研究人员通过一项多中心的前瞻性试验,评价了一种不吸收的钾粘合剂Patiromer的安全性和有效性。研究发现患有慢性肾病并接受RAAS抑制剂治疗的病人,同时合并高钾血症时,Patiromer治疗与血钾水平降低有关,与对照组相比,高钾血症复发也减少。

—2014年11月21日《新英格兰医学杂志》

中文译文


 

【题目】Patiromer治疗肾病合并高钾血症并接受RAAS抑制剂治疗的病人
【译文】
背景:高钾血症增加死亡的风险,并限制了高危病人使用肾素-血管紧张素-醛固酮系统(RAAS)抑制剂。我们通过一项多中心的前瞻性试验,评价了一种不吸收的钾粘合剂Patiromer的安全性和有效性。
方法:接受RAAS抑制剂治疗的慢性肾病病人和血钾在5.1到6.5mmol/L的病人,接受4周(初始治疗阶段)的Patiromer治疗(初始剂量为4.2g或8.4g,每天2次);主要效应终点是到第4周时,基于起始水平的血钾变化平均水平。符合条件的病人在第4周末(起始血钾为5.5到6.5mmol/L,治疗后降低了3.8到5.1mmol/L)进入8周随机撤出治疗阶段,他们随机分配到继续接受Patiromer治疗或接受安慰剂治疗。主要效应终点是该阶段前4周,两组之间血钾水平改变的中位数。
结果:在初始治疗阶段,237个病人接受Patiromer治疗,在3天后进行的随访中至少检测了1次血钾,血钾水平变化均值(±SE)为-1.01±0.03mmol/L(P<0.001)。在第4周,76%(95%可行区间 70-81)的病人达到目标血钾水平。之后的随机撤出阶段,107个病人随机分配为接受Patiromer(55人)或安慰剂(52人)治疗。血钾从该阶段的初始水平上升的中位数,在安慰剂组较Patiromer组高(P<0.001);8周之后,安慰剂组高钾血症(血钾<5.5mmol/L)复发率为60%,相比之下,Patiromer组为15%(P<0.001)。轻到中度便秘是最常见的副反应事件(11%的病人出现);3%病人发生低钾血症。
结论:患有慢性肾病并接受RAAS抑制剂治疗的病人,同时合并高钾血症时,Patiromer治疗与血钾水平降低有关,与对照组相比,高钾血症复发也减少。
英文原稿


 

[Title] Patiromer in Patients with Kidney Disease and Hyperkalemia Receiving RAAS Inhibitors

[Authors] Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; the OPAL-HK Investigators.
[Abstract]
BACKGROUND: Hyperkalemia 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.
METHODS: Patients 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.
RESULTS: In 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<0.001). At week 4, 76% (95% confidence interval, 70 to 81) of the patients had reached the target potassium level (3.8 to <5.1 mmol per liter). Subsequently, 107 patients were randomly assigned to patiromer (55 patients) or placebo (52 patients) for the randomized withdrawal phase. The median increase in the potassium level from baseline of that phase was greater with placebo than with patiromer (P<0.001); a recurrence of hyperkalemia (potassium level, ≥5.5 mmol per liter) occurred in 60% of the patients in the placebo group as compared with 15% in the patiromer group through week 8 (P<0.001). Mild-to-moderate constipation was the most common adverse event (in 11% of the patients); hypokalemia occurred in 3%.
CONCLUSIONS: In patients with chronic kidney disease who were receiving RAAS inhibitors and who had hyperkalemia, patiromer treatment was associated with a decrease in serum potassium levels and, as compared with placebo, a reduction in the recurrence of hyperkalemia.

 

原文网址:
http://www.nejm.org/doi/full/10.1056/NEJMoa1410853

 

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