EFFECT OF PATIROMER ON SERUM POTASSIUM AND HOSPITALIZATION OUTCOMES IN HEMODIALYSIS PATIENTS WITH OR WITHOUT CONGESTIVE HEART FAILURE: A RETROSPECTIVE COHORT ANALYSIS

 

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https://storage.unitedwebnetwork.com/files/1099/e206a40764fee2d02ac31d3aad800edb.pdf
EFFECT OF PATIROMER ON SERUM POTASSIUM AND HOSPITALIZATION OUTCOMES IN HEMODIALYSIS PATIENTS WITH OR WITHOUT CONGESTIVE HEART FAILURE: A RETROSPECTIVE COHORT ANALYSIS

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Meijiao
Zhou
Meijiao Zhou Meijiao.zhou@rriny.com Renal Research Institute, LLC Advanced Analytics & Innovations Waltham United States *
Linda Ficociello Linda.Ficociello@rriny.com Renal Research Institute, LLC Advanced Analytics & Innovations Waltham United States -
Maria Gil-Mir maria.gil-mir@freseniusmedicalcare.com Fresenius Medical Care Frenova Bad Homburg Germany -
Hans-Juergen Arens hans-juergen.arens@freseniusmedicalcare.com Fresenius Medical Care Frenova Bad Homburg Germany -
Despina Ruessmann despina.ruessmann@viforpharma.com CSL Vifor Pharma Group Global Medical Affairs Glattbrugg Switzerland -
Michael Anger michael.anger@freseniusmedicalcare.com Fresenius Medical Care Global Medical Office Waltham United States -
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Some potassium-binding agents have been associated with increased risk of fluid overload and edema, particularly in patients with congestive heart failure (CHF) or those on sodium-restricted diets. Patiromer (PAT) is a non-absorbed, sodium-free potassium binder used to manage hyperkalemia in patients receiving hemodialysis (HD). While its efficacy is well established, limited real-world data exist on its safety, especially in vulnerable populations such as those with CHF. This retrospective cohort study evaluated serum potassium (sK) levels and hospitalization outcomes before and after PAT initiation in HD patients with and without CHF, focusing on safety signals related to fluid overload and CHF risk.

We identified HD patients aged 18–89 years at Fresenius Kidney Care clinics in the U.S. who newly initiated PAT between January 1, 2016, and December 31, 2022, with no use in the prior year. Patients were on thrice-weekly HD for >90 days prior to PAT start and had ≥1 sK measurement in both baseline (≤91 days pre-initiation) and follow-up periods. Hospitalization rates were assessed for all-cause, hyperkalemia-related, fluid-overload, and CHF-related causes in the 3-month pre-PAT and up to 12-month post-PAT periods using poisson regression. Subgroups were stratified by baseline CHF status. sK changes were described for each subgroup.

Among 10,860 patients included, 2,224 (20.5%) had CHF at baseline.

After PAT initiation, the overall all-cause hospitalization rate decreased significantly (1.77 vs 1.68 per patient-year; p=0.004). Hyperkalemia-related hospitalizations decreased by 43% (0.35 to 0.20; p<0.0001). Fluid-overload hospitalizations decreased from 0.16 to 0.14 per patient year (p=0.006). CHF-related hospitalization rates remained stable (0.05 to 0.05, p=0.51).

In CHF patients, fluid-overload hospitalization rates were comparable (0.22 to 0.20; p=0.34), while CHF-related hospitalizations significantly declined (0.15 to 0.09; p=0.0005) after PAT started. Among non-CHF patients, fluid-overload hospitalizations (0.14 to 0.12, p=0.01) and CHF-related hospitalizations (0.03 to 0.04, p=0.02) didn’t have clinically meaningful changes, although they reached p<0.05 due to a large sample size (n=8635). Additionally, serum potassium levels declined steadily after PAT initiation in both CHF patients (5.55 to 5.15 mEq/L) and non-CHF patients (5.61 to 5.22 mEq/L) from baseline to the last quarter of follow up.

In this large real-world cohort of HD patients, PAT was associated with a significant reduction in hyperkalemia-related and fluid-overload hospitalizations, with no impact on CHF-related admissions. Both CHF and non-CHF groups had sustained sK decreased. CHF patients experienced significant reductions in CHF-related hospitalizations after PAT initiation. These findings support the efficacy and safety profile of PAT, addressing concerns seen with other potassium binders in similar populations.


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