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 language | English (US) |
|---|---|
| Pages (from-to) | 59-69 |
| Number of pages | 11 |
| Journal | American Journal of Kidney Diseases |
| Volume | 54 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jul 2009 |
Funding
Financial Disclosure: Amgen, which markets darbepoetin alfa, funded this study. Dr Pfeffer has received support (research grant to Brigham and Women's Hospital) for the conduct of TREAT and has served as a consultant to Amgen. Dr de Zeeuw is a member of the TREAT Steering Committee (financial compensation to the University Medical Center Groningen). Dr Burdmann has received support (research grant to Hospital de Base, São José do Rio Preto Medical School) and has served as a consultant to Amgen. Dr Parving has received lecture and consultant fees from Amgen. Dr Eckardt has received lecture and consulting fees from companies producing ESAs, including Amgen, Johnson & Johnson, Roche, Affymax, Stada, Sandoz, and Hexal. Drs Cooper and Ivanovich have received financial support from Amgen for work related to the study. Dr Solomon has received research support from Amgen. Dr Levey is a member of the TREAT Steering Committee (financial compensation to Tufts Medical Center). Dr Lewis has received support (research grant to Brigham and Women's Hospital) from Amgen and has served as a consultant to Amgen. Dr McGill has received consulting fees from Amgen (for the Executive Committee). Dr McMurray is a member of the TREAT Steering Committee (financial compensation to Glasgow University). Dr Parfrey has received research support from Amgen and Ortho Biotech to perform RCTs of anemia therapy. Dr Remuzzi has received lecture support from Merck, Amgen, and AstraZeneca. Drs Chen and Kewalramani are employees of Amgen.
Keywords
- Erythropoiesis-stimulating agents
- anemia
- chronic kidney disease
- diabetes
ASJC Scopus subject areas
- Nephrology
