Journal
DIABETES CARE
Volume 45, Issue 12, Pages 2991-2998Publisher
AMER DIABETES ASSOC
DOI: 10.2337/dc22-0294
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Funding
- Bayer AG
- AstraZeneca
- Novo Nordisk
- Abbott Vascular
- Vifor International
- European Union
- Dexcom
- Beta Bionics
- National Institutes of Health
- National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases
- U.S. Veterans Administration
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Finerenone reduces the risk of kidney and cardiovascular events in patients with CKD and type 2 diabetes, irrespective of SGLT2i use.
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 and FIGARO-DKD 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 to <= 5,000 mg/g and estimated glomerular filtration rate (eGFR) >= 25 mL/min/1.73 m(2) were randomly assigned 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 (kidney failure, sustained >= 57% eGFR decline, or renal death) end points, 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 (P-interaction = 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.
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