Wayne State University, Detroit, MI, USA.
Relypsa, Inc., a Vifor Pharma Company, Redwood City, CA, USA.
Prog Cardiovasc Dis. 2020 Sep-Oct;63(5):656-661. doi: 10.1016/j.pcad.2020.09.007. Epub 2020 Sep 30.
Hyperkalemia (HK) is a serious medical condition that can cause potentially fatal cardiac arrhythmias. Patients with heart failure (HF) are at risk of HK due to underlying chronic kidney disease and use of guideline-recommended renin-angiotensin-aldosterone system inhibitors. Patiromer, a sodium-free, non-absorbed potassium (K) binder, is indicated for the treatment of HK.
To evaluate the consistency of patiromer's effect on lowering serum K in patients with HF and HK using pooled data from three clinical trials.
This post-hoc analysis evaluated the efficacy and safety of patiromer for management of HK over a 4-week treatment period using combined data from three clinical trials (AMETHYST-DN, OPAL-HK and TOURMALINE). Eligible patients had HK (serum K > 5.0 mEq/L) at study entry. Starting doses of patiromer ranged from 8.4 to 33.6 g/day. In this analysis, efficacy was assessed as the mean (± standard error [SE]) change in serum K from baseline to Week 4. Safety outcomes evaluated included the incidence and severity of adverse events (AEs) during the 4-week treatment period.
In total, 653 patients who received ≥1 dose of patiromer were evaluable for efficacy (214 diagnosed with HF and 439 without HF). Mean baseline serum K was 5.4 mEq/L. Patient characteristics were generally similar between the HF and non-HF subgroups. Serum K decreased to <5.0mEq/L within one week of patients starting patiromer, reaching a nadir after 3 weeks in both the HF and non-HF subgroups (4.59 mEq/L and 4.64 mEq/L, respectively). The mean ± SE change from baseline to Week 4 in serum K was -0.79 ± 0.06 mEq/L (95% CI: -0.91, -0.68) in patients with HF and - 0.75 ± 0.02 mEq/L (95% CI: -0.79, -0.70) in patients without HF. AEs occurred in 31% of patients with HF and 37% of patients without HF and were mostly mild or moderate in severity. The most common AEs were constipation (HF patients: 7%, non-HF patients: 5%) and diarrhea (HF patients: 2%, non-HF patients: 4%). AEs leading to discontinuation of patiromer occurred in 7% of patients with HF and in 3% of patients without HF.
In this pooled analysis of patients with HK, patiromer was generally well tolerated and reduced serum K similarly in patients with and without HF over 4 weeks.
高钾血症（HK）是一种严重的医学病症，可能导致潜在致命的心律失常。由于潜在的慢性肾脏疾病和使用指南推荐的肾素-血管紧张素-醛固酮系统抑制剂，心力衰竭（HF）患者有发生 HK 的风险。聚对苯二甲酸丁二醇酯（patiromer）是一种不含钠、不被吸收的钾（K）结合剂，适用于治疗 HK。
使用三项临床试验的汇总数据评估聚对苯二甲酸丁二醇酯降低 HF 和 HK 患者血清 K 的效果的一致性。
这项事后分析使用三项临床试验（AMETHYST-DN、OPAL-HK 和 TOURMALINE）的汇总数据，评估了聚对苯二甲酸丁二醇酯在 4 周治疗期间治疗 HK 的疗效和安全性。合格患者在研究入组时 HK（血清 K>5.0mEq/L）。聚对苯二甲酸丁二醇酯的起始剂量范围为 8.4 至 33.6g/天。在这项分析中，疗效评估为从基线到第 4 周血清 K 的平均（±标准误差[SE]）变化。在 4 周治疗期间评估的安全性结果包括不良事件（AE）的发生率和严重程度。
共有 653 名接受了至少一剂聚对苯二甲酸丁二醇酯的患者可评估疗效（214 名诊断为 HF，439 名无 HF）。平均基线血清 K 为 5.4mEq/L。HF 和非 HF 亚组患者的特征一般相似。患者开始服用聚对苯二甲酸丁二醇酯后一周内血清 K 降至<5.0mEq/L，HF 和非 HF 亚组在第 3 周达到最低点（分别为 4.59mEq/L 和 4.64mEq/L）。HF 患者从基线到第 4 周血清 K 的平均变化为-0.79±0.06mEq/L（95%CI：-0.91，-0.68），非 HF 患者为-0.75±0.02mEq/L（95%CI：-0.79，-0.70）。HF 患者中 31%和非 HF 患者中 37%发生 AE，大多数为轻度或中度严重程度。最常见的 AE 是便秘（HF 患者：7%，非 HF 患者：5%）和腹泻（HF 患者：2%，非 HF 患者：4%）。因 AE 导致聚对苯二甲酸丁二醇酯停药的情况在 HF 患者中发生 7%，在非 HF 患者中发生 3%。
在这项 HK 患者的汇总分析中，聚对苯二甲酸丁二醇酯总体耐受性良好，在 4 周内对 HF 和非 HF 患者的血清 K 降低效果相似。
