This study aimed to evaluate the changes in iron-related parameters among patients treated with SFOH in the real-world setting. Method De-identified patient data were extracted from a clinical database (EuCliD®) for adult HD patients newly prescribed SFOH routinely for up to 1 year (1 Jan 2015–1 Jan 2019). Levels of serum ferritin, transferrin saturation (TSAT) and haemoglobin were compared between baseline (BL; 3-month period before starting SFOH) and each quarterly period in the year after starting SFOH treatment (Q1–Q4). Proportions of patients receiving intravenous (IV) iron and erythropoiesis-stimulating agent (ESA) therapies, in addition to their mean weekly doses, during each quarter were recorded. Results The cohort included 1,096 patients with recorded SFOH prescriptions (mean age: 60.6 years; 65.8% male). There were small, but significant increases in ferritin from BL to Q1–Q4 (P<0.05 for all periods vs BL). There were also increases in TSAT (P<0.05 at Q1 and Q2 vs BL) and haemoglobin (P<0.001 at Q1 and Q3 vs BL) (Table). During the 1-year SFOH treatment period, the proportion of patients receiving IV iron therapy decreased (P<0.05 at Q2 and Q3 vs BL) and there was a significant reduction in the mean weekly dose of IV iron administered (P<0.05 at Q2 and Q3 vs BL). The use of ESA therapy also declined (P<0.05 at Q3 and Q4) and there was a significant decrease in the mean weekly dose of ESA during the 1-year SFOH follow-up period (P<0.05 for all periods vs BL). Conclusion This real-world study showed that SFOH treatment in routine clinical practice for up to 1 year was associated with small increases in iron-related parameters and decreases in the use and mean dose of concomitant anti-anaemic therapies in European HD patients. The results from this study indicate that SFOH treatment may be associated with the reduction in concomitant IV iron and ESA use in HD patients, in line with previous findings from the Phase 3 study.
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关键词
sucroferric oxyhydroxide,haemodialysis patients,iron-related,anti-anaemic
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