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N Engl J Med. 2009 Nov 19;361(21):2019-32. doi: 10.1056/NEJMoa0907845. Epub 2009 Oct 30.

A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.

Collaborators (784)

Brenner R, Pfeffer M, Abrouk N, Carroll W, Green D, Klassen P, Lubina J, McMurray J, Messer L, Newmark R, Parfrey P, Solomon S, Pfeffer M, Burdmann E, Cooper M, de Zeeuw D, Eckardt KU, Ivanovich P, Levey A, McGill J, McMurray J, Parfrey P, Parving HH, Pereira B, Remuzzi G, Singh A, Solomon S, Toto R, Ivanovich P, Fishbane S, Nissenson A, Bechhofer R, DeMets D, Feyzi J, Henneken C, Chertow G, Frohlich E, O'Brien P, Rouleau J, Solomon S, Lewis E, Desai A, Duong C, Finn P, Hartley LH, Kesari S, Lin J, Meadows J, Mielniczuk L, Shamshad F, Singh A, Vasylyeva O, Weinrauch L, Adee A, Ahmed A, Blaisdell P, Brady P, Bucker L, Cap J, Carroll W, Chaparro D, Chen CY, Condon B, Cravario R, Damato R, Dellacroce K, DiRocco K, Donovan D, Doria B, Dougherty M, Droge J, Grewal A, Guimaraes L, Haynes P, Hevy J, Jambusaria T, James N, Kacprzak A, Kasenda M, Reddy SR, Kewalramani R, Kirby H, Klacker C, Kocsis T, Kondo A, Lauw M, Liebelt M, McElligott P, Mesquita B, Mix C, Mueller A, O'Callaghan S, Ocampo H, Olson K, Perez S, Pillai J, Pollock A, Poloni F, Polu K, Poston R, Ramirez G, Rasmussen A, Reeves L, Rocha M, Ross AP, Rossert J, Sahl B, See T, Shahinfar S, Shart K, Stehman-Breen C, Teh A, Tierra L, Vaghela M, White C, Garcia N, Penalba A, Juncos L, Maurich S, Orias M, Margulis F, Beresan H, Rosa-Diez G, Vallejos A, Cusumano AM, Douthat W, Carreno A, Roger S, Suranyi M, Mathew M, Jeffries W, Jerums G, Nicholson G, Russ G, Hutchison B, Johnson D, Jose M, Torpy D, Toplak H, Hörl W, Paulweber B, Forti A, Canziani ME, Montenegro R, Almeida FA, Burdmann E, de Faria JB, Baptista MA, Ferreira Filho SR, Schmid H, Gross JL, Carvalho DB, Coelho SN, Riella MC, Abensur H, Bastos M, d'Avila D, Lugon J, Moreira JC, Salgado N, Batista PB, Delgado AG, Noronha I, Vasconcelos L, Barros E, Martinelli R, Moyses Neto M, Yu L, Eliaschewitz F, Vasconcelos L, Saraiva JF, Mircheva T, Angelova A, Doncheva M, Hristozov H, Scott-Douglas N, Culleton B, Chow S, Dowell A, Tobe S, Sapir D, Weisnagel SJ, Nadeau A, Wong G, Wijeyesinghe E, Tanaka R, Haddad H, Ducharme A, Elliott T, Jindal K, Sohi P, Parfrey P, Kajbaf S, Soroka S, Belanger A, Muirhead N, Birbrager D, McFarlane P, Rabbat C, Churchill D, Pylypchuk G, Goldenberg R, Twum-Barima Y, Karunakaran S, Sussman J, Bichet Dl, Ekoe JM, Jolly S, Wong M, Innes P, Aronson R, Bailey G, Castillo A, Mezzano S, Calderara M, Becker J, Saudek F, Lacnak B, Povolny J, Marsová M, Rychlík I, Racicka E, Mácel I, Chmura P, Dunaj M, Hirmerová J, Tocìk J, Smahelová A, Záhalková J, Kvapil M, Oestergaard O, Rossing P, Parving HH, Urhammer S, Past M, Rosenberg M, Vides H, Viitas L, Ilmoja M, Zaoui P, Fauvel JP, Geffray L, Kraatz U, Dellanna F, Busch K, Kraatz G, Vosskühler A, Brunkhorst R, Eckartz A, Keller F, Merker L, Rattensperger D, Rump LC, Schramm L, Haller H, Steinhauer H, Eckardt KU, Klausmann G, Dragoun GP, Sehnert W, Schäffler A, Mitrovic V, Müller G, Zotz R, Salamon C, Dudas M, Gyimesi A, Koranyi L, Oroszián T, András K, Andrássy G, Simon K, Vándorfi G, Keltai M, Nagy L, Nagy J, Locatelli F, Coratelli P, Cianciaruso B, Villa G, Quarello F, Apperti M, Capasso G, Auricchio M, Lombardi L, Viviani G, Colussi G, Busnach G, Civati G, Bellinghieri G, Buongiorno E, Schena FP, Gronda E, Coppola S, Remuzzi G, Dal Canton A, Buoncristiani U, Fagugli R, De Ferrari G, Ferrandello FP, Pirags V, Romanova J, Grigane A, Lucenko A, Sokolova J, Petersons A, Jegere B, Teterovska D, Valtere A, Stelmane I, Zviedritis U, Lopes Alvarado A, Rico Hernandez RR, Chew-Wong A, Bochicchio-Ricardelli T, Ramirez G, Kornhauser-Araujo C, Ramos J, Breien-Alcaraz HS, Correa-Rotter R, Gonzalez-Galvez G, Melo-Sanchez MG, Cuellar-Gonzalez R, Vital M, Sanchez H, Guevara M, Herrera JP, Flores F, Obrador G, Quintana-Pina FE, Valdes A, Felisiak J, Pinis G, Kusnierz B, Malecki R, Polaszewska-Muszynska M, Bronisz M, Ponikowski P, Muszytowski M, Sulowicz W, Szelemej R, Szpajer M, Trafny R, Dluzniewski M, Grzeszczak W, Rydzewski A, Bloch C, Janik K, Romanczuk P, Miekus P, Musial W, Piotrowski W, Smolenski O, Marczewski K, Dulawa J, Gieroba A, Hruby Z, Ogorek MI, Siegel A, Janion M, Gozdzik Z, Piepiorka M, Vinhas JM, Pestana M, Silva AP, Correia P, Pais M, Voiculescu M, Ardelean L, Popescu A, Gluhovschi G, Loiart R, Olteanu D, Mircescu G, Dobronravov V, Zalevskaya A, Shestakova M, Karpova I, Volgina G, Zakharova E, Khokhlov A, Kolmakova E, Komandenko M, Tomilina N, Klimusheva N, Shostka G, Anashkin V, Milovanov Y, Nazarov A, Khrustalev O, Yakusevich V, Dmitriev A, Choustov S, Shilo V, Smolko P, Hrudova E, Sirotiakova J, Jankechova I, Hromec J, Javorsky P, Tkac I, Suchozova K, Preloznik M, Hojs R, Saksida S, Rus I, Macdougall I, Burns A, Reckless J, Jennings P, Smith R, Pritchard N, Page M, Borthwick L, Levy D, Savage M, Dasgupta I, Heller S, McMurray J, Abourawi F, Page S, Kaveh K, Sarkar S, Dhingra R, Moran J, Scott C, Moustafa M, Wiegmann T, Hertel J, Sholer C, Saxena R, Comianos M, Warren M, Buerkert J, Vaisman S, Salvato P, Akmal M, Jackson T, Goldberg N, Sotolongo R, Shettigar U, Navarro J, Hilton T, Sharma A, Thrasher J, Patel S, Scanlan B, Cottiero R, Weinberg M, Moore S, Nassri M, Malya R, Crouch T, Cheriyan R, Ahmed A, Awan T, Awan N, Hura C, Herman T, Clark B, Kaplan I, Kaplan M, Dumontier G, Peguero A, Hung A, Shepherd A, Argoud G, Saenz A, Yu H, Zeig S, Santacruz D, Blondin J, Smelser J, Sekkarie M, Albarracin C, Daigneault J, Rubin J, Bhatla B, Altschuller A, Walker G, Roppolo M, Singh J, Bisognano J, Liang CS, Levin S, Nammour M, Gaona R, Farag S, Sideropoulos H, Denker P, Cangiano J, Shafik S, Chonko A, Newman GE, Pierce K, Shapiro J, Acharya A, Perley M, Kapatkin K, Goswami A, Hartley P, Goldfarb D, Gifford C, Kelly J, Iranmanesh A, Ramstad D, King A, Leddy V, Agarwal A, Colan D, Anand I, Walls B, Amar M, Janosik D, Bleyer F, Campbell J, Quesada-Suarez L, Fierer R, Zabaneh R, Ranjit U, Youell T, Prabhakar S, Hamroff G, Houchin V, Cherlin R, Minasian R, White R, Buynak R, Brown E, Nivera N, Anger M, Blaze K, Liljenquist J, El-Shahawy M, Baker P, Roura FV, Lopez R, Moustafa M, Geneidy A, Barnum O, Harris R, Maldonado H, Krause M, Tello A, Endsley J, Young B, Banerjee S, Kazi F, Lawrence M, Davidson P, Streja D, Avva R, Seaton B, Donnan P, Kozinn M, Bradley P, Vannorsdall MD, Hoggard J, Rosenbilt P, Hargrove J, Peppers S, Doshi P, Kotz K, Whitesides P, Gibbs H, Sandoval J, Peters P, Lansden B, Piracha M, Wood M, Barranco E, Heidbrier E, Ghazal-Albar N, Stegman M, Husserl F, El-Shahawy M, Lee L, Gupta B, Livingstone D, Murray K, Lopez R, Williams K, Bloomberg R, Ricanati E, Reddy S, Goodman D, Alzohaili O, Fraser N, Rendell M, Lund R, Fox D, Persson D, Vicari R, Nwosu A, Ryckman G, Haidar A, Kopyt N, Ocampo E, Lorber D, Mazzotta F, Arcuri P, Belledonne M, Desai V, Evanko D, Mottram P, Cohen D, Schlau A, Koren M, Kashif M, Mahmood K, Frem G, Finkelstein S, Bakhshi V, DeVane M, Cook R, Lin M, Harris H, Pietri A, Tamkin J, Prasad J, Singh S, Thavarajah K, Grubb S, Scott D 3rd, Nielsen M, Agha M, Khan B, Kevish B, Lau A, Walczyk M, Doner D Jr, Smith P, Pudi K, Campbell J, Scott R, Geller M, Prasad S, Lasala G, Castellanos M, Effron B, Adler D, Johnson E, Tokatlian E, DiGiovanna M, Tsai C, Zacharia L, Dhillon G, Chandler B, Chien N, Gilbert J, Hamilton M, Handelsman S, Aiello J, Ling B, Fernandes J, Lown J, Andrawis N, Fagan T, Lasala G, Lew S, Prabhu R, Singh A, Stokes J, Morgan A, George W, Lillestol M, Martinez D, Nallasivan M, Rocco T, Morton K, Bilazarian S, Ho L, Knoll H, Mirani M, Fidelholtz J, Shrestha D, Wynstock L, Carlson R, Minnick D, Iteld B, Herron K, Riser J, Passarello M, Thompson S, Selam J, Charles A, Wright S, Eddy R, Coyne D, Raine C, Shenker Y, Ellis J, Haider M, Carr A, Giles T, Glatte H, Garrett P, Cohen J, Gleeson J, Adolphe A, Crouse L, Harper L, Vainer A, Molitch M, Casale P, Glaser L, Lader E, Adler O, Cunnar J, Minga T, Demby D, Koeper D, Palmer S, Bakdash M, Fishman N, Jain R, Yeoman G, George D, Srikanth S, Pareigis A, Gollapudi G, Gross-Sawicka E, Liu P, Stafford C, Atassi N, Sperling M, Canada RB, Acchiardo S, Khairi R, Raja R, Robinson M, Tso M, Adamson P, Kipperman R, Lu D, Yataco A, Fowler R, Narayan P, Thompson N, Pillon L, Montgomery R, Rocamora L, Blanchard R, Badillo L, Penabad J, Abarikwu C, Mersey J, Weil F, Wayne J, Kapoor A, Bennett N, Magee M, Miller G, Litt M, Hewitt M, Heber D, Janick J, Wigger M, Apantaku F, Kereiakes D, Rivera E, Schaer G, Sherraden T, Dunnigan E, Sharp C, Sundberg E, Patel B, Raval P, Barnes S, McCain A, Wadhwa A, Lee K, Hundley R, Parekh S, Grossman S, Morledge J, Nunyakpe A, Misra M, Pan P, Moreci J, Anderson C, Magana A, Kramer S, Kirshenbaum H.

Abstract

BACKGROUND:

Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested.

METHODS:

In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease.

RESULTS:

Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group.

CONCLUSIONS:

The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.)

2009 Massachusetts Medical Society

PMID:
19880844
[PubMed - indexed for MEDLINE]
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