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Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis

BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach. AIM: To evaluate the efficacy and saf...

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Autores principales: Chuengsaman, Piyatida, Narenpitak, Surapong, Sritippayawan, Suchai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Baishideng Publishing Group Inc 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641037/
https://www.ncbi.nlm.nih.gov/pubmed/34909408
http://dx.doi.org/10.5527/wjn.v10.i6.109
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author Chuengsaman, Piyatida
Narenpitak, Surapong
Sritippayawan, Suchai
author_facet Chuengsaman, Piyatida
Narenpitak, Surapong
Sritippayawan, Suchai
author_sort Chuengsaman, Piyatida
collection PubMed
description BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach. AIM: To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD). METHODS: This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36. RESULTS: All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators’ assessment. At week 12, the QoL scores in all domains were significantly increased from baseline. CONCLUSION: Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile.
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spelling pubmed-86410372021-12-13 Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis Chuengsaman, Piyatida Narenpitak, Surapong Sritippayawan, Suchai World J Nephrol Prospective Study BACKGROUND: Hema-Plus, a recombinant human erythropoietin (rHuEPO) or epoetin alfa has shown effectiveness in correction of anemia in Thai population in clinical practice. This study was aimed to demonstrate efficacy and safety under the evidence-based approach. AIM: To evaluate the efficacy and safety of rHuEPO (Hema-Plus) for treatment of anemia over 12 wk in Thai patients with Stage V chronic kidney disease (CKD) on peritoneal dialysis (PD). METHODS: This study was an open-label, multi-center study to enroll 30 CKD patients identified to start PD with hemoglobin (Hb) less than 9.5 g/dL, serum ferritin more than 100 ng/mL, serum transferrin saturation more than or equal to 20% and who had not previously received epoetin. Patients with conditions that could increase the risk of adverse effects from study participation or interfere with study outcomes, were using concomitant androgens or had secondary hyperparathyroidism were excluded. All eligible patients started Hema-Plus by SC injection at 4000 IU once or twice weekly (week 0) and with follow-up at weeks 2, 4, 8, and 12. Dosage adjustment could be done to achieve Hb level of 11-12 g/dL. Primary end point was mean change in Hb level from baseline to end of treatment (week 12). Safety was assessed throughout the study. Quality of life (QoL) was assessed using KDQOL-36. RESULTS: All 30 enrolled patients completed the study. Mean (standard deviation) Hb at baseline (week 0) to the end of 12 wk was significantly increased from 7.39 (1.29) g/dL to 11.15 (1.73) g/dL (paired t-test, P value < 0.001). Overall change of Hb means from baseline over the other 4 visits was statistically significantly increased (repeated measure ANOVA, P value < 0.001). Ten out of 39 adverse events (AEs) were serious. Two serious AEs were probably related to study medication by investigators’ assessment. At week 12, the QoL scores in all domains were significantly increased from baseline. CONCLUSION: Hema-Plus administered for 12 wk for treatment of anemia in patients on PD effectively increased Hb levels with acceptable safety profile. Baishideng Publishing Group Inc 2021-11-25 2021-11-25 /pmc/articles/PMC8641037/ /pubmed/34909408 http://dx.doi.org/10.5527/wjn.v10.i6.109 Text en ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved. https://creativecommons.org/licenses/by-nc/4.0/This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/Licenses/by-nc/4.0/
spellingShingle Prospective Study
Chuengsaman, Piyatida
Narenpitak, Surapong
Sritippayawan, Suchai
Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title_full Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title_fullStr Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title_full_unstemmed Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title_short Efficacy and safety of recombinant human erythropoietin (Hema-Plus(®)) for management of anemia in Thai patients on peritoneal dialysis
title_sort efficacy and safety of recombinant human erythropoietin (hema-plus(®)) for management of anemia in thai patients on peritoneal dialysis
topic Prospective Study
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8641037/
https://www.ncbi.nlm.nih.gov/pubmed/34909408
http://dx.doi.org/10.5527/wjn.v10.i6.109
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