Supplementary Material for: Real World Use and Effects of Calcimimetics in Treating Mineral and Bone Disorder in Hemodialysis Patients

Background: Calcimimetics are used to treat mineral and bone disorder by reducing parathyroid hormone (PTH), calcium (Ca), and phosphorus (Phos). The study objectives were to assess the control of PTH, Ca, and Phos over time in patients receiving cinacalcet or etelcalcetide as well as dosing and time to discontinuation for etelcalcetide. Methods: This was a retrospective cohort study using electronic medical records from small and independent dialysis centers. Adults ≥18 years of age were identified as cinacalcet or etelcalcetide users based on the first calcimimetic received in 2018 (index date). Patients were followed from the index date until parathyroidectomy, kidney transplant, death, or end of data (December 31, 2018). Analyses of mean PTH, Ca, and Phos, as well as target achievement of PTH, Ca, and Phos were conducted over a 9-month period. Discontinuation with etelcalcetide was measured with the Kaplan-Meier estimator. Results: There were 1,346 cinacalcet patients (mean age 60.5 years, 43.5% female, and 47.1% Black) and 1,255 etelcalcetide patients (mean age 63.4 years, 46.6% female, and 38.5% Black). At baseline, the proportions in target were similar for etelcalcetide versus cinacalcet: 36 versus 38% for PTH, 79 versus 80% for Ca, and 43 versus 44% for Phos. Overall, 40–47% of cinacalcet users and 48–62% of etelcalcetide users were observed to be in target for PTH over 9 months. The proportion in target for Phos ranged from 41 to 46% for cinacalcet and 46–51% for etelcalcetide. The proportion in target for Ca ranged from 74 to 78% for cinacalcet and 60–73% for etelcalcetide. Etelcalcetide 12-month discontinuation was 37.4%. Conclusion: Both calcimimetics were effective in keeping PTH, Ca, and Phos levels within target. Patients receiving etelcalcetide tended to have lower laboratory values for PTH, Ca, and Phos over time, while patients receiving cinacalcet tended to be more likely to be in target for Ca over time.

背景：钙敏剂（calcimimetics）可通过降低甲状旁腺激素（parathyroid hormone, PTH）、钙（calcium, Ca）及磷（phosphorus, Phos）水平，治疗矿物质与骨代谢紊乱。本研究的研究目标为评估接受西那卡塞（cinacalcet）或依特卡肽（etelcalcetide）治疗的患者中，PTH、Ca及Phos随时间的控制情况，同时分析依特卡肽的给药方案与停药时间。
方法：本研究为一项回顾性队列研究，采用小型独立透析中心的电子病历数据。以2018年首次使用钙敏剂的日期作为索引日期，筛选出年龄≥18岁的成年西那卡塞使用者或依特卡肽使用者。研究对象自索引日期起开始随访，直至接受甲状旁腺切除术、肾移植、死亡或研究数据截止日期（2018年12月31日）。在9个月的随访周期内，对PTH、Ca及Phos的平均值，以及三项指标的靶目标达标情况开展分析。采用Kaplan-Meier估计法评估依特卡肽的停药情况。
结果：本研究共纳入1346例西那卡塞使用者（平均年龄60.5岁，女性占比43.5%，黑人占比47.1%）及1255例依特卡肽使用者（平均年龄63.4岁，女性占比46.6%，黑人占比38.5%）。基线时，依特卡肽组与西那卡塞组的靶目标达标比例相近：PTH达标率分别为36%与38%，Ca达标率分别为79%与80%，Phos达标率分别为43%与44%。整体而言，9个月随访期间，西那卡塞使用者中40%~47%的患者PTH达标，依特卡肽使用者中该比例为48%~62%。西那卡塞组的Phos靶目标达标率范围为41%~46%，依特卡肽组为46%~51%；西那卡塞组的Ca靶目标达标率范围为74%~78%，依特卡肽组为60%~73%。依特卡肽组12个月停药率为37.4%。
结论：两种钙敏剂均可有效将PTH、Ca及Phos水平维持在靶目标范围内。随时间推移，接受依特卡肽治疗的患者PTH、Ca及Phos的实验室检测值普遍偏低，而接受西那卡塞治疗的患者Ca靶目标达标率相对更高。