NephroCare Spain, Nephrology, Madrid, Spain.
NephroCare France, Fresnes, France.
BMC Nephrol. 2020 Dec 7;21(1):530. doi: 10.1186/s12882-020-02188-8.
The iron-based phosphate binder (PB), sucroferric oxyhydroxide (SFOH), demonstrated its effectiveness for lowering serum phosphate levels, with low daily pill burden, in clinical trials of dialysis patients with hyperphosphatemia. This retrospective database analysis evaluated the real-world effectiveness of SFOH for controlling serum phosphate in European hemodialysis patients.
De-identified patient data were extracted from a clinical database (EuCliD®) for adult hemodialysis patients from France, Italy, Portugal, Russia and Spain who were newly prescribed SFOH for up to 1 year as part of routine clinical care. Serum phosphate and pill burden were compared between baseline (3-month period before starting SFOH) and four consecutive quarterly periods of SFOH therapy (Q1-Q4; 12 months) in the overall cohort and three subgroups: PB-naïve patients treated with SFOH monotherapy (mSFOH), and PB-pretreated patients who were either switched to SFOH monotherapy (PB → mSFOH), or received SFOH in addition to another PB (PB + SFOH).
1096 hemodialysis patients (mean age: 60.6 years; 65.8% male) were analyzed, including 796, 188 and 53 patients in, respectively, the PB + SFOH, mSFOH, and PB → mSFOH groups. In the overall cohort, serum phosphate decreased significantly from 1.88 mmol/L at baseline to 1.77-1.69 mmol/L during Q1-Q4, and the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased from 41.3% at baseline to 56.2-62.7% during SFOH treatment. Mean PB pill burden decreased from 6.3 pills/day at baseline to 5.0-5.3 pills/day during Q1-Q4. The subgroup analysis found the proportion of patients achieving serum phosphate ≤1.78 mmol/L increased significantly from baseline during SFOH treatment in the PB + SFOH group (from 38.1% up to 60.9% [Q2]) and the mSFOH group (from 49.5% up to 75.2% [Q2]), but there were no significant changes in the PB → mSFOH group. For the PB + SFOH group, serum phosphate reductions were achieved with a similar number of PB pills prescribed at baseline prior to SFOH treatment (6.5 vs 6.2 pills/day at Q4). SFOH daily pill burden was low across all 3 subgroups (2.1-2.8 pills/day).
In this real-world study of European hemodialysis patients, prescription of SFOH as monotherapy to PB-naïve patients, or in addition to existing PB therapy, was associated with significant improvements in serum phosphate control and a low daily pill burden.
铁基磷酸盐结合剂（PB）蔗糖铁氧羟化物（SFOH）在临床试验中已证明其在控制高磷血症方面的有效性，可降低血清磷水平，且每日服药负担较轻。本回顾性数据库分析评估了 SFOH 在欧洲血液透析患者中控制血清磷的真实世界疗效。
从临床数据库（EuCliD®）中提取了来自法国、意大利、葡萄牙、俄罗斯和西班牙的接受 SFOH 治疗的新成年血液透析患者的数据，这些患者在接受 SFOH 治疗的 1 年内接受了 SFOH 治疗。在整个队列和三个亚组（SFOH 单药治疗的 PB 初治患者（mSFOH）、转换为 SFOH 单药治疗的 PB 预处理患者（PB→mSFOH）和接受 SFOH 联合其他 PB 治疗的患者（PB+SFOH）中，比较基线（开始 SFOH 前 3 个月）和 SFOH 治疗的四个连续季度（Q1-Q4；12 个月）的血清磷和服药负担。
共分析了 1096 名血液透析患者（平均年龄：60.6 岁；65.8%为男性），分别在 PB+SFOH、mSFOH 和 PB→mSFOH 组中分析了 796、188 和 53 名患者。在整个队列中，血清磷从基线时的 1.88mmol/L 显著下降至 Q1-Q4 时的 1.77-1.69mmol/L，血清磷≤1.78mmol/L的患者比例从基线时的 41.3%上升至 SFOH 治疗期间的 56.2-62.7%。平均 PB 服药负担从基线时的 6.3 片/天降至 Q1-Q4 时的 5.0-5.3 片/天。亚组分析发现，在 PB+SFOH 组（从基线时的 38.1%增加至 Q2 时的 60.9%[Q2]）和 mSFOH 组（从基线时的 49.5%增加至 Q2 时的 75.2%[Q2]）中，患者的血清磷水平在 SFOH 治疗期间均显著改善，而在 PB→mSFOH 组中无显著变化。在 PB+SFOH 组中，SFOH 治疗前（Q4 时为 6.5 片/天）与基线时相同的 PB 剂量即可达到降磷效果。在所有 3 个亚组中，SFOH 的每日服药负担均较低（2.1-2.8 片/天）。
在这项欧洲血液透析患者的真实世界研究中，SFOH 作为单药治疗初治患者或联合现有 PB 治疗，与显著改善血清磷控制和降低每日服药负担有关。
