Dapagliflozin in patients with chronic kidney disease

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 glome...

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Autores: 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.
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2020
País:España
Recursos:Universidad de Barcelona
Repositorio:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/189959
Acesso em linha:https://hdl.handle.net/2445/189959
Access Level:acceso abierto
Palavra-chave:Malalties del ronyó
Diabetis
Glucòsids
Kidney diseases
Diabetes
Glucosides
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repository_id_str
spelling Dapagliflozin in patients with chronic kidney diseaseHeerspink, Hiddo J.L.Stefánsson, Bergur V.Correa-Rotter, RicardoChertow, Glenn M.Greene, TomHou, Fan-FanMann, Johannes F.E.McMurray, John J.V.Lindberg, MagnusRossing, PeterSjöström, C. DavidToto, Roberto D.Langkilde, Anna-MariaWheeler, David C.Cruzado, Josep Ma.Malalties del ronyóDiabetisGlucòsidsKidney diseasesDiabetesGlucosidesBackground: 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.Massachusetts Medical Society2020info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/2445/189959Articles publicats en revistes (Ciències Clíniques)reponame:Dipòsit Digital de la UBinstname:Universidad de BarcelonaInglésReproducció del document publicat a: https://doi.org/10.1056/NEJMoa2024816New England Journal of Medicine, 2020, vol. 383, num. 15, p. 1436-1446https://doi.org/10.1056/NEJMoa2024816(c) Massachusetts Medical Society, 2020info:eu-repo/semantics/openAccessoai:diposit.ub.edu:2445/1899592026-05-27T06:46:51Z
dc.title.none.fl_str_mv Dapagliflozin in patients with chronic kidney disease
title Dapagliflozin in patients with chronic kidney disease
spellingShingle Dapagliflozin in patients with chronic kidney disease
Heerspink, Hiddo J.L.
Malalties del ronyó
Diabetis
Glucòsids
Kidney diseases
Diabetes
Glucosides
title_short Dapagliflozin in patients with chronic kidney disease
title_full Dapagliflozin in patients with chronic kidney disease
title_fullStr Dapagliflozin in patients with chronic kidney disease
title_full_unstemmed Dapagliflozin in patients with chronic kidney disease
title_sort Dapagliflozin in patients with chronic kidney disease
dc.creator.none.fl_str_mv 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.
author Heerspink, Hiddo J.L.
author_facet 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.
author_role author
author2 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.
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Malalties del ronyó
Diabetis
Glucòsids
Kidney diseases
Diabetes
Glucosides
topic Malalties del ronyó
Diabetis
Glucòsids
Kidney diseases
Diabetes
Glucosides
description 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.
publishDate 2020
dc.date.none.fl_str_mv 2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/2445/189959
url https://hdl.handle.net/2445/189959
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa2024816
New England Journal of Medicine, 2020, vol. 383, num. 15, p. 1436-1446
https://doi.org/10.1056/NEJMoa2024816
dc.rights.none.fl_str_mv (c) Massachusetts Medical Society, 2020
info:eu-repo/semantics/openAccess
rights_invalid_str_mv (c) Massachusetts Medical Society, 2020
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv Articles publicats en revistes (Ciències Clíniques)
reponame:Dipòsit Digital de la UB
instname:Universidad de Barcelona
instname_str Universidad de Barcelona
reponame_str Dipòsit Digital de la UB
collection Dipòsit Digital de la UB
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15.301603

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