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Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Sodium–Glucose Cotransporter 2 Inhibitor Treatment: The FIDELITY Analysis

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posted on 2022-08-15, 18:32 authored by Peter Rossing, Stefan D. Anker, Gerasimos Filippatos, Bertram Pitt, Luis M. Ruilope, Andreas L. Birkenfeld, Janet B. McGill, Sylvia E. Rosas, Amer Joseph, Martin Gebel, Luke Roberts, Markus F. Scheerer, George L. Bakris, Rajiv Agarwal, the FIDELIO-DKD and FIGARO-DKD investigators

OBJECTIVE

Finerenone reduced the risk of kidney and cardiovascular events in people with chronic kidney disease (CKD) and type 2 diabetes in the FIDELIO-DKD (NCT02540993) and FIGARO-DKD (NCT02545049) phase 3 studies. Effects of finerenone on outcomes in patients taking sodium–glucose cotransporter 2 inhibitors (SGLT2is) were evaluated in a prespecified pooled analysis of these studies.

RESEARCH DESIGN AND METHODS

Patients with type 2 diabetes and urine albumin-to-creatinine ratio (UACR) ≥30–≤5,000 mg/g and estimated glomerular filtration rate (eGFR) ≥25 mL/min/1.73 m2 were randomized to finerenone or placebo; SGLT2is were permitted at any time. Outcomes included cardiovascular composite (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney composite end points (kidney failure, sustained ≥57% eGFR decline, or renal death), changes in UACR and eGFR, and safety outcomes.

RESULTS

Among 13,026 patients, 877 (6.7%) received an SGLT2i at baseline and 1,113 (8.5%) initiated one during the trial. For the cardiovascular composite, the hazard ratios (HRs) were 0.87 (95% CI 0.79–0.96) without SGLT2i and 0.67 (95% CI 0.42–1.07) with SGLT2i. For the kidney composite, the HRs were 0.80 (95% CI 0.69–0.92) without SGLT2i and 0.42 (95% CI 0.16–1.08) with SGLT2i. Baseline SGLT2i use did not affect risk reduction for the cardiovascular or kidney composites with finerenone (Pinteraction = 0.46 and 0.29, respectively); neither did SGLT2i use concomitant with study treatment.

CONCLUSIONS

Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.