American Diabetes Association
231107_FIDELITY_insulin_resistance_supplementary_Diabetes_Care_draft_5.pdf (336.96 kB)

Outcomes With Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes by Baseline Insulin Resistance

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posted on 2023-12-28, 03:02 authored by Thomas Ebert, Stefan D. Anker, Luis M. Ruilope, Paola Fioretto, Vivian Fonseca, Guillermo E. Umpierrez, Andreas L. Birkenfeld, Robert Lawatscheck, Charlie Scott, Katja Rohwedder, Peter Rossing

Objective To explore whether insulin resistance, assessed by estimated glucose disposal rate (eGDR), is associated with cardiorenal risk and whether it modifies finerenone efficacy. Research design and methods In FIDELITY (N=13,026), patients with type 2 diabetes, either I) urine albumin-to-creatinine ratio (UACR) ≥30–<300 mg/g and estimated glomerular filtration rate (eGFR) ≥25–≤90 mL/min/1.73 m2, or II) UACR ≥300–≤5000 mg/g and eGFR ≥25 mL/min/1.73 m2, and received optimized renin–angiotensin system blockade, were randomized to finerenone or placebo. Outcomes included cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) and kidney (kidney failure, sustained decrease ≥57% in eGFR from baseline, or renal death) composites. eGDR was calculated using waist circumference, hypertension status, and glycated hemoglobin for 12,964 patients. Results Median eGDR was 4.1 mg/kg/min. eGDR


The FIDELIO-DKD and FIGARO-DKD trials were conducted and sponsored by Bayer AG. The sponsor participated in the analysis design, data collection, data analysis, data interpretation, and approval of the manuscript. Analyses were conducted by the sponsor, and all authors had access to and participated in the interpretation of the data. The authors made the decision to submit the manuscript for publication.


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