Systematic Review and Meta-Analysis of Patiromer and Sodium Zirconium Cyclosilicate: A New Armamentarium for the Treatment of Hyperkalemia.

IF 3.5 2区物理与天体物理 Q2 PHYSICS, APPLIED

Applied Physics Letters Pub Date : 2017-04-01 Epub Date: 2017-03-10 DOI:10.1002/phar.1906

Calvin J Meaney, Mario V Beccari, Yang Yang, Jiwei Zhao

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引用次数: 0

Abstract

Objective: To compare and contrast the efficacy and safety of patiromer and sodium zirconium cyclosilicate (ZS-9) in the treatment of hyperkalemia.

Design: A systematic review and meta-analysis of phase II and III clinical trial data was completed.

Patients or participants: Eight studies (two phase II and four phase III trials with two subgroup analyses) were included in the qualitative analysis, and six studies (two phase II and four phase III trials) were included in the meta-analysis.

Measurements and results: Significant heterogeneity was found in the meta-analysis with an I² value ranging from 80.6-99.6%. A random-effects meta-analysis was applied for all end points. Each clinical trial stratified results by hyperkalemia severity and dosing; therefore, these were considered separate treatment groups in the meta-analysis. For patiromer, a significant -0.70 mEq/L (95% confidence interval [CI] -0.48 to -0.91 mEq/L) change was noted in potassium at 4 weeks. At day 3 of patiromer treatment, potassium change was -0.36 mEq/L (range of standard deviation 0.07-0.30). The primary end point for ZS-9-change in potassium at 48 hours-was -0.67 mEq/L (95% CI -0.45 to -0.89 mEq/L). By 1 hour after ZS-9 administration, change in potassium was -0.17 mEq/L (95% CI -0.05 to -0.30). Analysis of pooled adverse effects from these trials indicates that patiromer was associated with more gastrointestinal upset (7.6% constipation, 4.5% diarrhea) and electrolyte depletion (7.1% hypomagnesemia), whereas ZS-9 was associated with the adverse effects of urinary tract infections (1.1%) and edema (0.9%).

Conclusion: Patiromer and ZS-9 represent significant pharmacologic advancements in the treatment of hyperkalemia. Both agents exhibited statistically and clinically significant reductions in potassium for the primary end point of this meta-analysis. Given the adverse effect profile and the observed time-dependent effects, ZS-9 may play more of a role in treating acute hyperkalemia.

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帕替洛尔和环硅酸锆钠的系统回顾和元分析：治疗高钾血症的新武器。

目的比较和对比帕替洛尔和环硅酸锆钠（ZS-9）治疗高钾血症的疗效和安全性：设计：对 II 期和 III 期临床试验数据进行系统回顾和荟萃分析：定性分析包括 8 项研究（2 项 II 期临床试验和 4 项 III 期临床试验以及 2 项亚组分析），荟萃分析包括 6 项研究（2 项 II 期临床试验和 4 项 III 期临床试验）：在荟萃分析中发现了明显的异质性，I2 值介于 80.6-99.6% 之间。所有终点均采用随机效应荟萃分析。每项临床试验都根据高钾血症的严重程度和剂量对结果进行了分层；因此，在荟萃分析中，这些试验被视为不同的治疗组。对于帕替洛尔，4周时血钾的变化幅度为-0.70 mEq/L（95% 置信区间 [CI] -0.48 至 -0.91 mEq/L）。在帕替洛尔治疗的第 3 天，血钾变化为-0.36 mEq/L（标准偏差范围为 0.07-0.30）。ZS-9的主要终点--48小时的血钾变化为-0.67毫升/升（95% CI -0.45 至 -0.89毫升/升）。服用 ZS-9 1 小时后，血钾变化为 -0.17 mEq/L（95% CI -0.05 至 -0.30）。对这些试验的不良反应汇总分析表明，帕替洛尔与更多的胃肠道不适（7.6%便秘、4.5%腹泻）和电解质消耗（7.1%低镁血症）有关，而ZS-9与尿路感染（1.1%）和水肿（0.9%）的不良反应有关：结论：帕替洛尔和ZS-9是治疗高钾血症的重大药理进步。在这项荟萃分析的主要终点上，两种药物都能在统计学和临床上显著降低血钾。考虑到不良反应情况和观察到的时间依赖性效应，ZS-9 在治疗急性高钾血症方面可能会发挥更大的作用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Applied Physics Letters 物理-物理：应用

CiteScore

6.40

自引率

10.00%

发文量

1821

审稿时长

1.6 months

期刊介绍： Applied Physics Letters (APL) features concise, up-to-date reports on significant new findings in applied physics. Emphasizing rapid dissemination of key data and new physical insights, APL offers prompt publication of new experimental and theoretical papers reporting applications of physics phenomena to all branches of science, engineering, and modern technology. In addition to regular articles, the journal also publishes invited Fast Track, Perspectives, and in-depth Editorials which report on cutting-edge areas in applied physics. APL Perspectives are forward-looking invited letters which highlight recent developments or discoveries. Emphasis is placed on very recent developments, potentially disruptive technologies, open questions and possible solutions. They also include a mini-roadmap detailing where the community should direct efforts in order for the phenomena to be viable for application and the challenges associated with meeting that performance threshold. Perspectives are characterized by personal viewpoints and opinions of recognized experts in the field. Fast Track articles are invited original research articles that report results that are particularly novel and important or provide a significant advancement in an emerging field. Because of the urgency and scientific importance of the work, the peer review process is accelerated. If, during the review process, it becomes apparent that the paper does not meet the Fast Track criterion, it is returned to a normal track.