Finerenone improves CKD, CV outcomes in T2D

  • N Engl J Med

  • von Miriam Tucker
  • Clinical Essentials
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Takeaway

  • In patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), treatment with the investigational mineralocorticoid receptor antagonist finerenone reduced CKD progression and cardiovascular (CV) events.

Why this matters

  • T2D is the leading cause of CKD.

Study design

  • Phase 3, multicenter, double-blind trial with 5734 patients with T2D and CKD randomly assigned 1:1 to receive finerenone or placebo, with a median follow-up of 2.6 years.
  • Primary composite outcome: kidney failure, sustained decrease of ≥40% in estimated glomerular filtration rate from baseline, or death from renal cause.
  • Key secondary outcome: CV-related death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure.
  • Funding: Bayer.

Key results

  • Primary outcome:
    • 17.8% with finerenone vs 21.1% with placebo.
    • HR: 0.82 (P=.001).
    • Number needed to treat to prevent 1 outcome at 3 years: 29 (95% CI, 16-166).  
  • Key secondary outcome:
    • 13% with finerenone vs 14.8% with placebo.
    • HR: 0.86 (P=.03). 
    • Number needed to treat to prevent 1 outcome at 3 years: 42 (95% CI, 22-397).
  • Adverse event rates were similar except for those related to hyperkalemia: 18.3% finerenone vs 9.0% placebo.
  • Events led to discontinuation in 2.3% finerenone vs 0.9% placebo, with no deaths.  

Limitations

  • Most patients had advanced CKD.
  • Only 4.7% self-identified as Black.