Real world evaluation of etelcalcetide in the treatment of secondary hyperparathyroidism in hemodialysis patients in Argentina.

Daniela Wojtowicz, Gustavo Laham, Mariano Forrester, Elisa Del Valle, Adriana Peñalba, Graciela Filannino, Andrea Sammartino, Cecilia Mengarelli, Guillermo Rosa-Diez, Armando Luis Negri
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Abstract

Introduction: Secondary hyperparathyroidism (sHPT) is a common complication in patients with chronic kidney disease (CKD). Recently, etelcalcetide (EC), an intravenous calcimimetic, has been introduced as a treatment. We evaluated the efficacy of EC in treating sHPT.

Methods: We conducted a multicenter, observational, retrospective study involving hemodialysis patients with sHPT, treated for at least 3 months with EC. We analyzed baseline and follow-up values of intact parathyroid hormone (iPTH), calcium (Ca), phosphate (P), and alkaline phosphatase (ALP). Age, sex, time on dialysis, dialysate calcium concentration, and use of active vitamin D and phosphate binders were also recorded. Patients were divided into those receiving EC as de novo or after at least 3 months of cinacalcet treatment, and according to sHPT severity: PTH <1000 and >1000 pg/mL.

Results: The study included 196 patients. Mean age was 52 ± 15 years; 52.3% were male. Median time on hemodialysis was 46.5 (20-72) months. Significant reductions were observed in baseline iPTH (1053 pg/mL), Ca (8.7 mg/dL), and P (5.7 mg/dL) over 2 years (p < 0.0001), while ALP levels remained stable. iPTH reduction >30% was achieved in 37.5%, 64%, 66.7%, and 62.5% of patients at 3, 6, 12, and 24 months, respectively. EC was administered as initial treatment in 53% of patients, while 47% were switched from cinacalcet. Significantly iPTH reduction was observed in both groups. Greater reductions were noted in patients with initial PTH >1000 pg/mL (p = 0.009). Two patients discontinued due to severe hypocalcemia.

Conclusions: EC effectively lowered iPTH and P levels, with a sustained effect over 2 years.

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阿根廷对依替卡西肽治疗血液透析患者继发性甲状旁腺功能亢进症的真实世界评估。
简介继发性甲状旁腺功能亢进症(sHPT)是慢性肾脏病(CKD)患者常见的并发症。最近,静脉注射钙离子拮抗剂依替卡西肽(EC)作为一种治疗方法问世。我们评估了EC治疗sHPT的疗效:我们进行了一项多中心、观察性、回顾性研究,研究对象为接受 EC 治疗至少 3 个月的 sHPT 血液透析患者。我们分析了完整甲状旁腺激素(iPTH)、钙(Ca)、磷酸盐(P)和碱性磷酸酶(ALP)的基线值和随访值。我们还记录了患者的年龄、性别、透析时间、透析液钙浓度以及活性维生素 D 和磷酸盐结合剂的使用情况。根据 sHPT 的严重程度,将患者分为新接受 EC 者和接受至少 3 个月西那卡塞治疗后接受 EC 者:PTH 1000 pg/mL:研究包括 196 名患者。平均年龄为 52 ± 15 岁,52.3% 为男性。血液透析时间中位数为 46.5 (20-72) 个月。在 2 年的时间里,观察到基线 iPTH(1053 pg/mL)、Ca(8.7 mg/dL)和 P(5.7 mg/dL)显著降低(p 30%),分别有 37.5%、64%、66.7% 和 62.5%的患者在 3、6、12 和 24 个月时达到了这一目标。53%的患者在初始治疗时使用了EC,47%的患者是从西那卡西特转用EC的。两组患者的 iPTH 均显著降低。初始 PTH >1000 pg/mL 的患者的降幅更大(p = 0.009)。两名患者因严重低钙血症而停药:EC能有效降低iPTH和P水平,且效果可持续2年。
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