Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis
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...
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Elsevier
2024-11-01
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| Series: | Kidney International Reports |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468024924018771 |
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| author | John P. Middleton Shifeng Sun Susan Murray Clemontina A. Davenport James P. Daubert |
| author_facet | John P. Middleton Shifeng Sun Susan Murray Clemontina A. Davenport James P. Daubert |
| author_sort | John P. Middleton |
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| description | 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. |
| format | Article |
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| issn | 2468-0249 |
| language | English |
| publishDate | 2024-11-01 |
| publisher | Elsevier |
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| series | Kidney International Reports |
| spelling | doaj-art-d3c5a036f190438abce4e7c32e2f3b3c2025-08-20T02:06:15ZengElsevierKidney International Reports2468-02492024-11-019113218322510.1016/j.ekir.2024.08.005Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With HemodialysisJohn P. Middleton0Shifeng Sun1Susan Murray2Clemontina A. Davenport3James P. Daubert4Division of Nephrology, Duke Medicine, Duke University, Durham, North Carolina, USA; Correspondence: John P. Middleton, Duke Nephrology, 2424 Erwin Road Suite 605 Durham North Carolina 27705, USA.Duke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, USADivision of Nephrology, Duke Medicine, Duke University, Durham, North Carolina, USADuke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, USADivision of Nephrology, Duke Medicine, Duke University, Durham, North Carolina, USA; Division of Cardiology, Duke Medicine, Duke University, Durham, North Carolina, USAIntroduction: 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.http://www.sciencedirect.com/science/article/pii/S2468024924018771cardiac arrhythmiacardiovascular riskclinical trialhemodialysishyperkalemia |
| spellingShingle | John P. Middleton Shifeng Sun Susan Murray Clemontina A. Davenport James P. Daubert Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis Kidney International Reports cardiac arrhythmia cardiovascular risk clinical trial hemodialysis hyperkalemia |
| title | Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis |
| title_full | Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis |
| title_fullStr | Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis |
| title_full_unstemmed | Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis |
| title_short | Randomized Trial of Patiromer on Efficacy to Reduce Episodic Hyperkalemia in Patients with ESKD Treated With Hemodialysis |
| title_sort | randomized trial of patiromer on efficacy to reduce episodic hyperkalemia in patients with eskd treated with hemodialysis |
| topic | cardiac arrhythmia cardiovascular risk clinical trial hemodialysis hyperkalemia |
| url | http://www.sciencedirect.com/science/article/pii/S2468024924018771 |
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