TY - JOUR
T1 - Rationale-Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT)
T2 - Evolving the management of cardiovascular risk in patients with chronic kidney disease
AU - Mix, T. Christian H.
AU - Brenner, Robert M.
AU - Cooper, Mark E.
AU - De Zeeuw, Dick
AU - Ivanovich, Peter
AU - Levey, Andrew S.
AU - McGill, Janet B.
AU - McMurray, John J.V.
AU - Parfrey, Patrick S.
AU - Parving, Hans Henrik
AU - Pereira, Brian J.G.
AU - Remuzzi, Giuseppe
AU - Singh, Ajay K.
AU - Solomon, Scott D.
AU - Stehman-Breen, Catherine
AU - Toto, Robert D.
AU - Pfeffer, Marc A.
PY - 2005/3
Y1 - 2005/3
N2 - Background: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. Study Design: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb <9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb ≥9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.
AB - Background: Patients with chronic kidney disease (CKD) have a high burden of mortality and cardiovascular morbidity. Additional strategies to modulate cardiovascular risk in this population are needed. Data suggest that anemia is a potent and potentially modifiable risk factor for cardiovascular disease in patients with CKD, but these data remain unsubstantiated by any randomized controlled trial (RCT). Furthermore, the clinical practice guidelines for anemia management in patients with CKD are based on limited data. The need for new RCTs to address critical knowledge deficits, particularly with regard to the impact of anemia therapy on cardiovascular disease and survival, is recognized within the guidelines and independent comprehensive reviews of the existing published trial data. Study Design: The Trial to Reduce Cardiovascular Events with Aranesp (Amgen Inc, Thousand Oaks, Calif) (darbepoetin alfa) Therapy (TREAT) is a 4000-patient, multicenter, double-blind RCT, designed to determine the impact of anemia therapy with darbepoetin alfa on mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes mellitus. Subjects will be randomized in a 1:1 manner to either darbepoetin alfa therapy to a target hemoglobin (Hb) of 13 g/dL or control, consisting of placebo for Hb <9 g/dL or darbepoetin alfa for Hb <9 g/dL until Hb is again Hb ≥9 g/dL. TREAT is event-driven and has a composite primary end point comprising time to mortality and nonfatal cardiovascular events, including myocardial infarction, myocardial ischemia, stroke, and heart failure. TREAT will provide data that are critical to evolution of the management of cardiovascular risk in this high-risk population.
UR - http://www.scopus.com/inward/record.url?scp=17844369963&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2004.09.047
DO - 10.1016/j.ahj.2004.09.047
M3 - Article
C2 - 15864229
AN - SCOPUS:17844369963
SN - 0002-8703
VL - 149
SP - 408
EP - 413
JO - American Heart Journal
JF - American Heart Journal
IS - 3
ER -
