Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial.

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  • Additional Information
    • Corporate Authors:
    • Source:
      Publisher: American Diabetes Association Country of Publication: United States NLM ID: 7805975 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1935-5548 (Electronic) Linking ISSN: 01495992 NLM ISO Abbreviation: Diabetes Care Subsets: MEDLINE
    • Publication Information:
      Publication: Alexandria Va : American Diabetes Association
      Original Publication: New York, American Diabetes Assn.
    • Subject Terms:
    • Abstract:
      Objective: 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.
      Research Design and Methods: We enrolled participants with CKD, estimated glomerular filtration rate (eGFR) 25-75 mL/min/1.73 m 2 , 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.
      Results: 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.
      Conclusions: Dapagliflozin safely reduced kidney and cardiovascular events independent of baseline glycemic status.
      (© 2021 by the American Diabetes Association.)
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    • Molecular Sequence:
      ClinicalTrials.gov NCT03036150
      figshare 10.2337/figshare.14465844
    • Accession Number:
      0 (Benzhydryl Compounds)
      0 (Glucosides)
      0 (Sodium-Glucose Transporter 2 Inhibitors)
      1ULL0QJ8UC (dapagliflozin)
    • Publication Date:
      Date Created: 20210629 Date Completed: 20210930 Latest Revision: 20210930
    • Publication Date:
      20221213
    • Accession Number:
      PMC8385469
    • Accession Number:
      10.2337/dc21-0300
    • Accession Number:
      34183431