Abstract | BACKGROUND: METHODS: RESULTS: Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. CONCLUSIONS: The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.)
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Authors | Marc A Pfeffer, Emmanuel A Burdmann, Chao-Yin Chen, Mark E Cooper, Dick de Zeeuw, Kai-Uwe Eckardt, Jan M Feyzi, Peter Ivanovich, Reshma Kewalramani, Andrew S Levey, Eldrin F Lewis, Janet B McGill, John J V McMurray, Patrick Parfrey, Hans-Henrik Parving, Giuseppe Remuzzi, Ajay K Singh, Scott D Solomon, Robert Toto, TREAT Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 361
Issue 21
Pg. 2019-32
(Nov 19 2009)
ISSN: 1533-4406 [Electronic] United States |
PMID | 19880844
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Copyright | 2009 Massachusetts Medical Society |
Chemical References |
- Hematinics
- Hemoglobins
- Erythropoietin
- Darbepoetin alfa
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Topics |
- Aged
- Anemia
(drug therapy, etiology)
- Cardiovascular Diseases
(mortality, prevention & control)
- Darbepoetin alfa
- Diabetes Mellitus, Type 2
(complications)
- Double-Blind Method
- Erythropoietin
(adverse effects, analogs & derivatives, therapeutic use)
- Female
- Hematinics
(adverse effects, therapeutic use)
- Hemoglobins
(analysis)
- Humans
- Kaplan-Meier Estimate
- Kidney Failure, Chronic
(epidemiology, prevention & control)
- Male
- Middle Aged
- Neoplasms
(mortality)
- Renal Insufficiency, Chronic
(blood, complications)
- Stroke
(chemically induced, epidemiology)
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