Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial
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- Frederik Persson
- Steno Diabetes Center Copenhagen, Gentofte, Denmark
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- Peter Rossing
- Steno Diabetes Center Copenhagen, Gentofte, Denmark
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- Priya Vart
- Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
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- Glenn M. Chertow
- Departments of Medicine and Epidemiology and Population Health, Stanford University School of Medicine, Stanford, CA
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- Fan Fan Hou
- Division of Nephrology, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, Guangzhou, China
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- Niels Jongs
- Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
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- John J.V. McMurray
- Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, U.K
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- Ricardo Correa-Rotter
- National Medical Science and Nutrition Institute Salvador Zubirán, Mexico City, Mexico
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- Harpreet S. Bajaj
- LMC Diabetes and Endocrinology, Brampton, Ontario, Canada
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- Bergur V. Stefansson
- Late-stage Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden
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- Robert D. Toto
- Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, TX
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- Anna Maria Langkilde
- Late-stage Development, Cardiovascular, Renal and Metabolism, Biopharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden
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- David C. Wheeler
- Department of Renal Medicine, University College London, London, U.K.
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- Hiddo J.L. Heerspink
- Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands
説明
<jats:sec> <jats:title>OBJECTIVE</jats:title> <jats:p>The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) study demonstrated risk reduction for kidney and cardiovascular outcomes with dapagliflozin versus placebo in participants with chronic kidney disease (CKD) with and without diabetes. We compared outcomes according to baseline glycemic status.</jats:p> </jats:sec> <jats:sec> <jats:title>RESEARCH DESIGN AND METHODS</jats:title> <jats:p>We enrolled participants with CKD, estimated glomerular filtration rate (eGFR) 25–75 mL/min/1.73 m2, and urinary albumin-to-creatinine ratio 200–5,000 mg/g. The primary composite end point was sustained eGFR decline ≥50%, end-stage kidney disease, or kidney or cardiovascular death.</jats:p> </jats:sec> <jats:sec> <jats:title>RESULTS</jats:title> <jats:p>Of 4,304 participants, 738 had normoglycemia, 660 had prediabetes, and 2,906 had type 2 diabetes. The effect of dapagliflozin on the primary outcome was consistent (P for interaction = 0.19) in normoglycemia (hazard ratio [HR] 0.62 [95% CI 0.39, 1.01]), prediabetes (HR 0.37 [0.21, 0.66]), and type 2 diabetes (HR 0.64 [0.52, 0.79]). We found no evidence for effect modification on any outcome. Adverse events were similar, with no major hypoglycemia or ketoacidosis in participants with normoglycemia or prediabetes.</jats:p> </jats:sec> <jats:sec> <jats:title>CONCLUSIONS</jats:title> <jats:p>Dapagliflozin safely reduced kidney and cardiovascular events independent of baseline glycemic status.</jats:p> </jats:sec>
収録刊行物
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- Diabetes Care
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Diabetes Care 44 (8), 1894-1897, 2021-06-28
American Diabetes Association