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A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease.
N Engl J Med. 2009 Nov 19; 361(21):2019-32.NEJM

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.)

Authors+Show Affiliations

Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA. mpfeffer@rics.bwh.harvard.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19880844

Citation

Pfeffer, Marc A., et al. "A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease." The New England Journal of Medicine, vol. 361, no. 21, 2009, pp. 2019-32.
Pfeffer MA, Burdmann EA, Chen CY, et al. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. N Engl J Med. 2009;361(21):2019-32.
Pfeffer, M. A., Burdmann, E. A., Chen, C. Y., Cooper, M. E., de Zeeuw, D., Eckardt, K. U., Feyzi, J. M., Ivanovich, P., Kewalramani, R., Levey, A. S., Lewis, E. F., McGill, J. B., McMurray, J. J., Parfrey, P., Parving, H. H., Remuzzi, G., Singh, A. K., Solomon, S. D., & Toto, R. (2009). A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. The New England Journal of Medicine, 361(21), 2019-32. https://doi.org/10.1056/NEJMoa0907845
Pfeffer MA, et al. A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease. N Engl J Med. 2009 Nov 19;361(21):2019-32. PubMed PMID: 19880844.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. AU - Pfeffer,Marc A, AU - Burdmann,Emmanuel A, AU - Chen,Chao-Yin, AU - Cooper,Mark E, AU - de Zeeuw,Dick, AU - Eckardt,Kai-Uwe, AU - Feyzi,Jan M, AU - Ivanovich,Peter, AU - Kewalramani,Reshma, AU - Levey,Andrew S, AU - Lewis,Eldrin F, AU - McGill,Janet B, AU - McMurray,John J V, AU - Parfrey,Patrick, AU - Parving,Hans-Henrik, AU - Remuzzi,Giuseppe, AU - Singh,Ajay K, AU - Solomon,Scott D, AU - Toto,Robert, AU - ,, Y1 - 2009/10/30/ PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2009/12/16/medline SP - 2019 EP - 32 JF - The New England journal of medicine JO - N Engl J Med VL - 361 IS - 21 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.) SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/19880844/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJMoa0907845?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -