title: Baseline characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT).
abstract: BACKGROUND
  Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and therapies of TREAT participants and subgroups defined by the presence or absence of overt proteinuria and history of cardiovascular disease. The design of TREAT and baseline characteristics also are compared with 2 recent trials of nondialysis patients with chronic kidney disease (CKD) in which treatment with another erythropoiesis-stimulating agent targeting greater hemoglobin levels had either a neutral or adverse effect on clinical outcomes.
  
  
  METHODS
  Randomized trial.
  
  
  METHODS
  4,044 participants with type 2 diabetes, CKD (defined as estimated glomerular filtration rate of 20 to 60 mL/min/1.73 m(2)), and anemia (hemoglobin < or = 11 g/dL) from 24 countries.
  
  
  METHODS
  Darbepoetin alfa to attempt to increase hemoglobin levels to 13 g/dL compared with placebo.
  
  
  RESULTS
  TREAT is an event-driven design to continue until approximately 1,203 patients experience a primary event: the composite end point of death or cardiovascular morbidity (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia). The composite end point of death or need for long-term renal replacement therapy also is a primary end point.
  
  
  CONCLUSIONS
  With several-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia.
authors.affiliation: Cardiovascular Division, Brigham and Women's Hospital, Boston, MA 02115, USA. mpfeffer@rics.bwh.harvard.edu
authors.forename: Marc A
authors.initials: MA
authors.lastname: Pfeffer
authors.forename: Emmanuel A
authors.initials: EA
authors.lastname: Burdmann
authors.forename: Chao-Yin
authors.initials: CY
authors.lastname: Chen
authors.forename: Mark E
authors.initials: ME
authors.lastname: Cooper
authors.forename: Dick
authors.initials: D
authors.lastname: de Zeeuw
authors.forename: Kai-Uwe
authors.initials: KU
authors.lastname: Eckardt
authors.forename: Peter
authors.initials: P
authors.lastname: Ivanovich
authors.forename: Reshma
authors.initials: R
authors.lastname: Kewalramani
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Levey
authors.forename: Eldrin F
authors.initials: EF
authors.lastname: Lewis
authors.forename: Janet
authors.initials: J
authors.lastname: McGill
authors.forename: John J V
authors.initials: JJ
authors.lastname: McMurray
authors.forename: Patrick
authors.initials: P
authors.lastname: Parfrey
authors.forename: Hans-Henrik
authors.initials: HH
authors.lastname: Parving
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Ajay K
authors.initials: AK
authors.lastname: Singh
authors.forename: Scott D
authors.initials: SD
authors.lastname: Solomon
authors.forename: Robert
authors.initials: R
authors.lastname: Toto
authors.forename: Hajime
authors.initials: H
authors.lastname: Uno
mesh_terms: D000368:Aged; D000740:Anemia / Q000150:complications* / Q000188:drug therapy* / Q000503:physiopathology; D002318:Cardiovascular Diseases / Q000453:epidemiology* / Q000517:prevention & control*; D015331:Cohort Studies; D000068256:Darbepoetin alfa; D003924:Diabetes Mellitus, Type 2 / Q000150:complications / Q000503:physiopathology; D004921:Erythropoietin / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005919:Glomerular Filtration Rate / Q000502:physiology; D006397:Hematinics / Q000627:therapeutic use*; D006801:Humans; D007674:Kidney Diseases / Q000150:complications / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011507:Proteinuria / Q000150:complications / Q000503:physiopathology; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D006397:Hematinics; D004921:Erythropoietin; D000068256:Darbepoetin alfa