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Lancet. 2019 Jul 13;394(10193):131-138. doi: 10.1016/S0140-6736(19)31150-X. Epub 2019 Jun 9.

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

Collaborators (1421)

Abella M, Alebuena A, Almagro S, Amoroso E, Anadon P, Andreu E, Aristimuño G, Arzadun M, Barbieri M, Barcudi R, Bartolacci I, Bolobanich G, Bordonava A, Bustamante Labarta M, Bustos B, Caccavo A, Camino A, Cantero M, Carignano M, Cartasegna L, Cipullo M, Commendatore V, Conosciuto V, Costamagna O, Crespo C, Cuello J, Cuneo C, Cusimano S, Dean S, Dituro C, Dominguez A, Farah M, Fernandez A, Fernandez F, Ferrari A, Flammia P, Fuentealba J, Gallardo KB, Garcia C, Garcia Duran R, Garrido M, Gavicola R, Gerbaudo C, Gilli G, Giotto AP, Godoy Bolzán P, Gomez Vilamajo O, Guerlloy F, Guridi C, Gutierrez Garrido N, Hasbani E, Hermida S, Hominal M, Hrabar A, Ingaramo A, Izzicupo A, Krynski M, Lagrutta M, Lanchiotti P, Langhe M, Leonard V, Llanos J, Lopez Santi R, Lowenstein J, Luquez C, Mackinnon I, Mana M, Manzur S, Marino J, Martella C, Martinez R, Matias R, Matkovich J, Meritano M, Montaña O, Mulazzi M, Ochoa J, Paterlini G, Pelagagge M, Peralta Lopez ME, Prado A, Pruyas L, Racca M, Ricotti C, Rodriguez C, Romero Vidomlansky M, Ronderos R, Sadowski AL, Sala J, Sánchez A, Santoro A, Schiavi L, Sein M, Sernia V, Serra L, Sicer M, Smith T, Soso L, Sposetti G, Steinacher A, Stival J, Tedesco J, Tonin H, Tortolo M, Ulla M, Vallejos J, Vico M, Virgillito L, Visco V, Vogel D, Waisman F, Zaidman C, Zucchiatti N, Badshah I, Cohen N, Colman P, Colquhoun D, Davis T, Fourlanos S, Fulcher G, Hamlyn J, Haywood C, Hocking S, Huchinson M, Jeffries W, Kyl M, Lo C, Mah P, Makepeace A, Marope D, Nanayakkar N, Nankervis A, Palmer N, Palolus B, Pillai S, Price S, Price S, Proietto J, Reutens A, Rodrigo N, Sheikh A, Smith G, So M, Soldatos G, Stuckey B, Sumithran P, Teede H, Vora P, Williams L, Abib E, Adão Poço C, Alves ÉF, Andreatta Bernardi Barea J, Avezum Oliveira L, Castro DLDC, Correa da Cruz I, Costa M, Cruz I, Cunha S, Da Silva MAV, de Carvalho Camara Bona R, de Paula B, Eliaschewitz F, Fazolli G, Ferreira Filho CA, Fortes J, França C, Franco DR, Genestreti PR, Giorgeto F, Gonçalves RM, Grossman ME, Henrique Marcelino AC, Hernandes M, Horta A, Jaeger C, Kaneblai M, Kauffman Rutenberg C, Kerr Saraiva JF, Lemos MA, Maia L, Manenti ER, Marques M, Melissa Valerio C, Moreira R, Mothé F, Mouco OM, Moura P, Moura Jorge JC, Nakashima C, Nakazone M, Napoli T, Nunes C, Nunes Salles JE, Oliveira K, Oliveira M, Pantano GS, Petri F, Piazza L, Pires AC, Pizzato P, Prata S, Precoma D, Rech R, Reis G, Reis H, Resende E, Ribas Fortes J, Rodovalho S, Rossi Dos Santos F, Salles JE, Sampaio CR, Santos T, Santos Dos Santos V, Silva E Quadros T, Silveira D, Siqueira KN, Teireira M, Uehara M, Valerio C, Vianna H, Vidotti MH, Visconti GL, Zanella MT, Andreeva V, Borisov R, Botushanov N, Dimitrov G, Dimova K, Dragoychev T, Grigorova V, Gushterova V, Ivanov I, Kocelova T, Kurktschiev D, Miletieva M, Nenkova-Gugusheva N, Pancheva R, Pavlova M, Raev D, Spasova V, Stoikov A, Troev D, Yanev T, Yoncheva-Mihaylova M, Abitbol A, Ajala B, Alguwaihes A, Ardilouze JL, Aris-Jilwan N, Arnaout A, Aronson R, Aslam N, Babin S, Bailargeon JP, Bailey A, Bajaj H, Beauchesne C, Beca S, Belanger A, Bell A, Bellabarba D, Berard L, Berenbaum B, Bergeron V, Berlingieri J, Bernier F, Bishara P, Blank D, Blumer I, Brault S, Breton D, Carpentier A, Cha J, Chandra P, Chiasson JL, Conway JR, Couture G, Couture N, Dagenais G, Datta D, D'Ignazio G, Dumas R, Fay D, Frechette A, Frenette L, Fung D, Gagnon N, Galter M, Garon J, Gauthier JS, Geadah C, Gilbert J, Girard R, Goldenberg R, Grossman LD, Gupta N, Halle JP, Hivert MF, Houde G, Houlden R, Hramiak I, Jablonski T, Jain AJ, Khandwala H, Khosla M, Lachance C, Laflamme E, Langlois MF, Larivee L, Liutkus J, Lochnan H, Malik S, McDonald C, Mehta P, Mihailidis J, Milot A, Narula P, Nault P, Nayar A, Nisker W, Ouellet G, Palardy J, Patel M, Paul T, Pedersen S, Perron P, Pesant MH, Poirier P, Poulin MC, Punthakee Z, Rehman W, Ross S, Sagar P, Saliba N, Sandler S, Schiffrin A, Schlosser R, Seth-Sharma A, Sherman M, Sionit D, Sivakumar T, Soto J, St-Amour E, Steen O, Sussman J, Telner A, Tobe S, Twum-Barima DY, Van Zanten A, VanRossum N, Vecchiarelli J, Ward R, Wessengel J, Weisnagel S, Wilderman I, Woo V, Yakubovich N, Yale JF, Yared Z, Acevedo M, Aguirre ML, Aizman A, Barroso MS, Cobos L, Danin Vargas A, Descalzi B, Godoy G, Grumberg E, Lahsen R, Larenas G, Ortiz E, Paredes J, Potthoff S, Retamal E, Rojas L, Salgado M, Santibanez C, Solis C, Stokins B, Accini J, Acebedo J, Agudelo Baena LM, Alarcon S, Angel J, Arcos E, Aroca Martinez M, Atuesta L, Balaguera J, Ballestas D, Barrera SI, Barrios Reyes R, Bayona A, Bermudez A, Bernal DZ, Blanquicett M, Bravo V, Bueno W, Burbano Delgado A, Cadena A, Cadena A, Caicedo S, Celemin C, Consuegra R, Contreras Pimienta C, Corredor KJ, Cure C, De La Hoz Rueda LD, Delgado E, Diaz S, Diego M, Donado A, Encinales Sanabria W, Escobar J, Escorcia G, Forero L, Fuentes L, Garcia M, Garcia Lozada H, Garcia Ortiz L, Giraldo A, Gomez Gonzalez L, Granada J, Gutierrez C, Henao N, Hernandez E, Herrera Uejbe OM, 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Malecha J, Malicherova E, Neubauerova D, Oznerova M, Partys R, Pederzoliova E, Petrusova M, Prymkova V, Racicka E, Reissova I, Roderova E, Stanek L, Striova A, Svarcova D, Svoboda P, Szeghy Malicharova E, Urge J, Vesely L, Wasserburger B, Wasserburgerova H, Zahumensky E, Zamrazil V, Alawi H, Anastasiadis E, Axthelm E, Bieler T, Buhrig C, Degtyareva E, Dellanna F, Derwahl KM, Diessel S, Dogiami B, Dorn-Weitzel K, Ernst M, Faulmann G, Fetscher B, Forst T, Freyer-Lahres G, Funke K, Ganz X, Gleixner C, Hanefeld C, Heinrichs S, Helleberg S, Henkel E, Hetzel GR, Hoffmann C, Jacob F, Jacob S, John F, Jonczyk A, Kamke W, Klein C, Kleinhardt M, Kleophas W, Kosch C, Kreutzmann K, Kühn A, Lee-Barkey YH, Lier A, Maatouk S, Minnich J, Mitry M, Muessig I, Nicula D, Niemann M, Nothroff J, Ott P, Pfuetzner A, Pfützner A, Pistrosch F, Pohl W, Prochazkova Z, Retkowska M, Rosin H, Sachsenheimer D, Samer H, Sanuri M, Schaefer A, Schaper F, Schulze ED, Schulze M, Schumann M, Segiet T, Sowa V, Stahl HD, Steinfeldt F, Teige M, Trieb B, Tschoepe D, Uebel P, Warken B, Weigmann I, Weyland K, Wilhelm K, Balo T, Balsay M, Bende I, Bezzegh K, Birkus Z, Buday B, Csomai M, Deak L, Dezso E, Faludi P, Faluvegi M, Fazekas I, Feher A, Fejer C, Finta E, Fulcz A, Gaal Z, Gurzo M, Hati K, Herczeg G, Jozsef I, Juhasz M, Keltai K, Koranyi L, Kulcsar E, Kun K, Laczko A, Literáti-Nagy B, Mezo I, Mileder M, Moricz I, Nagy K, Nagybaczoni B, Nemeth C, Oze A, Pauer J, Peterfai E, Polocsanyi B, Poor F, Reiber I, Salamon C, Sebestyen J, Torok I, Tuu M, Varga A, Vass V, Ahn CM, Ahn C, ByungWon P, Chang HJ, Chang K, Choi EY, Choi HS, Chung JW, Hong BK, Hong YJ, Hyon MS, Jeong MH, Kang S, Kim BK, Kim JH, Kim JH, Kim KS, Kim KS, Kim MH, Kim PJ, Kim SK, Kim YS, Kim YK, Koh YS, Kwon HM, Lee BK, Lee BW, Lee JB, Lee MM, Lim YM, Min PK, Park JS, Park J, Park KH, Park S, Pyun WB, Rim SJ, Ryu DR, Seo HS, Seung KB, Shin DH, Sim DS, Yoon YW, Andersone I, Babicka K, Balcere I, Barons R, Capkovska I, Geldnere K, Grigane I, Jegere B, Lagzdina I, Mora L, Pastare S, Ritenberga R, Romanova J, Saknite I, Sidlovska N, Sokolova J, Steina S, Strizko I, Teterovska D, Vizina B, Barsiene L, Belozariene G, Daugintyte-Petrusiene L, Drungiliene N, Garsviene N, Grigiene A, Grizas V, Jociene V, Kalvaitiene D, Kaupiene J, Kavaliauskiene J, Kozloviene D, Lapteva I, Maneikiene B, Marcinkeviciene J, Markauskiene V, Meiluniene S, Norkus A, Norviliene R, Petrenko V, Radzeviciene R, Sakalyte G, Urbonas G, Urbutiene S, Vasiliauskas D, Velickiene D, Aguilar C, Alcocer M, Avalos-Ramirez JA, Banda-Elizondo R, Bricio-Ramirez R, Cardenas Mejia K, Cavazos F, Chapa J, Cienfuegos E, De la Peña A, de la Peña Topete G, De Los Rios Ibarra MO, Elias D, Flores-Moreno C, Garcia Hernandez P, Gonzalez LG, Guerra Moya RL, Guerra-Lopez A, Hernandez Baylon R, Herrera Colorado C, Herrera-Marmolejo M, Islas-Palacios N, Lopez E, Lopez F, Lopez Alvarado A, Luna Ceballos RI, Morales Villegas E, Moreno-Virgen G, Parra Perez RL, Pascoe Gonzalez S, 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Konieczny M, Korol M, Kozina M, Krzyzagorska E, Kucharczyk-Petryka E, Laz R, Majchrzak A, Mrozowska Z, Mularczyk M, Nowacka E, Peczynska J, Petryka R, Pietrzak R, Pisarczyk-Wiza D, Rozanska A, Ruzga Z, Rzeszotarska E, Sacha M, Sekulska M, Sidorowicz-Bialynicka A, Stasinska T, Strzelecka-Sosik A, Swierszcz T, Szymkowiak KM, Turowska O, Wisniewska K, Wiza M, Wozniak I, Zelazowska K, Ziolkowska-Gawron B, Zytkiewicz-Jaruga D, Albota A, Alexandru C, Avram R, Bala C, Barbonta D, Barbu R, Braicu D, Calutiu N, Catrinoiu D, Cerghizan A, Ciorba A, Craciun A, Doros R, Duma L, Dumitrache A, Ferariu I, Ferician Moza A, Ghergan A, Ghise G, Graur M, Gribovschi M, Mihai B, Mihalache L, Mihalcea M, Mindrescu N, Morosanu M, Morosoanu A, Mota M, Moza A, Nafornita V, Natea N, Nicodim S, Nita C, Onaca A, Onaca M, Pop C, Pop L, Popa A, Popescu A, Pruna L, Roman G, Rosu M, Sima A, Sipciu D, Sitterli-Natea CN, Szilagyi I, Tapurica M, Tase A, Tutescu AC, Vanghelie L, Verde I, Vlad A, Zarnescu M, Akhmetov R, 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Conradie H, Cronje T, de Jong D, Ellis G, Emanuel S, Engelbrecht I, Foulkes S, Fourie D, Gibson G, Govender T, Hansa S, Hemus AC, Hendricks F, Heradien M, Holmgren C, Hoosain Z, Horak E, Howard J, Immink I, Janari E, Jivan D, Klusmann K, Labuschagne W, Lai YY, Latiff G, Lombaard J, Lottering H, Meeding R, Middlemost S, Mitha H, Mitha I, Mkhwanazi S, Moodley R, Murray A, Musungaie D, Osman Y, Peacey K, Pillay-Ramaya L, Pretorius C, Prozesky H, Sarvan M, Scholtz E, Sebesteny A, Skinner B, Skriker M, Smit M, Stapelberg AM, Swanepoel N, Urbach D, van Aswegen D, van Zyl F, Van Zyl L, Venter E, Wadvalla S, Wing J, Wolmarans K, Abreu C, Aguilà P, Aguilera E, Alonso N, Alvarez C, Cajas P, Castro JC, Codinachs R, Contreras J, Coves MJ, Fajardo C, Ferrer JC, Font N, Garcia M, Gil MA, Gomez F, Gomez LA, Gonzalbez J, Griera JL, Masmiquel L, Mauricio D, Narejos Perez S, Nicolau JA, Noheda Contreras O, Olivan J, Olivares J, Ortega E, Pellitero S, Pertusa S, Rius F, Rodriguez I, Sánchez-Juan C, Santos D, Soldevila B, Subias D, Terns M, Trescoli C, Vilaplana J, Villanueva A, Albo J, Antus K, Axelsson M, Bergström L, Binsell-Gerdin E, Boman K, Botond F, Dotevall A, Graipe A, Jarnet C, Kaminska J, Kempe A, Korhonen M, Linderfalk C, Liu B, Ljungstroem K, Ljungström K, Malmqvist L, Mellbin L, Mooe T, Nicol P, Norrby A, Ohlsson A, Rosengren A, Saaf J, Salmonsson S, Strandberg O, Svensson KA, Tengmark BO, Tsatsaris G, Ulvenstam A, Vasko P, Chang CT, Chang HM, Chen JF, Chen TP, Chung MM, Fu CP, Hsia TL, Hua SC, Kuo MC, Lee CL, Lee IT, Liang KW, Lin SY, Lu CH, Ma WY, Pei D, Shen FC, Su CC, Su SW, Tai TS, Tsai WN, Tsai YT, Tung SC, Wang JS, Yu HI, Al-Qaissi A, Arutchelvam V, Atkin S, Au S, Aye MM, Bain S, Bejnariu C, Bell P, Bhatnagar D, Bilous R, Black N, Brennan U, Brett B, Bujanova J, Chow E, Collier A, Combe A, Courtney C, Courtney H, Crothers J, Eavis P, Elliott J, Febbraro S, Finlayson J, Gandhi R, Gillings S, Hamling J, Harper R, Harris T, Hassan K, Heller S, Jane A, Javed Z, 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Abstract

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.

PMID:
31189509
DOI:
10.1016/S0140-6736(19)31150-X
[Indexed for MEDLINE]

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