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A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease
Open accessAbstract
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.)
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“In pre-dialysis CKD patients with or without diabetes higher Hgb targets, particularly in patients with poor initial Hgb responses, were also associated with increased cardiovascular risk.”
From Regulation of erythropoiesis by hypoxia-inducible factors (2013) · cites this paper as [229]
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Metadata
- Authors
- 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. V., Parfrey, P., Parving, H.-H., Remuzzi, G., Singh, A. K., Solomon, S. D., & Toto, R.
- Affiliations
- Brigham and Women's Hospital (US)
- Hospital de Base (BR)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University of Wisconsin–Madison (US)
- Northwestern University (US)
- Tufts University (US)
- Harvard University (US)
- Washington University in St. Louis (US)
- University of Glasgow (GB)
- University of Copenhagen (DK)
- The University of Texas Southwestern Medical Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-11-19
- Volume
- 361
- Issue
- 21
- Pages
- 2019-2032
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1998943227
- Cited by
- 2,096
- References
- 32
- Citations by year
- 2026: 62 · 2025: 66 · 2024: 65 · 2023: 94 · 2022: 92 · 2021: 128 · 2020: 121 · 2019: 111 · 2018: 90 · 2017: 108 · 2016: 125 · 2015: 122 · 2014: 163 · 2013: 174 · 2012: 175
- FWCI
- 125.33
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Funders
- Robert Wood Johnson Foundation
- Amgen
- Bristol-Myers Squibb
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Biogen
- Louisiana Board of Regents
- Boston Scientific Corporation
- McGill University
- Celladon Corporation
- Covis Pharma
- Cytokinetics
- Servier
- Genentech
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- darbepoetin alfa, type 2 diabetes, chronic kidney disease, anemia, erythropoiesis-stimulating agents, cardiovascular events, end-stage renal disease, stroke, red blood cell transfusion, fatigue, hemoglobin target, cardiovascular risk reduction, non-dialysis patients
- MeSH terms
- Darbepoetin alfa, Aged, Anemia, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Erythropoietin, Female, Hematinics, Hemoglobins, Humans, Kidney Failure, Chronic, Male, Middle Aged, Neoplasms, Stroke, Renal Insufficiency, Chronic, Kaplan-Meier Estimate
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