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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- Peter Rossing
- 1Steno Diabetes Center Copenhagen, Herlev, Denmark
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- Stefan D. Anker
- 3Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies, German Centre for Cardiovascular Research Partner Site Berlin, Charité–Universitätsmedizin, Berlin, Germany
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- Gerasimos Filippatos
- 4School of Medicine, National and Kapodistrian University of Athens, Department of Cardiology, Attikon University Hospital, Athens, Greece
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- Bertram Pitt
- 5Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI
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- Luis M. Ruilope
- 6Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research Imas12, Madrid, Spain
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- Andreas L. Birkenfeld
- 9German Center for Diabetes Research (DZD), München-Neuherberg, Germany
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- Janet B. McGill
- 11Division of Endocrinology, Metabolism and Lipid Research, Washington University in St. Louis, St. Louis, MO
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- Sylvia E. Rosas
- 12Kidney and Hypertension Unit, Joslin Diabetes Center and Harvard Medical School, Boston, MA
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- Amer Joseph
- 14Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
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- Martin Gebel
- 15Statistics and Data Insights, Bayer AG, Wuppertal, Germany
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- Luke Roberts
- 16Clinical Development, Bayer PLC, Reading, U.K
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- Markus F. Scheerer
- 17Medical Affairs and Pharmacovigilance, Pharmaceuticals, Bayer AG, Berlin, Germany
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- George L. Bakris
- 18Department of Medicine, University of Chicago Medicine, Chicago, IL
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- Rajiv Agarwal
- 19Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN
抄録
<jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>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 m2 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.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>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.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Benefits of finerenone compared with placebo on cardiorenal outcomes in patients with CKD and type 2 diabetes were observed irrespective of SGLT2i use.</jats:p> </jats:sec>
収録刊行物
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- Diabetes Care
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Diabetes Care 45 (12), 2991-2998, 2022-08-15
American Diabetes Association