A prespecified exploratory analysis from FIDELITY examined finerenone use and kidney outcomes in patients with chronic kidney disease and type 2 diabetes.
A prespecified pooled FIDELITY analysis found that finerenone reduced cardiovascular and kidney composite outcomes in patients with CKD and type 2 diabetes, with benefits consistent regardless of SGLT2 inhibitor use.
Background
Finerenone, a nonsteroidal selective mineralocorticoid receptor antagonist, reduced kidney and cardiovascular events in patients with chronic kidney disease and type 2 diabetes in the phase 3 FIDELIO-DKD and FIGARO-DKD trials. The FIDELITY analysis prespecified a pooled examination of its effects, including in patients also taking SGLT2 inhibitors.
Study design
Patients with type 2 diabetes, a urine albumin-to-creatinine ratio of 30 to 5,000 mg/g, and an eGFR of at least 25 mL/min/1.73 m2 were randomly assigned to finerenone or placebo, with SGLT2 inhibitors permitted at any time. Among 13,026 patients, 877 (6.7%) received an SGLT2 inhibitor at baseline and 1,113 (8.5%) initiated one during the trial. Outcomes included cardiovascular and kidney composite endpoints, changes in albuminuria and eGFR, and safety.
Key findings
For the cardiovascular composite, the hazard ratios were 0.87 (95% CI 0.79-0.96) without SGLT2 inhibitor and 0.67 (95% CI 0.42-1.07) with one; for the kidney composite, 0.80 (95% CI 0.69-0.92) without and 0.42 (95% CI 0.16-1.08) with. Baseline or concomitant SGLT2 inhibitor use did not significantly modify the cardiovascular or kidney risk reductions with finerenone (interaction p=0.46 and 0.29, respectively).
Clinical implications
The cardiorenal benefits of finerenone over placebo in patients with CKD and type 2 diabetes were observed irrespective of SGLT2 inhibitor use, supporting the combined use of these complementary therapies. These exploratory findings reinforce guideline recommendations that layer finerenone onto foundational SGLT2 inhibitor and RAS-inhibitor therapy.
Category
Research
Source
Kidney Int
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