P. Monciino, L. Magagnoli, E. Fasulo, Michela Frittoli, Chiara Leotta, Hoang Nhat Pham, A. Stucchi, P. Ciceri, A. Galassi, M. Cozzolino
{"title":"Etelcalcetide治疗中重度继发性甲状旁腺功能亢进症血液透析患者的疗效和安全性","authors":"P. Monciino, L. Magagnoli, E. Fasulo, Michela Frittoli, Chiara Leotta, Hoang Nhat Pham, A. Stucchi, P. Ciceri, A. Galassi, M. Cozzolino","doi":"10.3390/kidneydial2030044","DOIUrl":null,"url":null,"abstract":"Background. Secondary hyperparathyroidism (SHPT) is a major risk factor for cardiovascular events and all-cause mortality in hemodialysis (HD) patients. The purpose of our study was to evaluate the effects and tolerability of etelcalcetide in HD patients with SHPT. Methods. An observational study was conducted on 16 hemodialysis patients with SHPT treated with etelcalcetide. All patients were followed up for a duration of 6 months. The primary endpoints were the reduction in mean PTH ≥ 30% and ≥40% from baseline after 6 months of etelcalcetide. All patients were divided into two groups (group A versus group B) based on baseline serum PTH level prior to etelcalcetide: above and below the median serum PTH (1300 pg/mL), respectively. Results. After 6 months, a significant decrease in PTH levels was achieved by all patients receiving etelcalcetide (p = 0.015). Both primary endpoint of reduction in PTH ≥ 40% at 6 months (p = 0.01), and the secondary endpoint of reduction in median PTH values (p = 0.0001) and median percentage reduction in PTH values (p = 0.009) were significantly achieved in group A. In contrast, a greater decline of calcium (p = 0.028) and phosphorus was reached in group B than group A. Dialysis vintage ≥ 36 months, arteriovenous fistula (AVF)-based hemodialysis, post-diluition hemodiafiltration (HDF) method, and baseline values of PTH < 1300 pg/mL can positively influence the achievement of the endpoints. Furthermore, the baseline PTH < 1300 pg/mL, among these variables, was the only one showing statistically significant relevance (OR 2.28, 95% CI 1.32–3.96, p = 0.015). The history of cinacalcet use negatively correlated with the possibility to reach therapeutic targets with etelcalcetide (OR 0.47, 95% CI 0.26–0.85, p = 0.031). Treatment with etelcalcetide was well tolerated and no adverse effects were observed. Conclusions. In our study, patients with low baseline PTH levels showed a better response to etelcalcetide than patients with higher PTH levels. Consequently, the possibility to reach desirable therapeutic targets could depend on SHPT severity at the time of initiation of therapy.","PeriodicalId":74038,"journal":{"name":"Kidney and dialysis","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and Safety of Etelcalcetide in Hemodialysis Patients with Moderate to Severe Secondary Hyperparathyroidism\",\"authors\":\"P. Monciino, L. Magagnoli, E. Fasulo, Michela Frittoli, Chiara Leotta, Hoang Nhat Pham, A. Stucchi, P. Ciceri, A. Galassi, M. Cozzolino\",\"doi\":\"10.3390/kidneydial2030044\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Background. Secondary hyperparathyroidism (SHPT) is a major risk factor for cardiovascular events and all-cause mortality in hemodialysis (HD) patients. The purpose of our study was to evaluate the effects and tolerability of etelcalcetide in HD patients with SHPT. Methods. An observational study was conducted on 16 hemodialysis patients with SHPT treated with etelcalcetide. All patients were followed up for a duration of 6 months. The primary endpoints were the reduction in mean PTH ≥ 30% and ≥40% from baseline after 6 months of etelcalcetide. All patients were divided into two groups (group A versus group B) based on baseline serum PTH level prior to etelcalcetide: above and below the median serum PTH (1300 pg/mL), respectively. Results. After 6 months, a significant decrease in PTH levels was achieved by all patients receiving etelcalcetide (p = 0.015). Both primary endpoint of reduction in PTH ≥ 40% at 6 months (p = 0.01), and the secondary endpoint of reduction in median PTH values (p = 0.0001) and median percentage reduction in PTH values (p = 0.009) were significantly achieved in group A. In contrast, a greater decline of calcium (p = 0.028) and phosphorus was reached in group B than group A. Dialysis vintage ≥ 36 months, arteriovenous fistula (AVF)-based hemodialysis, post-diluition hemodiafiltration (HDF) method, and baseline values of PTH < 1300 pg/mL can positively influence the achievement of the endpoints. Furthermore, the baseline PTH < 1300 pg/mL, among these variables, was the only one showing statistically significant relevance (OR 2.28, 95% CI 1.32–3.96, p = 0.015). The history of cinacalcet use negatively correlated with the possibility to reach therapeutic targets with etelcalcetide (OR 0.47, 95% CI 0.26–0.85, p = 0.031). Treatment with etelcalcetide was well tolerated and no adverse effects were observed. Conclusions. In our study, patients with low baseline PTH levels showed a better response to etelcalcetide than patients with higher PTH levels. 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引用次数: 0
摘要
背景。继发性甲状旁腺功能亢进(SHPT)是血液透析(HD)患者心血管事件和全因死亡率的主要危险因素。本研究的目的是评估依替卡肽对伴有SHPT的HD患者的疗效和耐受性。方法。对16例血液透析合并SHPT患者应用依替卡肽进行观察性研究。所有患者随访6个月。主要终点是使用依替卡肽6个月后平均PTH较基线降低≥30%和≥40%。所有患者根据使用替替卡肽前的基线血清PTH水平分为两组(A组和B组):分别高于和低于血清PTH中位数(1300 pg/mL)。结果。6个月后,所有接受依替卡肽治疗的患者PTH水平均显著下降(p = 0.015)。a组6个月时PTH降低≥40%的主要终点(p = 0.01),以及PTH中位值降低(p = 0.0001)和PTH中位值降低百分比(p = 0.009)的次要终点均显著达到。相比而言,B组钙和磷的下降幅度更大(p = 0.028),透析时间≥36个月,基于动静脉瘘(AVF)的血液透析,稀释后血液滤过(HDF)方法,PTH基线值< 1300 pg/mL对终点的实现有正向影响。此外,基线PTH < 1300 pg/mL是这些变量中唯一具有统计学意义的相关性(OR 2.28, 95% CI 1.32-3.96, p = 0.015)。依替卡肽的使用史与依替卡肽达到治疗目标的可能性呈负相关(OR 0.47, 95% CI 0.26-0.85, p = 0.031)。依替卡肽治疗耐受性良好,无不良反应。结论。在我们的研究中,基线PTH水平较低的患者比PTH水平较高的患者对依替卡肽的反应更好。因此,达到理想治疗目标的可能性取决于治疗开始时SHPT的严重程度。
Efficacy and Safety of Etelcalcetide in Hemodialysis Patients with Moderate to Severe Secondary Hyperparathyroidism
Background. Secondary hyperparathyroidism (SHPT) is a major risk factor for cardiovascular events and all-cause mortality in hemodialysis (HD) patients. The purpose of our study was to evaluate the effects and tolerability of etelcalcetide in HD patients with SHPT. Methods. An observational study was conducted on 16 hemodialysis patients with SHPT treated with etelcalcetide. All patients were followed up for a duration of 6 months. The primary endpoints were the reduction in mean PTH ≥ 30% and ≥40% from baseline after 6 months of etelcalcetide. All patients were divided into two groups (group A versus group B) based on baseline serum PTH level prior to etelcalcetide: above and below the median serum PTH (1300 pg/mL), respectively. Results. After 6 months, a significant decrease in PTH levels was achieved by all patients receiving etelcalcetide (p = 0.015). Both primary endpoint of reduction in PTH ≥ 40% at 6 months (p = 0.01), and the secondary endpoint of reduction in median PTH values (p = 0.0001) and median percentage reduction in PTH values (p = 0.009) were significantly achieved in group A. In contrast, a greater decline of calcium (p = 0.028) and phosphorus was reached in group B than group A. Dialysis vintage ≥ 36 months, arteriovenous fistula (AVF)-based hemodialysis, post-diluition hemodiafiltration (HDF) method, and baseline values of PTH < 1300 pg/mL can positively influence the achievement of the endpoints. Furthermore, the baseline PTH < 1300 pg/mL, among these variables, was the only one showing statistically significant relevance (OR 2.28, 95% CI 1.32–3.96, p = 0.015). The history of cinacalcet use negatively correlated with the possibility to reach therapeutic targets with etelcalcetide (OR 0.47, 95% CI 0.26–0.85, p = 0.031). Treatment with etelcalcetide was well tolerated and no adverse effects were observed. Conclusions. In our study, patients with low baseline PTH levels showed a better response to etelcalcetide than patients with higher PTH levels. Consequently, the possibility to reach desirable therapeutic targets could depend on SHPT severity at the time of initiation of therapy.