Patiromer in Patients with Kidney Disease and Hyperkalemia Receiving RAAS Inhibitors
Patiromer in Patients with Kidney Disease and Hyperkalemia Receiving RAAS Inhibitors
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DOI：
10.1056/nejmoa1410853
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发表时间：
2015-01-15
影响因子：
158.5
通讯作者：
Pitt, Bertram
中科院分区：
文献类型：
--
作者：
Weir, Matthew R.;Bakris, George L.;Pitt, Bertram
背景高钾血症增加了死亡风险，限制了高风险患者使用肾素-血管紧张素-醛固酮系统（RAAS）抑制剂。我们在一项多中心前瞻性试验中评估了patiromer的安全性和有效性，patiromer是一种非吸收性钾结合剂，接受RAAS抑制剂治疗且血清钾水平为5.1至低于6.5 mmol/L的慢性肾脏疾病患者接受patiromer治疗（初始剂量为4.2 g或8.4 g，每日两次）持续4周（初始治疗期）;主要疗效终点为血清钾水平从基线至第4周的平均变化。第4周结束时的合格患者（那些基线钾水平为5.5至< 6.5 mmol/L的人，其中钾水平下降至3.8至< 5.1 mmol/L）进入为期8周的随机停药期，在此期间他们被随机分配继续服用patiromer或改用安慰剂;主要疗效终点是在该阶段的前4周内血清钾水平的中值变化的组间差异。结果在初始治疗阶段，在237例接受patiromer治疗的患者中，在第3天后的计划访视时至少进行了一次钾测量，血清钾水平的平均（+/- SE）变化为-1.01 +/- 0.03 mmol/L（P
BackgroundHyperkalemia increases the risk of death and limits the use of inhibitors of the renin-angiotensin-aldosterone system (RAAS) in high-risk patients. We assessed the safety and efficacy of patiromer, a nonabsorbed potassium binder, in a multicenter, prospective trial.MethodsPatients with chronic kidney disease who were receiving RAAS inhibitors and who had serum potassium levels of 5.1 to less than 6.5 mmol per liter received patiromer (at an initial dose of 4.2 g or 8.4 g twice a day) for 4 weeks (initial treatment phase); the primary efficacy end point was the mean change in the serum potassium level from baseline to week 4. Eligible patients at the end of week 4 (those with a baseline potassium level of 5.5 to < 6.5 mmol per liter in whom the level decreased to 3.8 to < 5.1 mmol per liter) entered an 8-week randomized withdrawal phase in which they were randomly assigned to continue patiromer or switch to placebo; the primary efficacy end point was the between-group difference in the median change in the serum potassium level over the first 4 weeks of that phase.ResultsIn the initial treatment phase, among 237 patients receiving patiromer who had at least one potassium measurement at a scheduled visit after day 3, the mean (+/- SE) change in the serum potassium level was -1.01 +/- 0.03 mmol per liter (P