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Hyperkalemia Risk with Finerenone: Results from the FIDELIO-DKD Trial
Rajiv Agarwal1, Amer Joseph2, Stefan D Anker3
1Division of Nephrology, Department of Medicine, Richard L. Roudebush Veterans Affairs Medical Center and Indiana University, Indianapolis, Indiana.
Journal of the American Society of Nephrology : JASN
|November 4, 2021
Summary
Finerenone increased hyperkalemia risk in patients with CKD and type 2 diabetes. However, careful monitoring and management strategies effectively minimized this risk in the FIDELIO-DKD trial.
Area of Science:
- Nephrology
- Cardiology
- Endocrinology
Background:
- Finerenone demonstrated cardiorenal benefits in patients with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD trial.
- Hyperkalemia is a known side effect of mineralocorticoid receptor antagonists.
Purpose of the Study:
- To report the incidences and identify risk factors for hyperkalemia in patients treated with finerenone versus placebo.
- To analyze the relationship between serum potassium changes and hyperkalemia risk.
Main Methods:
- A post hoc safety analysis of the FIDELIO-DKD trial defined hyperkalemia based on serum potassium levels.
- Cumulative incidences were calculated using the Aalen-Johansen estimator, with death as a competing risk.
- Multivariate Cox models and restricted cubic splines identified predictors and assessed risk relationships.
Main Results:
- Over 2.6 years, 21.4% of finerenone patients and 9.2% of placebo patients experienced mild hyperkalemia (≥5.5 mmol/L).
- Moderate hyperkalemia (≥6.0 mmol/L) occurred in 4.5% of finerenone and 1.4% of placebo patients.
- Independent risk factors included higher baseline potassium, lower eGFR, and finerenone use; diuretic or SGLT2 inhibitor use reduced risk.
Conclusions:
- Finerenone use was independently associated with an increased risk of hyperkalemia.
- Routine potassium monitoring and management strategies successfully minimized the clinical impact of hyperkalemia.
- These findings support the clinical use of finerenone with appropriate safety measures.
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