Safety and tolerability of the novel non-steroidal mineralocorticoid receptor antagonist BAY 94-8862 in patients with chronic heart failure and mild or moderate chronic kidney disease: a randomized, double-blind trial

AIMS: Mineralocorticoid receptor antagonists (MRAs) improve outcomes in patients with heart failure and reduced left ventricular ejection fraction (HFrEF), but their use is limited by hyperkalaemia and/or worsening renal function (WRF). BAY 94-8862 is a highly selective and strongly potent non-steroidal MRA. We investigated its safety and tolerability in patients with HFrEF associated with mild or moderate chronic kidney disease (CKD). METHODS AND RESULTS: This randomized, controlled, phase II trial consisted of two parts. In part A, the safety and tolerability of oral BAY 94-8862 [2.5, 5, or 10 mg once daily (q.d.)] was assessed in 65 patients with HFrEF and mild CKD. In part B, BAY 94-8862 (2.5, 5, or 10 mg…

• AL
  Abbott Laboratories
• EL
  Eli Lilly and Company
• P
  Pfizer
• A
  AstraZeneca
• G
  GlaxoSmithKline
• S
  Sanofi
• TP
  Takeda Pharmaceuticals North America
• I
  Ikaria
• BS
  Boston Scientific Corporation
• C
  Cytokinetics
• R
  ResMed
• EC
  European Commission
• BH
  Bayer HealthCare
• AP
  Astellas Pharma
• VP
  Vifor Pharma
• S
  Servier
• NP
  Novartis Pharma
• BU
  Bayer, United Kingdom
• BV
  Bayer Vital