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Empagliflozin in Patients with Chronic Kidney Disease

BACKGROUND: This study, the EMPA-KIDNEY trial, was designed to assess the effects of empagliflozin in a broad range of patients with chronic kidney disease (CKD) at risk of progression. METHODS: We randomly assigned 6609 participants to empagliflozin (10mg once daily) versus matching placebo. Eligib...

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Autores principales: Herrington, William G., Staplin, Natalie, Wanner, Christoph, Green, Jennifer B., Hauske, Sibylle J., Emberson, Jonathan R., Preiss, David, Judge, Parminder, Mayne, Kaitlin J., Ng, Sarah Y.A., Sammons, Emily, Zhu, Doreen, Hill, Michael, Stevens, Will, Wallendszus, Karl, Brenner, Susanne, Cheung, Alfred K., Liu, Zhi-Hong, Li, Jing, Hooi, Lai Seong, Liu, Wen, Kadowaki, Takashi, Nangaku, Masaomi, Levin, Adeera, Cherney, David, Maggioni, Aldo P., Pontremoli, Roberto, Deo, Rajat, Goto, Shinya, Rossello, Xavier, Tuttle, Katherine R., Steubl, Dominik, Petrini, Michaela, Massey, Dan, Eilbracht, Jens, Brueckmann, Martina, Landray, Martin J., Baigent, Colin, Haynes, Richard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7614055/
https://www.ncbi.nlm.nih.gov/pubmed/36331190
http://dx.doi.org/10.1056/NEJMoa2204233
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author Herrington, William G.
Staplin, Natalie
Wanner, Christoph
Green, Jennifer B.
Hauske, Sibylle J.
Emberson, Jonathan R.
Preiss, David
Judge, Parminder
Mayne, Kaitlin J.
Ng, Sarah Y.A.
Sammons, Emily
Zhu, Doreen
Hill, Michael
Stevens, Will
Wallendszus, Karl
Brenner, Susanne
Cheung, Alfred K.
Liu, Zhi-Hong
Li, Jing
Hooi, Lai Seong
Liu, Wen
Kadowaki, Takashi
Nangaku, Masaomi
Levin, Adeera
Cherney, David
Maggioni, Aldo P.
Pontremoli, Roberto
Deo, Rajat
Goto, Shinya
Rossello, Xavier
Tuttle, Katherine R.
Steubl, Dominik
Petrini, Michaela
Massey, Dan
Eilbracht, Jens
Brueckmann, Martina
Landray, Martin J.
Baigent, Colin
Haynes, Richard
author_facet Herrington, William G.
Staplin, Natalie
Wanner, Christoph
Green, Jennifer B.
Hauske, Sibylle J.
Emberson, Jonathan R.
Preiss, David
Judge, Parminder
Mayne, Kaitlin J.
Ng, Sarah Y.A.
Sammons, Emily
Zhu, Doreen
Hill, Michael
Stevens, Will
Wallendszus, Karl
Brenner, Susanne
Cheung, Alfred K.
Liu, Zhi-Hong
Li, Jing
Hooi, Lai Seong
Liu, Wen
Kadowaki, Takashi
Nangaku, Masaomi
Levin, Adeera
Cherney, David
Maggioni, Aldo P.
Pontremoli, Roberto
Deo, Rajat
Goto, Shinya
Rossello, Xavier
Tuttle, Katherine R.
Steubl, Dominik
Petrini, Michaela
Massey, Dan
Eilbracht, Jens
Brueckmann, Martina
Landray, Martin J.
Baigent, Colin
Haynes, Richard
collection PubMed
description BACKGROUND: This study, the EMPA-KIDNEY trial, was designed to assess the effects of empagliflozin in a broad range of patients with chronic kidney disease (CKD) at risk of progression. METHODS: We randomly assigned 6609 participants to empagliflozin (10mg once daily) versus matching placebo. Eligibility required an estimated glomerular filtration rate (eGFR) of ≥20 to <45 ml/minute/1.73m(2); or ≥45 to <90 ml/minute/1.73m(2) with a urinary albumin-to-creatinine ratio (ACR) of ≥200 mg/g. The primary outcome was a composite of kidney disease progression (end-stage kidney disease, a sustained eGFR <10 ml/minute/1.73m(2), a sustained decline in eGFR of ≥40%, or a renal death) or death from cardiovascular causes. RESULTS: During a median of 2.0 years follow-up, a primary outcome event occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% CI 0.64 to 0.82; P<0.001), with consistent results in those with or without diabetes and across the range of eGFR studied. There were fewer hospitalizations from any cause in the empagliflozin group (0.86; 0.78 to 0.95, P=0.003), but no statistically significant effect on hospitalization for heart failure or cardiovascular death (4.0% vs 4.6%), or death from any cause (4.5% vs 5.1%). The rates of serious adverse events were broadly similar in the two groups. CONCLUSIONS: Empagliflozin reduced the risk of the composite outcome of kidney disease progression or cardiovascular death in a wide range of patients at risk of CKD progression. (Funding:Boehringer Ingelheim, Eli Lilly and others; Clinicaltrials.gov:NCT03594110, EuDRACT: 2017-002971-24).
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spelling pubmed-76140552023-01-12 Empagliflozin in Patients with Chronic Kidney Disease Herrington, William G. Staplin, Natalie Wanner, Christoph Green, Jennifer B. Hauske, Sibylle J. Emberson, Jonathan R. Preiss, David Judge, Parminder Mayne, Kaitlin J. Ng, Sarah Y.A. Sammons, Emily Zhu, Doreen Hill, Michael Stevens, Will Wallendszus, Karl Brenner, Susanne Cheung, Alfred K. Liu, Zhi-Hong Li, Jing Hooi, Lai Seong Liu, Wen Kadowaki, Takashi Nangaku, Masaomi Levin, Adeera Cherney, David Maggioni, Aldo P. Pontremoli, Roberto Deo, Rajat Goto, Shinya Rossello, Xavier Tuttle, Katherine R. Steubl, Dominik Petrini, Michaela Massey, Dan Eilbracht, Jens Brueckmann, Martina Landray, Martin J. Baigent, Colin Haynes, Richard N Engl J Med Article BACKGROUND: This study, the EMPA-KIDNEY trial, was designed to assess the effects of empagliflozin in a broad range of patients with chronic kidney disease (CKD) at risk of progression. METHODS: We randomly assigned 6609 participants to empagliflozin (10mg once daily) versus matching placebo. Eligibility required an estimated glomerular filtration rate (eGFR) of ≥20 to <45 ml/minute/1.73m(2); or ≥45 to <90 ml/minute/1.73m(2) with a urinary albumin-to-creatinine ratio (ACR) of ≥200 mg/g. The primary outcome was a composite of kidney disease progression (end-stage kidney disease, a sustained eGFR <10 ml/minute/1.73m(2), a sustained decline in eGFR of ≥40%, or a renal death) or death from cardiovascular causes. RESULTS: During a median of 2.0 years follow-up, a primary outcome event occurred in 432 of 3304 patients (13.1%) in the empagliflozin group and in 558 of 3305 patients (16.9%) in the placebo group (hazard ratio, 0.72; 95% CI 0.64 to 0.82; P<0.001), with consistent results in those with or without diabetes and across the range of eGFR studied. There were fewer hospitalizations from any cause in the empagliflozin group (0.86; 0.78 to 0.95, P=0.003), but no statistically significant effect on hospitalization for heart failure or cardiovascular death (4.0% vs 4.6%), or death from any cause (4.5% vs 5.1%). The rates of serious adverse events were broadly similar in the two groups. CONCLUSIONS: Empagliflozin reduced the risk of the composite outcome of kidney disease progression or cardiovascular death in a wide range of patients at risk of CKD progression. (Funding:Boehringer Ingelheim, Eli Lilly and others; Clinicaltrials.gov:NCT03594110, EuDRACT: 2017-002971-24). 2023-01-12 2022-11-04 /pmc/articles/PMC7614055/ /pubmed/36331190 http://dx.doi.org/10.1056/NEJMoa2204233 Text en https://creativecommons.org/licenses/by-nd/4.0/This work is licensed under a CC BY-ND 4.0 (https://creativecommons.org/licenses/by-nd/4.0/) International license.
spellingShingle Article
Herrington, William G.
Staplin, Natalie
Wanner, Christoph
Green, Jennifer B.
Hauske, Sibylle J.
Emberson, Jonathan R.
Preiss, David
Judge, Parminder
Mayne, Kaitlin J.
Ng, Sarah Y.A.
Sammons, Emily
Zhu, Doreen
Hill, Michael
Stevens, Will
Wallendszus, Karl
Brenner, Susanne
Cheung, Alfred K.
Liu, Zhi-Hong
Li, Jing
Hooi, Lai Seong
Liu, Wen
Kadowaki, Takashi
Nangaku, Masaomi
Levin, Adeera
Cherney, David
Maggioni, Aldo P.
Pontremoli, Roberto
Deo, Rajat
Goto, Shinya
Rossello, Xavier
Tuttle, Katherine R.
Steubl, Dominik
Petrini, Michaela
Massey, Dan
Eilbracht, Jens
Brueckmann, Martina
Landray, Martin J.
Baigent, Colin
Haynes, Richard
Empagliflozin in Patients with Chronic Kidney Disease
title Empagliflozin in Patients with Chronic Kidney Disease
title_full Empagliflozin in Patients with Chronic Kidney Disease
title_fullStr Empagliflozin in Patients with Chronic Kidney Disease
title_full_unstemmed Empagliflozin in Patients with Chronic Kidney Disease
title_short Empagliflozin in Patients with Chronic Kidney Disease
title_sort empagliflozin in patients with chronic kidney disease
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7614055/
https://www.ncbi.nlm.nih.gov/pubmed/36331190
http://dx.doi.org/10.1056/NEJMoa2204233
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