Rationale—Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease - 21/08/11

Doi : 10.1016/j.ahj.2004.09.047

T.-Christian H. Mix, MD ^a, Robert M. Brenner, MD ^a, Mark E. Cooper, MD ^b, Dick de Zeeuw, MD ^c, Peter Ivanovich, MD ^d, Andrew S. Levey, MD ^e, Janet B. McGill, MD ^f, John J.V. McMurray, MD ^g, Patrick S. Parfrey, MD ^h, Hans-Henrik Parving, MD ⁱ, Brian J.G. Pereira, MD ^e, Giuseppe Remuzzi, MD ^j, Ajay K. Singh, MD ^k, Scott D. Solomon, MD ^l, Catherine Stehman-Breen, MD ^a, Robert D. Toto, MD ^m, Marc A. Pfeffer, MD, PhD ^l,⁎
^a Departments of Development and Medical Affairs, Amgen Inc., Thousand Oaks, Calif
^b Department of Medicine, University of Melbourne, Melbourne, Australia
^c Department of Clinical Pharmacology, Groningen University Medical Center, Groningen, The Netherlands
^d Division of Nephrology/Hypertension, Northwestern University, and Jesse Brown VA Medical Center, Chicago, Ill
^e Division of Nephrology, Tufts-New England Medical Center, Boston, Mass
^f Division of Endocrinology, Washington University School of Medicine, St. Louis, Mo
^g Department of Cardiology, Western Infirmary, Glasgow, Scotland, UK
^h Clinical Epidemiology Unit and Division of Nephrology, Memorial University, St. John's, Newfoundland, Canada
ⁱ Steno Diabetes Center, Copenhagen, Denmark
^j Instituto di Richerche, Farmacologiche ‘Mario Negri,’ Bergamo, Italy
^k Renal Division, Brigham and Women's Hospital, Boston, Mass
^l Cardiovascular Division, Brigham and Women's Hospital, Boston, Mass
^m Division of Nephrology, University of Texas Southwestern, Dallas, Texas

Reprint requests: Marc A. Pfeffer, MD, PhD, Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.

Résumé

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.

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Plan

The role of diabetes and anemia in cardiovascular disease

Compounded cardiovascular risk in the setting of coexistent diabetes, CKD, and anemia

Rationale for an RCT of anemia therapy: an opportunity to advance the anemia management guidelines for patients with CKD

Trial to Reduce Cardiovascular Events with Aranesp Therapy

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Vol 149 - N° 3

P. 408-413 - mars 2005 Retour au numéro

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Rationale—Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease - 21/08/11

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Background

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Plan

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