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

T. Christian H Mix, Robert M. Brenner, Mark E. Cooper, Dick De Zeeuw, Peter Ivanovich, Andrew S. Levey, Janet B. McGill, John J V McMurray, Patrick S. Parfrey, Hans Henrik Parving, Brian J G Pereira, Giuseppe Remuzzi, Ajay K. Singh, Scott D. Solomon, Catherine Stehman-Breen, Robert D. Toto, Marc A. Pfeffer

Research output: Contribution to journalArticle

101 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)408-413
Number of pages6
JournalAmerican Heart Journal
Volume149
Issue number3
DOIs
StatePublished - Mar 2005

Fingerprint

Risk Management
Chronic Renal Insufficiency
Hemoglobins
Anemia
Therapeutics
Mortality
Cardiovascular Diseases
Randomized Controlled Trials
Darbepoetin alfa
Practice Guidelines
Type 2 Diabetes Mellitus
Population
Myocardial Ischemia
Heart Failure
Stroke
Myocardial Infarction
Placebos
Guidelines
Morbidity
Survival

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

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

In: American Heart Journal, Vol. 149, No. 3, 03.2005, p. 408-413.

Research output: Contribution to journalArticle

Mix, TCH, Brenner, RM, Cooper, ME, De Zeeuw, D, Ivanovich, P, Levey, AS, McGill, JB, McMurray, JJV, Parfrey, PS, Parving, HH, Pereira, BJG, Remuzzi, G, Singh, AK, Solomon, SD, Stehman-Breen, C, Toto, RD & Pfeffer, MA 2005, 'Rationale-Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease', American Heart Journal, vol. 149, no. 3, pp. 408-413. https://doi.org/10.1016/j.ahj.2004.09.047
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. / Rationale-Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) : Evolving the management of cardiovascular risk in patients with chronic kidney disease. In: American Heart Journal. 2005 ; Vol. 149, No. 3. pp. 408-413.
@article{cdbfbde77fbf4b77a27f7350e8d07555,
title = "Rationale-Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease",
abstract = "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.",
author = "Mix, {T. Christian H} and Brenner, {Robert M.} and Cooper, {Mark E.} and {De Zeeuw}, Dick and Peter Ivanovich and Levey, {Andrew S.} and McGill, {Janet B.} and McMurray, {John J V} and Parfrey, {Patrick S.} and Parving, {Hans Henrik} and Pereira, {Brian J G} and Giuseppe Remuzzi and Singh, {Ajay K.} and Solomon, {Scott D.} and Catherine Stehman-Breen and Toto, {Robert D.} and Pfeffer, {Marc A.}",
year = "2005",
month = "3",
doi = "10.1016/j.ahj.2004.09.047",
language = "English (US)",
volume = "149",
pages = "408--413",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
number = "3",

}

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

UR - http://www.scopus.com/inward/citedby.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

VL - 149

SP - 408

EP - 413

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 3

ER -