Supplementary Material for: Serum phosphorus management with sucroferric oxyhydroxide as a first-line phosphate binder within the first year of hemodialysis

Introduction: Sucroferric oxyhydroxide (SO), a non-calcium, chewable, iron-based phosphate binder (PB), effectively lowers serum phosphorus (sP) concentrations while reducing pill burden relative to other PBs. To date, SO studies have largely examined treatment-experienced, prevalent hemodialysis populations. We aimed to explore the role of first-line SO initiated during the first year of dialysis.
Methods: We retrospectively analyzed de-identified data from adults receiving in-center hemodialysis who were prescribed SO monotherapy within the first year of hemodialysis as part of routine clinical care. All patients continuing SO monotherapy for 12 months were included. Changes from baseline in sP, achievement of sP ≤5.5 and ≤4.5 mg/dL, and other laboratory parameters were analyzed quarterly for one year.
Results: The overall cohort included 596 patients, 286 of whom had a dialysis vintage ≤3 months. In the 3 months preceding SO initiation, sP rapidly increased (mean increases of 1.02 mg/dL and 1.65 mg/dL, in the overall cohort and incident cohort, respectively). SO treatment was associated with significant decreases in quarterly sP (mean decreases of 0.26-0.36; p<0.0001 for each quarter and overall). While receiving SO, 55%-60% of patients achieved sP ≤5.5 mg/dL and 21%-24% achieved sP ≤4.5 mg/dL (p<0.0001 for each quarter and overall vs baseline). Daily PB pill burden was approximately 4 pills. Serum calcium concentrations increased and intact parathyroid hormone concentrations decreased during SO treatment (p<0.0001 vs baseline).
Conclusions: Among patients on hemodialysis, initiating SO as a first-line PB resulted in significant reductions in sP while maintaining a relatively low PB pill burden.

研究背景：蔗糖铁氢氧化合物（Sucroferric oxyhydroxide, SO）是一种非钙类咀嚼型铁基磷酸盐结合剂（phosphate binder, PB），可有效降低血清磷（serum phosphorus, sP）水平，且相较于其他磷酸盐结合剂，其服药负担更低。迄今为止，针对SO的相关研究大多聚焦于经治的维持性血液透析人群，本研究旨在探讨透析初始1年内启动一线SO治疗的临床价值。
研究方法：本研究回顾性分析了常规临床诊疗中，于血液透析初始1年内接受SO单药治疗的成年中心血液透析患者的去标识化数据。纳入所有持续接受12个月SO单药治疗的患者。研究在为期1年的随访中按季度分析了血清磷水平较基线的变化、血清磷≤5.5mg/dL及≤4.5mg/dL的达标率，以及其他实验室指标的变化情况。
研究结果：整体队列共纳入596例患者，其中286例患者的透析龄≤3个月。在启动SO治疗前的3个月内，整体队列及新发透析队列的血清磷水平均快速升高，平均增幅分别为1.02mg/dL与1.65mg/dL。SO治疗可使血清磷水平出现显著的季度性下降，平均降幅为0.26~0.36mg/dL；各季度及整体对比基线的差异均具有统计学意义（p<0.0001）。接受SO治疗期间，55%~60%的患者血清磷水平可达到≤5.5mg/dL，21%~24%的患者可达到≤4.5mg/dL；各季度及整体达标率较基线均具有显著统计学差异（p<0.0001）。每日磷酸盐结合剂的服药负担约为4片。SO治疗期间，患者血清钙水平升高，全段甲状旁腺激素（intact parathyroid hormone, iPTH）水平降低，较基线均具有显著统计学差异（p<0.0001）。
研究结论：在血液透析患者中，将SO作为一线磷酸盐结合剂启动治疗，可在显著降低血清磷水平的同时，维持相对较低的服药负担。