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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Empagliflozin and progression of kidney disease in type 2 diabetes
New England Journal of Medicine, Volume 375, No. 4, Year 2016
Notification
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Description
BACKGROUND Diabetes confers an increased risk of adverse cardiovascular and renal events. In the EMPA-REG OUTCOME trial, empagliflozin, a sodium-glucose cotransporter 2 inhibitor, reduced the risk of major adverse cardiovascular events in patients with type 2 diabetes at high risk for cardiovascular events. We wanted to determine the long-term renal effects of empagliflozin, an analysis that was a prespecified component of the secondary microvascular outcome of that trial. METHODS We randomly assigned patients with type 2 diabetes and an estimated glomerular filtration rate of at least 30 ml per minute per 1.73 m2 of body-surface area to receive either empagliflozin (at a dose of 10 mg or 25 mg) or placebo once daily. Prespecified renal outcomes included incident or worsening nephropathy (progression to macroalbuminuria, doubling of the serum creatinine level, initiation of renal-replacement therapy, or death from renal disease) and incident albuminuria. RESULTS Incident or worsening nephropathy occurred in 525 of 4124 patients (12.7%) in the empagliflozin group and in 388 of 2061 (18.8%) in the placebo group (hazard ratio in the empagliflozin group, 0.61; 95% confidence interval, 0.53 to 0.70; P<0.001). Doubling of the serum creatinine level occurred in 70 of 4645 patients (1.5%) in the empagliflozin group and in 60 of 2323 (2.6%) in the placebo group, a significant relative risk reduction of 44%. Renal-replacement therapy was initiated in 13 of 4687 patients (0.3%) in the empagliflozin group and in 14 of 2333 patients (0.6%) in the placebo group, representing a 55% lower relative risk in the empagliflozin group. There was no significant between-group difference in the rate of incident albuminuria. The adverse-event profile of empagliflozin in patients with impaired kidney function at baseline was similar to that reported in the overall trial population. CONCLUSIONS In patients with type 2 diabetes at high cardiovascular risk, empagliflozin was associated with slower progression of kidney disease and lower rates of clinically relevant renal events than was placebo when added to standard care. © Copyright 2016 Massachusetts Medical Society.
Authors & Co-Authors
Wanner, Christoph
Germany, Wurzburg
Universitätsklinikum Würzburg
Inzucchi, Silvio E.
United States, New Haven
Yale School of Medicine
Lachin, John M.
United States, Washington, D.c.
The George Washington University
Zinman, Bernard
Canada, Toronto
University of Toronto
Canada, Toronto
Mount Sinai Hospital of University of Toronto
Waitman, Jorge N.
Unknown Affiliation
Fideleff, Hugo L.
Unknown Affiliation
Lagrutta, Mariana
Unknown Affiliation
Ferré Pácora, Fredy Antoni
Unknown Affiliation
Maffei, Laura Elena
Unknown Affiliation
Selvanayagam, JOSEPH B.
Unknown Affiliation
Paulweber, Bernhard
Unknown Affiliation
Toplak, Hermann
Unknown Affiliation
Luger, Aanton F.
Unknown Affiliation
Drexel, Heinz
Unknown Affiliation
Präger, Rudolf J.F.
Unknown Affiliation
Scheen, André J.
Unknown Affiliation
van Gaal, Luc F.
Unknown Affiliation
Persu, Alexandre
Unknown Affiliation
Hermans, Michel Paul
Unknown Affiliation
van de Borne, Philippe J.H.
Unknown Affiliation
Mathieu, Chantal
Unknown Affiliation
Keymeulen, Bart
Unknown Affiliation
Chacra, Antǒnio Roberto
Unknown Affiliation
Manenti, Euler Roberto Fernandes
Unknown Affiliation
Felício, João Soares
Unknown Affiliation
Borges, João Lindolfo Cunha
Unknown Affiliation
Saraiva, José Francisco Kerr
Unknown Affiliation
Chan, Yih Kai
Unknown Affiliation
Gupta, Milan K.
Unknown Affiliation
Woo, Vincent C.
Unknown Affiliation
Yupanqui-Lozno, Hernán
Unknown Affiliation
Urina-Triana, Miguel
Unknown Affiliation
López-Jaramillo, P.
Unknown Affiliation
Sánchez, Gregorio T.
Unknown Affiliation
Krarup, Thure
Unknown Affiliation
Tarnow, Lise
Unknown Affiliation
Christensen, Per Dahl
Unknown Affiliation
Marandi, Toomas
Unknown Affiliation
Zaoui, Philippe M.
Unknown Affiliation
Choukroun, Gabriel J.
Unknown Affiliation
Hadjadj, Samy
Unknown Affiliation
Kurashvili, Ramaz B.
Unknown Affiliation
McKnight, John A.
Unknown Affiliation
Pearson, Ewan Robert
Unknown Affiliation
Tentolouris, Nikolaos K.
Unknown Affiliation
Tabák, Ádám Gy
Unknown Affiliation
Tamás, Gyula
Unknown Affiliation
Bantwal, Ganapathi
Unknown Affiliation
Mohan, Viswanathan Krishna
Unknown Affiliation
Deshpande, Neeta Rohit
Unknown Affiliation
Premchand, Rajendra Kumar
Unknown Affiliation
Pandey, Ambarish
Unknown Affiliation
Gupta, Sumeet C.
Unknown Affiliation
Suastika, Ketut
Unknown Affiliation
Budi Siswanto, Bambang Budi
Unknown Affiliation
Jaffe, Allan S.
Unknown Affiliation
Taddei, Stefano
Unknown Affiliation
Arca, Marcello
Unknown Affiliation
Calabrò, Paolo
Unknown Affiliation
Fioretto, Paola
Unknown Affiliation
Marchesini Reggiani, Giulio Reggiani
Unknown Affiliation
Marchionni, Niccolò Ò.
Unknown Affiliation
Bucci, Marco
Unknown Affiliation
Pozzilli, Paolo
Unknown Affiliation
Colivicchi, Furio
Unknown Affiliation
Fucili, Alessandro
Unknown Affiliation
Takenaka, Tsuneo
Unknown Affiliation
Okubo, Minoru
Unknown Affiliation
Hong, Tianpei
Unknown Affiliation
Seung, Ki-bae
Unknown Affiliation
Rha, Seungwoon
Unknown Affiliation
Wan Mohamed, Wan Mohd Izani
Unknown Affiliation
Abdul Ghani, Rohana
Unknown Affiliation
Khalid, Bin Abdul Kadir
Unknown Affiliation
Aguilar Salinas, Carlos A.
Unknown Affiliation
Cardona-Muñoz, Ernesto Germán
Unknown Affiliation
Kooy, Adriaan
Unknown Affiliation
Ronner, Eelko F.
Unknown Affiliation
Nierop, Pieter R.
Unknown Affiliation
Al-Windy, Nadea Y.Y.
Unknown Affiliation
Krebs, Jeremy D.
Unknown Affiliation
Scott, R. S.
Unknown Affiliation
Langslet, Gisle
Unknown Affiliation
Lema-Osores, Juan
Unknown Affiliation
Tan, Gavin S.W.
Unknown Affiliation
Panelo, Araceli A.
Unknown Affiliation
Militaru, Constantin
Unknown Affiliation
Barbarash, Olga Leonidovna
Unknown Affiliation
Distiller, Lawrence A.
Unknown Affiliation
Pretorius, Martha M.
Unknown Affiliation
Nortje, Hendrik F.M.
Unknown Affiliation
Mitha, Essack Aziz
Unknown Affiliation
Burgess, Lesley Jean
Unknown Affiliation
Lombaard, Johannes Jurgens
Unknown Affiliation
Govind, U.
Unknown Affiliation
Mookadam, Mohamed
Unknown Affiliation
Jurgens, Jaco
Unknown Affiliation
Podgorski, Gracjan P.
Unknown Affiliation
Naidoo, Datshanna Prakesh
Unknown Affiliation
Emanuel, Shaunagh
Unknown Affiliation
Amod, Aslam
Unknown Affiliation
van Zyl, Louis T.
Unknown Affiliation
Gõmez-Peralta, Fernando
Unknown Affiliation
Camafort Babkowski, Miguel
Unknown Affiliation
Trescolí, Carlos
Unknown Affiliation
Somasundaram, Noel Pratheepan
Unknown Affiliation
Wen, Meiching
Unknown Affiliation
Deerochanawong, Chaicharn
Unknown Affiliation
Godlevska, Olga
Unknown Affiliation
Weiss, Robert J.
Unknown Affiliation
Lewis, David A.
Unknown Affiliation
Graf, Ronald J.
Unknown Affiliation
Uwaifo, Gabriel Ikponmosa
Unknown Affiliation
Fitz-Patrick, David
Unknown Affiliation
Blaze, Kenneth
Unknown Affiliation
Halpern, Scott D.
Unknown Affiliation
Bergenstal, Richard M.
Unknown Affiliation
Matfin, G.
Unknown Affiliation
Sitar, Sandra
Unknown Affiliation
Shah, Sapna
Unknown Affiliation
Hammond, Gregory W.
Unknown Affiliation
Kereiakes, Dean J.
Unknown Affiliation
Rosenstock, Julio
Unknown Affiliation
Sanders, David M.
Unknown Affiliation
Brandon, Donald M.
Unknown Affiliation
Welty, Francine K.
Unknown Affiliation
Parhofer, Klaus Georg
Unknown Affiliation
Pedersen, Terje R.
Unknown Affiliation
Clayton, Tim C.
Unknown Affiliation
Pocock, Stuart J.
Unknown Affiliation
Palmer, Mike K.
Unknown Affiliation
Clemmensen, Peter Michael
Unknown Affiliation
Grande, Peer I.
Unknown Affiliation
Januzzi, James Louis
Unknown Affiliation
Petrie, Mark C.
Unknown Affiliation
Tatlisumak, Turgut
Unknown Affiliation
Soinne, Lauri
Unknown Affiliation
Turan, Tanya N.
Unknown Affiliation
Watkins, Peter J.
Unknown Affiliation
Sullivan, Ryan Joseph
Unknown Affiliation
Schumacher, Martin
Unknown Affiliation
Statistics
Citations: 2,335
Authors: 141
Affiliations: 6
Identifiers
Doi:
10.1056/NEJMoa1515920
ISSN:
00284793
Research Areas
Environmental
Noncommunicable Diseases
Study Design
Cross Sectional Study