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Hyperkalemia risk with finerenone: Results from the FIDELIO-DKD Trial

Journal of the American Society of Nephrology Nov 09, 2021

Agarwal R, Joseph A, Anker S, et al. - Findings demonstrate an independent association of finerenone with hyperkalemia. However, the effect of hyperkalemia was minimized through routine potassium monitoring and hyperkalemia management strategies used in the FIDELIO-DKD trial, affording a basis for clinical employment of finerenone.

  • In the FIDELIO-DKD trial, finerenone decreased risk of cardiorenal outcomes in cases with CKD and type 2 diabetes.

  • This post hoc analysis was conducted to assess incidences and risk factors for hyperkalemia with finerenone and placebo in FIDELIO-DKD.

  • A 2.6 years' median follow-up revealed treatment-emergent ≥mild hyperkalemia in 21.4% and 9.2% of patients treated with finerenone and placebo, respectively; moderate hyperkalemia occurred in 4.5% and 1.4%, respectively.

  • Higher serum potassium, lower eGFR, elevated urine albumin-to-creatinine ratio, younger age, female gender, beta-blocker use, and finerenone assignment were independent risk factors for ≥mild hyperkalemia, while risk was reduced with diuretic or sodium-glucose co-transporter-2 inhibitor use.

  • In both groups, short-term increments in serum potassium and reductions in eGFR were related to subsequent hyperkalemia.

  • With finerenone, the magnitude of elevated hyperkalemia risk for any change from baseline was smaller at month 4, vs with placebo.

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