Biosimilar erythropoietin in anemia treatment (BEAT)—Efficacy and safety of a 1:1 dose conversion from EPREX® to EPIAO® in patients with end-stage renal disease on hemodialysis: A prospective, randomized, double blind, parallel group study
Bolong MiaoАлина ИсачкинаEvgeny Viktorovich ShutovAlexander Alekseevich SelyutinLyudmila Vladimirovna KvitkovaShilo VIuVetchinnikova OnI. V. AlexandrovDavid S. PerlinAlexander Vasilievich ZuevИ. Л. ДавыдкинTatyana Pavlovna MironovaOlga Mikhailovna SolovyovaAlexey Pavlovich TutinAlexey Mikhailovich OmelchenkoKriengsak VareesangthipNadezhda Georgievna KhadikovaMan LiXiang Li
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Background: EPREX ® /ERYPO ® /PROCRIT ® (epoetin alfa, Janssen-Cilag GmbH) was the first available recombinant human erythropoietin (rHuEPO) and was universally reference product as per the recommendation provided by European Medicines Agency. EPIAO ® is a biosimilar formulation of EPREX ® , and making it a 1:1 dose conversion from EPREX ® according to recommendation of European Medicines Agency. This study evaluated the clinical efficacy and safety of EPIAO ® in subjects with end-stage renal disease receiving hemodialysis after intravenous administration. Methods: This study was a multicenter, prospective, randomized, double-blind, parallel-group, 2-cohort, maintenance phase, therapeutic equivalence study to evaluate a 1:1 dose conversion from EPREX ® to EPIAO ® in terms of clinical efficacy and safety that was conducted at 20 sites in 2 countries in patients with end-stage renal disease on hemodialysis. Eligible subjects were treated with EPREX ® (reference product of epoetin) for a period of at least 3 months before the treatment period, and then were randomly assigned to the group of EPREX ® or EPIAO ® . Primary endpoints were mean absolute change in hemoglobin level and mean absolute change in weekly epoetin dosage from baseline to 6 months after treatment with EPIAO ® /EPREX ® in parallel groups. Results: A total of 200 people received the random intervention and were included in the safety set. After 6, 9, and 12 months of treatment with EPIAO ® or EPREX ® , there were no significant differences in the hemoglobin levels of the 2 groups compared with baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ±0.5 g/dL. There were no significant differences in the epoetin dosage of the 2 groups compared with the baseline. The 95% confidence interval for the treatment difference was within the predetermined acceptable range: ± 45 IU/kg. There were no significant differences in the incidence of adverse events between the EPIAO ® and EPREX ® groups. Most adverse events were mild to moderate and were reverted/resolved. Conclusion: EPIAO ® demonstrated promising effectiveness and manageable safety in patients with end-stage renal disease on hemodialysis.Keywords:
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Abstract Anemia is a common complication of chronic kidney disease, particularly in patients who are on dialysis. The use of recombinant human erythropoietin has led to the eradication of severe anemia in the dialysis population. Correction of anemia in these patients has been associated with better quality of life and clinical outcomes. Some hemodialysis patients have anemia that either is relatively refractory to epoetin therapy or requires very high doses of epoetin (i.e., hyporesponsiveness), despite having adequate iron stores, and are thus unable to achieve or maintain target hemoglobin levels. Several pharmacologic agents have been studied for effects on improving response to epoetin, either to counter hyporesponsiveness or simply to reduce epoetin use for purely economic reasons. This review examines the available literature regarding the efficacy of these potential pharmacologic adjuvants to epoetin in the treatment of anemia in patients on maintenance hemodialysis, with special emphasis on androgens, vitamin C (ascorbic acid), and l ‐carnitine. A review of published guidelines and recommendations for use of these agents in hemodialysis patients is provided.
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Numerous reports on recombinant human erythropoietin (rHuEPO, epoetin alfa) treatment of cancer-related anemia in adult patients have been published to date. These have shown that epoetin increases hemoglobin levels, significantly ameliorates symptoms of anemia, and improves adult patients' quality of life. Unfortunately, less is known about the impact of epoetin on anemia in pediatric cancer patients.It is the objective of this review to summarize and analyze data of clinical trials of epoetin treatment of anemia in pediatric cancer patients.A total of 15 studies were reviewed; eight were considered for detailed analysis and demonstrated important variabilities in study methods. Four of the eight were controlled, randomized trials and four were open label.These studies suggested an overall beneficial effect of epoetin alfa for treating anemia in children with cancer. Three large, multicenter clinical trials of the efficacy and safety of epoetin alfa in anemic children with cancer are currently underway, one in Europe and two in North America.
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From August 1989 to August 1994, 173 arteriovenous fistules were constructed in 162 patients for permanent hemodialysis: 49 autogenous and 124 graft fistulas (polytetraflouroethylene (PTFE)-119, others-5). Previous access procedures were noted in 93 graft fistulas (76%) versus 8 autogenous fistulas (16.3%). In the immediate postoperative period, 13 graft fistulas (10.6%) developed complications (5 anastomotic hemorrhages, 4 thrombosis, 3 hypotension without hemorrhage, and 1 sepsis), while 2 (4.1%) autogenous fistulas developed immediate postoperative complications (1 anastomotic hemorrhage and 1 thrombosis). Graft fistulas had a higher, although not statistically significant incidence of immediate postoperative complications versus autogenous fistulas. These graft fistula complications were associated with multiple access procedures and required surgical exploration. Based on these results, we should make every effort to construct the autogenous fistula as the first choice of hemodialysis access procedure in properly selected patients.
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Recombinant human erythropoietin was administered to 59 patients over 65 years of age receiving maintenance hemodialysis treatment in Kyoto and Shiga district, in order to evaluate its utility on renal anemia. After 6 months of administration, the hematocrit rose from 20.8 +/- 3.5% to 28.0 +/- 3.7% with concomitant improvement of subjective symptoms related to anemia. Twelve patients developed side effects, in 10 of whom elevation of blood pressure was observed. We found no clinically significant abnormalities in the laboratory data. In conclusion, recombinant human erythropoietin is highly useful in the treatment of renal anemia in elderly hemodialysis patients.
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Nephrologists use recombinant human erythropoietin (epoetin) widely to treat anemia in hemodialysis patients. However, the best route of administration is uncertain.
In this study, researchers randomized 208 long-term patients at 24 Veterans Affairs …
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The preventive effects of recombinant human erythropoietin (rhEPO) administration on progression of anemia were evaluated during hemodialysis in nephrectomized dogs. In control dogs given no rhEPO, anemia gradually progressed with repeated hemodialysis and with little erythropoietic response observed in the bone marrow. In dogs administered with rhEPO, however, an active erythropoietic response was induced in the bone marrow, indicating that anemia due to hemodialysis was being prevented.
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Anemia, a common complication of chronic kidney disease, usually develops as a consequence of erythropoietin deficiency. Recombinant human erythropoietin (epoetin alfa) is indicated for the correction of anemia associated with this condition. However, the optimal level of hemoglobin correction is not defined.
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The use of recombinant human erythropoietin (rHuEpo) became an essential part of the treatment of anemia in patients with end stage renal failure (ESRF). Our experience at the Hajjah region, Yemen, confirms that the use of rHuEpo significantly increases the level of hemoglobin (HB) and hematocrit (Hct), improves work tolerance and overall quality of life of patients on hemodialysis. The observable improvement occurred in 87.5% of patients. The most prominent factors that caused deterioration in the increment of HB and Hct were infection with malaria and chronic infection. Failure of patients' compliance, largely due to lack of education, was another important factor effecting the results. Many of our patients did not understand the importance of diet and drug regime. It is very important to spend more time on educating such patients.
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