ASN's Mission

To create a world without kidney diseases, the ASN Alliance for Kidney Health elevates care by educating and informing, driving breakthroughs and innovation, and advocating for policies that create transformative changes in kidney medicine throughout the world.

learn more

Contact ASN

1401 H St, NW, Ste 900, Washington, DC 20005

email@asn-online.org

202-640-4660

The Latest on X

Kidney Week

Please note that you are viewing an archived section from 2019 and some content may be unavailable. To unlock all content for 2019, please visit the archives.

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 –