University of Rochester School of Medicine and Dentistry, Rochester, New York.
CSL Vifor, Redwood City, California.
Am J Kidney Dis. 2023 Jul;82(1):97-104. doi: 10.1053/j.ajkd.2023.01.444. Epub 2023 Mar 23.
RATIONALE & OBJECTIVE: Patients with chronic kidney disease (CKD), hyperkalemia (serum potassium [sK]>5.0 mEq/L), and hyperphosphatemia experience poor clinical outcomes. Patiromer, a potassium binder that uses calcium as the exchange ion, may also reduce serum phosphorus (sP). We characterized the effect of patiromer on sP in patients with CKD, hyperkalemia, and hyperphosphatemia.
A post hoc pooled analysis of individual-level data from the AMETHYST-DN, OPAL-HK, and TOURMALINE trials of patiromer.
SETTING & PARTICIPANTS: Patients with CKD and hyperkalemia.
Patients treated with patiromer (8.4-33.6 g/day).
Mean changes from baseline in sP, sK, serum calcium (sCa2), and serum magnesium (sMg2) after 2 and 4 weeks of treatment.
Descriptive statistics to summarize pooled data on the study outcomes from the 3 studies.
We included 578 patients in the analysis. Of these participants, 86 patients (14.9%) had baseline hyperphosphatemia of whom 75.6% (65 of 86) had CKD stage 4/5 and 31.1% (153 of 492) with sP≤4.5mg/dL had CKD stage 4/5. Among the patients with elevated sP and sKat baseline, the mean±SD reduction in sP and sKafter 4 weeks of patiromer treatment was-0.62±1.09mg/dL and-0.71± 0.51 mEq/L, respectively. Additionally, the mean±SD reduction in sMgin these patients was -0.25±0.23mg/dL while sCaremained unchanged. Both sMgand sCaremained within the normal range. Patiromer was generally well tolerated, and no serious adverse events were considered related to patiromer.
These were post hoc analyses, no placebo comparison was performed due to the design of the original studies, and the follow-up period was limited to 4 weeks.
Reductions in sP and sKto the normal range were observed after 2 weeks of patiromer treatment, and the reduction was sustained during 4 weeks of treatment among patients with non-dialysis-dependent CKD, hyperkalemia, and hyperphosphatemia. Future controlled trials are needed to establish if patiromer is useful to reduce both sKand sP in hyperkalemic patients with CKD and hyperphosphatemia.
患有慢性肾脏病（CKD）、高钾血症（血清钾[sK]>5.0mEq/L）和高磷血症的患者临床结局较差。聚克酸鉀，一种使用钙作为交换离子的钾结合剂，也可能降低血清磷（sP）。我们描述了聚克酸鉀对 CKD、高钾血症和高磷血症患者 sP 的影响。
对聚克酸鉀的 AMETHYST-DN、OPAL-HK 和 TOURMALINE 试验的个体水平数据进行事后汇总分析。
CKD 合并高钾血症患者。
接受聚克酸鉀治疗（8.4-33.6g/天）的患者。
治疗 2 周和 4 周后 sP、sK、血清钙（sCa2）和血清镁（sMg2）的基线平均变化。
使用描述性统计方法对来自 3 项研究的研究结局汇总数据进行总结。
我们对 578 名患者进行了分析。这些参与者中，86 名患者（14.9%）基线时存在高磷血症，其中 75.6%（65/86）患有 CKD 4/5 期，31.1%（153/492）sP≤4.5mg/dL 的患者患有 CKD 4/5 期。在基线 sP 和 sK 升高的患者中，聚克酸鉀治疗 4 周后 sP 和 sK 的平均（±SD）降低分别为-0.62±1.09mg/dL 和-0.71±0.51mEq/L。此外，这些患者的 sMg 平均（±SD）降低了-0.25±0.23mg/dL，而 sCa 保持不变。sMg 和 sCa 均保持在正常范围内。聚克酸鉀通常具有良好的耐受性，没有严重的不良事件被认为与聚克酸鉀有关。
这些是事后分析，由于原始研究的设计，没有进行安慰剂对照，且随访时间限制在 4 周。
在接受聚克酸鉀治疗 2 周后，sP 和 sK 降低至正常范围，在非透析依赖的 CKD、高钾血症和高磷血症患者中，治疗 4 周时，sP 和 sK 的降低持续存在。需要进行对照试验来确定聚克酸鉀是否可用于降低 CKD 和高磷血症伴高钾血症患者的 sK 和 sP。
