Switch from epoetin to darbepoetin alfa in hemodialysis: dose equivalence and hemoglobin stability

Arrieta, Javier; Moina, Iñigo; Molina, José; Gallardo, Isabel; Muñiz, María Luisa; Robledo, Carlos; García, Óscar Coyoli; Vidaur, F; Muñoz, Rosa Inés; Iribar, Izaskun; Aguirre, R.D Bonilla; Maza, A. Madrazo

doi:10.2147/ijnrd.s61895

Cited by 4 publications

(3 citation statements)

References 27 publications

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“…In this context, it is of utmost importance to underline that none of the studies conducted performed a direct comparison among different switching groups. In particular, three of these studies showed conflicting results in terms of the doses of ESA α that were required to control anaemia in CKD patients switching from originator to biosimilar [29–31].…”

Section: Discussionmentioning

confidence: 99%

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study

Belleudi¹,

Trotta

Addis³

et al. 2019

Drug Saf

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IntroductionReal-world data on the comparative effectiveness and safety of switching among different epoetins (including originators and biosimilars) are limited. In light of current debate about interchangeability, prescribers, some patient groups and decision makers are calling for additional post-marketing evidence on the clinical effects of switching between originator and biosimilar epoetins in chronic kidney disease (CKD) patients.ObjectiveThe objective of this study was to evaluate the effectiveness and safety of switching versus non-switching and of switching from originator/biosimilar epoetin alpha (ESA α) to any other epoetin in CKD patients.MethodsAn observational, record-linkage, multi-database, retrospective cohort study was carried out in four Italian geographical areas. All subjects with at least one ESA α dispensing between 1 January 2009 and 31 December 2015 were retrieved. Switching was defined as any transition between originator/biosimilar ESA α to any other epoetin in a series of two consecutive prescriptions up to 2 years. Switchers were matched 1:1 with non-switchers by baseline propensity score and by duration of ESA α treatment. Switchers and non-switchers were followed up from switching date to a maximum of 1 year. Lack of effectiveness and safety of switching versus non-switching were evaluated through Cox regression models (hazard ratio [HR], 95% confidence interval [CI]). A direct comparison between the two switcher categories (switchers from originator/biosimilar ESA α to any other epoetin) was also performed.ResultsOverall, 14,400 incident users of ESA α for anaemia due to CKD (61.4% originator, 38.6% biosimilar) were available for analysis. During the follow-up, we found no differences on effectiveness (HR 1.02, 95% CI 0.79–1.31 originators; HR 1.16, 95% CI 0.75–1.79 biosimilars) and safety outcomes (HR 1.08, 95% CI 0.77–1.50 originators; HR 1.20, 95% CI 0.66–2.21 biosimilars) between switchers and non-switchers of ESA α. Cumulative probabilities of recording an adverse event, either in terms of lack of effectiveness or safety issue, were the same for two switching categoriesConclusionsIn this large-scale Italian observational multi-database study, switching versus non-switching as well as switching from biosimilar/originator ESA α to any other epoetin in CKD patients is not associated with any effectiveness and safety outcomes.Electronic supplementary materialThe online version of this article (10.1007/s40264-019-00845-y) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study

Belleudi¹,

Trotta

Addis³

et al. 2019

Drug Saf

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“…al. [51] HD patients Switch from EPO to DPO resulted in a consistent and substantial 65% reduction in the required dose (p < 0.0001).…”

Section: Arrieta Etmentioning

confidence: 92%

Advancing Anemia Management in Chronic Kidney Disease: Assessing the Superiority of Darbepoetin Alfa Over Erythropoietin Alpha

Khullar,

Muchhala,

2024

Cureus

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Anemia is a prevalent and debilitating complication in patients with chronic kidney disease (CKD). It presents multifaceted challenges that impact patients' quality of life and overall well-being. The advent of darbepoetin alfa (DPO) as a therapeutic alternative to recombinant human erythropoietin alpha (EPO) has revolutionized the management of CKD-associated anemia. This review article presents a comprehensive comparative analysis highlighting the advantages of DPO over EPO in the effective management of anemia, in both predialysis and dialysis-dependent (DD) CKD patients. DPO's distinct pharmacokinetic advantages play a pivotal role in its efficacy and safety. With a significantly longer half-life and several-fold increased biological activity compared to EPO, DPO enables extended dosing intervals. Through an in-depth examination of diverse clinical trials, it becomes evident that DPO consistently demonstrates remarkable efficacy and safety in improving and maintaining hemoglobin (Hb) levels. Furthermore, its simplified dosage regimen, coupled with the convenience of less frequent administration, not only improves patient adherence but also translates to reduced healthcare costs and resource utilization. In conclusion, this review provides compelling evidence of the advantages of DPO over conventional recombinant human EPO for managing anemia in CKD patients, both in the predialysis and dialysis-dependent CKD patients. DPO's pharmacokinetic advantages, patient-centered advantages, enhanced compliance, and cost-effectiveness converge to establish DPO as a transformative therapeutic option. In both predialysis and dialysis settings, DPO's superior efficacy and patient-centric attributes collectively redefine the landscape of anemia management in CKD.

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“…Dose equivalence was calculated due to the fact that the patients were using different EPO forms. Conversion from epoetin alfa dose to darbopoetin alfa dose was calculated with a conversion ratio of 300:1 for patients receiving epoetin alfa (≤200 IU/kg/week), while a 350:1 ratio was used for patients receiving higher doses [5].…”

Section: Methodsmentioning

confidence: 99%

The effect of subclinic thyroid pathologies on erythropoietine dose in hemodialysis patients

et al. 2022

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The effect of subclinical thyroid pathologies on erythropoietin (EPO) treatment has not been well defined. The aim of the study is to compare the frequency and dose of EPO administration in patients with subclinical thyroid pathology and euthyroid hemodialysis patients.Methods: A cross-sectional and retrospective study was conducted with 210 patients. Special conditions were excluded, a total of 191 patients were included. Patients were divided into three groups.Results: The incidences of subclinical hypothyroidism, subclinical hyperthyroidism and euthyroidism were 10.5%, 3.1%, and 86.4%, respectively. Statistically significant difference was found between subclinical hypothyroid and euthyroid patients in terms of the number of patients using EPO (p = 0.0207), monthly total EPO doses (p = 0.003), and total monthly EPO doses per weight (p = 0.001). Conclusion:The EPO dose required to achieve similar hemoglobin levels in hemodialysis patients was significantly higher in subclinical hypothyroid patients than in euthyroid patients.

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Switch from epoetin to darbepoetin alfa in hemodialysis: dose equivalence and hemoglobin stability

Cited by 4 publications

References 27 publications

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study

Effectiveness and Safety of Switching Originator and Biosimilar Epoetins in Patients with Chronic Kidney Disease in a Large-Scale Italian Cohort Study

Advancing Anemia Management in Chronic Kidney Disease: Assessing the Superiority of Darbepoetin Alfa Over Erythropoietin Alpha

The effect of subclinic thyroid pathologies on erythropoietine dose in hemodialysis patients

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