R Foundation for Statistical Computing. 20030125 Study Group Trial(1), Glaspy J, Vadhan-Raj S, Patel R, Bosserman L, Hu E, Lloyd RE, Boccia RV, Tomita D, Rossi G. J Clin Oncol. The commonly reported events in both the treatment groups were pyrexia (DA-α vs. EPO: 9.5% vs. 7.9%), cough (9.5% vs. 15.9%), vomiting (4.8% vs. 6.3%), nasopharyngitis (4.8% vs. 6.3%), increased blood creatinine and urea (4.8% vs. 4.8% for each) and decreased glomerular filtration rate (4.8% vs. 4.8%). In DA-α group, the most commonly reported TEAEs by SOC were; respiratory, thoracic and mediastinal disorders (14.3%), general disorders and administration site conditions (12.7%), investigations (9.5%), and infections and infestations (7.9%). A sensitivity analysis will be included to evaluate any effect of radiation-only studies on the results. Storring PL, Tiplady RJ, Gaines Das RE, et al. Measurements and Main Results. C.E.R.A. (DOCX 14 kb). Aranesp® is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. Question 1. Transfusion incidence from week 5 to the end of the treatment phase (the primary end point) was 21% in the DA group and 16% in the EA group; noninferiority was concluded because the upper 95% CI limit of the difference between groups (10.8%) was below the prespecified noninferiority margin. Comparative effectiveness of epoetin and darbepoetin for managing anemia in patients undergoing cancer treatment. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02049346. Epoetin alfa for the treatment of the anemia of multiple myeloma. Nissenson AR, Swan SK, Lindberg JS. Relevant extracted data will be summarized in Word evidence tables. The existence of multiple confounding factors in observational studies may also limit interpretation of these data, particularly considering the complex nature of ESA use in cancer patients with anemia undergoing chemotherapy. Epoetin alfa and beta differ in their erythropoietin isoform compositions and biological properties. Epub 2005 Dec 6. Data supporting the findings are presented within the manuscript and additional datasets used are available from the corresponding author on request. Erythropoietins in Management of Anemia of End Stage Renal Disease: A Prospective Study From Qatar. In February 2009, the manufacturer elected to withdraw the product from the market for commercial reasons and it is now discontinued. Methods: The study was a randomized controlled trial (see details under Criteria for Considering Studies). If a dose of Epoetin alpha or beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used. If you do not receive an email within 10 minutes, your email address may not be registered, Doses of C.E.R.A. A majority of the reported AEs were due to the underlying disease and its treatment; in addition, only few AEs were associated with EPO use, and none were related to DA-α use. Change from baseline to the end of first evaluation period in Hb levels was equal in PP population for both treatment groups. Google Scholar. LASA, VAS, and CLAS scales will be excluded. Treatment emergent adverse events (TEAEs) were evaluated throughout the study. J Natl Cancer Inst. Beguin Y. Chronic anemia may result in severe organ damage affecting the cardiovascular system, immune system, lungs, kidneys, muscles and the central nervous system.12 In addition to the physical symptoms, the subjective impact of cancer-related anemia on quality of life (QoL), mental health and social activities may be substantial. Darbepoetin alfa: a new erythropoietic drug for the treatment of renal anaemia. The results of this study demonstrated that, the efficacy of DA-α, when administered at reduced dose frequency, is similar to EPO for treating renal anaemia in patients undergoing dialysis. Atkins R. The epidemiology of chronic kidney disease. Authors would like to thank Darbepoetin investigator group (Dr. Abraham, Dr. Hegde, Dr. Parekh, Dr. Vakil, Dr. Goplani, Dr. Sajgure, Dr. Amitabh Anantrao Kulkarni, Dr. Dilip M Babu, Dr. A Anuradha, and Dr. Dinesh Khullar) for conducting this study. 2003;12:139–43. In both of the treatment arms, appropriate dose adjustments were made to achieve and maintain patients’ Hb level within the target range, i.e ≥ 1 g/dL increase from baseline Hb, and within the range of 10–12 g/dL during the 36-week study period. However, its optimal route of administration and dosage are debatable due to its short half-life . Study record managers: refer to the Data Element Definitions if submitting registration or results information. Reviewers in the relevant research area assess submitted manuscripts for originality, validity, and significance to help editors to determine whether the manuscript should be published in the journal. Most fundamental is the balance of potential benefits (QoL, fewer transfusions) and harms (increased mortality, thromboembolic events) and how treatment strategies (thresholds for initiation, therapy duration) might affect that balance. Terms and Conditions, Studies that meet all criteria will be included in the group of higher quality trials for purposes of sensitivity analysis.2. Quality of life in chronic anemia of cancer during treatment with recombinant human erythropoietin. The results of our study demonstrated that efficacy and safety of DA-α (manufactured by Hetero Biopharma), when administered at a reduced dose frequency, is similar to EPO for treating renal anemia in Indian patients with ESRD undergoing dialysis. How do alternative thresholds for initiating treatment compare as regards their affect on the benefits and harms of erythropoietic stimulants? 2006 Sep 1;24(25):e46. Talk with your doctor and family members or friends about deciding to join a study. The journal is dedicated to following best practices on ethical matters, errors, and retractions. For patients with lymphoma, anemia is present in approximately 40% of patients at diagnosis; following 3 to 4 cycles of chemotherapy up to 70% of the patients will be anemic.9, The pathophysiology of tumor anemia is multi-factorial. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American Society of Hematology clinical practice guideline update. Garton JP, Gertz MA, Witzig TE, et al. Two forms of recombinant human erythropoietin—epoetin alfa and epoetin beta (the latter not commercially available in the United States)—have been extensively studied and used clinically for more than a decade to treat various anemias; they have similar clinical efficacy.3,4 In a recent review of safety concerns associated with recombinant human erythropoietins, a U.S. Food and Drug Administration (FDA) briefing document5 noted that “…the biochemical differences between various erythropoietin products are not associated with marked differences in the pharmacodynamic properties of the different products when used at recommended doses, thus effects observed with these non-US-licensed products may also be associated with the U.S. licensed product.” For this reason, both forms of epoetin will be evaluated in this review. If a placebo was not used, or if there was no mention that a placebo was used, or if it was stated that the study was unblinded, the study will be classified as unblinded. Accordingly, a systematic update addressing uncertainties in the body of evidence is timely. DOWNLOAD ARTICLE HERE: 13.Mathew George, Lincy Joseph, Christy K Jose, and Pournami A S. 901 total views, 3 views today. Since the screening time and evaluation periods of the various patient subgroups were different, the time points for immunogenicity varied accordingly. In the third group Mircera® (F.Hoffmann-La Roche Ltd., Basel, Switzerland) is provided as pre-filled syringes. In the study analyses was one of the following techniques used to examine causal effects: 1) appropriate propensity score approaches, 2) instrumental variable methods, 3) inverse probability weighting, or 4) G-estimation techniques to take into account potential bias. studies with a homogeneous patient population undergoing a predefined anticancer therapy, with predefined criteria when and how tumor response will be assessed and a clear definition of tumor response. Engert A. Recombinant human erythropoietin as an alternative to blood transfusion in cancer-related anaemia. Patients in that arm received Intravenous MIRCERA monthly. After adjusting for covariates, the difference was − 0.2878 g/dL (95% CI -0.936 to0.360). Doses of Darbepoetin alfa were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. Patients. Level I trauma center intensive care units. Patients were randomly assigned 1:1 to DA 200 microg every two weeks (Q2W) or EA 40,000 units every week (QW) for up to 16 weeks with identical dose adjustment rules. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. Grade 0, within normal limits, hemoglobin values are 12.0 to 16.0 g/dL for women and 14.0 t… Applicability of findings in this review will be assessed within the EPICOT framework (Evidence, Population, Intervention, Comparison, Outcome, Time stamp)45. and you may need to create a new Wiley Online Library account. The study was conducted in accordance with the ethical guidelines outlined in the Declaration of Helsinki, 1964 as revised in 2013. Although determining how alternative thresholds (KQ2) for initiating treatment compare regarding their effect on the benefits and harms of erythropoietic stimulants is important, it is not clear how well this can be addressed using the available literature and the confounding information from other factors including gradually increasing ESA use at higher initiation thresholds over time, coincident with increasing vigilance for survival and other adverse events over time, and changing indications for ESA use. Concept and design of trial: SS1, KB and BB, PT; data collection: KM, VP, RP, SS2, SD, SC; statistical analysis: SC; Overall project management, drafting of manuscript, revising manuscript as per editor’s comments, statistical analysis and data interpretation and conclusion analysis, corresponding author: PT. Secondary efficacy endpoints were Hb variability during correction phase, mean change in Hb levels from baseline to week-4 and week-36 (EOM), proportion of patients achieving the Hb target (defined as Hb increase ≥ 1 g/dL from baseline) at EOC, mean DA-α dose, proportion of patients who could maintain the target Hb of 10–12 g/dL at EOM, and time to initial achievement of Hb target. Higgins JPT, Green S, eds. Dynepo had been approved in Europe for the treatment of symptomatic anemia associated with chronic renal failure in adult patients and has been studied almost entirely in this population. Randomized comparison of every-2-week darbepoetin alfa and weekly epoetin alfa for the treatment of chemotherapy-induced anemia: the 20030125 Study Group Trial. All authors read and approved the final manuscript. eCollection 2015. Comparative pharmacokinetics and pharmacodynamics of epoetin alfa and epoetin beta. Wood PA, Hrushesky WJ. Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Retrospective Studies[MH] AND ("Erythropoietin, Recombinant"[Mesh] OR "Erythropoietin"[Mesh] OR "continuous erythropoietin receptor activator "[Substance Name] OR ("Epoetin Alfa"[Mesh] OR "epoetin beta "[Substance Name] OR "darbepoetin alfa "[Substance Name] OR erythropoietin OR epoetin* OR eprex OR neorecormon OR aranesp OR procrit OR darbepoetin OR CERA OR "C.E.R.A. Viechtbauer V. 2010. metafor: Meta-Analysis Package for R. R package version 1.1-0. To compare the effectiveness of darbepoetin alfa with epoetin alfa (recombinant human erythropoietin [rHuEPO]) for achieving transfusion independence and increasing hemoglobin concentrations in critically ill patients. Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense EPOGEN® (Epoetin alfa) to patients with cancer.
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