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Kidney Week

Abstract: SA-OR20

Patiromer to Enable Spironolactone in Patients with Resistant Hypertension and CKD (AMBER): Results in the Prespecified Subgroup with Diabetes

Session Information

Category: Diabetic Kidney Disease

  • 602 Diabetic Kidney Disease: Clinical

Authors

  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Rossignol, Patrick, University of Lorraine and FCRIN INI-CRCT, Nancy, France
  • Arthur, Susan, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Conrad, Ansgar, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • White, William B., University of Connecticut School of Medicine, Farmington, Connecticut, United States
  • Williams, Bryan, University College London (UCL), London, United Kingdom
Background

Spironolactone (SPIRO) reduces BP in patients (pts) with resistant hypertension (RHTN); however, its use in pts with advanced chronic kidney disease (CKD) is often limited by hyperkalemia (HK). In AMBER, patiromer (PAT) enabled more persistent use of SPIRO in pts with RHTN and CKD. As SPIRO is recommended in RHTN and diabetes mellitus (DM) increases HK risk, we report results in prespecified subgroups with Type 1 or 2 DM (DM+) and without (DM).

Methods

Randomized, double-blind, placebo (PBO)-controlled trial in adults with RHTN and eGFR 25 to ≤45 mL/min/1.73 m2. Pts were assigned (1:1) to PBO or PAT, and SPIRO 25 mg QD, with dose titrations permitted after 1 wk for PAT/PBO and 3 wks for SPIRO. The primary endpoint, between-group difference at Wk 12 in % of pts on SPIRO, was assessed prospectively in prespecified DM subgroups.

Results

295 pts were randomized, 145 (49%) DM+ and 150 (51%) DM. Baseline mean (SD) serum K+ (mEq/L) was 4.76 (0.34) in DM+ and 4.67 (0.39) in DM. Significantly more pts treated with PAT than with PBO remained on SPIRO at Wk 12 in both subgroups (Figure). LS Mean (SE) cumulative SPIRO dose was higher with PAT than PBO, by 438.7 (177.7) mg in DM+ and 317.8 (175.0) mg in DM. Adverse events occurred in 61% (PBO) and 60% (PAT) of DM+ pts and in 46% (PBO) and 51% (PAT) of DM pts. Four pts had serum magnesium (Mg2+) <1.4 mg/dL between baseline and Wk 12 (none <1.2 mg/dL), including 3 DM+ (1 PBO, 2 PAT) and 1 DM (PAT) pts. None of these pts had cardiac arrhythmias temporally associated with low Mg2+ levels, neuromuscular abnormalities, or serum K+ below the LLN (3.5 mEq/L).

Conclusion

PAT enabled more pts with advanced CKD and RHTN to continue treatment with SPIRO, regardless of DM status.