Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial.

Changes With Lanthanum Carbonate, Calcium Acetate, and Phosphorus Restriction in CKD: A Randomized Controlled Trial.
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DOI:
10.1016/j.ekir.2018.03.011
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发表时间:
2018-07
影响因子:
6
通讯作者:
Jarmukli N
Jarmukli N
中科院分区:
医学2区
文献类型:
--
作者:
Kovesdy CP;Lu JL;Wall BM;Gyamlani G;Naseer A;Wallick A;Han Z;Thomas F;Quarles LD;Jarmukli N

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磷稳态异常在慢性肾脏病(CKD)的早期发展。目前尚不清楚其纠正是否会改善非透析依赖性CKD的临床结局。我们对120例估计肾小球滤过率为15 ~ 59 ml/min/1.73 m2和磷稳态异常(血清磷>4.6 mg/dl,甲状旁腺激素[PTH] >70 pg/ml或肾小管磷重吸收[TRP] <80%)的患者进行了随机对照、平行设计的临床试验。患者被随机分配至开放标签碳酸镧组、醋酸钙组和饮食干预组,为期1年。所有患者的共同主要结局为第12个月(与基线相比)生化(血清磷、TRP、PTH、钙、骨特异性碱性磷酸酶[bALP]和成纤维细胞生长因子23 [FGF 23])和血管参数(冠状动脉钙评分、脉搏波速度和内皮功能障碍)。次要结局是第12个月和基线之间每个参数变化的治疗间差异。所有分析均为意向性治疗。3组的基线特征相似。共有107名患者(89%)完成了12个月的随访。第12个月时差异不显著(与基线相比)除bALP外的任何结局(第12个月与基线相比的中位数[第25,第75]百分位数:13.8 [10.6,17.6] vs. 15.8 [12.1,21.1],P < .001)和FGF 23(132 [99,216] vs. 133 [86,189],P = .002)。除醋酸钙能更有效地抑制PTH外,3组所有结局的变化相似(P <0.001)。使用饮食限制或2种不同的磷结合剂限制磷吸收的1年干预导致bALP降低,表明3/4期CKD患者的骨转换改善,但生化或血管参数无其他显著变化。(ClinicalTrials.gov:NCT 01357317)
Abnormal phosphorus homeostasis develops early in chronic kidney disease (CKD). It is unclear if its correction results in improved clinical outcomes in non–dialysis dependent CKD. We conducted a randomized controlled, parallel design clinical trial in 120 patients with estimated glomerular filtration rate 15 to 59 ml/min per 1.73 m2 and abnormal phosphorus homeostasis (serum phosphorus >4.6 mg/dl, parathyroid hormone [PTH] >70 pg/ml or tubular reabsorption of phosphorus [TRP] <80%). Patients were randomized to open-label lanthanum carbonate versus calcium acetate versus dietary intervention over 1 year. The co-primary outcomes were month 12 (vs. baseline) biochemical (serum phosphorus, TRP, PTH, calcium, bone-specific alkaline phosphatase [bALP], and fibroblast growth factor 23 [FGF23]) and vascular parameters (coronary artery calcium score, pulse wave velocity, and endothelial dysfunction) in all patients. Secondary outcomes were between-treatment differences in change for each parameter between month 12 and baseline. All analyses were intention to treat. Baseline characteristics were similar in the 3 groups. A total of 107 patients (89%) completed 12 months of follow-up. Differences were not significant at month 12 (vs. baseline) for any of the outcomes except bALP (median [25th, 75th] percentile at month 12 versus baseline: 13.8 [10.6, 17.6] vs. 15.8 [12.1, 21.1], P < .001) and FGF23 (132 [99, 216] vs. 133 [86, 189], P = .002). Changes for all outcomes were similar in the 3 arms except for PTH, which was suppressed more effectively by calcium acetate (P < .001). A 1-year intervention to limit phosphorus absorption using dietary restriction or 2 different phosphorus binders resulted in decreased bALP suggesting improved bone turnover, but no other significant changes in biochemical or vascular parameters in patients with CKD stage 3/4. (ClinicalTrials.gov: NCT01357317)
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