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2020-09-24

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Dapagliflozin in patients with chronic kidney disease

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https://doi.org/10.1056/NEJMoa2024816

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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.

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Malalties del ronyó, Diabetis, Glucòsids

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Kidney diseases, Diabetes, Glucosides

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HEERSPINK, Hiddo j.l., STEFÁNSSON, Bergur v., CORREA-ROTTER, Ricardo, CHERTOW, Glenn m., GREENE, Tom, HOU, Fan-fan, MANN, Johannes f.e., MCMURRAY, John j.v., LINDBERG, Magnus, ROSSING, Peter, SJÖSTRÖM, C. david, TOTO, Roberto d., LANGKILDE, Anna-maria, WHEELER, David c., CRUZADO, Josep ma.. Dapagliflozin in patients with chronic kidney disease. _New England Journal of Medicine_. 2020. Vol. 383, núm. 15, pàgs. 1436-1446. [consulta: 23 de gener de 2026]. ISSN: 0028-4793. [Disponible a: https://hdl.handle.net/2445/189959]

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