Dapagliflozin in Patients with Chronic Kidney Disease
- PMID: 32970396
- DOI: 10.1056/NEJMoa2024816
Dapagliflozin in Patients with Chronic Kidney Disease
Abstract
Background: Patients with chronic kidney disease have a high risk of adverse kidney and cardiovascular outcomes. The effect of dapagliflozin in patients with chronic kidney disease, with or without type 2 diabetes, is not known.
Methods: We randomly assigned 4304 participants with an estimated glomerular filtration rate (GFR) of 25 to 75 ml per minute per 1.73 m2 of body-surface area and a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 200 to 5000 to receive dapagliflozin (10 mg once daily) or placebo. The primary outcome was a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes.
Results: The independent data monitoring committee recommended stopping the trial because of efficacy. Over a median of 2.4 years, a primary outcome event occurred in 197 of 2152 participants (9.2%) in the dapagliflozin group and 312 of 2152 participants (14.5%) in the placebo group (hazard ratio, 0.61; 95% confidence interval [CI], 0.51 to 0.72; P<0.001; number needed to treat to prevent one primary outcome event, 19 [95% CI, 15 to 27]). The hazard ratio for the composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal causes was 0.56 (95% CI, 0.45 to 0.68; P<0.001), and the hazard ratio for the composite of death from cardiovascular causes or hospitalization for heart failure was 0.71 (95% CI, 0.55 to 0.92; P = 0.009). Death occurred in 101 participants (4.7%) in the dapagliflozin group and 146 participants (6.8%) in the placebo group (hazard ratio, 0.69; 95% CI, 0.53 to 0.88; P = 0.004). The effects of dapagliflozin were similar in participants with type 2 diabetes and in those without type 2 diabetes. The known safety profile of dapagliflozin was confirmed.
Conclusions: Among patients with chronic kidney disease, regardless of the presence or absence of diabetes, the risk of a composite of a sustained decline in the estimated GFR of at least 50%, end-stage kidney disease, or death from renal or cardiovascular causes was significantly lower with dapagliflozin than with placebo. (Funded by AstraZeneca; DAPA-CKD ClinicalTrials.gov number, NCT03036150.).
Copyright © 2020 Massachusetts Medical Society.
Comment in
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More reasons to use SGLT2 inhibitors: EMPEROR-reduced and DAPA-CKD.Kidney Int. 2020 Dec;98(6):1387-1389. doi: 10.1016/j.kint.2020.10.002. Epub 2020 Oct 14. Kidney Int. 2020. PMID: 33068607 No abstract available.
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Organ protection beyond glycaemic control with SGLT2 inhibitors.Nat Rev Nephrol. 2021 Apr;17(4):223-224. doi: 10.1038/s41581-020-00373-4. Nat Rev Nephrol. 2021. PMID: 33159190 No abstract available.
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Dapagliflozin in Patients with Chronic Kidney Disease.N Engl J Med. 2021 Jan 28;384(4):388-389. doi: 10.1056/NEJMc2032809. N Engl J Med. 2021. PMID: 33503360 No abstract available.
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Dapagliflozin in Patients with Chronic Kidney Disease.N Engl J Med. 2021 Jan 28;384(4):389. doi: 10.1056/NEJMc2032809. N Engl J Med. 2021. PMID: 33503361 No abstract available.
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In CKD, dapagliflozin reduced a composite of eGFR decline, end-stage kidney disease, or CV or renal mortality.Ann Intern Med. 2021 Feb;174(2):JC20. doi: 10.7326/ACPJ202102160-020. Epub 2021 Feb 2. Ann Intern Med. 2021. PMID: 33524285
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SGLT-2-Hemmer schützt Herz und Nieren.MMW Fortschr Med. 2023 Mar;165(4):66. doi: 10.1007/s15006-023-2422-1. MMW Fortschr Med. 2023. PMID: 36826674 German. No abstract available.
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