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