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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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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Baishideng Publishing Group Inc
2021
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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. |
format | Online Article Text |
id | pubmed-8641037 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Baishideng Publishing Group Inc |
record_format | MEDLINE/PubMed |
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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