Rationale—Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease

• Published in: The American heart journal 2005-03, Vol.149 (3), p.408-413
• Main Authors: Mix, T.-Christian H., Brenner, Robert M., Cooper, Mark E., de Zeeuw, Dick, Ivanovich, Peter, Levey, Andrew S., McGill, Janet B., McMurray, John J.V., Parfrey, Patrick S., Parving, Hans-Henrik, Pereira, Brian J.G., Remuzzi, Giuseppe, Singh, Ajay K., Solomon, Scott D., Stehman-Breen, Catherine, Toto, Robert D., Pfeffer, Marc A.
• Format: Article
• Language: English
• Subjects: Anemia - complications; Anemia - therapy; Atherosclerosis (general aspects, experimental research); Biological and medical sciences; Blood and lymphatic vessels; Cardiology; Cardiology. Vascular system; Cardiovascular disease; Cardiovascular Diseases - etiology; Cardiovascular Diseases - prevention & control; Chronic Disease; Clinical trials; Comorbidity; Darbepoetin alfa; Diabetes; Diabetes Mellitus, Type 2 - complications; Double-Blind Method; Erythropoietin - analogs & derivatives; Erythropoietin - therapeutic use; Health maintenance organizations; Health risk assessment; Heart attacks; Heart failure; HMOs; Humans; Hypertension; Kidney diseases; Kidney Diseases - complications; Medical sciences; Medicare; Morbidity; Mortality; Multicenter Studies as Topic - methods; Patient safety; Randomized Controlled Trials as Topic - methods; Research Design; Risk Assessment; Risk Reduction Behavior
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2004.09.047

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. 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