Comparative effectiveness of erythropoietin alpha and beta in hemodialysis patients: a single-center prospective observational study

Ahsan, Muhammad; Asif, Naveed; Khanzada, Shafqat Waqar; Asghar, Muhammad Sohaib; Yasmin, Farah; Khalid, Faran; Fareed, Shameen; Irshad, Syeda Ghazala

doi:10.1080/20009666.2021.1983980

Cited by 5 publications

(2 citation statements)

References 11 publications

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“…The test product is a biological product that is considered biosimilar to the original reference product hence the evaluation of the efficacy and safety comparison is important. The other studies, Comparative effectiveness of erythropoietin alpha and beta in hemodialysis patients: a single-center prospective observational study is to compare therapeutic efficacy of both erythropoietin alpha and erythropoietin beta in treating anemia associated with chronic kidney disease in our study population with the desired hemoglobin levels of ≥ 11 g/l [13].…”

Section: Discussionmentioning

confidence: 99%

Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients

Dwitanto

Angginy

Sutandar³

2023

Drug Res (Stuttg)

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Purpose This study was conducted to evaluate whether the efficacy and safety profile of recombinant human erythropoietin (rhEPO) manufactured by Daewoong Pharmaceutical Co., Ltd was similar to biological products approved by the drug safety regulatory authority. Patients and methods It was an open-label, randomized, comparative, parallel, multi-center study in hemodialysis patients with anemia. The reference product at an individualized dose 3 times a week was given in 4–8 weeks of titration period and hemoglobin (Hb) level was controlled to reach the range of 10–12 g/dL. Then, the subjects were randomly administered with reference or test product with the same dose regimen. The primary endpoints were to demonstrate the Hb level change between baseline and evaluation period in both treatment groups, while the secondary endpoints were the mean change in weekly dosage per kg body weight and the instability rate of Hb level during maintenance and evaluation period. The safety was evaluated based on the adverse events incidence. Results There was no statistical difference in the change of Hb between test and reference (0.14 g/dL and 0.75 g/dL respectively, with p>0.05), also for the mean changes of weekly dosage between groups (1091.40 IU and 570.15 IU respectively, with p>0.05). The instability rate of Hb in both test and reference was not statistically significantly different as well (26 and 15% respectively, with p>0.05). Conclusion This study proves that the efficacy indicated by the change instability of Hb and safety indicated by adverse event incidence of Epodion and the reference product on chronic kidney disease were similar.

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Section: Discussionmentioning

confidence: 99%

Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients

Dwitanto

Angginy

Sutandar³

2023

Drug Res (Stuttg)

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“…Similarly, results of a randomized, active-controlled, double-blind, parallel, and noninferiority trial in Iran about the comparison of Cinnapoietin ® with Eprex ® suggested that Cinnapoietin ® was noninferior to Eprex ® in the treatment of anemia in hemodialysis patients [22]. On the other hand, fndings of two other studies in Pakistan and Japan favored EPO beta over alpha in the management of anemia in patients with CKD under or not under hemodialysis [25,26]. In contrast, a prospective, observational study in patients with CKD under hemodialysis in Indonesia reported that EPO alpha is more efective in achieving the goal hemoglobin level compared to EPO beta [27].…”

Section: Discussionmentioning

confidence: 99%

Drug Utilization Evaluation of Erythropoietin at a Referral Teaching Hospital in Iran

Karimzadeh,

Rasekh,

Karimian

et al. 2023

Advances in Pharmacological and Pharmaceutical Sciences

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Objectives. Drug utilization evaluation (DUE) studies aim to survey the appropriateness of drug use. DUE is an executive approach used to improve the use of medications as well as reduce the cost of treatment, ensure drug adequacy, and improve patient safety. The aim of this study was to evaluate the pattern of erythropoietin use, according to standard guidelines, in patients admitted to Namazi Hospital in Shiraz, Iran. Methods. In this descriptive, retrospective study, 230 patients were assessed. All patients who were hospitalized in different wards of Namazi Hospital, affiliated to Shiraz University of Medical Sciences, and received at least three doses of erythropoietin from September 2019 to March 2020 participated in this study. The following standard indicators of erythropoietin use were evaluated through reviewing medical charts of the cohort: drug dose, dosing intervals, route of administration, indication, monitoring of laboratory parameters, drug dose adjustment based on the response rate as well as target hemoglobin ≥12 g/dl, attention to major drug interactions, and administration of injectable or oral iron supplementation during treatment. Results. Most (65.2%) of the participants were male. The mean ± SD age of the patients was 47.55 ± 22.71 years. More than half (51.3%) of the included subjects were hospitalized in the nephrology ward. PDpoetin® and Cinnapoietin® were given to 52.6% and 47.4% of the study participants, respectively. Treatment of anemia due to chronic kidney disease was the most frequent indication of erythropoietin. The time interval of erythropoietin administration was three times a week for 68.3% of the patients. The most frequently administered weekly dose of erythropoietin was 12,000 units. The weekly dose, dose interval, and route of administration of erythropoietin were appropriate in 52.6%, 77.4%, and 100% of the patients, respectively. Dose adjustment based on the response rate, attention to major drug interactions as well as absolute-relative contraindications, and attention to the target hemoglobin ≥12 g/dl to decide whether or not to continue treatment were based on standard guideline in 98.1%, 98.7%, and 93% of the patients, respectively. The sum indexes of erythropoietin use were in line with standard guidelines in 75.84% of the cases. Conclusion. According to our results, in the setting of erythropoietin use in hospitals, physicians need more attention and education in areas such as selecting the proper dose of medication, correct indication of the drug, temporal arrangement of monitoring laboratory items, and the patient’s need for iron supplements.

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Challenges and recent advances in erythropoietin stability

Fayed,

Luo,

Yassin

2024

Pharmaceutical Development and Technology

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Comparative effectiveness of erythropoietin alpha and beta in hemodialysis patients: a single-center prospective observational study

Cited by 5 publications

References 11 publications

Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients

Comparative Study of Recombinant Human Erythropoietin (rhEPO) Products on CKD (Chronic Kidney Disease) Patients

Drug Utilization Evaluation of Erythropoietin at a Referral Teaching Hospital in Iran

Challenges and recent advances in erythropoietin stability

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