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Mortality risk of darbepoetin alfa versus epoetin alfa in patients with CKD: systematic review and meta-analysis.
Am J Kidney Dis. 2015 Jul; 66(1):69-74.AJ

Abstract

BACKGROUND

Epoetin alfa (EPO) and darbepoetin alfa (DPO) are erythropoiesis-stimulating agents that are widely and interchangeably used for the treatment of anemia in patients with advanced chronic kidney disease and end-stage renal disease. No study has specifically compared the risks of hard study outcomes between EPO and DPO, including mortality.

STUDY DESIGN

Systematic review of the literature and meta-analysis.

SETTING & POPULATION

Patients enrolled in randomized trials comparing EPO versus DPO for the treatment of anemia in adults with chronic kidney disease, including those requiring dialysis.

SELECTION CRITERIA FOR STUDIES

We conducted a systematic search of the literature (PubMed, CENTRAL, SCOPUS, and EMBASE, all years) and industry resources, using predefined search terms and data abstraction tools. We then summarized key characteristics and findings of these trials and performed a random-effects meta-analysis of trials with at least 3 months' duration to identify the summary OR of mortality between patients randomly assigned to DPO versus EPO.

INTERVENTION

DPO versus EPO.

OUTCOME

All-cause mortality.

RESULTS

We identified 9 trials that met the stated inclusion criteria. Overall, 2,024 patients were included in the meta-analysis, of whom 126 died during follow-up, which ranged from 20 to 52 weeks. We found no significant difference in mortality between patients randomly assigned to DPO versus EPO (OR, 1.33; 95% CI, 0.88-2.01). No treatment heterogeneity across studies was detected (Q statistic=4.60; P=0.8).

LIMITATIONS

Generalizability to nontrial populations is uncertain.

CONCLUSIONS

Few trials directly comparing DPO and EPO have been conducted and follow-up was limited. In aggregate, no effect of specific erythropoiesis-stimulating agent on mortality was identified, but the confidence limits were wide and remained compatible with considerable harm from DPO. Absent adequately powered randomized trials, observational postmarketing comparative effectiveness studies comparing these erythropoiesis-stimulating agents are required to better characterize the long-term safety profiles of these agents.

Authors+Show Affiliations

Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA.Division of Nephrology, Stanford University School of Medicine, Palo Alto, CA; Section of Nephrology, Baylor College of Medicine, Houston, TX. Electronic address: winkelma@bcm.edu.

Pub Type(s)

Comparative Study
Journal Article
Meta-Analysis
Research Support, N.I.H., Extramural
Review
Systematic Review

Language

eng

PubMed ID

25636816

Citation

Wilhelm-Leen, Emilee R., and Wolfgang C. Winkelmayer. "Mortality Risk of Darbepoetin Alfa Versus Epoetin Alfa in Patients With CKD: Systematic Review and Meta-analysis." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 66, no. 1, 2015, pp. 69-74.
Wilhelm-Leen ER, Winkelmayer WC. Mortality risk of darbepoetin alfa versus epoetin alfa in patients with CKD: systematic review and meta-analysis. Am J Kidney Dis. 2015;66(1):69-74.
Wilhelm-Leen, E. R., & Winkelmayer, W. C. (2015). Mortality risk of darbepoetin alfa versus epoetin alfa in patients with CKD: systematic review and meta-analysis. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 66(1), 69-74. https://doi.org/10.1053/j.ajkd.2014.12.012
Wilhelm-Leen ER, Winkelmayer WC. Mortality Risk of Darbepoetin Alfa Versus Epoetin Alfa in Patients With CKD: Systematic Review and Meta-analysis. Am J Kidney Dis. 2015;66(1):69-74. PubMed PMID: 25636816.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Mortality risk of darbepoetin alfa versus epoetin alfa in patients with CKD: systematic review and meta-analysis. AU - Wilhelm-Leen,Emilee R, AU - Winkelmayer,Wolfgang C, Y1 - 2015/01/28/ PY - 2014/07/11/received PY - 2014/12/21/accepted PY - 2015/2/1/entrez PY - 2015/2/1/pubmed PY - 2015/9/12/medline KW - Erythropoiesis-stimulating agents KW - anemia KW - carbohydrate side chain KW - chronic kidney disease (CKD) KW - darbepoetin alfa (DPO) KW - drug safety KW - end-stage renal disease (ESRD) KW - epoetin alfa (EPO) KW - hemoglobin variability KW - meta-analysis KW - mortality KW - recombinant human erythropoietin (rHuEPO) SP - 69 EP - 74 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 66 IS - 1 N2 - BACKGROUND: Epoetin alfa (EPO) and darbepoetin alfa (DPO) are erythropoiesis-stimulating agents that are widely and interchangeably used for the treatment of anemia in patients with advanced chronic kidney disease and end-stage renal disease. No study has specifically compared the risks of hard study outcomes between EPO and DPO, including mortality. STUDY DESIGN: Systematic review of the literature and meta-analysis. SETTING & POPULATION: Patients enrolled in randomized trials comparing EPO versus DPO for the treatment of anemia in adults with chronic kidney disease, including those requiring dialysis. SELECTION CRITERIA FOR STUDIES: We conducted a systematic search of the literature (PubMed, CENTRAL, SCOPUS, and EMBASE, all years) and industry resources, using predefined search terms and data abstraction tools. We then summarized key characteristics and findings of these trials and performed a random-effects meta-analysis of trials with at least 3 months' duration to identify the summary OR of mortality between patients randomly assigned to DPO versus EPO. INTERVENTION: DPO versus EPO. OUTCOME: All-cause mortality. RESULTS: We identified 9 trials that met the stated inclusion criteria. Overall, 2,024 patients were included in the meta-analysis, of whom 126 died during follow-up, which ranged from 20 to 52 weeks. We found no significant difference in mortality between patients randomly assigned to DPO versus EPO (OR, 1.33; 95% CI, 0.88-2.01). No treatment heterogeneity across studies was detected (Q statistic=4.60; P=0.8). LIMITATIONS: Generalizability to nontrial populations is uncertain. CONCLUSIONS: Few trials directly comparing DPO and EPO have been conducted and follow-up was limited. In aggregate, no effect of specific erythropoiesis-stimulating agent on mortality was identified, but the confidence limits were wide and remained compatible with considerable harm from DPO. Absent adequately powered randomized trials, observational postmarketing comparative effectiveness studies comparing these erythropoiesis-stimulating agents are required to better characterize the long-term safety profiles of these agents. SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/25636816/Mortality_risk_of_darbepoetin_alfa_versus_epoetin_alfa_in_patients_with_CKD:_systematic_review_and_meta_analysis_ DB - PRIME DP - Unbound Medicine ER -