Abstract: PO2370
Patiromer Enables Sustained RAAS Inhibitor Therapy over 52 Weeks: A Post Hoc Analysis of 246 Patients Who Completed the AMETHYST-DN Study
Session Information
- CKD: Insights from Recent Clinical Trials and Large Real-World Effectiveness Studies
November 04, 2021 | Location: On-Demand, Virtual Only
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Epstein, Murray, University of Miami School of Medicine, Miami, Florida, United States
- Arthur, Susan, Vifor Pharma Group, Redwood City, California, United States
- Budden, Jeffrey J., Vifor Pharma Group, Redwood City, California, United States
Background
Hyperkalemia (HK) is a common electrolyte abnormality in CKD patients (pts) with type 2 diabetes mellitus (T2DM) and leads to underutilization of RAAS inhibitors (RAASi). KDIGO guidelines recommend RAASi dose should be reduced or discontinued only as a last resort in HK pts after measures to control serum potassium (sK) have failed. Patiromer (PAT) is a non-absorbed, sodium-free, K binder documented to reduce sK in pts with HK, and consequently enables sustained RAASi therapy. This post-hoc analysis of AMETHYST-DN analyzed in-depth the ability of PAT to maintain RAASi in a large cohort of pts with diabetic kidney disease (DKD) and HK who completed 1 year of treatment with PAT.
Methods
AMETHYST-DN was a multicenter, open-label trial of PAT in adult pts on RAASi with eGFR 15–<60 mL/min/1.73m2, T2DM, hypertension, and HK (sK >5.0 mEq/L). Pts were randomized to PAT 8.4–33.6 g/d to start. The 52-wk study included an 8-wk treatment phase, followed, in pts on a stable PAT dose for ≥3 consecutive wks, by a 44-wk long-term maintenance phase (LTMP). This analysis evaluated dose modifications of RAASi among pts who completed the LTMP.
Results
304 pts were randomized and received ≥1 PAT dose. Of these, 246 pts were on a stable PAT dose and entered the LTMP, and 197 pts completed 52 wks of treatment. All pts were receiving RAASi at baseline. By protocol, RAASi could not be downtitrated or discontinued because of HK during the study. In total, 195/197 pts who completed the LTMP remained on RAASi for the entire 44-wk LTMP period. Most pts (n=176) had no RAASi dose change, 14 had RAASi dose changes but remained stable or uptitrated, and 5 had their dose downtitrated. Of the 49 pts who withdrew early from the LTMP, 27 did so for clinical reasons (AEs, 12; low sK, 5; death, 4; deterioration of renal function, 4; high sK, 2), whereas 22 had reasons related to investigator/patient factors (consent withdrawal, 12; noncompliance, 7; investigator decision, 1; other, 2). During the LTMP, ≥1 AE was reported for 158/246 pts.
Conclusion
This analysis of AMETHYST-DN demonstrates that the vast majority of hyperkalemic pts with DKD who completed the LTMP of the study were able to sustain their RAASi dose over an extended 44 weeks without downtitration or discontinuation of RAASi therapy. Only 2 pts withdrew early from the LTMP due to recurrent HK.
Funding
- Commercial Support – Vifor Pharma