Roggeri Daniela Paola, Cozzolino Mario, Mazzaferro Sandro, Brancaccio Diego, Paoletti Ernesto, Roggeri Alessandro, Costanzo Anna Maria, di Luzio Paparatti Umberto, Festa Vincenzo, Messa Piergiorgio
ProCure Solutions, Nembro, Bergamo, Italy.
Department of Health Sciences, University of Milan, Milan, Italy.
Int J Nephrol Renovasc Dis. 2014 Dec 16;8:1-6. doi: 10.2147/IJNRD.S72011. eCollection 2015.
The aim of this analysis was to estimate biochemical parameters and the costs of treatment of secondary hyperparathyroidism (SHPT) in a subpopulation of the FARO-2 study.
The FARO-2 observational study aimed at evaluating the patterns of treatment for SHPT in naïve hemodialysis patients. Data related to pharmacological treatments and biochemical parameters (parathyroid hormone [PTH], calcium, phosphate) were recorded at entry to hemodialysis (baseline) and 6 months later (second survey). The analysis was performed from the Italian National Health Service perspective.
Two prominent treatment groups were identified, ie, one on oral calcitriol (n=105) and the other on intravenous paricalcitol (n=33); the intravenous calcitriol and intravenous paricalcitol + cinacalcet combination groups were not analyzed due to low patient numbers. At baseline, serum PTH levels were significantly higher in the intravenous paricalcitol group (P<0.0001). At the second survey, the intravenous paricalcitol group showed a higher percentage of patients at target for PTH than in the oral calcitriol group without changing the percentage of patients at target for phosphate. Moreover, between baseline and the second survey, intravenous paricalcitol significantly increased both the percentage of patients at target for PTH (P=0.033) and the percentage of patients at target for the combined endpoint PTH, calcium, and phosphate (P=0.001). The per-patient weekly pharmaceutical costs related to SHPT treatment, erythropoietin-stimulating agents and phosphate binders accounted for 186.32€ and 219.94€ at baseline for oral calcitriol and intravenous paricalcitol, respectively, while after 6 months, the costs were 180.51€ and 198.79€, respectively. Either at the beginning of dialysis or 6 months later, the total cost of SHPT treatment was not significantly lower in the oral calcitriol group compared with the intravenous paricalcitol group, with a difference among groups that decreased by 46% between the two observations. The cost of erythropoietin stimulating agents at the second survey was lower (-22%) in the intravenous paricalcitol group than in the oral calcitriol group (132.13€ versus 168.36€, respectively).
Intravenous paricalcitol significantly increased the percentage of patients at target for the combined endpoint of PTH, calcium, and phosphate (P=0.001). The total cost of treatment for the patients treated with intravenous paricalcitol 6 months after entry to dialysis was not significantly higher than the cost for patients treated with oral calcitriol.
本分析旨在评估FARO - 2研究亚组中继发性甲状旁腺功能亢进症（SHPT）的生化参数及治疗成本。
FARO - 2观察性研究旨在评估初治血液透析患者SHPT的治疗模式。记录血液透析开始时（基线）及6个月后（第二次调查）与药物治疗及生化参数（甲状旁腺激素[PTH]、钙、磷）相关的数据。分析是从意大利国家医疗服务体系的角度进行的。
确定了两个主要治疗组，即一组使用口服骨化三醇（n = 105），另一组使用静脉注射帕立骨化醇（n = 33）；由于患者数量少，未对静脉注射骨化三醇组及静脉注射帕立骨化醇+西那卡塞联合治疗组进行分析。在基线时，静脉注射帕立骨化醇组的血清PTH水平显著更高（P < 0.0001）。在第二次调查时，静脉注射帕立骨化醇组达到PTH目标值的患者百分比高于口服骨化三醇组，而达到磷目标值的患者百分比未改变。此外，在基线至第二次调查期间，静脉注射帕立骨化醇显著提高了达到PTH目标值的患者百分比（P = 0.033）以及达到PTH、钙和磷联合终点目标值的患者百分比（P = 0.001）。与SHPT治疗、促红细胞生成素和磷结合剂相关的每位患者每周药物成本，在基线时口服骨化三醇组和静脉注射帕立骨化醇组分别为186.32€和219.94€，而6个月后，成本分别为180.51€和198.79€。无论是在透析开始时还是6个月后，口服骨化三醇组SHPT治疗的总成本与静脉注射帕立骨化醇组相比并无显著降低，两组之间的差异在两次观察之间减少了46%。在第二次调查时，静脉注射帕立骨化醇组促红细胞生成素的成本低于口服骨化三醇组（分别为132.13€和168.36€，降低了22%）。
静脉注射帕立骨化醇显著提高了达到PTH、钙和磷联合终点目标值的患者百分比（P = 0.001）。透析开始6个月后接受静脉注射帕立骨化醇治疗的患者的总治疗成本并不显著高于接受口服骨化三醇治疗的患者。
