Selamerex: regional real-world practice and perspective of therapy optimisation

T. A. Yagupova, O. Kurochkina, O. A. Minchenkova, Yu. I. Sevalneva, P. A. Bubnova, A. V. Sokolov, K. Vishnevskii, D. Sadovskaya
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Abstract

 Перенести в английский вариант   BACKGROUND. Hyperphosphatemia in CKD is spread widely, represents as independent factor of mortality at all stages of CKD, after transplantation, reduces the effectiveness of nephroprotection, leads to vascular calcification, stimulates hyperparathyroidism. Achieving the phosphatemia target is a difficult task and is based on a combination of a hypophosphate diet, effective dialysis, the antihyperparathyroidic measures and the phosphate-binders (PBs).   THE AIM. The aim is to evaluate the effectiveness of sevelamertherapy in real clinical practice as part of a hypophosphatemic strategy with clarification of the conditions and measures under which it is optimal.   PATIENTS AND METHODS. In an eight-month study in a region where there are no restrictions on access to calcium-free PBs, 127 patients were included in the study after the "washing period ": the of sevelamer doses were titrated until phosphatemia reaches below 1.58 mmol/l in parallel with individual measures of four-component hypophosphatemic strategy.   RESULTS. From the starting dose of 3-6 tablets/day, 38 patients experienced either dose increase (+ 1016 ± 760 mg) or in 28 patients– decrease (- 1427 ± 1059 mg). By the third month of therapy, the proportion of patients with phosphatemia < 1.58 mmol/l reached 70 %, < 1.78 mmol/l – 90 %. The decrease magnitude depended on the initial phosphatemia, the level of PTH (maximum in the range of 150-600 pg/ml), occurs more slowly in men. During therapy, there was a decrease in the need for antihyperparathyroid therapy in the absence of dynamics in the parathyroid hormone level. In multiple regression analysis models, the independent factors associated with phosphatemia during treatment were sevelamer dose, dialysis dose, baseline phosphate and parathyroid hormone levels; the magnitude of phosphatemia reduction was independently associated with sevelamer dose, dialysis dose, baseline parathyroid hormone level, and assessment of treatment compliance.   CONCLUSION. Sevelamer in a moderate well–tolerated doses as part of an individualized hyperphosphatemia correction strategy is able to achieve target phosphatemia (< 1.58 mmol/L) in 70 % of cases, and relatively safe level (< 1.78 mmol/L) – in 90 %.
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Selamerex:区域现实世界的实践和治疗优化的观点
Перенести Перенести английский вариант背景。高磷血症在CKD中广泛传播,是CKD各阶段死亡的独立因素,移植后降低肾保护的有效性,导致血管钙化,刺激甲状旁腺功能亢进。实现磷血症目标是一项艰巨的任务,需要结合低磷酸盐饮食、有效透析、抗甲状旁腺功能亢进措施和磷酸盐结合剂(PBs)。的目标。目的是评估sevelamertherapy在实际临床实践中的有效性,作为低磷策略的一部分,并明确其最佳条件和措施。患者和方法。在一个对获得无钙PBs没有限制的地区进行的一项为期8个月的研究中,127名患者在“洗涤期”后被纳入研究:与四组分低磷策略的个体测量平行,滴定七维拉默剂量直到磷血症达到1.58 mmol/l以下。结果。从起始剂量3-6片/天开始,38例患者的剂量增加(+ 1016±760 mg)或28例患者的剂量减少(- 1427±1059 mg)。到治疗第3个月,磷血症< 1.58 mmol/l的患者比例达到70%,< 1.78 mmol/l的患者比例达到90%。下降幅度取决于初始磷血症,甲状旁腺激素水平(最高在150-600 pg/ml范围内)在男性中发生较慢。在治疗期间,在甲状旁腺激素水平缺乏动态变化的情况下,抗甲状旁腺功能亢进治疗的需求减少。在多元回归分析模型中,治疗期间与磷血症相关的独立因素有:西维拉默剂量、透析剂量、基线磷酸盐和甲状旁腺激素水平;磷血症减少的程度与司维拉默剂量、透析剂量、基线甲状旁腺激素水平和治疗依从性评估独立相关。结论。作为个体化高磷血症纠正策略的一部分,中等耐受剂量的Sevelamer能够在70%的病例中达到目标磷血症(< 1.58 mmol/L),在90%的病例中达到相对安全水平(< 1.78 mmol/L)。
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