Division of Nephrology, Department of Internal Medicine, Showa University Northern Yokohama Hospital, Chigasaki-chuo 35-1, Tsuzuki, Yokohama, Kanagawa, 224-8503, Japan.
Division of Nephrology, Endocrinology and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Clin Exp Nephrol. 2022 Dec;26(12):1223-1232. doi: 10.1007/s10157-022-02270-5. Epub 2022 Sep 5.
Coronary artery calcification (CAC) is predictive of cardiovascular events. We assessed whether a non-calcium-based phosphate binder, lanthanum carbonate (LC), could delay CAC progression compared with a calcium-based phosphate binder, calcium carbonate (CC), in hemodialysis patients.
This was a subsidiary of the LANDMARK study, which is a multicenter, open-label, randomized control study comparing LC and CC for cardiovascular events among Japanese hemodialysis patients with hyperphosphatemia who were at risk of vascular calcification. Participants were randomly assigned (1:1) to receive LC or CC. The changes in the total Agatston score of CAC 2 years from baseline were the primary outcome. Secondary outcomes included the changes in the total Agatston score at 1 year from baseline and the changes in serum phosphate, corrected calcium, and intact parathyroid hormone concentrations.
Of 239 patients, 123 comprised the full analysis set. The median daily drug dose (mg) was 750 [interquartile range (IQR), 750‒1500] in the LC group and 3000 (IQR, 3000‒3000) in the CC group; it remained constant throughout the study period. There was no significant difference in the change in total Agatston score from baseline to 2 years between the LC and CC groups [368 (95% confidence interval, 57-680) in the LC group vs. 611 (105-1118) in the CC group; difference, 243 (- 352-838)].
LC-based treatment for hyperphosphatemia did not delay CAC for 2 years compared with CC-based treatment in hemodialysis patients with at least one risk factor for vascular calcification.
冠状动脉钙化(CAC)可预测心血管事件。我们评估了与碳酸钙(CC)相比,一种非钙基磷酸盐结合剂,碳酸镧(LC),是否可以延迟血液透析患者 CAC 的进展。
这是 LANDMARK 研究的一个分支,这是一项多中心、开放标签、随机对照研究,比较了 LC 和 CC 在有血管钙化风险的日本血液透析高磷血症患者中的心血管事件。参与者被随机分配(1:1)接受 LC 或 CC。从基线开始 2 年 CAC 的总 Agatston 评分变化是主要结局。次要结局包括从基线开始 1 年 CAC 的总 Agatston 评分变化和血清磷酸盐、校正钙和完整甲状旁腺激素浓度的变化。
在 239 名患者中,有 123 名患者纳入全分析集。LC 组的中位日药物剂量(mg)为 750 [四分位间距(IQR),750-1500],CC 组为 3000(IQR,3000-3000);整个研究期间保持不变。LC 组和 CC 组从基线到 2 年的总 Agatston 评分变化无显著差异[LC 组 368(95%置信区间,57-680)与 CC 组 611(105-1118);差值,243(-352-838)]。
与 CC 相比,至少有一种血管钙化危险因素的血液透析患者中,使用 LC 治疗高磷血症并未延迟 CAC 2 年的进展。