John P. Middleton , Shifeng Sun , Susan Murray , Clemontina A. Davenport , James P. Daubert
{"title":"Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis","authors":"John P. Middleton , Shifeng Sun , Susan Murray , Clemontina A. Davenport , James P. Daubert","doi":"10.1016/j.ekir.2024.08.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Introduction</h3><div>Individuals with end-stage kidney disease (ESKD) maintained on hemodialysis (HD) carry a high risk of cardiac arrhythmias. This risk is heightened by episodic hyperkalemia. The purpose of the study was to investigate whether patiromer administered daily reduced episodes of hyperkalemia in those with ESKD who receive HD, and to explore whether prescription of patiromer reduced the number of significant arrhythmia events.</div></div><div><h3>Methods</h3><div>This was a prospective, randomized, open-label trial. Eligible patients with ESKD on HD were identified. Participants were randomized 1:1 to patiromer versus usual care. Those randomized to patiromer were administered the medication daily, and the dose was titrated based on serum potassium concentrations at the start of weeks 1, 2, and 3. All participants received 7-day continuous cardiac monitors at baseline and at week 4.</div></div><div><h3>Results</h3><div>Of the 33 participants who were randomized, 1 withdrew due to adverse symptoms, and 1 withdrew due to pregnancy, leaving 31 in our analytic cohort. The mean age of randomized participants was 56 years, 55% were male, 81% were Black, and 10% were Hispanic/Latino. In week 4, the number of episodes of serum potassium ≥ 5.5 mEq/l was 13 in the patiromer group and 41 in the control group; with median number of episodes of hyperkalemia in the patiromer group significantly lower than that of control group (0 vs. 3, <em>P</em> = 0.024). In week 4 continuous cardiac monitors, 6 participants had > 1000/24 h premature ventricular contractions, 5 had no sustained ventricular tachycardia (VT), 3 had atrial fibrillation, and 1 had bradycardia, with no significant differences between the groups.</div></div><div><h3>Conclusion</h3><div>Patiromer administered daily reduced the frequency of hyperkalemia in study participants with ESKD who receive thrice-weekly HD. Larger studies are needed to determine whether patiromer reduces significant cardiac events.</div></div>","PeriodicalId":17761,"journal":{"name":"Kidney International Reports","volume":null,"pages":null},"PeriodicalIF":5.7000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Kidney International Reports","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2468024924018771","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"UROLOGY & NEPHROLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Introduction
Individuals with end-stage kidney disease (ESKD) maintained on hemodialysis (HD) carry a high risk of cardiac arrhythmias. This risk is heightened by episodic hyperkalemia. The purpose of the study was to investigate whether patiromer administered daily reduced episodes of hyperkalemia in those with ESKD who receive HD, and to explore whether prescription of patiromer reduced the number of significant arrhythmia events.
Methods
This was a prospective, randomized, open-label trial. Eligible patients with ESKD on HD were identified. Participants were randomized 1:1 to patiromer versus usual care. Those randomized to patiromer were administered the medication daily, and the dose was titrated based on serum potassium concentrations at the start of weeks 1, 2, and 3. All participants received 7-day continuous cardiac monitors at baseline and at week 4.
Results
Of the 33 participants who were randomized, 1 withdrew due to adverse symptoms, and 1 withdrew due to pregnancy, leaving 31 in our analytic cohort. The mean age of randomized participants was 56 years, 55% were male, 81% were Black, and 10% were Hispanic/Latino. In week 4, the number of episodes of serum potassium ≥ 5.5 mEq/l was 13 in the patiromer group and 41 in the control group; with median number of episodes of hyperkalemia in the patiromer group significantly lower than that of control group (0 vs. 3, P = 0.024). In week 4 continuous cardiac monitors, 6 participants had > 1000/24 h premature ventricular contractions, 5 had no sustained ventricular tachycardia (VT), 3 had atrial fibrillation, and 1 had bradycardia, with no significant differences between the groups.
Conclusion
Patiromer administered daily reduced the frequency of hyperkalemia in study participants with ESKD who receive thrice-weekly HD. Larger studies are needed to determine whether patiromer reduces significant cardiac events.
期刊介绍:
Kidney International Reports, an official journal of the International Society of Nephrology, is a peer-reviewed, open access journal devoted to the publication of leading research and developments related to kidney disease. With the primary aim of contributing to improved care of patients with kidney disease, the journal will publish original clinical and select translational articles and educational content related to the pathogenesis, evaluation and management of acute and chronic kidney disease, end stage renal disease (including transplantation), acid-base, fluid and electrolyte disturbances and hypertension. Of particular interest are submissions related to clinical trials, epidemiology, systematic reviews (including meta-analyses) and outcomes research. The journal will also provide a platform for wider dissemination of national and regional guidelines as well as consensus meeting reports.