Finerenone in Patients With Chronic Kidney Disease and Type 2 Diabetes According to Baseline HbA1c and Insulin Use: An Analysis From the FIDELIO-DKD Study
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- Peter Rossing
- 1Steno Diabetes Center Copenhagen, Herlev, Denmark
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- Ellen Burgess
- 3Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
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- Rajiv Agarwal
- 4Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, IN
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- Stefan D. Anker
- 5Department of Cardiology, 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
- 6National and Kapodistrian University of Athens, School of Medicine, Department of Cardiology, Attikon University Hospital, Athens, Greece
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- Bertram Pitt
- 7Department of Medicine, University of Michigan School of Medicine, Ann Arbor, MI
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- Luis M. Ruilope
- 8Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
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- Pieter Gillard
- 11Department of Endocrinology, University Hospital Leuven – Katholieke Universiteit Leuven, Leuven, Belgium
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- Richard J. MacIsaac
- 12Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne and University of Melbourne, Melbourne, Victoria, Australia
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- Julio Wainstein
- 13Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
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- Amer Joseph
- 15Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
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- Meike Brinker
- 15Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
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- Lothar Roessig
- 15Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany
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- Charlie Scott
- 16Data Science and Analytics, Bayer PLC, Reading, U.K.
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- George L. Bakris
- 17Department of Medicine, University of Chicago Medicine, Chicago, IL
抄録
<jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>Finerenone significantly improved cardiorenal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) in the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease trial. We explored whether baseline HbA1c level and insulin treatment influenced outcomes.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>Patients with T2D, urine albumin-to-creatinine ratio (UACR) of 30–5,000 mg/g, estimated glomerular filtration rate (eGFR) of 25 to <75 mL/min/1.73 m2, and treated with optimized renin–angiotensin system blockade were randomly assigned to receive finerenone or placebo. Efficacy outcomes included kidney (kidney failure, sustained decrease ≥40% in eGFR from baseline, or renal death) and cardiovascular (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure) composite endpoints. Patients were analyzed by baseline insulin use and by baseline HbA1c <7.5% (58 mmol/mol) or ≥7.5%.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>Of 5,674 patients, 3,637 (64.1%) received insulin at baseline. Overall, 5,663 patients were included in the analysis for HbA1c; 2,794 (49.3%) had baseline HbA1c <7.5% (58 mmol/mol). Finerenone significantly reduced risk of the kidney composite outcome independent of baseline HbA1c level and insulin use (Pinteraction = 0.41 and 0.56, respectively). Cardiovascular composite outcome incidence was reduced with finerenone irrespective of baseline HbA1c level and insulin use (Pinteraction = 0.70 and 0.33, respectively). Although baseline HbA1c level did not affect kidney event risk, cardiovascular risk increased with higher HbA1c level. UACR reduction was consistent across subgroups. Adverse events were similar between groups regardless of baseline HbA1c level and insulin use; few finerenone-treated patients discontinued treatment because of hyperkalemia.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Finerenone reduces kidney and cardiovascular outcome risk in patients with CKD and T2D, and risks appear consistent irrespective of HbA1c levels or insulin use.</jats:p> </jats:sec>
収録刊行物
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- Diabetes Care
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Diabetes Care 45 (4), e888-e897, 2022-01-21
American Diabetes Association