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Abstract: TH-PO0524

Effects of Sodium Zirconium Cyclosilicate on Volume Status in Hemodialysis: Post Hoc Analysis from the DIALIZE Outcomes Trial

Session Information

Category: Dialysis

  • 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

  • Fishbane, Steven, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
  • Dember, Laura M., University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • Jadoul, Michel, Cliniques Universitaires Saint-Luc, UCLouvain, Brussels, Belgium
  • Kovesdy, Csaba P., University of Tennessee Health Science Center, Memphis, Tennessee, United States
  • Herzog, Charles A., Hennepin Healthcare/University of Minnesota, Minneapolis, Minnesota, United States
Background

DIALIZE-Outcomes studied sodium zirconium cyclosilicate (SZC) as a treatment for hyperkalemia in hemodialysis (HD). The objective was to reduce arrhythmia-related cardiovascular events. In this post hoc analysis, the effects on volume status of SZC compared with placebo were evaluated.

Methods

Patients on HD with hyperkalemia (serum potassium [sK+] ≥5.5 mmol/L) were randomized 1:1 to blinded treatment with SZC (starting dose, 5 g on non-dialysis days, then titrated as needed) or placebo. The effects on indicators of volume status were compared.

Results

Overall, 2690 participants were randomized, and mean treatment duration was 12.4 and 11.3 months for SZC and placebo, respectively. Improved sK+ control was achieved in the SZC group (P<0.0001). There was no significant difference between the SZC versus placebo groups in heart failure (HF) adverse events (3.0% vs 3.2%; P=not significant [NS]), hypertension events (9.8% vs 9.6%; P=NS [including hypertensive emergencies]) or edema events (4.7% vs 4.6%; P=NS; Table), change in systolic blood pressure (BP) (−2.1±24.3 mmHg vs −2.2±22.1 mmHg; P=NS), diastolic BP (−0.9±15.0 mmHg vs −0.8±14.2 mmHg; P=NS), number of antihypertensive drugs needed (P=NS), or change in interdialytic weight gain (IDWG) from baseline to final study visit (0.2±2.6 kg vs 0.1±2.3 kg; P=NS).

Conclusion

In a post hoc analysis of a large, blinded randomized controlled trial comparing SZC (administered on non-dialysis days) to placebo in patients on HD, there were no discernible differences in any of the measured indicators of volume status. This was true for AEs of HF, hypertension, edema, BP, antihypertensive drugs, and IDWG.

Table. Events related to volume status in patients on hemodialysis with hyperkalemia
Event, n (%)SZC
(n=1348)
Placebo
(n=1338)
Heart failure39 (2.9)43 (3.2)
Hypertension132 (9.8)129 (9.6)
Hypertension emergencies29 (2.1)29 (2.2
Edema all64 (4.7)61 (4.6)

SZC, sodium zirconium cyclosilicate.

Funding

  • Commercial Support – This study was funded by AstraZeneca

Digital Object Identifier (DOI)