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Effects of finerenone in people with chronic kidney disease and type 2 diabetes are independent of HbA1c at baseline,HbA1c variability,diabetes duration and insulin use at baseline |
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| Authors: | Janet B McGill MD Rajiv Agarwal MD Stefan D Anker MD George L Bakris MD Gerasimos Filippatos MD Bertram Pitt MD Luis M Ruilope MD Andreas L Birkenfeld MD Maria L Caramori MD Meike Brinker MD Amer Joseph MBBS Andrea Lage MD Robert Lawatscheck MD Charlie Scott MSc Peter Rossing MD the FIDELIO-DKD and FIGARO-DKD investigators |
| Institution: | 1. Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA;2. Richard L. Roudebush VA Medical Center and Indiana University, Indianapolis, Indiana, USA;3. Department of Cardiology (CVK), Berlin, Germany;4. Department of Medicine, University of Chicago Medicine, Chicago, Illinois, USA;5. Department of Cardiology, School of Medicine, National and Kapodistrian University of Athens, Attikon University Hospital, Athens, Greece;6. Department of Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan, USA;7. Cardiorenal Translational Laboratory and Hypertension Unit, Institute of Research imas12, Madrid, Spain
CIBER-CV, Hospital Universitario 12 de Octubre, Madrid, Spain Faculty of Sport Sciences, European University of Madrid, Madrid, Spain;8. Department of Diabetology, Endocrinology and Nephrology, University Clinic, Tübingen, Germany;9. Diabetes & Metabolism Institute, Cleveland Clinic, Cleveland, Ohio, USA Department of Medicine, University of Minnesota, Minneapolis, MN, USA;10. Cardiology and Nephrology Clinical Development, Bayer AG, Wuppertal, Germany;11. Cardiology and Nephrology Clinical Development, Bayer AG, Berlin, Germany;12. Cardiology and Nephrology Clinical Development, Bayer SA, São Paulo, Brazil;13. Clinical Research, Bayer AG, Berlin, Germany;14. Data Science and Analytics, Bayer PLC, Reading, UK;15. Steno Diabetes Center Copenhagen, Herlev, Denmark |
| Abstract: | AimTo evaluate the effect of finerenone by baseline HbA1c, HbA1c variability, diabetes duration and baseline insulin use on cardiorenal outcomes and diabetes progression.Materials and MethodsComposite efficacy outcomes included cardiovascular (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for heart failure), kidney (kidney failure, sustained ≥ 57% estimated glomerular filtration rate decline or renal death) and diabetes progression (new insulin initiation, increase in antidiabetic medication, 1.0% increase in HbA1c from baseline, new diabetic ketoacidosis diagnosis or uncontrolled diabetes).ResultsIn 13 026 participants, risk reductions in the cardiovascular and kidney composite outcomes with finerenone versus placebo were consistent across HbA1c quartiles (P interaction .52 and .09, respectively), HbA1c variability (P interaction .48 and .10), diabetes duration (P interaction .12 and .75) and insulin use (P interaction .16 and .52). HbA1c variability in the first year of treatment was associated with a higher risk of cardiovascular and kidney events (hazard ratio HR] 1.20; 95% confidence interval CI] 1.07-1.35; P = .0016 and HR 1.36; 95% CI 1.21-1.52; P < .0001, respectively). There was no effect on diabetes progression with finerenone or placebo (HR 1.00; 95% CI 0.95-1.04). Finerenone was well-tolerated across subgroups; discontinuation and hospitalization because of hyperkalaemia were low.ConclusionsFinerenone efficacy was not modified by baseline HbA1c, HbA1c variability, diabetes duration or baseline insulin use. Greater HbA1c variability appeared to be associated with an increased risk of cardiorenal outcomes. |
| Keywords: | cardiovascular disease clinical trial diabetes complications diabetic nephropathy type 2 diabetes |