A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. Export

@article{citeulike:6088435, abstract = {BACKGROUND: Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. METHODS: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. 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.) Copyright 2009 Massachusetts Medical Society.}, author = {Pfeffer, Marc A. and Burdmann, Emmanuel A. and Chen, Chao-Yin Y. and Cooper, Mark E. and de Zeeuw, Dick and Eckardt, Kai-Uwe U. and Feyzi, Jan M. and Ivanovich, Peter and Kewalramani, Reshma and Levey, Andrew S. and Lewis, Eldrin F. and McGill, Janet B. and McMurray, John J. and Parfrey, Patrick and Parving, Hans-Henrik H. and Remuzzi, Giuseppe and Singh, Ajay K. and Solomon, Scott D. and Toto, Robert and {the TREAT Investigators}}, citeulike-article-id = {6088435}, citeulike-linkout-0 = {http://dx.doi.org/10.1056/NEJMoa0907845}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19880844}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19880844}, day = {30}, doi = {10.1056/NEJMoa0907845}, issn = {1533-4406}, journal = {The New England journal of medicine}, keywords = {ckd, dm, epo, outcome, rct}, month = {October}, posted-at = {2009-11-09 14:02:21}, priority = {2}, title = {A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease.}, url = {http://dx.doi.org/10.1056/NEJMoa0907845}, year = {2009} }

TY - JOUR ID - citeulike:6088435 L3 - citeulike-article-id:6088435 N2 - BACKGROUND: Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. METHODS: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. 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.) Copyright 2009 Massachusetts Medical Society. JF - The New England journal of medicine SN - 1533-4406 TI - A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. KW - ckd KW - dm KW - epo KW - outcome KW - rct AU - Pfeffer, Marc AU - Burdmann, Emmanuel AU - Chen, Chao-Yin AU - Cooper, Mark AU - de Zeeuw, Dick AU - Eckardt, Kai-Uwe AU - Feyzi, Jan AU - Ivanovich, Peter AU - Kewalramani, Reshma AU - Levey, Andrew AU - Lewis, Eldrin AU - McGill, Janet AU - McMurray, John AU - Parfrey, Patrick AU - Parving, Hans-Henrik AU - Remuzzi, Giuseppe AU - Singh, Ajay AU - Solomon, Scott AU - Toto, Robert PY - 2009/10/30/ UR - http://dx.doi.org/10.1056/NEJMoa0907845 ER -