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[PMID]:29172979
[Au] Autor:Sagi S; Cohen HP; Woollett GR
[Ad] Endereço:1 Sandoz Biopharmaceuticals, Singapore.
[Ti] Título:Pharmacovigilance of Biologics in a Multisource Environment.
[So] Source:J Manag Care Spec Pharm;23(12):1249-1254, 2017 Dec.
[Is] ISSN:2376-1032
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:It is important that systems are in place to ensure that appropriate and comprehensive records are kept for use of all medications. It is fundamental to an effective pharmacovigilance system that patient medical records contain sufficient information to identify which medication has been prescribed, when it was administered, and at what dose. The availability of biologics from multiple sponsors has raised questions by some health care providers about the ability of current pharmacovigilance systems to trace specific biologics. In this article, periodic safety update reports were used to assess current postapproval safety monitoring for 3 biosimilars (epoetin alfa, somatropin, and filgrastim) that collectively represented nearly 350 million patient days of treatment worldwide. The reference products have each been marketed for over 10 years, forming a strong baseline of postmarketing safety data against which the safety of biosimilars can be compared. Published data from Denmark were also reviewed as additional evidence of how current pharmacovigilance systems are able to attribute adverse events to particular medicines. Collectively, the data show that spontaneous adverse drug reactions are reported by brand name in the majority of cases and are attributable to a specific medicine. Also discussed are the informational elements critical to monitoring biologics, or indeed any medicine, to ensure the availability of complete information so medicines that a patient has received can be quickly identified should a safety event occur. We support the addition of a single data element, the batch/lot number, to enhance the value of current pharmacovigilance systems. Adoption of 2-D barcodes in the European Union (EU) and standardized numerical identifiers in the United States addresses this need, since they include batch/lot numbers. These identifiers are already being implemented in the United States and the EU to improve patient safety, reduce medication errors, facilitate anticounterfeiting, and enable effective product recalls and adverse event reporting. Importantly, electronic identifiers will ameliorate safety reporting concerns with respect to biosimilars, while concurrently achieving these much broader public health objectives through more complete pharmacovigilance data. DISCLOSURES: This work was funded by Sandoz, a Novartis division. The authors were fully responsible for the content, editorial decisions, and opinions expressed in this article. No author received an honorarium related to the development of this manuscript. Sagi and Cohen are employees of Sandoz, and Woollett is an employee of Avalere Health. Study concept and design were contributed by Sagi and Woollett, along with Cohen. Data were primarily collected by Sagi, along with Woollett, and data interpretation was provided by all the authors. The manuscript was written by Woollett, along with Sagi and Cohen, and revised by Sagi and Cohen, along with Woollett.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/efeitos adversos
Epoetina alfa/efeitos adversos
Filgrastim/efeitos adversos
Hormônio do Crescimento Humano/efeitos adversos
Farmacovigilância
[Mh] Termos MeSH secundário: Sistemas de Notificação de Reações Adversas a Medicamentos
Processamento Automatizado de Dados/métodos
Produtos Biológicos/administração & dosagem
Produtos Biológicos/efeitos adversos
Medicamentos Biossimilares/administração & dosagem
Medicamentos Falsificados
Epoetina alfa/administração & dosagem
União Europeia
Filgrastim/administração & dosagem
Hormônio do Crescimento Humano/administração & dosagem
Seres Humanos
Erros de Medicação/prevenção & controle
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biological Products); 0 (Biosimilar Pharmaceuticals); 0 (Counterfeit Drugs); 12629-01-5 (Human Growth Hormone); 64FS3BFH5W (Epoetin Alfa); PVI5M0M1GW (Filgrastim)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180201
[Lr] Data última revisão:
180201
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171128
[St] Status:MEDLINE
[do] DOI:10.18553/jmcp.2017.23.12.1249


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[PMID]:28782299
[Au] Autor:Saglimbene VM; Palmer SC; Ruospo M; Natale P; Craig JC; Strippoli GF
[Ad] Endereço:Medical Scientific Office, Diaverum, Lund, Sweden.
[Ti] Título:Continuous erythropoiesis receptor activator (CERA) for the anaemia of chronic kidney disease.
[So] Source:Cochrane Database Syst Rev;8:CD009904, 2017 08 07.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Continuous erythropoiesis receptor activator (CERA) is a newer, longer acting ESA which might be preferred to other ESAs (epoetin or darbepoetin) based on its lower frequency of administration. Different dosing requirements and molecular characteristics of CERA compared with other ESAs may lead to different health outcomes (mortality, cardiovascular events, quality of life) in people with anaemia and chronic kidney disease (CKD). OBJECTIVES: To assess benefits and harms of CERA compared with other epoetins (darbepoetin alfa and epoetin alfa or beta) or placebo/no treatment or CERA with differing strategy of administration for anaemia in individuals with CKD. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 13 June 2017 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: We included randomised controlled trials (RCTs) of at least three months' duration, comparing CERA with a different ESA (darbepoetin alfa or epoetin alfa or beta) or placebo or standard care or versus CERA with different strategies for administration in people with any stage of CKD. DATA COLLECTION AND ANALYSIS: Data were extracted by two independent investigators. We summarised patient-centred outcomes (all-cause and cardiovascular mortality, major adverse cardiovascular events, red cell blood transfusion, iron therapy, cancer, hypertension, seizures, dialysis vascular access thrombosis, drug injection-related events, hyperkalaemia and health-related quality of life and haemoglobin levels) using random effects meta-analysis. Treatment estimates were expressed as risk ratios (RR) and their 95% confidence intervals (CI) for dichotomous outcomes and mean differences or standardized mean difference with 95% CI for continuous outcomes. MAIN RESULTS: We included 27 studies involving 5410 adults with CKD. Seven studies (1273 participants) involved people not requiring dialysis, 19 studies (4209 participants) involved people treated with dialysis and one study (71 participants) evaluated treatment in recipients of a kidney transplant. Treatment was given for 24 weeks on average. No data were available for children with CKD. Studies were generally at high or unclear risk of bias from allocation concealment and blinding of outcomes. Only two studies masked participants and investigators to treatment allocation. One study compared CERA with placebo, nine studies CERA with epoetin alfa or beta, nine studies CERA with darbepoetin alfa, and two studies compared CERA with epoetin alfa or beta and darbepoetin alfa. Three studies assessed the effects of differing frequencies of CERA administration and five assessed differing CERA doses.There was low certainty evidence that CERA had little or no effects on mortality (RR 1.07, 95% CI 0.73 to 1.57; RR 1.11, 95% CI 0.75 to 1.65), major adverse cardiovascular events (RR 5.09, 95% CI 0.25 to 105.23; RR 5.56, 95% CI 0.99 to 31.30), hypertension (RR 1.01, 95% CI 0.75 to 1.37; RR 1.00, 95% CI 0.79 to 1.28), need for blood transfusion (RR 1.02, 95% CI 0.72 to 1.46; RR 0.94, 95% CI 0.55 to 1.61), or additional iron therapy (RR 1.03, 95% CI 0.91 to 1.15; RR 0.99, 95% CI 0.95 to 1.03) compared to epoetin alfa/beta or darbepoetin alfa respectively. There was insufficient evidence to compare the effect of CERA to placebo on clinical outcomes. Only one low quality study reported that CERA compared to placebo might lead to little or no difference in the risk of major cardiovascular events (RR 2.97, 95% CI 0.31 to 28.18) and hypertension ((RR 0.73, 95% CI 0.35 to 1.52). There was low certainty evidence that different doses (higher versus lower) or frequency (twice versus once monthly) of CERA administration had little or no different effect on all-cause mortality (RR 3.95, 95% CI 0.17 to 91.61; RR 0.97, 95% CI 0.56 to 1.66), hypertension (RR 0.45, 95% CI 0.08 to 2.52; RR 0.85, 95% CI 0.60 to 1.21), and blood cell transfusions (RR 4.16, 95% CI 0.89 to 19.53; RR 0.91, 95% CI 0.51 to 1.62). No studies reported comparative treatment effects of different ESAs on health-related quality of life. AUTHORS' CONCLUSIONS: There is low certainty evidence that CERA has little or no effects on patient-centred outcomes compared with placebo, epoetin alfa or beta or darbepoetin alfa for adults with CKD. The effects of CERA among children who have CKD have not studied in RCTs.
[Mh] Termos MeSH primário: Anemia/tratamento farmacológico
Eritropoetina/uso terapêutico
Polietilenoglicóis/uso terapêutico
Insuficiência Renal Crônica/complicações
[Mh] Termos MeSH secundário: Adulto
Idoso
Anemia/sangue
Anemia/etiologia
Doenças Cardiovasculares/etiologia
Causas de Morte
Darbepoetina alfa/efeitos adversos
Darbepoetina alfa/uso terapêutico
Epoetina alfa/efeitos adversos
Epoetina alfa/uso terapêutico
Transfusão de Eritrócitos/efeitos adversos
Transfusão de Eritrócitos/estatística & dados numéricos
Eritropoetina/efeitos adversos
Seres Humanos
Hipertensão/etiologia
Meia-Idade
Polietilenoglicóis/efeitos adversos
Viés de Publicação
Ensaios Clínicos Controlados Aleatórios como Assunto
Proteínas Recombinantes/efeitos adversos
Proteínas Recombinantes/uso terapêutico
Diálise Renal
Insuficiência Renal Crônica/terapia
Trombose/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Recombinant Proteins); 0 (continuous erythropoietin receptor activator); 0 (epoetin beta); 11096-26-7 (Erythropoietin); 15UQ94PT4P (Darbepoetin alfa); 30IQX730WE (Polyethylene Glycols); 64FS3BFH5W (Epoetin Alfa)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170919
[Lr] Data última revisão:
170919
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170808
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD009904.pub2


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[PMID]:28778295
[Au] Autor:O'Malley P
[Ad] Endereço:Department of Nursing Research, Premier Health, Center of Nursing Excellence, 1 Wyoming Street, Dayton, OH 45409, USA; School of Nursing, Indiana University East, 2325 Chester Boulevard, Richmond, IN 47374, USA. Electronic address: pomalley@premierhealth.com.
[Ti] Título:Hidden Anemias in the Critically Ill.
[So] Source:Crit Care Nurs Clin North Am;29(3):363-368, 2017 Sep.
[Is] ISSN:1558-3481
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:With increasing knowledge of the risks associated with receiving blood transfusions, a new paradigm of bloodless medicine is needed. Principles of bloodless medicine include careful monitoring for obvious and hidden anemias, rapid intervention, minimizing blood losses from laboratory testing and procedures, and careful management of bleeding diatheses. As evidence is revealed and refined, standard treatment of anemia in the intensive care unit will include erythropoietin-stimulating agents, iron, folate, and vitamin B12, which will reduce risks associated with blood transfusions.
[Mh] Termos MeSH primário: Anemia/terapia
Transfusão de Sangue/métodos
Procedimentos Médicos e Cirúrgicos de Sangue/métodos
Estado Terminal
[Mh] Termos MeSH secundário: Anemia/tratamento farmacológico
Anemia/etiologia
Enfermagem de Cuidados Críticos
Epoetina alfa/uso terapêutico
Insuficiência Cardíaca/terapia
Hematínicos/uso terapêutico
Seres Humanos
Unidades de Terapia Intensiva
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Hematinics); 64FS3BFH5W (Epoetin Alfa)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171010
[Lr] Data última revisão:
171010
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:170806
[St] Status:MEDLINE


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[PMID]:28650704
[Au] Autor:Inotai A; Prins CPJ; Csanádi M; Vitezic D; Codreanu C; Kaló Z
[Ad] Endereço:a Syreon Research Institute , Budapest , Hungary.
[Ti] Título:Is there a reason for concern or is it just hype? - A systematic literature review of the clinical consequences of switching from originator biologics to biosimilars.
[So] Source:Expert Opin Biol Ther;17(8):915-926, 2017 Aug.
[Is] ISSN:1744-7682
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: While prescribing biosimilars to patients naive to a biologic treatment is a well-accepted practice, switching clinically stable patients from an originator to a biosimilar is an issue for clinicians. Well-designed clinical trials and real-world data which study the consequences of switching from an originator biologic treatment to its biosimilar alternative are limited, especially for monoclonal antibodies. Areas covered: A systematic literature review was conducted on PubMed to identify evidence of the consequences of switching from original biologics to biosimilars. References of included papers were also scrutinized. After a title-, abstract- and full text screening, out of the 153 original hits and 77 additional ones from screening the references, 58 papers (12 empirical papers, 5 systematic reviews and 41 non-empirical papers) were included. Expert opinion: Preventing patients on biologic medicines from switching to biosimilars due to anticipated risks seems to be disproportional compared to the expected cost savings and/or improved patient access. Indeed, it is the opinion of the authors that the concern of switching to biosimilars is overhyped.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/uso terapêutico
[Mh] Termos MeSH secundário: Anemia/tratamento farmacológico
Anemia/etiologia
Medicamentos Biossimilares/efeitos adversos
Bases de Dados Factuais
Epoetina alfa/efeitos adversos
Epoetina alfa/uso terapêutico
Custos de Cuidados de Saúde
Seres Humanos
Doenças Inflamatórias Intestinais/tratamento farmacológico
Falência Renal Crônica/complicações
Neoplasias/tratamento farmacológico
Aplasia Pura de Série Vermelha/etiologia
Doenças Reumáticas/tratamento farmacológico
Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Biosimilar Pharmaceuticals); 64FS3BFH5W (Epoetin Alfa)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171113
[Lr] Data última revisão:
171113
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170627
[St] Status:MEDLINE
[do] DOI:10.1080/14712598.2017.1341486


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[PMID]:28255868
[Au] Autor:Castelli R; Sciara S; Lambertenghi Deliliers G; Pantaleo G
[Ad] Endereço:Department of Biomedical and Clinical Sciences Luigi Sacco, Luigi Sacco Hospital Milan, University of Milan, Milan, Italy. roberto.castelli@unimi.it.
[Ti] Título:Biosimilar epoetin alfa increases haemoglobin levels and brings cognitive and socio-relational benefits to elderly transfusion-dependent multiple myeloma patients: results from a pilot study.
[So] Source:Ann Hematol;96(5):779-786, 2017 May.
[Is] ISSN:1432-0584
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Anaemia is a complication reported in up to 70% of the multiple myeloma patients (MM), with remarkable clinical, cognitive and socio-relational consequences. Anaemia relates to the course of MM, normalizing in patients during remission and reappearing in relapsing/non-responding patients. In a pilot study with 31 patients with MM and transfusion-dependent anaemia, we evaluated the effects of Binocrit (biosimilar epoetin alfa) on transfusions, haemoglobin levels, mental status (mini-mental state evaluation) and the patients' social-relational functioning and quality of life (QoL). Within a 12-week interval, patients received 40.000 U Binocrit once a week. Binocrit significantly decreased the incidence of transfusion, regardless of the patients' transfusion history, and significantly increased haemoglobin levels (before-and-after-treatment median haemoglobin values = 8.20 vs. 9.40 g/dl, respectively; Wilcoxon Z test, p < .001). A comparatively greater increment in haemoglobin levels among patients who responded to first vs. additional lines of chemotherapy was also observed. Importantly, we additionally found moderate-to-strong positive associations between increments in haemoglobin levels and corresponding increments both in psychological well-being and QoL (FACT-An scores) and the patients' cognitive status (mini-mental state evaluation scores). After statistically controlling for possible concurrent benefits of anti-myeloma therapy, increments in haemoglobin levels clearly predicted both increments in socio-relational FACT-An scores (Spearman's rho = 0.60, p < .001) and in cognitive functioning scores (Spearman's rho = 0.49, p < .006). Binocrit thus appears as an effective, well-tolerated agent for the management of myeloma anaemia, whose documented benefits include amelioration of anaemia, reduction in transfusion, and improvements in the patients' social-relational functioning and cognitive well-being.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/uso terapêutico
Epoetina alfa/uso terapêutico
Hemoglobinas
Mieloma Múltiplo/sangue
Mieloma Múltiplo/terapia
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Anemia/sangue
Anemia/etiologia
Anemia/terapia
Transfusão de Sangue
Cognição
Feminino
Seres Humanos
Masculino
Mieloma Múltiplo/complicações
Mieloma Múltiplo/diagnóstico
Projetos Piloto
Qualidade de Vida
Resultado do Tratamento
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Biosimilar Pharmaceuticals); 0 (Hemoglobins); 64FS3BFH5W (Epoetin Alfa)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170418
[Lr] Data última revisão:
170418
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170304
[St] Status:MEDLINE
[do] DOI:10.1007/s00277-017-2950-9


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[PMID]:28120313
[Au] Autor:Kurki P; van Aerts L; Wolff-Holz E; Giezen T; Skibeli V; Weise M
[Ad] Endereço:Finnish Medicines Agency, FIMEA, Mannerheimintie 103b, P.O. Box 55, 00034, Helsinki, Finland. pekka.kurki@fimea.fi.
[Ti] Título:Interchangeability of Biosimilars: A European Perspective.
[So] Source:BioDrugs;31(2):83-91, 2017 Apr.
[Is] ISSN:1179-190X
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:Many of the best-selling 'blockbuster' biological medicinal products are, or will soon be, facing competition from similar biological medicinal products (biosimilars) in the EU. Biosimilarity is based on the comparability concept, which has been used successfully for several decades to ensure close similarity of a biological product before and after a manufacturing change. Over the last 10 years, experience with biosimilars has shown that even complex biotechnology-derived proteins can be copied successfully. Most best-selling biologicals are used for chronic treatment. This has triggered intensive discussion on the interchangeability of a biosimilar with its reference product, with the main concern being immunogenicity. We explore the theoretical basis of the presumed risks of switching between a biosimilar and its reference product and the available data on switches. Our conclusion is that a switch between comparable versions of the same active substance approved in accordance with EU legislation is not expected to trigger or enhance immunogenicity. On the basis of current knowledge, it is unlikely and very difficult to substantiate that two products, comparable on a population level, would have different safety or efficacy in individual patients upon a switch. Our conclusion is that biosimilars licensed in the EU are interchangeable.
[Mh] Termos MeSH primário: Medicamentos Biossimilares/efeitos adversos
[Mh] Termos MeSH secundário: Adalimumab/efeitos adversos
Adalimumab/uso terapêutico
Anticorpos Monoclonais/efeitos adversos
Medicamentos Biossimilares/farmacocinética
Indústria Farmacêutica/métodos
Epoetina alfa/efeitos adversos
Etanercepte/efeitos adversos
Etanercepte/uso terapêutico
União Europeia
Filgrastim/efeitos adversos
Hormônio do Crescimento Humano/efeitos adversos
Seres Humanos
Sistema Imunitário/efeitos dos fármacos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Biosimilar Pharmaceuticals); 0 (CT-P13); 12629-01-5 (Human Growth Hormone); 64FS3BFH5W (Epoetin Alfa); FYS6T7F842 (Adalimumab); OP401G7OJC (Etanercept); PVI5M0M1GW (Filgrastim)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170515
[Lr] Data última revisão:
170515
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170126
[St] Status:MEDLINE
[do] DOI:10.1007/s40259-017-0210-0


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[PMID]:28066881
[Au] Autor:Hahn D; Esezobor CI; Elserafy N; Webster AC; Hodson EM
[Ad] Endereço:Department of Nephrology, The Children's Hospital at Westmead, Locked Bag 4001, Westmead, NSW, Australia, 2145.
[Ti] Título:Short-acting erythropoiesis-stimulating agents for anaemia in predialysis patients.
[So] Source:Cochrane Database Syst Rev;1:CD011690, 2017 01 09.
[Is] ISSN:1469-493X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The benefits of erythropoiesis-stimulating agents (ESA) for chronic kidney disease (CKD) patients have been previously demonstrated. However, the efficacy and safety of short-acting epoetins administered at larger doses and reduced frequency as well as of new epoetins and biosimilars remains uncertain. OBJECTIVES: This review aimed to evaluate the benefits and harms of different routes, frequencies and doses of epoetins (epoetin alpha, epoetin beta and other short-acting epoetins) for anaemia in adults and children with CKD not receiving dialysis. SEARCH METHODS: We searched the Cochrane Kidney and Transplant Specialised Register to 12 September 2016 through contact with the Information Specialist using search terms relevant to this review. Studies contained in the Specialised Register are identified through search strategies specifically designed for CENTRAL, MEDLINE, and EMBASE; handsearching conference proceedings; and searching the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov. SELECTION CRITERIA: We included randomised control trials (RCTs) comparing different frequencies, routes, doses and types of short-acting ESAs in CKD patients. DATA COLLECTION AND ANALYSIS: Two authors independently assessed study eligibility and four authors assessed risk of bias and extracted data. Results were expressed as risk ratio (RR) or risk differences (RD) with 95% confidence intervals (CI) for dichotomous outcomes. For continuous outcomes the mean difference (MD) with 95% confidence intervals (CI) was used. Statistical analyses were performed using the random-effects model. MAIN RESULTS: We identified 14 RCTs (2616 participants); nine studies were multi-centre and two studies involved children. The risk of bias was high in most studies; only three studies demonstrated adequate random sequence generation and only two studies were at low risk of bias for allocation concealment. Blinding of participants and personnel was at low risk of bias in one study. Blinding of outcome assessment was judged at low risk in 13 studies as the outcome measures were reported as laboratory results and therefore unlikely to be influenced by blinding. Attrition bias was at low risk of bias in eight studies while selective reporting was at low risk in six included studies.Four interventions were compared: epoetin alpha or beta at different frequencies using the same total dose (six studies); epoetin alpha at the same frequency and different total doses (two studies); epoetin alpha administered intravenously versus subcutaneous administration (one study); epoetin alpha or beta versus other epoetins or biosimilars (five studies). One study compared both different frequencies of epoetin alpha at the same total dose and at the same frequency using different total doses.Data from only 7/14 studies could be included in our meta-analyses. There were no significant differences in final haemoglobin (Hb) levels when dosing every two weeks was compared with weekly dosing (4 studies, 785 participants: MD -0.20 g/dL, 95% CI -0.33 to -0.07), when four weekly dosing was compared with two weekly dosing (three studies, 671 participants: MD -0.16 g/dL, 95% CI -0.43 to 0.10) or when different total doses were administered at the same frequency (four weekly administration: one study, 144 participants: MD 0.17 g/dL 95% CI -0.19 to 0.53).Five studies evaluated different interventions. One study compared epoetin theta with epoetin alpha and found no significant differences in Hb levels (288 participants: MD -0.02 g/dL, 95% CI -0.25 to 0.21). One study found significantly higher pain scores with subcutaneous epoetin alpha compared with epoetin beta. Two studies (165 participants) compared epoetin delta with epoetin alpha, with no results available since the pharmaceutical company withdrew epoetin delta for commercial reasons. The fifth study comparing the biosimilar HX575 with epoetin alpha was stopped after patients receiving HX575 subcutaneously developed anti-epoetin antibodies and no results were available.Adverse events were poorly reported in all studies and did not differ significantly within comparisons. Mortality was only detailed adequately in four studies and only one study included quality of life data. AUTHORS' CONCLUSIONS: Epoetin alpha given at higher doses for extended intervals (two or four weekly) is non-inferior to more frequent dosing intervals in maintaining final Hb levels with no significant differences in adverse effects in non-dialysed CKD patients. However the data are of low methodological quality so that differences in efficacy and safety cannot be excluded. Further large, well designed, RCTs with patient-centred outcomes are required to assess the safety and efficacy of large doses of the shorter acting ESAs, including biosimilars of epoetin alpha, administered less frequently compared with more frequent administration of smaller doses in children and adults with CKD not on dialysis.
[Mh] Termos MeSH primário: Anemia/tratamento farmacológico
Epoetina alfa/administração & dosagem
Eritropoetina/administração & dosagem
Hematínicos/administração & dosagem
Diálise Renal
Insuficiência Renal Crônica/sangue
[Mh] Termos MeSH secundário: Adulto
Anemia/sangue
Criança
Hemoglobina A
Seres Humanos
Injeções Intravenosas
Ensaios Clínicos Controlados Aleatórios como Assunto
Proteínas Recombinantes/administração & dosagem
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Hematinics); 0 (Recombinant Proteins); 0 (epoetin beta); 11096-26-7 (Erythropoietin); 64FS3BFH5W (Epoetin Alfa); 9034-51-9 (Hemoglobin A)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170426
[Lr] Data última revisão:
170426
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170110
[St] Status:MEDLINE
[do] DOI:10.1002/14651858.CD011690.pub2


  8 / 1421 MEDLINE  
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Texto completo
[PMID]:27579991
[Au] Autor:Mateus V; Rocha J; Alves P; Mota-Filipe H; Sepodes B; Pinto RM
[Ad] Endereço:Lisbon School of Health Technology (ESTeSL), Polytechnic Institute of Lisbon, Lisbon, Portugal.
[Ti] Título:Anti-Inflammatory Effect of Erythropoietin in the TNBS-induced Colitis.
[So] Source:Basic Clin Pharmacol Toxicol;120(2):138-145, 2017 Feb.
[Is] ISSN:1742-7843
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Erythropoietin is a potent stimulator of erythroid progenitor cells, which is able to inhibit NF-kB activation, due to its pleiotropic properties, thus promoting an anti-inflammatory effect. As inflammatory bowel disease is a chronic disease with reduced quality of life, and the current pharmacotherapy only induces or maintains the patient in remission, there is a crucial need of new pharmacological approaches. The main objective of this study was to evaluate the effect of erythropoietin in the TNBS-induced colitis model in mice with a normal intestinal flora. Mice with TNBS-induced colitis were treated with a daily dose of erythropoietin at 500 IU/kg bw/day and 1000 IU/Kg bw/day IP during 4 days. As to clinical symptoms/signs, erythropoietin attenuated the decreased body-weight and reduced diarrhoea and oedema of the anus registered in the non-treated mice group in a dose-dependent manner. The anti-inflammatory properties of erythropoietin in the TNBS-induced colitis were confirmed by suppression of pro-inflammatory mediators, such as TNF-α, IL-1ß and MPO, as well as a significant increase in the anti-inflammatory cytokine, IL-10, was promoted. These treated mice also presented a reduction in haemoglobin faecal and ALP, suggesting a beneficial effect of erythropoietin in the haemorrhagic focus and destruction of the enterocyte associated with the colon injury induced by TNBS, respectively. The histopathological score was reduced after treatment with erythropoietin, decreasing the severity and extension of the colitis. Furthermore, renal and hepatic biomarkers, as well as haematocrit concentration, remained stabilized after treatment. In conclusion, erythropoietin reduces the inflammatory response associated with TNBS-induced colitis in mice.
[Mh] Termos MeSH primário: Anti-Inflamatórios/farmacologia
Colite/prevenção & controle
Colo/efeitos dos fármacos
Epoetina alfa/farmacologia
Ácido Trinitrobenzenossulfônico
[Mh] Termos MeSH secundário: Animais
Biomarcadores/metabolismo
Colite/induzido quimicamente
Colite/metabolismo
Colite/patologia
Colo/metabolismo
Colo/patologia
Citocinas/metabolismo
Modelos Animais de Doenças
Relação Dose-Resposta a Droga
Mediadores da Inflamação/metabolismo
Masculino
Camundongos
Peroxidase/metabolismo
Índice de Gravidade de Doença
Fatores de Tempo
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents); 0 (Biomarkers); 0 (Cytokines); 0 (Inflammation Mediators); 64FS3BFH5W (Epoetin Alfa); 8T3HQG2ZC4 (Trinitrobenzenesulfonic Acid); EC 1.11.1.7 (Peroxidase)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170227
[Lr] Data última revisão:
170227
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160901
[St] Status:MEDLINE
[do] DOI:10.1111/bcpt.12663


  9 / 1421 MEDLINE  
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[PMID]:27888589
[Au] Autor:Banaei S; Ahmadiasl N; Alihemmati A
[Ad] Endereço:Department of Physiology, School of Medicine, Ardabil University of Medical Sciences, Ardabil, Iran.
[Ti] Título:Combination Anti-Apoptotic Effect of Erythropoietin and Melatonin on Ischemia Reperfusion-Induced Renal Injury in Rats.
[So] Source:Acta Med Iran;54(10):624-630, 2016 Oct.
[Is] ISSN:1735-9694
[Cp] País de publicação:Iran
[La] Idioma:eng
[Ab] Resumo:Renal ischemia-reperfusion (IR) contributes to the development of acute renal failure (ARF). Oxygen free radicals are considered to be principal components involved in the pathophysiological tissue alterations observed during renal IR. The purpose of this study was to investigate the combination effect of melatonin (MEL) and erythropoietin (EPO), which are a potent antioxidant and anti-apoptotic agents, in IR-induced renal injury in rats. Wistar Albino rats were unilaterally nephrectomized and subjected to 45 min of renal pedicle occlusion followed by 24 h reperfusion. MEL (10 mg/kg, i.p) and EPO (5000 U/kg, i.p) were administered prior to ischemia. After 24 h reperfusion, following decapitation, blood samples were collected for the determination of superoxide dismutase (SOD), glutathione peroxidase (GPx), and malondialdehyde (MDA) levels. Also, renal samples were taken for histological evaluation and apoptosis assay. Ischemia-reperfusion increased SOD, GPx, MDA levels, and TUNEL positive cells. Histopathological findings of the IR group confirmed that there was renal impairment in the tubular epithelium. Treatment with EPO and MEL decreased SOD, GPx, and MDA levels, histopathological changes, and TUNEL positive cells. These results indicated that the combination of MEL and EPO could not exert more nephroprotective and anti-apoptotic effects than MEL treatment in renal ischemia-reperfusion injury.
[Mh] Termos MeSH primário: Lesão Renal Aguda/induzido quimicamente
Antioxidantes/farmacologia
Apoptose/efeitos dos fármacos
Eritropoetina/farmacologia
Melatonina/farmacologia
Traumatismo por Reperfusão/induzido quimicamente
[Mh] Termos MeSH secundário: Animais
Epoetina alfa
Glutationa Peroxidase
Masculino
Malondialdeído
Ratos
Ratos Wistar
Superóxido Dismutase
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antioxidants); 0 (EPO protein, human); 11096-26-7 (Erythropoietin); 4Y8F71G49Q (Malondialdehyde); 64FS3BFH5W (Epoetin Alfa); EC 1.11.1.9 (Glutathione Peroxidase); EC 1.15.1.1 (Superoxide Dismutase); JL5DK93RCL (Melatonin)
[Em] Mês de entrada:1702
[Cu] Atualização por classe:170215
[Lr] Data última revisão:
170215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161127
[St] Status:MEDLINE


  10 / 1421 MEDLINE  
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Registro de Ensaios Clínicos
[PMID]:27706045
[Au] Autor:Sühs KW; Papanagiotou P; Hein K; Pul R; Scholz K; Heesen C; Diem R
[Ad] Endereço:Department of Neurology, Medical School Hannover, Carl-Neuberg Str. 1, 30625 Hannover, Germany. Suehs.Kurt-Wolfram@mh-hannover.de.
[Ti] Título:Disease Activity and Conversion into Multiple Sclerosis after Optic Neuritis Is Treated with Erythropoietin.
[So] Source:Int J Mol Sci;17(10), 2016 Sep 30.
[Is] ISSN:1422-0067
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:Changes in cerebral lesion load by magnetic resonance imaging (MRI) in patients from a double-blind, placebo-controlled, phase II study on erythropoietin in clinically isolated optic neuritis (ClinicalTrials.gov, NCT00355095) were analyzed. Therefore, patients with acute optic neuritis were assigned to receive either 33,000 IU of recombinant human erythropoietin (IV) daily for three days, or a placebo, as an add-on to methylprednisolone. Of 35 patients, we investigated changes in cerebral lesion load in MRIs obtained at baseline and at weeks 4, 8, and 16. In 5 of the 35 patients, we found conversion into multiple sclerosis (MS) based on MRI progression only. These five patients had received the placebo. Another five patients showed MRI progression together with relapses. Three of these patients had received erythropoietin, and two the placebo. Yet, analyzing the change in absolute numbers of periventricular, juxtacortical, and infratentorial lesions including gadolinium-enhancing lesions, there were no significant differences between the groups. Although effective in terms of retinal nerve fiber layer protection, erythropoietin treatment of acute isolated optic neuritis did not influence further evolution of MRI lesions in the brain when comparing absolute numbers. However, early conversion from clinically isolated syndrome to MS assessed by MRI activity seemed to occur more frequently in the placebo-treated group.
[Mh] Termos MeSH primário: Epoetina alfa/uso terapêutico
Hematínicos/uso terapêutico
Esclerose Múltipla/diagnóstico
Neurite Óptica/tratamento farmacológico
[Mh] Termos MeSH secundário: Adolescente
Adulto
Progressão da Doença
Método Duplo-Cego
Feminino
Seres Humanos
Imagem por Ressonância Magnética
Masculino
Metilprednisolona/uso terapêutico
Meia-Idade
Esclerose Múltipla/etiologia
Fármacos Neuroprotetores/uso terapêutico
Neurite Óptica/complicações
Efeito Placebo
Acuidade Visual
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Hematinics); 0 (Neuroprotective Agents); 64FS3BFH5W (Epoetin Alfa); X4W7ZR7023 (Methylprednisolone)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170410
[Lr] Data última revisão:
170410
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161006
[Cl] Clinical Trial:ClinicalTrial
[St] Status:MEDLINE



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