Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)

Marc A. Pfeffer, Emmanuel A. Burdmann, Chao Yin Chen, Mark E. Cooper, Dick de Zeeuw, Kai Uwe Eckardt, Peter Ivanovich, Reshma Kewalramani, Andrew S. Levey, Eldrin F. Lewis, Janet McGill, John J V McMurray, Patrick Parfrey, Hans Henrik Parving, Giuseppe Remuzzi, Ajay K. Singh, Scott D. Solomon, Robert Toto, Hajime Uno

Research output: Contribution to journalArticle

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. Study Design: Randomized trial. Setting & Participants: 4,044 participants with type 2 diabetes, CKD (defined as estimated glomerular filtration rate of 20 to 60 mL/min/1.73 m2), and anemia (hemoglobin ≤ 11 g/dL) from 24 countries. Intervention: Darbepoetin alfa to attempt to increase hemoglobin levels to 13 g/dL compared with placebo. Outcomes: 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.

Original languageEnglish
Pages (from-to)59-69
Number of pages11
JournalAmerican Journal of Kidney Diseases
Volume54
Issue number1
DOIs
Publication statusPublished - Jul 2009

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Chronic Renal Insufficiency
Type 2 Diabetes Mellitus
Anemia
Hemoglobins
Therapeutics
Placebos
Hematinics
Kidney
Renal Replacement Therapy
Darbepoetin alfa
Glomerular Filtration Rate
Proteinuria
Myocardial Ischemia
Hospitalization
Cardiovascular Diseases
Heart Failure
Stroke
Myocardial Infarction
Morbidity
Safety

Keywords

  • anemia
  • chronic kidney disease
  • diabetes
  • Erythropoiesis-stimulating agents

ASJC Scopus subject areas

  • Nephrology

Cite this

Pfeffer, M. A., Burdmann, E. A., Chen, C. Y., Cooper, M. E., de Zeeuw, D., Eckardt, K. U., ... Uno, H. (2009). Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). American Journal of Kidney Diseases, 54(1), 59-69. https://doi.org/10.1053/j.ajkd.2009.04.008

Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). / Pfeffer, Marc A.; Burdmann, Emmanuel A.; Chen, Chao Yin; Cooper, Mark E.; de Zeeuw, Dick; Eckardt, Kai Uwe; Ivanovich, Peter; Kewalramani, Reshma; Levey, Andrew S.; Lewis, Eldrin F.; McGill, Janet; McMurray, John J V; Parfrey, Patrick; Parving, Hans Henrik; Remuzzi, Giuseppe; Singh, Ajay K.; Solomon, Scott D.; Toto, Robert; Uno, Hajime.

In: American Journal of Kidney Diseases, Vol. 54, No. 1, 07.2009, p. 59-69.

Research output: Contribution to journalArticle

Pfeffer, MA, Burdmann, EA, Chen, CY, Cooper, ME, de Zeeuw, D, Eckardt, KU, Ivanovich, P, Kewalramani, R, Levey, AS, Lewis, EF, McGill, J, McMurray, JJV, Parfrey, P, Parving, HH, Remuzzi, G, Singh, AK, Solomon, SD, Toto, R & Uno, H 2009, 'Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)', American Journal of Kidney Diseases, vol. 54, no. 1, pp. 59-69. https://doi.org/10.1053/j.ajkd.2009.04.008
Pfeffer, Marc A. ; Burdmann, Emmanuel A. ; Chen, Chao Yin ; Cooper, Mark E. ; de Zeeuw, Dick ; Eckardt, Kai Uwe ; Ivanovich, Peter ; Kewalramani, Reshma ; Levey, Andrew S. ; Lewis, Eldrin F. ; McGill, Janet ; McMurray, John J V ; Parfrey, Patrick ; Parving, Hans Henrik ; Remuzzi, Giuseppe ; Singh, Ajay K. ; Solomon, Scott D. ; Toto, Robert ; Uno, Hajime. / Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). In: American Journal of Kidney Diseases. 2009 ; Vol. 54, No. 1. pp. 59-69.
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