-
Something wrong with this record ?
Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial
HC. Gerstein, HM. Colhoun, GR. Dagenais, R. Diaz, M. Lakshmanan, P. Pais, J. Probstfield, FT. Botros, MC. Riddle, L. Rydén, D. Xavier, CM. Atisso, L. Dyal, S. Hall, P. Rao-Melacini, G. Wong, A. Avezum, J. Basile, N. Chung, I. Conget, WC. Cushman,...
Language English Country Great Britain
Document type Journal Article, Multicenter Study, Randomized Controlled Trial
NLK
ProQuest Central
from 1992-01-04 to 3 months ago
Nursing & Allied Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Health & Medicine (ProQuest)
from 1992-01-04 to 3 months ago
Family Health Database (ProQuest)
from 1992-01-04 to 3 months ago
Psychology Database (ProQuest)
from 1992-01-04 to 3 months ago
Health Management Database (ProQuest)
from 1992-01-04 to 3 months ago
Public Health Database (ProQuest)
from 1992-01-04 to 3 months ago
- MeSH
- Albuminuria prevention & control MeSH
- Diabetes Mellitus, Type 2 drug therapy MeSH
- Diabetic Nephropathies prevention & control MeSH
- Double-Blind Method MeSH
- Glucagon-Like Peptides analogs & derivatives therapeutic use MeSH
- Glomerular Filtration Rate drug effects MeSH
- Hypoglycemic Agents therapeutic use MeSH
- Immunoglobulin Fc Fragments therapeutic use MeSH
- Creatinine urine MeSH
- Middle Aged MeSH
- Humans MeSH
- Recombinant Fusion Proteins therapeutic use MeSH
- Aged MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Multicenter Study MeSH
- Randomized Controlled Trial MeSH
BACKGROUND: Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. METHODS: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p<0·0001), with HRs of 0·89 (0·78-1·01; p=0·066) for sustained decline in eGFR of 30% or more and 0·75 (0·39-1·44; p=0·39) for chronic renal replacement therapy. INTERPRETATION: Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. FUNDING: Eli Lilly and Company.
Baker Heart and Diabetes Institute Melbourne VIC Australia
Department of Internal Medicine Dresden Technical University Dresden Germany
Department of Medicine K2 Karolinska Institutet Stockholm Sweden
Department of Medicine Oregon Health and Science University Portland OR USA
Department of Medicine University of Washington Seattle WA USA
ECLA Estudios Clínicos Latinoamérica Rosario Argentina
Eli Lilly and Company Indianapolis IN USA
Endocrinology and Nutrition Department Hospital Clínic i Universitari Barcelona Spain
Institut Universitaire de Cardiologie et Pneumologie Université Laval Québec City QC Canada
Instituto Dante Pazzanese de Cardiologia and University Santo Amaro São Paulo Brazil
Iuliu Hatieganu University of Medicine and Pharmacy Cluj Napoca Romania
Latvijas Universitate Riga Latvia
Li Ka Shing Knowledge Institute St Michael's Hospital University of Toronto Toronto ON Canada
Medical University of South Carolina Charleston SC USA
Memphis Veterans Affairs Medical Center Memphis TN USA
National Medical Research Center of Cardiology Moscow Russia
Research Institute FOSCAL and Medical School Universidad de Santander UDES Bucaramanga Colombia
Robert Koch Medical Centre Sofia Bulgaria
Semmelweis University Hungarian Institute of Cardiology Budapest Hungary
St John's Research Institute Bangalore India
Taichung Veterans General Hospital Taichung Taiwan
Universidad de Guadalajara Centro Universitario de Ciencias de la Salud Guadalajara Mexico
Universidad de La Frontera Temuco Chile
University Hospital Motol Prague Czech Republic
University of Cape Town Cape Town South Africa
University of Edinburgh Edinburgh UK
References provided by Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc19044762
- 003
- CZ-PrNML
- 005
- 20200115092122.0
- 007
- ta
- 008
- 200109s2019 xxk f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1016/S0140-6736(19)31150-X $2 doi
- 035 __
- $a (PubMed)31189509
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a xxk
- 100 1_
- $a Gerstein, Hertzel C $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.
- 245 10
- $a Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial / $c HC. Gerstein, HM. Colhoun, GR. Dagenais, R. Diaz, M. Lakshmanan, P. Pais, J. Probstfield, FT. Botros, MC. Riddle, L. Rydén, D. Xavier, CM. Atisso, L. Dyal, S. Hall, P. Rao-Melacini, G. Wong, A. Avezum, J. Basile, N. Chung, I. Conget, WC. Cushman, E. Franek, N. Hancu, M. Hanefeld, S. Holt, P. Jansky, M. Keltai, F. Lanas, LA. Leiter, P. Lopez-Jaramillo, EG. Cardona Munoz, V. Pirags, N. Pogosova, PJ. Raubenheimer, JE. Shaw, WH. Sheu, T. Temelkova-Kurktschiev, REWIND Investigators,
- 520 9_
- $a BACKGROUND: Two glucagon-like peptide-1 (GLP-1) receptor agonists reduced renal outcomes in people with type 2 diabetes at risk for cardiovascular disease. We assessed the long-term effect of the GLP-1 receptor agonist dulaglutide on renal outcomes in an exploratory analysis of the REWIND trial of the effect of dulaglutide on cardiovascular disease. METHODS: REWIND was a multicentre, randomised, double-blind, placebo-controlled trial at 371 sites in 24 countries. Men and women aged at least 50 years with type 2 diabetes who had either a previous cardiovascular event or cardiovascular risk factors were randomly assigned (1:1) to either weekly subcutaneous injection of dulaglutide (1·5 mg) or placebo and followed up at least every 6 months for outcomes. Urinary albumin-to-creatinine ratios (UACRs) and estimated glomerular filtration rates (eGFRs) were estimated from urine and serum values measured in local laboratories every 12 months. The primary outcome (first occurrence of the composite endpoint of non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular causes), secondary outcomes (including a composite microvascular outcome), and safety outcomes of this trial have been reported elsewhere. In this exploratory analysis, we investigate the renal component of the composite microvascular outcome, defined as the first occurrence of new macroalbuminuria (UACR >33·9 mg/mmol), a sustained decline in eGFR of 30% or more from baseline, or chronic renal replacement therapy. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS: Between Aug 18, 2011, and Aug 14, 2013, 9901 participants were enrolled and randomly assigned to receive dulaglutide (n=4949) or placebo (n=4952). At baseline, 791 (7·9%) had macroalbuminuria and mean eGFR was 76·9 mL/min per 1·73 m2 (SD 22·7). During a median follow-up of 5·4 years (IQR 5·1-5·9) comprising 51 820 person-years, the renal outcome developed in 848 (17·1%) participants at an incidence rate of 3·5 per 100 person-years in the dulaglutide group and in 970 (19·6%) participants at an incidence rate of 4·1 per 100 person-years in the placebo group (hazard ratio [HR] 0·85, 95% CI 0·77-0·93; p=0·0004). The clearest effect was for new macroalbuminuria (HR 0·77, 95% CI 0·68-0·87; p<0·0001), with HRs of 0·89 (0·78-1·01; p=0·066) for sustained decline in eGFR of 30% or more and 0·75 (0·39-1·44; p=0·39) for chronic renal replacement therapy. INTERPRETATION: Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. FUNDING: Eli Lilly and Company.
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a albuminurie $x prevence a kontrola $7 D000419
- 650 _2
- $a kreatinin $x moč $7 D003404
- 650 _2
- $a diabetes mellitus 2. typu $x farmakoterapie $7 D003924
- 650 _2
- $a diabetické nefropatie $x prevence a kontrola $7 D003928
- 650 _2
- $a dvojitá slepá metoda $7 D004311
- 650 _2
- $a ženské pohlaví $7 D005260
- 650 _2
- $a hodnoty glomerulární filtrace $x účinky léků $7 D005919
- 650 _2
- $a glukagonu podobné peptidy $x analogy a deriváty $x terapeutické užití $7 D004763
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a hypoglykemika $x terapeutické užití $7 D007004
- 650 _2
- $a imunoglobuliny - Fc fragmenty $x terapeutické užití $7 D007141
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a lidé středního věku $7 D008875
- 650 _2
- $a rekombinantní fúzní proteiny $x terapeutické užití $7 D011993
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a multicentrická studie $7 D016448
- 655 _2
- $a randomizované kontrolované studie $7 D016449
- 700 1_
- $a Colhoun, Helen M $u University of Edinburgh, Edinburgh, UK.
- 700 1_
- $a Dagenais, Gilles R $u Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada.
- 700 1_
- $a Diaz, Rafael $u ECLA, Estudios Clínicos Latinoamérica, Rosario, Argentina.
- 700 1_
- $a Lakshmanan, Mark $u Eli Lilly and Company, Indianapolis, IN, USA.
- 700 1_
- $a Pais, Prem $u St John's Research Institute, Bangalore, India.
- 700 1_
- $a Probstfield, Jeffrey $u Department of Medicine, University of Washington, Seattle, WA, USA.
- 700 1_
- $a Botros, Fady T $u Eli Lilly and Company, Indianapolis, IN, USA.
- 700 1_
- $a Riddle, Matthew C $u Department of Medicine, Oregon Health & Science University Portland, OR, USA.
- 700 1_
- $a Rydén, Lars $u Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.
- 700 1_
- $a Xavier, Denis $u St John's Research Institute, Bangalore, India.
- 700 1_
- $a Atisso, Charles Messan $u Eli Lilly and Company, Indianapolis, IN, USA.
- 700 1_
- $a Dyal, Leanne $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
- 700 1_
- $a Hall, Stephanie $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
- 700 1_
- $a Rao-Melacini, Purnima $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
- 700 1_
- $a Wong, Gloria $u Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada.
- 700 1_
- $a Avezum, Alvaro $u Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, São Paulo, Brazil.
- 700 1_
- $a Basile, Jan $u Medical University of South Carolina, Charleston, SC, USA.
- 700 1_
- $a Chung, Namsik $u Yonsei University Health System, Seoul, South Korea.
- 700 1_
- $a Conget, Ignacio $u Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.
- 700 1_
- $a Cushman, William C $u Memphis Veterans Affairs Medical Center, Memphis, TN, USA.
- 700 1_
- $a Franek, Edward $u Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland.
- 700 1_
- $a Hancu, Nicolae $u Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.
- 700 1_
- $a Hanefeld, Markolf $u Department of Internal Medicine, Dresden Technical University, Dresden, Germany.
- 700 1_
- $a Holt, Shaun $u Victoria University of Wellington, Wellington, New Zealand.
- 700 1_
- $a Jansky, Petr $u University Hospital Motol, Prague, Czech Republic.
- 700 1_
- $a Keltai, Matyas $u Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary.
- 700 1_
- $a Lanas, Fernando $u Universidad de La Frontera, Temuco, Chile.
- 700 1_
- $a Leiter, Lawrence A $u Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.
- 700 1_
- $a Lopez-Jaramillo, Patricio $u Research Institute, FOSCAL and Medical School, Universidad de Santander UDES, Bucaramanga, Colombia.
- 700 1_
- $a Cardona Munoz, Ernesto German $u Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico.
- 700 1_
- $a Pirags, Valdis $u Latvijas Universitate, Riga, Latvia.
- 700 1_
- $a Pogosova, Nana $u National Medical Research Center of Cardiology, Moscow, Russia.
- 700 1_
- $a Raubenheimer, Peter J $u University of Cape Town, Cape Town, South Africa.
- 700 1_
- $a Shaw, Jonathan E $u Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.
- 700 1_
- $a Sheu, Wayne H-H $u Taichung Veterans General Hospital, Taichung, Taiwan.
- 700 1_
- $a Temelkova-Kurktschiev, Theodora $u Robert Koch Medical Centre, Sofia, Bulgaria.
- 710 2_
- $a REWIND Investigators
- 773 0_
- $w MED00010161 $t Lancet (London, England) $x 1474-547X $g Roč. 394, č. 10193 (2019), s. 131-138
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/31189509 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y a $z 0
- 990 __
- $a 20200109 $b ABA008
- 991 __
- $a 20200115092455 $b ABA008
- 999 __
- $a ok $b bmc $g 1483031 $s 1083435
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2019 $b 394 $c 10193 $d 131-138 $e 20190609 $i 1474-547X $m Lancet $n Lancet $x MED00010161
- LZP __
- $a Pubmed-20200109
