RWTH University Hospital Aachen, Germany.
Gr.T. Popa University of Medicine and Pharmacy, Iasi, Romania.
Nephrol Dial Transplant. 2017 Nov 1;32(11):1918-1926. doi: 10.1093/ndt/gfw460.
Sucroferric oxyhydroxide is a noncalcium, iron-based phosphate binder that demonstrated sustained serum phosphorus control, good tolerability and lower pill burden compared with sevelamer carbonate (sevelamer) in a Phase 3 study conducted in dialysis patients. This subanalysis examines the efficacy and tolerability of sucroferric oxyhydroxide and sevelamer in the peritoneal dialysis (PD) patient population.
The initial study (NCT01324128) and its extension (NCT01464190) were multicenter, Phase 3, open-label, randomized (2:1), active-controlled trials comparing sucroferric oxyhydroxide (1.0-3.0 g/day) with sevelamer (2.4-14.4 g/day) in dialysis patients over 52 weeks in total.
In the overall study, 84/1055 (8.1%) patients received PD and were eligible for efficacy analysis (sucroferric oxyhydroxide, n = 56; sevelamer, n = 28). The two groups were broadly comparable to each other and to the overall study population. Serum phosphorus concentrations decreased comparably with both phosphate binders by week 12 (mean change from baseline - 0.6 mmol/L). Over 52 weeks, sucroferric oxyhydroxide effectively reduced serum phosphorus concentrations to a similar extent as sevelamer; 62.5% and 64.3% of patients, respectively, were below the Kidney Disease Outcomes Quality Initiative target range (≤1.78 mmol/L). This was achieved with a lower pill burden (3.4 ± 1.3 versus 8.1 ± 3.7 tablets/day) with sucroferric oxyhydroxide compared with sevelamer. Treatment adherence rates were 91.2% with sucroferric oxyhydroxide and 79.3% with sevelamer. The proportion of patients reporting at least one treatment-emergent adverse event was 86.0% with sucroferric oxyhydroxide and 93.1% with sevelamer. The most common adverse events with both treatments were gastrointestinal: diarrhea and discolored feces with sucroferric oxyhydroxide and nausea, vomiting and constipation with sevelamer.
Sucroferric oxyhydroxide is noninferior to sevelamer for controlling serum phosphorus in patients undergoing PD, while providing a relatively low pill burden and a high rate of adherence.
蔗糖铁氧羟化物是一种非钙、铁基的磷酸盐结合剂，与碳酸司维拉姆（sevelamer）相比，在接受透析治疗的患者中进行的 3 期研究中，它具有持续的血清磷控制、良好的耐受性和较低的服药负担。这项亚分析检查了蔗糖铁氧羟化物和 sevelamer 在腹膜透析（PD）患者人群中的疗效和耐受性。
初始研究（NCT01324128）及其扩展研究（NCT01464190）为多中心、3 期、开放标签、随机（2:1）、活性对照试验，比较了蔗糖铁氧羟化物（1.0-3.0g/天）与 sevelamer（2.4-14.4g/天）在总共 52 周内对 1055 例透析患者的疗效，其中 84 例（8.1%）患者接受 PD 治疗，有资格进行疗效分析（蔗糖铁氧羟化物组，n=56；sevelamer 组，n=28）。两组患者彼此之间以及与总体研究人群之间均具有广泛的可比性。在第 12 周时，两种磷酸盐结合剂都能使血清磷浓度同样降低（与基线相比，平均变化-0.6mmol/L）。在 52 周期间，蔗糖铁氧羟化物有效地将血清磷浓度降低到与 sevelamer 相似的程度；分别有 62.5%和 64.3%的患者磷浓度低于肾脏病预后质量倡议（Kidney Disease Outcomes Quality Initiative）的目标范围（≤1.78mmol/L）。与 sevelamer 相比，蔗糖铁氧羟化物的用药负担更低（3.4±1.3 片/天对 8.1±3.7 片/天），达到了相同的效果。蔗糖铁氧羟化物的治疗依从率为 91.2%，sevelamer 的治疗依从率为 79.3%。蔗糖铁氧羟化物组和 sevelamer 组分别有 86.0%和 93.1%的患者报告至少有一次治疗出现的不良事件。两种治疗方法最常见的不良事件都是胃肠道不良事件：蔗糖铁氧羟化物组为腹泻和粪便变色，sevelamer 组为恶心、呕吐和便秘。
在接受 PD 治疗的患者中，蔗糖铁氧羟化物在控制血清磷方面与 sevelamer 相当，但用药负担较低，且治疗依从率较高。
