Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa

Chazot, Charles; Terrat, Jean Claude; Dumoulin, A.; Ang, Kim-Seng; Gassia, Jean Paul; Chedid, Khalil; Maurice, François; Canaud, Bernard

doi:10.1345/aph.1k664

Cited by 5 publications

(2 citation statements)

References 13 publications

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“…The randomization procedure was described in 14 RCTs 8,34,42–50,52,54,55 . All but two trials documented blinding, but the procedure was described in only 8, of which 6 were “double blinded.” The blinding procedure was well-documented in only four studies 8,28,34,43 .…”

Section: Resultsmentioning

confidence: 99%

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Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis

Koulouridis

Alfayez

Trikalinos

et al. 2013

American Journal of Kidney Diseases

168

119

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Background Targeting higher hemoglobin with erythropoiesis-stimulating agents (ESAs) to treat anemia of chronic kidney disease (CKD) is associated with increased cardiovascular risk. Study Design Meta-regression analysis examining the association of ESA dose with adverse outcomes, independent of target or achieved hemoglobin. Setting and Population Patients with anemia of CKD, irrespective of dialysis status. Selection Criteria for Studies We searched MEDLINE (inception to August 2010) and bibliographies of published meta-analyses and selected randomized controlled trials assessing the efficacy of ESAs for treatment of anemia in adults with CKD, with minimum 3-month duration. Two authors independently screened citations and extracted relevant data. Individual study arms were treated as cohorts and constituted the unit of analysis. Predictors ESA dose standardized to a weekly epoetin alfa equivalent, and hemoglobin levels. Outcomes All-cause and cardiovascular mortality, cardiovascular events, kidney disease progression or transfusion requirement. Results 31 trials (12,956 patients) met criteria. All-cause mortality was associated with higher (per epoetin-alfa–equivalent 10,000-U/wk increment) first-3-month mean ESA dose (incidence rate ratio [IRR], 1.42; 95% CI, 1.10–1.83) and higher total-study-period mean ESA dose (IRR, 1.09; 95% CI, 1.02–1.18). First-3-month ESA dose remained significant after adjusting for first-3-month mean hemoglobin (IRR, 1.48; 95% CI, 1.02- 2.14), as did total-study-period mean ESA dose adjusting for target hemoglobin (IRR, 2 1.41; 95% CI, 1.08–1.82). Parameter estimates between ESA dose and cardiovascular mortality were similar in magnitude and direction but not statistically significant. Higher total-study-period mean ESA dose was also associated with increased rate of hypertension, stroke, and thrombotic events including dialysis vascular access-related thrombotic events. Limitations use of study-level aggregated data; use of epoetin alfa–equivalent doses; lack of adjustment for confounders. Conclusions In patients with CKD, higher ESA dose might be associated with all-cause mortality and cardiovascular complications independent of hemoglobin.

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Section: Resultsmentioning

confidence: 99%

“…Two trials did not report their drop-out rates 39,53 . Among the 29 trials that provided sufficient documentation, the intention-to-treat principle was followed in 21 8,28–31,33–37,41–43,45 - 49,52,53,55 .…”

Section: Resultsmentioning

confidence: 99%

Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis

Koulouridis

Alfayez

Trikalinos

et al. 2013

American Journal of Kidney Diseases

168

119

View full text Add to dashboard Cite

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Frequency of administration of erythropoiesis-stimulating agents for the anaemia of end-stage kidney disease in dialysis patients

Hahn

Cody

Hodson

2014

Cochrane Database of Systematic Reviews

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Longer-acting ESA (darbepoetin and CERA) administered at one to four week intervals are non-inferior to rHuEPO given one to three times/week in terms of achieving haemoglobin targets without any significant differences in adverse events in haemodialysis patients. Additional RCTs are required to evaluate different frequencies of ESA in peritoneal and paediatric dialysis patients and to compare different longer-acting ESA (such as darbepoetin compared with CERA).

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Darbepoetin for the anaemia of chronic kidney disease

Palmer

Saglimbene

Craig

et al. 2014

Cochrane Database of Systematic Reviews

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Randomized Equivalence Study Evaluating the Possibility of Switching Hemodialysis Patients Receiving Subcutaneous Human Erythropoietin Directly to Intravenous Darbepoetin Alfa

Abstract: This study has shown equivalent efficacy on Hb stability without the need for dosage increase in patients switched directly from subcutaneous rHuEPO to intravenous darbepoetin.

Cited by 5 publications

References 13 publications

Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis

Dose of Erythropoiesis-Stimulating Agents and Adverse Outcomes in CKD: A Metaregression Analysis

Frequency of administration of erythropoiesis-stimulating agents for the anaemia of end-stage kidney disease in dialysis patients

Darbepoetin for the anaemia of chronic kidney disease

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