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Abstract: TH-OR052

Patiromer vs. Placebo to Enable Spironolactone in Patients with Resistant Hypertension and CKD According to Baseline Kidney Function (AMBER Trial)

Session Information

Category: CKD (Non-Dialysis)

  • 2102 CKD (Non-Dialysis): Clinical, Outcomes, and Trials

Authors

  • Agarwal, Rajiv, Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Rossignol, Patrick, University of Lorraine and FCRIN INI-CRCT, NANCY, France
  • Garza, Dahlia, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Mayo, Martha, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Warren, Suzette, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States
  • Ma, Jia, 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, London, United Kingdom
Background

Spironolactone (SPIRO) is effective at reducing BP in patients (pts) with resistant hypertension (RHTN); however, its use in pts with CKD is often limited by hyperkalemia. In AMBER, patiromer (PAT) enabled more persistent use of SPIRO in pts with RHTN and eGFR 25 to ≤45 mL/min/1.73 m2. We report results in prespecified subgroups with eGFR <30 and ≥30 mL/min/1.73 m2.

Methods

This was a randomized, double-blind, placebo (PBO)-controlled RCT in adults with eGFR 25-≤45 mL/min/1.73 m2 and uncontrolled RHTN. Pts were assigned (1:1) to receive PBO or PAT, and SPIRO 25 mg QD, with dose titrations permitted after 1 wk (PAT) and 3 wk (SPIRO). The primary endpoint (between-group difference at wk 12 in the % of pts on SPIRO) was assessed in prespecified subgroups with eGFR <30 and ≥30 mL/min/1.73m2.

Results

295 pts were randomized, 66 (22.4%) and 229 (77.6%) with baseline (BL) eGFR <30 (median [Q1, Q3], 27 [25, 29]) and ≥30 (median [Q1, Q3], 38 [34, 42]) mL/min/1.73 m2, respectively. BL mean (SD) automated office systolic BP (mmHg) was 143.7 (6.7) and 144.2 (6.8) and serum K+ (mEq/L) was 4.78 (0.38) and 4.70 (0.36), respectively. Significantly more pts treated with PAT than with PBO remained on SPIRO at wk 12 in both subgroups (between treatment difference of 28.5% [P=0.0158] for pts with eGFR <30 mL/min/1.73 m2 and 16.8% [P=0.0033] for pts with eGFR ≥30 mL/min/1.73 m2) with P=0.46 for interaction between subgroups (Figure). Mean (SE) cumulative SPIRO dose was higher with PAT than PBO, by 732 (274) mg and 274 (140) mg in pts with eGFR <30 and eGFR ≥30 mL/min/1.73 m2, respectively. Adverse events occurred in 56% (PBO) and 63% (PAT) with eGFR <30 and in 53% (PBO) and 54% (PAT) with eGFR ≥30. No pts had serum Mg <1.2 mg/dL; 1 PBO and 3 PAT pts (all with eGFR ≥30) had serum Mg 1.2 to <1.4 mg/dL.

Conclusion

PAT enabled more pts with advanced CKD and RHTN to continue treatment with SPIRO, regardless of whether eGFR is <30 or ≥30 mL/min/1.73 m2.

Funding

  • Commercial Support –