Dulaglutide and renal outcomes in type 2 diabetes: an exploratory analysis of the REWIND randomised, placebo-controlled trial.

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From: The Lancet(Vol. 394, Issue 10193)
Publisher: Elsevier B.V.
Document Type: Article
Length: 3,949 words

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Summary 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 m.sup.2 (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 Interpretation Long-term use of dulaglutide was associated with reduced composite renal outcomes in people with type 2 diabetes. Funding Eli Lilly and Company. Author Affiliation: (a) Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada (b) University of Edinburgh, Edinburgh, UK (c) Institut Universitaire de Cardiologie et Pneumologie, Université Laval, Québec City, QC, Canada (d) ECLA, Estudios Clínicos Latinoamérica, Rosario, Argentina (e) Eli Lilly and Company, Indianapolis, IN, USA (f) St John's Research Institute, Bangalore, India (g) Department of Medicine, University of Washington, Seattle, WA, USA (h) Department of Medicine, Oregon Health & Science University Portland, OR, USA (i) Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden (j) Instituto Dante Pazzanese de Cardiologia and University Santo Amaro, São Paulo, Brazil (k) Medical University of South Carolina, Charleston, SC, USA (l) Yonsei University Health System, Seoul, South Korea (m) Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain (n) Memphis Veterans Affairs Medical Center, Memphis, TN, USA (o) Mossakowski Medical Research Centre, Polish Academy of Sciences and Central Clinical Hospital MSWiA, Warsaw, Poland (p) Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania (q) Department of Internal Medicine, Dresden Technical University, Dresden, Germany (r) Victoria University of Wellington, Wellington, New Zealand (s) University Hospital Motol, Prague, Czech Republic (t) Semmelweis University, Hungarian Institute of Cardiology, Budapest, Hungary (u) Universidad de La Frontera, Temuco, Chile (v) Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada (w) Research Institute, FOSCAL and Medical School, Universidad de Santander UDES, Bucaramanga, Colombia (x) Universidad de Guadalajara Centro Universitario de Ciencias de la Salud, Guadalajara, Mexico (y) Latvijas Universitate, Riga, Latvia (z) National Medical Research Center of Cardiology, Moscow, Russia (aa) University of Cape Town, Cape Town, South Africa (ab) Baker Heart and Diabetes Institute, Melbourne, VIC, Australia (ac) Taichung Veterans General Hospital, Taichung, Taiwan (ad) Robert Koch Medical Centre, Sofia, Bulgaria * Correspondence to: Prof Hertzel C Gerstein, Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, ON, L8S 4K1, Canada (footnote)[Dagger] Investigators listed in the Byline: Prof Hertzel C Gerstein, MD [gerstein@mcmaster.ca] (a), Prof Helen M Colhoun, MD (b), Prof Gilles R Dagenais, MD (c), Rafael Diaz, MD (d), Mark Lakshmanan, MD (e), Prof Prem Pais, MD (f), Prof Jeffrey Probstfield, MD (g), Fady T Botros, PhD (e), Prof Matthew C Riddle, MD (h), Prof Lars Rydén, MD (i), Prof Denis Xavier, MD (f), Charles Messan Atisso, PhD (e), Leanne Dyal, MSc (a), Stephanie Hall, BA (a), Purnima Rao-Melacini, MSc (a), Gloria Wong, BSc (a), Prof Alvaro Avezum, MD (j), Prof Jan Basile, MD (k), Prof Namsik Chung, MD (l), Ignacio Conget, MD (m), William C Cushman, MD (n), Prof Edward Franek, MD (o), Prof Nicolae Hancu, MD (p), Prof Markolf Hanefeld, PhD (q), Shaun Holt, MBChB [Hons] (r), Petr Jansky, MD (s), Prof Matyas Keltai, MD (t), Prof Fernando Lanas, PhD (u), Prof Lawrence A Leiter, MD (v), Prof Patricio Lopez-Jaramillo, PhD (w), Ernesto German Cardona Munoz, MD (x), Prof Valdis Pirags, MD (y), Prof Nana Pogosova, MD (z), Peter J Raubenheimer, MBBCh (aa), Prof Jonathan E Shaw, MD (ab), Prof Wayne H-H Sheu, MD (ac), Prof Theodora Temelkova-Kurktschiev, PhD (ad), Mercedes Abella, Andrea Alebuena, Sandra Almagro, Eduardo Amoroso, Paula Anadon, Elizabeth Andreu, Guillermo Aristimuño, Maria Arzadun, Maria Barbieri, Raul Barcudi, Ines Bartolacci, Gabriel Bolobanich, Anselmo Bordonava, Miguel Bustamante Labarta, Betina Bustos, Alberto Caccavo, Alejandra Camino, Maria Cantero, Maria Carignano, Luis Cartasegna, Marcela Cipullo, Víctor Commendatore, Victoria Conosciuto, Osvaldo Costamagna, Claudia Crespo, Jose Cuello, Carlos Cuneo, Sandra Cusimano, Sofia Dean, Claudio Dituro, Andrea Dominguez, Miguel Farah, Alberto Fernandez, Florencia Fernandez, Adriana Ferrari, Patricia Flammia, Jose Fuentealba, Karina Beatriz Gallardo, Celso Garcia, Ruben Garcia Duran, Marcelo Garrido, Rodolfo Gavicola, Claudio Gerbaudo, Graciela Gilli, Ana Paula Giotto, Pedro Godoy Bolzán, Oscar Gomez Vilamajo, Fernando Guerlloy, Cristian Guridi, Narcisa Gutierrez Garrido, Eduardo Hasbani, Sonia Hermida, Miguel Hominal, Adrian Hrabar, Adrián Ingaramo, Alejandra Izzicupo, Mario Krynski, Mariana Lagrutta, Paulina Lanchiotti, Maria Langhe, Veronica Leonard, Javier Llanos, Ricardo Lopez Santi, Jorge Lowenstein, Cecilia Luquez, Ignacio Mackinnon, Melina Mana, Sara Manzur, Javier Marino, Carolina Martella, Roger Martinez, Re Matias, Javier Matkovich, Monica Meritano, Oscar Montaña, María Mulazzi, Juan Ochoa, Gustavo Paterlini, María Pelagagge, Maria Elena Peralta Lopez, Aldo Prado, Lorena Pruyas, Martín Racca, Carola Ricotti, Carolina Rodriguez, Mariano Romero Vidomlansky, Ricardo Ronderos, Ana Laura Sadowski, Jorgelina Sala, Alejandro Sánchez, Andrea Santoro, Lilia Schiavi, Mariano Sein, Virginia Sernia, Leonardo Serra, Maximiliano Sicer, Tomas Smith, Leonardo Soso, Georgina Sposetti, Andrea Steinacher, Jorge Stival, Jorge Tedesco, Hugo Tonin, Mauro Tortolo, Maria Ulla, Julio Vallejos, Marisa Vico, Luciana Virgillito, Virginia Visco, Daniel Vogel, Florencia Waisman, César Zaidman, Noemi Zucchiatti, Imran Badshah, Neale Cohen, Peter Colman, David Colquhoun, Timothy Davis, Spiros Fourlanos, Greg Fulcher, Jane Hamlyn, Cilla Haywood, Samantha Hocking, Maeve Huchinson, William Jeffries, Mervyn Kyl, Clement Lo, PeakMann Mah, Ashley Makepeace, Dolly Marope, Natalie Nanayakkar, Alison Nankervis, Neil Palmer, Barbara Palolus, Satish Pillai, Sarah Price, Sarah Price, Joseph Proietto, Anne Reutens, Natassia Rodrigo, Abdul Sheikh, Greg Smith, Michelle So, Georgia Soldatos, Bronwyn Stuckey, Priya Sumithran, Helena Teede, Parind Vora, Lyn Williams, 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Source Citation

Source Citation   

Gale Document Number: GALE|A593024170