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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.
Afiliação
  • Herrington WG; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Staplin N; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Wanner C; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Green JB; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Hauske SJ; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Emberson JR; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Preiss D; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Judge P; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Mayne KJ; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Ng SYA; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Sammons E; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Zhu D; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Hill M; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Stevens W; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Wallendszus K; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Brenner S; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Cheung AK; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Liu ZH; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Li J; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Hooi LS; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Liu W; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Kadowaki T; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Nangaku M; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Levin A; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Cherney D; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Maggioni AP; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Pontremoli R; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Deo R; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Goto S; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Rossello X; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Tuttle KR; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Steubl D; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Petrini M; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Massey D; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Eilbracht J; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Brueckmann M; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Landray MJ; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Baigent C; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
  • Haynes R; The affiliations of the members of the writing committee are as follows: the Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health (W.G.H., N.S., J.R.E., D.P., P.J., K.J.M., S.Y.A.N., E.S., D.Z., M.H., W.S., K.W., M.J.L., C.B., R.H.), and the Medical
N Engl J Med ; 388(2): 117-127, 2023 01 12.
Article em En | MEDLINE | ID: mdl-36331190
ABSTRACT

BACKGROUND:

The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients.

METHODS:

We enrolled patients with chronic kidney disease who had an estimated glomerular filtration rate (eGFR) of at least 20 but less than 45 ml per minute per 1.73 m2 of body-surface area, or who had an eGFR of at least 45 but less than 90 ml per minute per 1.73 m2 with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of at least 200. Patients were randomly assigned to receive empagliflozin (10 mg once daily) or matching placebo. The primary outcome was a composite of progression of kidney disease (defined as end-stage kidney disease, a sustained decrease in eGFR to <10 ml per minute per 1.73 m2, a sustained decrease in eGFR of ≥40% from baseline, or death from renal causes) or death from cardiovascular causes.

RESULTS:

A total of 6609 patients underwent randomization. During a median of 2.0 years of follow-up, progression of kidney disease or death from cardiovascular causes 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% confidence interval [CI], 0.64 to 0.82; P<0.001). Results were consistent among patients with or without diabetes and across subgroups defined according to eGFR ranges. The rate of hospitalization from any cause was lower in the empagliflozin group than in the placebo group (hazard ratio, 0.86; 95% CI, 0.78 to 0.95; P = 0.003), but there were no significant between-group differences with respect to the composite outcome of hospitalization for heart failure or death from cardiovascular causes (which occurred in 4.0% in the empagliflozin group and 4.6% in the placebo group) or death from any cause (in 4.5% and 5.1%, respectively). The rates of serious adverse events were similar in the two groups.

CONCLUSIONS:

Among a wide range of patients with chronic kidney disease who were at risk for disease progression, empagliflozin therapy led to a lower risk of progression of kidney disease or death from cardiovascular causes than placebo. (Funded by Boehringer Ingelheim and others; EMPA-KIDNEY ClinicalTrials.gov number, NCT03594110; EudraCT number, 2017-002971-24.).
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 6_ODS3_enfermedades_notrasmisibles Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Diabetes Mellitus Tipo 2 / Insuficiência Renal Crônica / Inibidores do Transportador 2 de Sódio-Glicose Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article
Texto completo
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Texto completo: 1 Coleções: 01-internacional Contexto em Saúde: 6_ODS3_enfermedades_notrasmisibles Base de dados: MEDLINE Assunto principal: Doenças Cardiovasculares / Diabetes Mellitus Tipo 2 / Insuficiência Renal Crônica / Inibidores do Transportador 2 de Sódio-Glicose Tipo de estudo: Clinical_trials Limite: Humans Idioma: En Revista: N Engl J Med Ano de publicação: 2023 Tipo de documento: Article