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 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 and 3 wks for SPIRO. Primary endpoint: between-group difference at Wk 12 in % of pts on SPIRO.
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 of hyperkalemia or blood K+ increased occurred in 7 (PBO) and 8 (PAT) DM+ patients and 7 (PBO) and 1 (PAT) DM- patients.
Conclusions: PAT enabled more pts with advanced CKD and RHTN to continue treatment with SPIRO, regardless of DM status.
R. Agarwal: Other Relationship; Self; AbbVie Inc., Akebia Therapeutics, Amgen, AstraZeneca, Bayer Inc., Bird Rock Bio, Boehringer Ingelheim Pharmaceuticals, Inc., Celgene, Daiichi Sankyo, Eli Lilly and Company, GlaxoSmithKline plc., Ironwood Pharmaceuticals, Johnson & Johnson, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, OPKO Health, Inc., Reata, Relypsa, Inc.,Sandoz, Sanofi, Takeda Pharmaceutical Company Limited, ZS Pharma. P. Rossignol: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Idorsia, Novartis France, Novo Nordisk Inc., Relypsa, Inc., Servier, Vifor Pharma Group. Stock/Shareholder; Self; CardioRenal: cofounder. S. Arthur: Employee; Self; Relypsa, Inc. A. Conrad: Employee; Self; Relypsa, Inc. Stock/Shareholder; Self; Vifor Pharma Group. W.B. White: Consultant; Self; Relypsa, Inc. B. Williams: Consultant; Self; Novartis AG, Relypsa, Inc., Vascular Dynamics Inc. Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Novartis AG, Pfizer Inc., Servier.