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Kidney Week

Abstract: FR-PO255

Patiromer Controls Serum Potassium for Up to 1 Year in Hyperkalemic Patients with Diabetes and Advanced Kidney Disease on RAAS Inhibitors Regardless of Age

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Weir, Matthew R., University of Maryland School of Medicine, Baltimore, Maryland, United States
  • Mayo, Martha, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Garza, Dahlia, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Budden, Jeffrey J., Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Arthur, Susan, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Bakris, George L., The University of Chicago Medicine, Chicago, Illinois, United States
Background

Patiromer (PAT) is a sodium-free, non-absorbed potassium binder approved for the treatment of hyperkalemia (HK). Published data from the OPAL-HK study describes the efficacy and safety of patiromer in controlling serum potassium (sK+) while maintaining RAAS inhibitor therapy in younger and older adult HK patients (pts) over 3 months of study treatment.

Methods

AMETHYST-DN was a 52-week, multicenter, open-label trial of 304 pts on RAAS inhibitors with eGFR 15–<60 mL/min/1.73m2, type 2 diabetes, hypertension, and documented HK (sK+ >5.0 mEq/L). PAT was titrated, if needed, to achieve and maintain sK+ ≤5.0 mEq/L. Pts <65 (n=122), 65–74 (n=122), and ≥75 (n=60) years of age were randomized and received ≥1 dose of PAT.

Results

Baseline mean (SE) sK+ levels were 5.32±0.35, 5.31±0.37, and 5.19±0.38 mEq/L in pts <65, 65–74, and ≥75 years of age respectively. By Day 3 (~48 hr after the first PAT dose), mean sK+ levels were reduced in all 3 age groups (4.97±0.42, 4.90±0.44, 4.89±0.45 mEq/L respectively). The least squares (LS) mean (SE) changes in sK+ from baseline to Week 4 were –0.67 mEq/L (P<0.0001), –0.82 mEq/L (P<0.0001), and –0.65 mEq/L (P<0.0001), respectively. After 52 weeks (end of treatment), the LS mean (SE) changes from baseline in sK+ were –0.66 mEq/L (P<0.0001), –0.68 mEq/L (P<0.0001), and –0.61 mEq/L (P<0.0001), respectively.
The figure shows mean sK+ over 52 weeks for all age groups; patiromer cessation led to a rise in mean sK+ during follow-up. Through 1 year, 18%, 23%, and 17% of pts reported ≥1 PAT-related AE (most common: constipation). There were few AEs leading to discontinuations through 1 year: 9%, 9%, and 10% of pts across the 3 cohorts.

Conclusion

Regardless of patient age, daily treatment with PAT reduced and maintained control of sK+ for up to 1 year in hyperkalemic pts with advanced diabetic kidney disease receiving RAAS inhibitors. PAT was generally well tolerated.

Funding

  • Commercial Support