Department of Medicine, Zucker School of Medicine at Hofstra/Northwell, 100 Community Dr, Great Neck, NY, 11021, USA.
Department of Renal Medicine, King's College Hospital NHS Trust, London, UK.
BMC Nephrol. 2022 Feb 8;23(1):59. doi: 10.1186/s12882-021-02569-7.
Sodium zirconium cyclosilicate (SZC) is an effective and well-tolerated treatment for hyperkalemia in maintenance hemodialysis patients. In post-hoc analyses of the phase 3b DIALIZE study, we examined the spectrum of potassium responses to SZC.
Post-hoc analyses with SZC and placebo included: the number of long interdialytic interval (LIDI) visits during the 4-week evaluation period where patients attained pre-dialysis serum potassium (sK) concentrations of 4.0-5.0 and 4.0-5.5 mmol/L; potassium gradient (the difference between pre-dialysis sK and dialysate potassium) at days 36, 43, 50, and 57, and change from baseline to the end of treatment (EOT) using categories of potassium gradient (1 to < 2, 2 to < 3, 3 to < 4, and ≥ 4 mmol/L).
A greater proportion of patients achieved the ranges of pre-dialysis sK concentration with SZC versus placebo for ≥1, ≥ 2, ≥ 3, and 4 LIDI visits over 4 weeks; 23.7 and 48.5% of patients in the SZC group achieved pre-dialysis sK concentrations of 4.0-5.0 and 4.0-5.5 mmol/L, respectively, at all 4 LIDI visits. Baseline mean potassium gradient was similar with SZC and placebo. At day 57, mean (standard deviation) potassium gradient was 2.78 (0.08) mmol/L with SZC and 3.52 (0.08) mmol/L with placebo; mean difference (95% confidence interval) was - 0.74 mmol/L (- 0.97 to - 0.52). A greater reduction in potassium gradient category from baseline towards lower-risk categories at EOT was observed with SZC versus placebo.
These analyses expand our knowledge of the spectrum of potassium responses with SZC in hyperkalemic hemodialysis patients.
NCT03303521 .
硅酸锆酸钠（SZC）是一种有效且耐受性良好的维持性血液透析患者高钾血症治疗药物。在 3b 期 DIALIZE 研究的事后分析中，我们检查了 SZC 对钾的反应谱。
SZC 和安慰剂的事后分析包括：在 4 周评估期间，患者实现透析前血清钾（sK）浓度为 4.0-5.0 和 4.0-5.5mmol/L 的长间歇透析间隔（LIDI）次数；第 36、43、50 和 57 天的钾梯度（透析前 sK 与透析液钾之间的差异），以及使用钾梯度类别（1 至<2、2 至<3、3 至<4 和≥4mmol/L）从基线到治疗结束（EOT）的变化。
与安慰剂相比，SZC 组在 4 周内实现≥1、≥2、≥3 和 4 次 LIDI 访问的透析前 sK 浓度范围的患者比例更大；SZC 组分别有 23.7%和 48.5%的患者在所有 4 次 LIDI 访问时达到透析前 sK 浓度为 4.0-5.0 和 4.0-5.5mmol/L。SZC 和安慰剂的基线平均钾梯度相似。第 57 天，SZC 的平均（标准差）钾梯度为 2.78（0.08）mmol/L，安慰剂为 3.52（0.08）mmol/L；平均差异（95%置信区间）为-0.74mmol/L（-0.97 至-0.52）。与安慰剂相比，SZC 组在 EOT 时从基线向低风险类别更显著地降低了钾梯度类别。
这些分析扩展了我们对 SZC 治疗高钾血症血液透析患者的钾反应谱的认识。
NCT03303521。
