Hospital Universitario La Paz, Madrid, Instituto de Investigación Sanitaria del HULP (IdiPAZ), Madrid, Spain; Redes de Investigación Cooperativa Orientadas a Resultados en Salud (RICORS) del Instituto de Salud Carlos III, Universidad Autónoma Madrid, Madrid, Spain.
Fresenius Medical Care San Luciano, Madrid, Spain.
Nefrologia (Engl Ed). 2022 Sep-Oct;42(5):594-606. doi: 10.1016/j.nefroe.2021.04.012. Epub 2023 Feb 2.
In this study, we show the results of the subset of Spanish patients of the VERIFIE study, the first post-marketing study assessing the long-term safety and effectiveness of sucroferric oxyhydroxide (SFOH) in patients with hyperphosphatemia undergoing dialysis during clinical practice.
Patients undergoing hemodialysis and peritoneal dialysis with indication of SFOH treatment were included. Follow-up duration was 12-36 months after SFOH initiation. Primary safety variables were the incidence of adverse drug reactions (ADRs), medical events of special interest (MESIs), and variations in iron-related parameters. SFOH effectiveness was evaluated by the change in serum phosphorus levels.
A total of 286 patients were recruited and data from 282 were analyzed. Among those 282 patients, 161 (57.1%) withdrew the study prematurely and 52.5% received concomitant treatment with other phosphate binders. ADRs were observed in 35.1% of patients, the most common of which were gastrointestinal disorders (77.1%) and mild/moderate in severity (83.7%). MESIs were reported in 14.2% of patients, and 93.7% were mild/moderate. An increase in ferritin (386.66ng/mL vs 447.55ng/mL; p=0.0013) and transferrin saturation (28.07% vs 30.34%; p=0.043) was observed from baseline to the last visit (p=0.0013). Serum phosphorus levels progressively decreased from 5.69mg/dL at baseline to 4.84mg/dL at the last visit (p<0.0001), increasing by 32.2% the proportion of patients who achieved serum phosphorus levels ≤5.5mg/dL, with a mean daily SFOH dose of 1.98 pills/day.
SFOH showed a favorable effectiveness profile, a similar safety profile to that observed in the international study with most adverse events of mild/moderate severity, and a low daily pill burden in Spanish patients in dialysis.
本研究报告了 VERIFIE 研究中西班牙患者亚组的结果，该研究是首个评估在临床实践中接受透析治疗的高磷血症患者使用苏糖酸铁氧羟（SFOH）的长期安全性和有效性的上市后研究。
纳入接受血液透析和腹膜透析且有 SFOH 治疗适应证的患者。在 SFOH 开始后，随访时间为 12-36 个月。主要安全性变量为药物不良反应（ADR）、特别关注的医学事件（MESIs）和铁相关参数的变化。SFOH 的有效性通过血清磷水平的变化来评估。
共招募了 286 名患者，其中 282 名患者的数据进行了分析。在这 282 名患者中，161 名（57.1%）提前退出研究，52.5%同时接受其他磷酸盐结合剂治疗。35.1%的患者观察到 ADR，最常见的是胃肠道疾病（77.1%），且严重程度为轻度/中度（83.7%）。14.2%的患者报告了 MESI，93.7%为轻度/中度。从基线到最后一次就诊，铁蛋白（386.66ng/mL 比 447.55ng/mL；p=0.0013）和转铁蛋白饱和度（28.07%比 30.34%；p=0.043）增加。血清磷水平从基线时的 5.69mg/dL 逐渐下降到最后一次就诊时的 4.84mg/dL（p<0.0001），血清磷水平≤5.5mg/dL 的患者比例增加了 32.2%，平均每日 SFOH 剂量为 1.98 片/天。
SFOH 在西班牙透析患者中显示出良好的疗效，安全性与国际研究相似，大多数不良事件为轻度/中度严重程度，每日用药负担较低。
