Physicians' Academy for Cardiovascular Education

Diuretics do not alter beneficial CV effects of nonsteroidal MRA in CKD and T2D

News - Sep. 5, 2023

Efficacy and safety of finerenone in patients with chronic kidney disease and type 2 diabetes by diuretic use: A FIDELITY analysis

Presented at the ESC congress 2023 by: Robert Mentz, MD - Durham, NC, USA

Introduction and methods

Thiazide and loop diuretics are commonly used to treat hypertension and volume overload in patients with CKD. However, diuretics may induce potassium loss, which is associated with poor CV outcomes. In addition, the use and dose of diuretics serve as a marker of disease severity, and diuretic requirement is potentially also a marker and mediator of adverse outcomes.

Previously, the FIDELITY (FInerenone in chronic kiDney diseasE and type 2 diabetes: Combined FIDELIO-DKD and FIGARO-DKD Trial programme analYsis) analysis showed the selective nonsteroidal MRA finerenone improved CV outcomes and slowed CKD progression compared with placebo in patients with CKD and T2D. In the current post-hoc exploratory analysis of the FIDELITY dataset, the efficacy and safety of finerenone were assessed by baseline diuretic use.

FIDELITY is a prespecified, individual patient-level data pooled analysis of 2 phase 3 trials: FIDELIO-DKD (Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease; n=5674) and FIGARO-DKD (Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease; n=7352). In these RCTs, patients with CKD and T2D on maximally tolerated RAASi therapy were randomized to finerenone (10 or 20 mg once daily based on eGFR at screening visit) or placebo. Eligibility criteria included serum potassium ≤4.8 mmol/L. Median follow-up duration was 3 years. At baseline, 51.5% of the 13,026 patients were treated with diuretics at baseline, of whom 41.8% were on loop diuretics and 47.0% were on thiazide diuretics.

Outcomes of the current analysis were: (1) composite CV outcome, consisting of time to CV death, nonfatal MI, nonfatal stroke, or hospitalization for HF; (2) treatment-emergent hypokalemia; and (3) safety events, including hyperkalemia.

Main results


This post-hoc exploratory analysis of the FIDELITY dataset showed that finerenone reduced the risk of CV outcomes compared with placebo in patients with CKD and T2D irrespective of baseline diuretic use or dose. In addition, finerenone reduced the risk of treatment-emergent hypokalemia in both patients with and without diuretics. The incidence of treatment-emergent adverse events was also not influenced by diuretic use.

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