Heart failure & cardiomyopathies
Finerenone, Serum Potassium, and Clinical Outcomes in Heart Failure With Mildly Reduced or Preserved Ejection Fraction
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
Methodological detailsmulticentre
- Multicentre
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.
Summarised from the published abstract; every number is checked against it