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Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.

Abstract 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.
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Authors

Mayor MeshTerms
Keywords
Journal Title the new england journal of medicine
Publication Year Start
%A Wanner, Christoph; Inzucchi, Silvio E.; Lachin, John M.; Fitchett, David; von Eynatten, Maximilian; Mattheus, Michaela; Johansen, Odd Erik; Woerle, Hans J.; Broedl, Uli C.; Zinman, Bernard
%A EMPA-REG OUTCOME Investigators
%T Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
%J The New England journal of medicine, vol. 375, no. 4, pp. 323-334
%D 07/2016
%V 375
%N 4
%M eng
%B 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.
%K Aged, Albuminuria, Benzhydryl Compounds, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Diabetic Nephropathies, Disease Progression, Female, Glomerular Filtration Rate, Glucosides, Humans, Hypoglycemic Agents, Intention to Treat Analysis, Kaplan-Meier Estimate, Kidney, Male, Microvessels, Middle Aged, Proportional Hazards Models, Risk Factors
%P 323
%L 334
%Y 10.1056/NEJMoa1515920
%W PHY
%G AUTHOR
%R 2016......375..323W

@Article{Wanner2016,
author="Wanner, Christoph
and Inzucchi, Silvio E.
and Lachin, John M.
and Fitchett, David
and von Eynatten, Maximilian
and Mattheus, Michaela
and Johansen, Odd Erik
and Woerle, Hans J.
and Broedl, Uli C.
and Zinman, Bernard
and {EMPA-REG OUTCOME Investigators}",
title="Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.",
journal="The New England journal of medicine",
year="2016",
month="Jul",
day="28",
volume="375",
number="4",
pages="323--334",
keywords="Aged",
keywords="Albuminuria",
keywords="Benzhydryl Compounds",
keywords="Cardiovascular Diseases",
keywords="Diabetes Mellitus, Type 2",
keywords="Diabetic Nephropathies",
keywords="Disease Progression",
keywords="Female",
keywords="Glomerular Filtration Rate",
keywords="Glucosides",
keywords="Humans",
keywords="Hypoglycemic Agents",
keywords="Intention to Treat Analysis",
keywords="Kaplan-Meier Estimate",
keywords="Kidney",
keywords="Male",
keywords="Microvessels",
keywords="Middle Aged",
keywords="Proportional Hazards Models",
keywords="Risk Factors",
abstract="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.",
issn="1533-4406",
doi="10.1056/NEJMoa1515920",
url="http://www.ncbi.nlm.nih.gov/pubmed/27299675",
language="eng"
}

%0 Journal Article
%T Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
%A Wanner, Christoph
%A Inzucchi, Silvio E.
%A Lachin, John M.
%A Fitchett, David
%A von Eynatten, Maximilian
%A Mattheus, Michaela
%A Johansen, Odd Erik
%A Woerle, Hans J.
%A Broedl, Uli C.
%A Zinman, Bernard
%A EMPA-REG OUTCOME Investigators
%J The New England journal of medicine
%D 2016
%8 Jul 28
%V 375
%N 4
%@ 1533-4406
%G eng
%F Wanner2016
%X 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.
%K Aged
%K Albuminuria
%K Benzhydryl Compounds
%K Cardiovascular Diseases
%K Diabetes Mellitus, Type 2
%K Diabetic Nephropathies
%K Disease Progression
%K Female
%K Glomerular Filtration Rate
%K Glucosides
%K Humans
%K Hypoglycemic Agents
%K Intention to Treat Analysis
%K Kaplan-Meier Estimate
%K Kidney
%K Male
%K Microvessels
%K Middle Aged
%K Proportional Hazards Models
%K Risk Factors
%U http://dx.doi.org/10.1056/NEJMoa1515920
%U http://www.ncbi.nlm.nih.gov/pubmed/27299675
%P 323-334

PT Journal
AU Wanner, C
   Inzucchi, SE
   Lachin, JM
   Fitchett, D
   von Eynatten, M
   Mattheus, M
   Johansen, OE
   Woerle, HJ
   Broedl, UC
   Zinman, B
AU EMPA-REG OUTCOME Investigators
TI Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
SO The New England journal of medicine
JI N. Engl. J. Med.
PD Jul
PY 2016
BP 323
EP 334
VL 375
IS 4
DI 10.1056/NEJMoa1515920
LA eng
DE Aged; Albuminuria; Benzhydryl Compounds; Cardiovascular Diseases; Diabetes Mellitus, Type 2; Diabetic Nephropathies; Disease Progression; Female; Glomerular Filtration Rate; Glucosides; Humans; Hypoglycemic Agents; Intention to Treat Analysis; Kaplan-Meier Estimate; Kidney; Male; Microvessels; Middle Aged; Proportional Hazards Models; Risk Factors
AB 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.
ER

PMID- 27299675
OWN - NLM
STAT- MEDLINE
DA  - 20160728
DCOM- 20160805
IS  - 1533-4406 (Electronic)
IS  - 0028-4793 (Linking)
VI  - 375
IP  - 4
DP  - 2016 Jul 28
TI  - Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
PG  - 323-34
LID - 10.1056/NEJMoa1515920 [doi]
AB  - 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 m(2)
      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. (Funded by the Boehringer Ingelheim and Eli Lilly and Company Diabetes
      Alliance; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).
FAU - Wanner, Christoph
AU  - Wanner C
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Inzucchi, Silvio E
AU  - Inzucchi SE
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Lachin, John M
AU  - Lachin JM
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Fitchett, David
AU  - Fitchett D
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - von Eynatten, Maximilian
AU  - von Eynatten M
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Mattheus, Michaela
AU  - Mattheus M
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Johansen, Odd Erik
AU  - Johansen OE
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Woerle, Hans J
AU  - Woerle HJ
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Broedl, Uli C
AU  - Broedl UC
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
FAU - Zinman, Bernard
AU  - Zinman B
AD  - From the Department of Medicine, Division of Nephrology, Wurzburg University
      Clinic, Wurzburg (C.W.), and Boehringer Ingelheim Pharma, Ingelheim (M.E., M.M., 
      H.J.W., U.C.B.) - both in Germany; the Section of Endocrinology, Yale University 
      School of Medicine, New Haven, CT (S.E.I.); the Biostatistics Center, George
      Washington University, Rockville, MD (J.M.L.); the Divisions of Cardiology (D.F.)
      and Endocrinology (B.Z.), University of Toronto, and the Lunenfeld-Tanenbaum
      Research Institute, Mount Sinai Hospital (B.Z.) - both in Toronto; and Boehringer
      Ingelheim Norway, Asker, Norway (O.E.J.).
CN  - EMPA-REG OUTCOME Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT01131676
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20160614
PL  - United States
TA  - N Engl J Med
JT  - The New England journal of medicine
JID - 0255562
RN  - 0 (Benzhydryl Compounds)
RN  - 0 (Glucosides)
RN  - 0 (Hypoglycemic Agents)
RN  - HDC1R2M35U (empagliflozin)
SB  - AIM
SB  - IM
CIN - N Engl J Med. 2016 Jul 28;375(4):380-2. PMID: 27331286
MH  - Aged
MH  - Albuminuria
MH  - Benzhydryl Compounds/adverse effects/*therapeutic use
MH  - Cardiovascular Diseases/etiology
MH  - Diabetes Mellitus, Type 2/*complications/drug therapy
MH  - Diabetic Nephropathies/*drug therapy
MH  - Disease Progression
MH  - Female
MH  - Glomerular Filtration Rate
MH  - Glucosides/adverse effects/*therapeutic use
MH  - Humans
MH  - Hypoglycemic Agents/adverse effects/*therapeutic use
MH  - Intention to Treat Analysis
MH  - Kaplan-Meier Estimate
MH  - Kidney/blood supply
MH  - Male
MH  - Microvessels/drug effects
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Risk Factors
EDAT- 2016/06/15 06:00
MHDA- 2016/08/06 06:00
CRDT- 2016/06/15 06:00
PHST- 2016/06/14 [aheadofprint]
AID - 10.1056/NEJMoa1515920 [doi]
PST - ppublish
SO  - N Engl J Med. 2016 Jul 28;375(4):323-34. doi: 10.1056/NEJMoa1515920. Epub 2016
      Jun 14.
TY  - JOUR
AU  - Wanner, Christoph
AU  - Inzucchi, Silvio E.
AU  - Lachin, John M.
AU  - Fitchett, David
AU  - von Eynatten, Maximilian
AU  - Mattheus, Michaela
AU  - Johansen, Odd Erik
AU  - Woerle, Hans J.
AU  - Broedl, Uli C.
AU  - Zinman, Bernard
AU  - EMPA-REG OUTCOME Investigators
PY  - 2016/Jul/28
TI  - Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
T2  - N. Engl. J. Med.
JO  - The New England journal of medicine
SP  - 323
EP  - 334
VL  - 375
IS  - 4
KW  - Aged
KW  - Albuminuria
KW  - Benzhydryl Compounds
KW  - Cardiovascular Diseases
KW  - Diabetes Mellitus, Type 2
KW  - Diabetic Nephropathies
KW  - Disease Progression
KW  - Female
KW  - Glomerular Filtration Rate
KW  - Glucosides
KW  - Humans
KW  - Hypoglycemic Agents
KW  - Intention to Treat Analysis
KW  - Kaplan-Meier Estimate
KW  - Kidney
KW  - Male
KW  - Microvessels
KW  - Middle Aged
KW  - Proportional Hazards Models
KW  - Risk Factors
N2  - 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.
SN  - 1533-4406
UR  - http://dx.doi.org/10.1056/NEJMoa1515920
UR  - http://www.ncbi.nlm.nih.gov/pubmed/27299675
ID  - Wanner2016
ER  - 
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