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Kidney Week

Abstract: TH-PO296

Patiromer Efficacy to Reduce Episodic Hyperkalemia in ESRD Patients: The PEARL-HD Study

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Middleton, John Paul, Duke University, Durham, North Carolina, United States
  • Sun, Shifeng, Duke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, United States
  • Davenport, Clemontina A., Duke University Department of Biostatistics and Bioinformatics, Durham, North Carolina, United States
  • Daubert, James Patrick, Duke University, Durham, North Carolina, United States
Background

Patients who have end-stage kidney disease (ESKD) maintained on hemodialysis (HD) are exposed to a high risk of cardiac arrhythmias, and this risk is augmented by periodic exposures to hyperkalemia (HK). Use of dialysate with a low potassium concentration may increase the risk of sudden cardiac death. Furthermore, HD patients carry a high pill burden, and it is unclear if prescription of an additional oral medication will reduce the frequency of episodic HK. The purpose of the study is to determine whether patiromer (P) administered daily will effectively reduce episodes of HK in ESKD patients who receive HD, and to explore whether P administration reduces the number of significant arrhythmia events.

Methods

This is a prospective, randomized, open-label trial. Eligible ESKD patients who were on thrice-weekly HD were screened from health records. A total of 33 patients were randomized 1:1 to P vs usual care. Patients randomized to P were administered the medication daily with breakfast or lunch in place of their prescribed phosphate binder, and the dose was titrated based on pre-HD serum potassium concentrations at start of weeks 1, 2, and 3. All participants received 7-day continuous cardiac monitors (CCM) at baseline and at week 4. A Mann-Whitney test was used to compare median number of HK episodes across groups. Fisher’s exact test was used to compare the probability of at least 1 HK episode.

Results

Of those randomized, one withdrew due to adverse symptoms, and one withdrew due to pregnancy. The mean age of randomized patients was 57 y, 50% were male, 79% were Black, 11% were Hispanic/Latino, and mean HD vintage was 6 y. The P group had significantly lower median HK episodes compared to the control group (0 vs 3, p=0.002). Those in the P group were significantly less likely to have at least one HK episode compared to the control group (21% vs 71%; p=0.021). On the week 4 CCMs, 5 participants had > 1000/24 hr premature ventricular contractions, 4 had ventricular tachycardia events, 3 had atrial fibrillation, and 0 had bradycardia events, with no differences between the groups.

Conclusion

Patiromer administered orally once a day effectively reduces frequency of HK in ESKD patients who receive thrice-weekly HD. Larger studies are needed to determine whether patiromer reduces significant cardiac events.

Funding

  • Commercial Support – Vifor