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Empagliflozin in Patients with Chronic Kidney Disease

The EMPA-KIDNEY Collaborative Group , Herrington WG 1 , Staplin N 1 , Wanner C 1 , Green JB 1 , Hauske SJ 1 Show all authors , Emberson JR 1 , Preiss D 1 , Judge P 1 , Mayne KJ 1 , Ng SYA 1 , Sammons E 1 , Zhu D 1 , Hill M 1 , Stevens W 1 , Wallendszus K 1 , Brenner S 1 , Cheung AK 1 , Liu ZH 1 , Li J 1 , Hooi LS 1 , Liu W 1 , Kadowaki T 1 , Nangaku M 1 , Levin A 1 , Cherney D 1 , Maggioni AP 1 , Pontremoli R 1 , Deo R 1 , Goto S 1 , Rossello X 1 , Tuttle KR 1 , Steubl D 1 , Petrini M 1 , Massey D 1 , Eilbracht J 1 , Brueckmann M 1 , Landray MJ 1 , Baigent C 1 , Haynes R 1

Affiliations 

  • 1 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 Research Council Population Health Research Unit (W.G.H., N.S., J.R.E., D.P., M.H., M.J.L., C.B., R.H.), University of Oxford, Oxford; University Clinic Würzburg, Würzburg (C.W., S.B.), Boehringer Ingelheim International (S.J.H., D.S., J.E., M.B.) and Boehringer Ingelheim Pharmaceuticals (M.P.), Ingelheim am Rhein, Elderbrook Solutions, Bietigheim-Bissingen (D.M.), the Fifth Department of Medicine, University Medical Center Mannheim (S.J.H.) and the First Department of Medicine, Faculty of Medicine Mannheim (M.B.), University of Heidelberg, Mannheim, and the Department of Nephrology, Hospital Rechts der Isar, Technical University of Munich, Munich (D.S.) - all in Germany; Duke Clinical Research Institute, Durham, NC (J.B.G.); University of Utah, Salt Lake City (A.K.C.); National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine, Nanjing (Z.-H.L.), and Fuwai Hospital, Chinese Academy of Medical Sciences, National Center for Cardiovascular Diseases, Beijing (J.L.) - both in China; Hospital Sultanah Aminah, Johor Bahru, Malaysia (L.S.H., W.L.); the University of Tokyo School of Medicine, Toranomon Hospital (T.K.), and the University of Tokyo School of Medicine (M.N.), Tokyo, Tokai University School of Medicine, Isehara (S.G.) - both in Japan; University of British Columbia, Vancouver (A.L.), and University of Toronto, Toronto (D.C.) - both in Canada; Università degli Studi and IRCCS Ospedale Policlinico San Martino di Genova, Genoa (R.P.), and Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence (A.P.M.) - both in Italy; University of Pennsylvania Perelman School of Medicine, Philadelphia (R.D.); Providence Health, Renton, and University of Washington, Seattle (K.R.T.) - both in Washington; and Hospital Universitari Son Espases, Health Research Institute of the Balearic Islands, University of the Balearic Islands, Palma de Mallorca, Spain (X.R.)
N Engl J Med, 2023 Jan 12;388(2):117-127.
PMID: 36331190 DOI: 10.1056/NEJMoa2204233

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.).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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