Heart failure & cardiomyopathiesSecondary analysis
Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- Secondary analysis of the FINEARTS-HF randomised trial
- multicentre
Authors' conclusion
In patients with heart failure with mildly reduced or preserved ejection fraction, finerenone resulted in more frequent hyperkalemia and less frequent hypokalemia. However, with protocol-directed surveillance and dose adjustment, clinical benefit associated with finerenone relative to placebo was maintained even in those whose potassium level increased to greater than 5.5 mmol/L.
Study context
- Population
- HF with LVEF ≥40%, NYHA class II–IV symptoms and elevated natriuretic peptides
- Participants
- 6,001 participants
- Comparison
- Finerenone vs placebo, by postrandomisation serum potassium
- Finerenonen = 3,003
- Placebon = 2,998reference
- Primary endpoint
- Composite of:
- Total worsening HF events
- CV death
- Follow-up
- Median 32 months
Primary result
As reported in the abstract
Serum potassium increase
Median difference, mmol/L
- 1 month; IQR 0.17-0.21
- 0.19
- 3 months; IQR 0.21-0.25
- 0.23
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| Primary outcome by postrandomisation potassium level (both treatment groups) — Potassium <3.5 mmol/L vs Placebo · higher subsequent risk | 2.49 (1.8–3.43) | |
| Primary outcome by postrandomisation potassium level (both treatment groups) — Potassium >5.5 mmol/L vs Placebo · higher subsequent risk | 1.64 (1.04–2.58) | |
| 0.20.5125Hazard ratio (log scale) |
Primary outcome by postrandomisation potassium level (both treatment groups)
- Risk of primary outcome generally lower with finerenone vs placebo, even when potassium rose >5.5 mmol/L
Safety
| Outcome | HR (95% CI) | P value | |
|---|---|---|---|
| Potassium >5.5 mmol/L (hyperkalaemia) | 2.16 (1.83–2.56) | P < 0.001 | |
| Potassium <3.5 mmol/L (hypokalaemia) | 0.46 (0.38–0.56) | P < 0.001 | |
| 0.20.5125Hazard ratio (log scale) |
Original publication
Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction. JAMA Cardiol. Published 1 January 2025. doi:10.1001/jamacardio.2024.4539
Summarised from the published abstract; every number is checked against it