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1.
Medicine (Baltimore) ; 99(2): e18749, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31914095

RESUMO

A multicenter cohort study.The DialysisNet was previously developed for the management of hemodialysis (HD) patients based on the American Society for Testing and Materials Continuity of Care Records by metadata transformation. DialysisNet is a dialysis patient management program created by using the personal health record care platform to overcome the problems of registry studies, in real-time.Here, we aimed to investigate the pattern of treatment for renal anemia in HD patients using DialysisNet.We performed a multicenter cohort study among HD patients who were treated at one of the three Korean university-affiliated hospitals from January 2016 to December 2016. Subjects were divided into 4 hemoglobin variability groups by quartiles. The variable anemia treatment pattern was reviewed. To determine renal anemia treatment patterns, we automatically collected information on the practice of anemia treatment patterns such as erythropoietin stimulating agent (ESA) doses and administration frequencies, and targeted hemoglobin maintenance rate. Individual hemoglobin variabilities were expressed as (standard deviations)/(√(n/[n-1]).The records of 159 patients were analyzed (Hospital A: 35, Hospital B: 21, Hospital C: 103). Mean patients' age was 65.6 ±â€Š12.8 years, and 61.6% were men. Overall, hemoglobin level was 10.5[7.43;13.93] g/dL. 158 (99.3%) patients were using ESA; and overall, the epoetin alfa dose was 33,000[4000;136,800] U per week. Hemoglobin levels (P = .206) and epoetin alfa doses were similar (P = .924) for patients with different hemoglobin variabilities. The hemoglobin target maintenance rate was lower in the highest hemoglobin variability group than in the lowest variability group (P = .045).In this study, detailed information on the actual anemia treatment patterns were obtained using the DialysisNet. We expect that DialysisNet will simplify and improve the renal anemia management for both dialysis patients and health care providers.


Assuntos
Anemia/etiologia , Anemia/terapia , Bases de Dados Factuais , Epoetina alfa/uso terapêutico , Hematínicos/uso terapêutico , Diálise Renal/efeitos adversos , Idoso , Relação Dose-Resposta a Droga , Registros Eletrônicos de Saúde , Epoetina alfa/administração & dosagem , Feminino , Hematínicos/administração & dosagem , Hemoglobinas , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
2.
J Med Econ ; 22(8): 736-741, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-30915883

RESUMO

Objectives: There is a lack of data in Panama on the potential differences in total healthcare professional (HCP) time between routine administrations of short-acting erythropoietin simulating agents (ESAs) (i.e. epoetin alfa) and continuous erythropoietin receptor activator (CERA) (i.e. methoxy polyethylene glycol-epoetin beta). This study aimed to quantify the HCP time associated with a single administration of epoetin alfa and CERA for the treatment of anemic patients with chronic kidney disease (CKD) on hemodialysis. Methods: This was a multi-center, cross-sectional study, using a time-and-motion methodology. Costs related to HCP time and consumables usage associated with administration of epoetin alfa and CERA were estimated. Results: Based on 60 administrations of either CERA or epoetin alfa, the estimated savings in mean total active HCP time were 2.34 (95% confidence interval = 1.87-2.81) min (-30%) per administration. When extrapolating to a full year's treatment with intravenous ESA, it would require a total of 20.3 (95% CI = 19.90-20.71) h of HCP time for epoetin alfa vs 1.1 (95% CI = 1.01-1.19) h for CERA per patient per year. Estimated savings in active HCP time per patient per year were 19.20 (95% CI = 19.20-19.21) h (-95%). This, in turn, translates into staff cost efficiency that favors Mircera with an estimated annual saving of $78.24 (95% CI = 78.24-78.28) (-95%) per patient. Conclusions: Data from a real-world setting showed that the adoption of CERA could potentially lead to a reduction in active HCP time. Highlights Few comparative data have explored the costs and potential savings of using long-acting erythropoietin-stimulating agents (ESA) instead of short-acting ESAs to treat anemia in CKD patients on hemodialysis. This time-and-motion study shows that use of CERA reduces total healthcare professional time and could represent a save for an institution in a real-world setting in Panama.


Assuntos
Epoetina alfa/economia , Eritropoetina/economia , Pessoal de Saúde/economia , Hematínicos/economia , Polietilenoglicóis/economia , Anemia/tratamento farmacológico , Anemia/etiologia , Estudos Transversais , Custos de Medicamentos , Epoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Feminino , Pessoal de Saúde/estatística & dados numéricos , Hematínicos/administração & dosagem , Humanos , Masculino , Panamá , Polietilenoglicóis/administração & dosagem , Diálise Renal/efeitos adversos , Insuficiência Renal Crônica/terapia , Fatores de Tempo
3.
Am J Nephrol ; 48(3): 214-224, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30196301

RESUMO

BACKGROUND: For patients with anemia undergoing hemodialysis, erythropoiesis-stimulating agents (ESAs) are typically dosed via precise algorithms. Using one such algorithm, we assessed the maintenance of hemoglobin levels in patients switched from epoetin alfa reference product (Epogen®) to epoetin alfa-epbx (RetacritTM; a biosimilar to US-licensed Epogen®/Procrit®). METHODS: This randomized, open-label, non-inferiority study was conducted at Fresenius Medical Care North America (FMCNA) hemodialysis centers. Patients with anemia and chronic kidney disease undergoing maintenance hemodialysis and receiving routine intravenous (IV) Epogen® were randomized 1: 1 to switch to IV RetacritTM or continue standard-of-care (Epogen®) for 24 weeks, using analogous versions of the FMCNA ESA-dosing algorithm. The primary endpoint was the proportion of time patients' hemoglobin was 9-11 g/dL during weeks 17-24. RESULTS: Of 432 randomized patients, 418 received treatment (RetacritTM, n = 212; standard-of-care, n = 206) and comprised the full analysis set. A similar proportion of patients discontinued from each arm. The proportion of time patients' hemoglobin was within the target range was 61.9% (95% CI 57.5-66.2) in the RetacritTM arm and 63.3% (95% CI 58.7-67.7) in the standard-of-care arm. The difference in proportions between treatment arms was -1.4% (95% CI -7.6 to 4.9), and the lower bound of the confidence interval was within the pre-specified non-inferiority margin of -12.5%. There was no statistically significant difference between arms in the mean change from baseline in the weekly mean ESA dose during weeks 17-24, and no clinically relevant differences in safety outcomes. CONCLUSIONS: Switching to RetacritTM was non-inferior to continuing -Epogen® in maintaining hemoglobin levels in patients receiving hemodialysis, when both ESAs were dosed using a specified algorithm (ClinicalTrials.gov, NCT02504294).


Assuntos
Anemia/tratamento farmacológico , Medicamentos Biossimilares/administração & dosagem , Epoetina alfa/administração & dosagem , Hematínicos/administração & dosagem , Falência Renal Crônica/complicações , Adulto , Idoso , Idoso de 80 Anos ou mais , Algoritmos , Anemia/sangue , Anemia/etiologia , Medicamentos Biossimilares/efeitos adversos , Relação Dose-Resposta a Droga , Cálculos da Dosagem de Medicamento , Substituição de Medicamentos , Epoetina alfa/efeitos adversos , Feminino , Hematínicos/efeitos adversos , Hemoglobinas/análise , Humanos , Injeções Intravenosas , Falência Renal Crônica/sangue , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Diálise Renal/efeitos adversos , Estudos Retrospectivos , Resultado do Tratamento , Adulto Jovem
4.
Am J Nephrol ; 48(4): 251-259, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30253403

RESUMO

BACKGROUND: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. METHODS: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10-12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. RESULTS: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10-12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. CONCLUSION: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639).


Assuntos
Anemia/tratamento farmacológico , Epoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Falência Renal Crônica/complicações , Adulto , Idoso , Anemia/sangue , Anemia/etiologia , Epoetina alfa/efeitos adversos , Eritropoetina/efeitos adversos , Feminino , Hematínicos/efeitos adversos , Hemoglobinas/análise , Humanos , Injeções Subcutâneas , Falência Renal Crônica/sangue , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/efeitos adversos , Diálise Renal , Resultado do Tratamento
5.
Anesthesiology ; 129(4): 710-720, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30074935

RESUMO

WHAT WE ALREADY KNOW ABOUT THIS TOPIC: WHAT THIS ARTICLE TELLS US THAT IS NEW: BACKGROUND:: Preoperative administration of epoetin-α with iron is commonly used in anemic patients undergoing major orthopedic surgery, but the optimal route of iron intake is controversial. The aim of this study was to compare the clinical effects of erythropoietin in combination with oral or intravenous iron supplementation. METHODS: This study was a prospective, randomized, single-blinded, parallel arm trial. Patients scheduled for elective hip or knee arthroplasty with hemoglobin 10 to 13 g/dl received preoperative injections of erythropoietin with oral ferrous sulfate or intravenous ferric carboxymaltose. The primary endpoint was the hemoglobin value the day before surgery. RESULTS: One hundred patients were included in the analysis. The day before surgery, hemoglobin, increase in hemoglobin, and serum ferritin level were higher in the intravenous group. For the intravenous and oral groups, respectively, hemoglobin was as follows: median, 14.9 g/dl (interquartile range, 14.1 to 15.6) versus 13.9 g/dl (interquartile range, 13.2 to 15.1), group difference, 0.65 g/dl (95% CI, 0.1 to 1.2; P = 0.017); increase in hemoglobin: 2.6 g/dl (interquartile range, 2.1 to 3.2) versus 1.9 g/dl (interquartile range, 1.4 to 2.5), group difference, 0.7 g/dl (95% CI, 0.3 to 1.1; P < 0.001); serum ferritin: 325 µg/l (interquartile range, 217 to 476) versus 64.5 µg/l (interquartile range, 44 to 107), group difference, 257 µg/l (95% CI, 199 to 315; P < 0.001). The percentage of patients with nausea, diarrhea, or constipation was higher in the oral group, 52% versus 2%; group difference, 50% (95% CI, 35 to 64%; P < 0.0001). CONCLUSIONS: After preoperative administration of erythropoietin, body iron stores and stimulation of the erythropoiesis were greater with intravenous ferric carboxymaltose than with oral ferrous sulfate supplementation.


Assuntos
Epoetina alfa/administração & dosagem , Compostos Férricos/administração & dosagem , Compostos Ferrosos/administração & dosagem , Hematínicos/administração & dosagem , Maltose/análogos & derivados , Procedimentos Ortopédicos/tendências , Cuidados Pré-Operatórios/métodos , Administração Intravenosa , Administração Oral , Idoso , Quimioterapia Combinada , Feminino , Humanos , Ferro/sangue , Masculino , Maltose/administração & dosagem , Pessoa de Meia-Idade , Procedimentos Ortopédicos/efeitos adversos , Complicações Pós-Operatórias/sangue , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/prevenção & controle , Estudos Prospectivos , Método Simples-Cego
6.
Clin J Am Soc Nephrol ; 13(8): 1204-1214, 2018 08 07.
Artigo em Inglês | MEDLINE | ID: mdl-29921734

RESUMO

BACKGROUND AND OBJECTIVES: This study was conducted to compare the safety and efficacy of intravenous epoetin alfa-epbx, an epoetin alfa biosimilar, to epoetin alfa in patients on hemodialysis with ESKD and anemia. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: In this 24-week, multicenter, double-blind comparative efficacy and safety study, 612 patients on hemodialysis with ESKD and anemia who had stable hemoglobin and were receiving stable doses of intravenous epoetin alfa were randomized (1:1) to intravenous epoetin alfa or epoetin alfa-epbx. Dosing was adjusted according to the epoetin alfa prescribing information. The coprimary efficacy end points were the least squares mean difference between the two treatments in mean weekly hemoglobin level and mean weekly epoetin dose per kilogram of body weight during the last 4 weeks of treatment. RESULTS: The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly hemoglobin was -0.12 g/dl and the 95% confidence interval (-0.25 to 0.01) was contained within the prespecified equivalence margin (-0.5 to 0.5 g/dl). The least squares mean difference between epoetin alfa-epbx and epoetin alfa in weekly epoetin dose per kilogram of body weight was 0.37 U/kg per week, and the 95% confidence interval (-10.40 to 11.13) was contained within the prespecified equivalence margin (-45 to 45 U/kg per week). Incidences of adverse events (77.1% versus 75.3%), serious adverse events (24.9% versus 27.0%), and deaths (n=5 versus 6) were similar between the epoetin alfa-epbx and epoetin alfa groups, respectively. Five patients tested positive for anti-recombinant human erythropoietin antibodies at baseline, and two additional patients (n=1 per group) developed anti-recombinant human erythropoietin antibodies while on study treatment. All patients tested negative for neutralizing antibodies, and no patient in either group experienced an event of pure red cell aplasia. CONCLUSIONS: This 24-week, comparative, clinical trial in patients on hemodialysis with ESKD and anemia demonstrated there is no clinically meaningful difference in efficacy or safety between epoetin alfa-epbx and epoetin alfa.


Assuntos
Anemia/tratamento farmacológico , Medicamentos Biossimilares/administração & dosagem , Epoetina alfa/análogos & derivados , Epoetina alfa/administração & dosagem , Hematínicos/administração & dosagem , Administração Intravenosa , Anemia/etiologia , Método Duplo-Cego , Feminino , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Masculino , Pessoa de Meia-Idade , Diálise Renal
7.
J Knee Surg ; 31(7): 594-599, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-29727870

RESUMO

Blood loss management is critical to positive outcomes in patients undergoing total knee arthroplasty (TKA). Transfusions are associated with an increased risk of major and minor adverse events, length of hospitalization, and overall cost associated with surgery. Many techniques have been investigated and compared. Tranexamic acid (TXA), an antifibrinolytic drug widely known to reduce blood loss, may be a bridge to the goal of eliminating blood transfusions from TKA. Administration of TXA can be performed intravenously, topically at the knee joint, orally, or in combination. A single bolus or multiple doses have reduced total blood loss and transfusion rates consistently, safely, and cost-effectively. The uptake in use of TXA by surgeons has been slow due to concerns in patients deemed high risk for thromboembolic events. Newer evidence from studies specifically involving high-risk patients demonstrates that TXA is indeed safe in this cohort and provides benefits that greatly outweigh potential risks. Incorporation of TXA as a routine part of TKA is in the best interest of patients, health care teams, and medical institutions. TXA can be employed seamlessly with other blood saving techniques and has the capacity to increase productivity and decrease overall cost. This can be achieved by reducing the incidence of transfusion and length of stay, and the need for practices such as preoperative anemia treatment and suction drainage.


Assuntos
Artroplastia do Joelho , Perda Sanguínea Cirúrgica/prevenção & controle , Fármacos Hematológicos/administração & dosagem , Hemorragia Pós-Operatória/prevenção & controle , Transfusão de Sangue/métodos , Epoetina alfa/administração & dosagem , Adesivo Tecidual de Fibrina/administração & dosagem , Fármacos Hematológicos/efeitos adversos , Humanos , Articulação do Joelho/cirurgia , Hemorragia Pós-Operatória/etiologia , Sucção/instrumentação , Tromboembolia/etiologia , Torniquetes , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/efeitos adversos
8.
Trials ; 19(1): 234, 2018 Apr 19.
Artigo em Inglês | MEDLINE | ID: mdl-29673379

RESUMO

BACKGROUND: Electroconvulsive therapy (ECT) is the most effective treatment for severe depression, but its use is impeded by its cognitive side effects. Novel treatments that can counteract these side effects may therefore improve current treatment strategies for depression. The present randomized trial investigates (1) whether short-term add-on treatment with erythropoietin (EPO) can reduce the cognitive side -effects of ECT and (2) whether such effects are long-lasting. Further, structural and functional magnetic resonance imaging (MRI) will be used to explore the neural underpinnings of such beneficial effects of EPO. Finally, the trial examines whether potential protective effects of EPO on cognition are accompanied by changes in markers of oxidative stress, inflammation, and neuroplasticity. METHODS/DESIGN: The trial has a double-blind, randomized, placebo-controlled, parallel group design. Patients with unipolar or bipolar disorder with current moderate to severe depression referred to ECT (N = 52) are randomized to receive four high-dose infusions of EPO (40,000 IU/ml) or placebo (saline). The first EPO/saline infusion is administered within 24 h before the first ECT. The following three infusions are administered at weekly intervals immediately after ECT sessions 1, 4, and 7. Cognition assessments are conducted at baseline, after the final EPO/saline infusion (3 days after eight ECT sessions), and at a 3 months follow-up after ECT treatment completion. The neuronal substrates for potential cognitive benefits of EPO are investigated with structural and functional MRI after the final EPO/saline infusion. The primary outcome is change from baseline to after EPO treatment (3 days after eight ECT sessions) in a cognitive composite score spanning attention, psychomotor speed, and executive functions. With a sample size of N = 52 (n = 26 per group), we have ≥ 80% power to detect a clinically relevant between-group difference in the primary outcome measure at an alpha level of 5% (two-sided test). Behavioral, mood, and blood-biomarker data will be analyzed using repeated measures analysis of covariance. Functional MRI data will be preprocessed and analyzed using the FMRIB Software Library. DISCUSSION: If EPO is found to reduce the cognitive side effects of ECT, this could have important implications for future treatment strategies for depression and for the scientific understanding of the neurobiological etiology of cognitive dysfunction in patients treated with ECT. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03339596 . Registered on 10 November 2017.


Assuntos
Transtorno Bipolar/terapia , Transtornos Cognitivos/prevenção & controle , Cognição/efeitos dos fármacos , Transtorno Depressivo/terapia , Eletroconvulsoterapia/efeitos adversos , Epoetina alfa/administração & dosagem , Adolescente , Adulto , Idoso , Transtorno Bipolar/diagnóstico , Transtorno Bipolar/psicologia , Transtornos Cognitivos/diagnóstico , Transtornos Cognitivos/etiologia , Transtornos Cognitivos/psicologia , Dinamarca , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/psicologia , Método Duplo-Cego , Esquema de Medicação , Epoetina alfa/efeitos adversos , Feminino , Humanos , Infusões Intravenosas , Imagem por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
9.
Clin Nephrol ; 89 (2018)(1): 1-9, 2018 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29168688

RESUMO

AIMS: To assess real-world effectiveness and safety of intravenous (IV) HX575, a biosimilar epoetin-α, in hemodialysis (HD) patients. MATERIALS AND METHODS: This prospective, observational, pharmacoepidemiological study of adult HD patients treated with IV HX575 for renal anemia for up to 24 months was conducted in 114 centers in 10 European countries. Of 2,086 enrolled subjects (safety sample), 2,023 had ≥ 1 follow-up visit (effectiveness sample). RESULTS: Most (59.3%) patients were male, median age was 68 years. At enrollment, most (82.5%) had been treated with an erythropoiesis-stimulating agent, and 73.0% had adequate iron stores. At baseline, mean (± standard deviation) baseline hemoglobin (Hb) was 11.09 (± 1.14) g/dL and HX575 dose 106.5 (± 78.7) international units (IU)/kg/week; at month 24, Hb was 11.25 (± 1.19) g/dL and HX575 dose 113.0 (± 102.5) IU/kg/week. Variations in mean HX575 dose and Hb over the study were not statistically significant. As to safety, 140 patients (6.7%) experienced ≥ 1 adverse event; of these, 19 events (16 patients; 0.8%) were related to HX575 treatment, 148 (108 patients; 5.2%) were reported as serious, including 12 events in 11 patients (0.5%) stated to be related. No cases of anti-epoetin antibodies or pure red cell aplasia were reported. CONCLUSIONS: MONITOR-CKD5 confirmed the real-world effectiveness and safety profile of IV biosimilar HX575. HD patients treated for up to 24 months showed stable dosing patterns and Hb outcomes. The safety profile of HX575 is likewise comparable to reference epoetin-α.
.


Assuntos
Anemia , Epoetina alfa , Hematínicos , Falência Renal Crônica , Diálise Renal , Idoso , Anemia/complicações , Anemia/tratamento farmacológico , Medicamentos Biossimilares , Epoetina alfa/administração & dosagem , Epoetina alfa/uso terapêutico , Feminino , Hematínicos/administração & dosagem , Hematínicos/uso terapêutico , Hemoglobinas/análise , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Masculino , Estudos Prospectivos
10.
Health Serv Res ; 53(3): 1900-1918, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-28560811

RESUMO

OBJECTIVE: To compare the effectiveness of dynamic anemia management strategies by applying the parametric g-formula to electronic health records. DATA SOURCE/STUDY SETTING: Patients with end-stage renal disease from the US Renal Data System who had congestive heart failure or ischemic heart disease and were undergoing hemodialysis in outpatient dialysis facilities between 2006 and 2010. STUDY DESIGN: We explicitly emulated a target trial of three erythropoietin dosing strategies (aimed at achieving a low, middle, or high hematocrit) and estimated the observational analog of the per-protocol effect. RESULTS: Of 156,945 eligible patients, 41,970 died during the 18-month follow-up. Compared to the low-hematocrit strategy, the estimated risk of death was 4.6 (95% CI 4.4-4.9) percentage points higher under the high-hematocrit strategy and 1.8 (95% CI 1.7-1.9) percentage points higher under the mid-hematocrit strategy. The corresponding risk differences for a composite outcome of death and myocardial infarction were similar. CONCLUSION: An explicit emulation of a target trial using electronic health records, combined with the parametric g-formula, allowed comparison of real-world dynamic strategies that have not been compared in randomized trials.


Assuntos
Anemia/epidemiologia , Registros Eletrônicos de Saúde/estatística & dados numéricos , Epoetina alfa/administração & dosagem , Hematócrito , Projetos de Pesquisa , Relação Dose-Resposta a Droga , Epoetina alfa/uso terapêutico , Insuficiência Cardíaca/epidemiologia , Humanos , Falência Renal Crônica/epidemiologia , Falência Renal Crônica/terapia , Isquemia Miocárdica/epidemiologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Diálise Renal/métodos
11.
Drug Des Devel Ther ; 11: 3127-3135, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-29138535

RESUMO

Purpose: This study aimed to assess and compare the pharmacokinetic (PK) and pharmacodynamic (PD) properties following a single subcutaneous injection of epoetin alfa (Eporon®) with those of the comparator (Eprex®) in healthy male subjects. Subjects and methods: A randomized, double-blind, two-sequence, crossover study was conducted. Subjects were randomly assigned to receive a single dose, that is, 4,000 IU, of the test or comparator epoetin alfa. After 4 weeks, all subjects received the alternative formulation. The primary PK parameters, maximum observed concentration (Cmax) and area under the curve extrapolated to infinity (AUCinf), were calculated with the serum erythropoietin (EPO) concentrations from blood samples collected for 144 h after dosing. The reticulocyte, hematocrit, hemoglobin and red blood cell counts were measured up to 312 h as PD markers. The primary PD parameters, maximum observed effect (Emax) and area under the effect curve (AUEC), were obtained from the baseline-corrected reticulocyte count. The serum EPO concentration and the reticulocyte count were used to assess the concentration-response relationship. The tolerability and immunogenicity profiles were assessed together. Results: Forty-two subjects completed the study. The mean EPO concentration-time profiles were comparable between the two formulations. The geometric mean ratios (90% CI) of the Cmax and AUCinf were 0.908 (0.843-0.978) and 1.049 (0.999-1.101), respectively, both of which were within the regulatory range of 0.80-1.25. Additionally, the PD and tolerability profiles were similar between the two formulations. The time-matched serum EPO concentration and PD markers presented a counterclockwise hysteresis, suggesting a time delay between the measured concentration and the response. Both formulations were well tolerated, and production of anti-drug antibodies was not observed. Conclusion: The two epoetin alfa formulations had similar PK, PD and tolerability profiles. Furthermore, both formulations had a similar time-matched serum EPO concentration and erythropoietic response profile. Thus, the two formulations are expected to be used interchangeably in clinical settings.


Assuntos
Composição de Medicamentos , Epoetina alfa/farmacocinética , Adulto , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Tolerância a Medicamentos , Epoetina alfa/administração & dosagem , Epoetina alfa/efeitos adversos , Voluntários Saudáveis , Humanos , Injeções Subcutâneas , Masculino , Pessoa de Meia-Idade , Adulto Jovem
12.
J Manag Care Spec Pharm ; 23(12): 1249-1254, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29172979

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.


Assuntos
Medicamentos Biossimilares/efeitos adversos , Epoetina alfa/efeitos adversos , Filgrastim/efeitos adversos , Hormônio do Crescimento Humano/efeitos adversos , Farmacovigilância , Sistemas de Notificação de Reações Adversas a Medicamentos , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Medicamentos Biossimilares/administração & dosagem , Medicamentos Falsificados , Processamento Eletrônico de Dados/métodos , Epoetina alfa/administração & dosagem , União Europeia , Filgrastim/administração & dosagem , Hormônio do Crescimento Humano/administração & dosagem , Humanos , Erros de Medicação/prevenção & controle , Estados Unidos
13.
Basic Clin Pharmacol Toxicol ; 121(6): 453-464, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-28639431

RESUMO

Recombinant human erythropoietin (rhEpo) is a multi-functional drug with antioxidant potential. However, the underlying molecular mechanisms of its action are still unclear. The purpose of this study was to investigate the effects of rhEpo on the brain infarct volume as well as on the levels of the neuronal damage, oxidative stress parameters and active caspase-3, nuclear factor erythroid 2-related factor 2 (Nrf2) and haemeoxygenase-1 (HO-1) expressions in the hippocampi of rats exposed to the right middle cerebral artery occlusion (MCAO) for 1 hr. Ischaemic animals received either vehicle or rhEpo (5000 IU/kg, i.p.) immediately or 3 hr after the induction of ischaemia. Sham-operated, vehicle-treated animals served as the control group. Rats were killed 24 hr after the onset of the ischaemic or sham experimental procedure. MCAO caused ipsilateral brain infarction within the striatum and cortex. In the CA1 region of the hippocampi, we did not find significant neuronal loss, but a statistically significant rise in the active caspase-3 and Nrf2 protein expressions was registered. We detected also significant increases in the hippocampal levels of oxidative stress parameters (thiobarbituric acid-reactive substances, superoxide dismutase, glutathione peroxidase). Post-ischaemic administration of rhEpo significantly reduced the brain infarct volume, decreased levels of all tested oxidative stress parameters and increased the Nrf2 expression level. These findings suggest that decrease in oxidative stress parameters in the hippocampus could be an early indicator of post-ischaemic neuroprotective effect of rhEpo in rats exposed to focal cerebral ischaemia and that this effect could be attributable to additional post-ischaemic activation of Nrf2 endogenous antioxidant system.


Assuntos
Antioxidantes/uso terapêutico , Isquemia Encefálica/tratamento farmacológico , Epoetina alfa/uso terapêutico , Hipocampo/metabolismo , Fármacos Neuroprotetores/uso terapêutico , Estresse Oxidativo/efeitos dos fármacos , Animais , Antioxidantes/administração & dosagem , Região CA1 Hipocampal/efeitos dos fármacos , Região CA1 Hipocampal/metabolismo , Região CA1 Hipocampal/patologia , Caspase 3/biossíntese , Córtex Cerebral/patologia , Epoetina alfa/administração & dosagem , Heme Oxigenase-1/biossíntese , Hipocampo/efeitos dos fármacos , Humanos , Infarto da Artéria Cerebral Média/tratamento farmacológico , Infarto da Artéria Cerebral Média/metabolismo , Masculino , Microinjeções , Fator 2 Relacionado a NF-E2/biossíntese , Neostriado/patologia , Fármacos Neuroprotetores/administração & dosagem , Ratos , Ratos Wistar
15.
J Arthroplasty ; 32(9): 2688-2693, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28529107

RESUMO

BACKGROUND: Several treatment modalities exist for the treatment of perioperative anemia. We determined the effect of oral iron supplementation on preoperative anemia, and the use of blood-conserving interventions before total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: A total of 3435 total joint arthroplasties (1461 THAs and 1974 TKAs) were analyzed during 2 phases of a blood conservation program. The first phase used erythropoietin alfa (EPO) or intravenous (IV) iron for patients at risk for perioperative anemia. The second phase included these interventions, as well as preoperative iron supplementation. The effect on preoperative hemoglobin (Hb) and serum ferritin, as well as EPO and IV iron utilization, was determined. RESULTS: Oral iron therapy increased preoperative Hb level by 6 g/L (P < .001) and 7 g/L (P < .001) in the hip and knee cohorts, respectively. Serum ferritin level rose by 80 µg/L (P < .001) and 52 µg/L (P < .001) in the hip and knee cohorts, respectively. The number of patients with an Hb level <130 g/L was significantly reduced (P < .001 for both cohorts), as were patients with serum ferritin levels <35 µg/L (P = .002 for hip and P < .001 for knee cohorts). Utilization of EPO reduced from 16% to 6% (P < .001) and 18% to 6% (P < .001) in the hip and knee cohorts, respectively. Utilization of IV iron reduced from 4% to 2% (P = .05) and 5% to 2% (P < .001) in the hip and knee cohorts, respectively. CONCLUSION: Oral iron therapy reduced the burden of perioperative anemia and reduced utilization of other blood-conserving therapies before THA and TKA. Future research should delineate the cost-effectiveness of oral iron therapy.


Assuntos
Anemia/tratamento farmacológico , Artroplastia de Quadril , Artroplastia do Joelho , Hematínicos/administração & dosagem , Ferro/administração & dosagem , Artropatias/cirurgia , Administração Intravenosa , Administração Oral , Adulto , Idoso , Anemia/complicações , Transfusão de Sangue , Procedimentos Médicos e Cirúrgicos de Sangue , Análise Custo-Benefício , Suplementos Nutricionais , Epoetina alfa/administração & dosagem , Feminino , Hemoglobinas/análise , Humanos , Artropatias/complicações , Masculino , Pessoa de Meia-Idade , Cuidados Pré-Operatórios
16.
Exp Clin Endocrinol Diabetes ; 125(6): 384-391, 2017 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-28407666

RESUMO

HbA1c is the most accepted laboratory parameter for the long term observation of glucose control. There is still much of a debate about the use of HbA1c as a metabolic indicator in diabetic patients (DM) on haemodialysis (HD) and erythropoiesis-stimulating agent (ESA) therapy because of the altered erythrocyte turn over in patients with chronic kidney disease and haemodialysis (CKD5D). In 102 CKD5 patients with and without diabetes mellitus, we examined the dose dependent variability in HbA1c and fructosamine levels under haemodialysis and treated with epoetin α (n=48) and a new generation agent with continuous stimulation of methoxy polyethylene glycol epoetin beta (C.E.R.A.; n=54). HbA1c levels were affected by therapy with ESA treatments. ESA dose was inversely correlated with HbA1c and an escalation of 10.000 IU per week induced an estimated decrease of HbA1c of 0.6 percent. In addition, the increase of reticulocyte number as a marker for erythropoiesis was significantly inversely correlated with the increase of ΔHbA1c. ESA treatments had no such effect on the alternative metabolic parameter fructosamine. When compared, both therapeutic agents had comparable success in attaining haemoglobin (Hb) target values. C.E.R.A. showed better correlation and was more effective over a longer dose interval. Our results show that HbA1c levels in patients should be carefully interpreted based on interfering factors. Nevertheless, HbA1c is currently the most consistent parameter for use ascertaining metabolic status of patients suffering from diabetes mellitus.


Assuntos
Nefropatias Diabéticas , Epoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Frutosamina/sangue , Hemoglobina A Glicada/metabolismo , Hematínicos/administração & dosagem , Polietilenoglicóis/administração & dosagem , Diálise Renal , Insuficiência Renal Crônica , Adulto , Idoso , Idoso de 80 Anos ou mais , Nefropatias Diabéticas/sangue , Nefropatias Diabéticas/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/terapia
17.
Int Urol Nephrol ; 49(5): 903-908, 2017 May.
Artigo em Inglês | MEDLINE | ID: mdl-28058668

RESUMO

PURPOSE: In the general population, haemoglobin (Hb) concentration is higher in men than in women. However, target Hb levels in dialysis patients are set constant regardless of the patient's sex. The aim of this study was to evaluate Hb concentration and the use of erythropoiesis-stimulating agents (ESA) in peritoneal dialysis (PD) patients taking gender and dialysis adequacy into account. METHODS: The study comprised two parts. The first was a cross-sectional analysis of Hb and ESA in 2180 prevalent PD patients. The second included 88 incident PD patients, followed for 36 months. During this time, the major parameters recorded at 12-month intervals included: Hb concentration, weekly ESA, total, renal, and peritoneal Kt/V. Erythropoietin resistance index (ERI) was calculated as the ratio between ESA dose and achieved Hb. RESULTS: In prevalent PD patients, Hb concentration was significantly lower in women, (11.2 ± 1.4 vs. 11.5 ± 1.6 g/dl; p < 0.001), despite higher doses of ESA (2691 ± 1821 vs. 2344 ± 1422; p = 0.001). Hb concentrations were related to dialysis adequacy in both cohorts. However, despite significantly higher Kt/V, women were characterized by a lower Hb level. In incident patients, this association was present throughout the observation period, while the ESA dose in women was significantly higher at every time point. In multiple regression analysis, gender was an independent determinant of ERI (b = 0.34; p < 0.05). CONCLUSIONS: Despite higher dialysis adequacy, Hb concentration in women treated with PD is significantly lower, and the ability to correct it impaired, as compared to men.


Assuntos
Anemia/tratamento farmacológico , Anemia/etiologia , Epoetina alfa/administração & dosagem , Hemoglobinas/metabolismo , Falência Renal Crônica/terapia , Diálise Peritoneal/efeitos adversos , Idoso , Anemia/fisiopatologia , Estudos Transversais , Feminino , Hematínicos/administração & dosagem , Humanos , Falência Renal Crônica/sangue , Falência Renal Crônica/diagnóstico , Masculino , Pessoa de Meia-Idade , Diálise Peritoneal/métodos , Prognóstico , Sistema de Registros , Estudos Retrospectivos , Medição de Risco , Fatores Sexuais , Resultado do Tratamento
18.
Cochrane Database Syst Rev ; 1: CD011690, 2017 01 09.
Artigo em Inglês | MEDLINE | ID: mdl-28066881

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.


Assuntos
Anemia/tratamento farmacológico , Epoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Diálise Renal , Insuficiência Renal Crônica/sangue , Adulto , Anemia/sangue , Criança , Hemoglobina A , Humanos , Injeções Intravenosas , Ensaios Clínicos Controlados Aleatórios como Assunto , Proteínas Recombinantes/administração & dosagem
19.
J Am Coll Cardiol ; 68(1): 40-9, 2016 07 05.
Artigo em Inglês | MEDLINE | ID: mdl-27364049

RESUMO

BACKGROUND: Preliminary data suggested a clinical benefit in treating out-of-hospital cardiac arrest (OHCA) patients with a high dose of erythropoietin (Epo) analogs. OBJECTIVES: The authors aimed to evaluate the efficacy of epoetin alfa treatment on the outcome of OHCA patients in a phase 3 trial. METHODS: The authors performed a multicenter, single-blind, randomized controlled trial. Patients still comatose after a witnessed OHCA of presumed cardiac origin were eligible. In the intervention group, patients received 5 intravenous injections spaced 12 h apart during the first 48 h (40,000 units each, resulting in a maximal dose of 200,000 total units), started as soon as possible after resuscitation. In the control group, patients received standard care without Epo. The main endpoint was the proportion of patients in each group reaching level 1 on the Cerebral Performance Category (CPC) scale (survival with no or minor neurological sequelae) at day 60. Secondary endpoints included all-cause mortality rate, distribution of patients in CPC levels at different time points, and side effects. RESULTS: In total, 476 patients were included in the primary analysis. Baseline characteristics were similar in the 2 groups. At day 60, 32.4% of patients (76 of 234) in the intervention group reached a CPC 1 level, as compared with 32.1% of patients (78 of 242) in the control group (odds ratio: 1.01; 95% confidence interval: 0.68 to 1.48). The mortality rate and proportion of patients in each CPC level did not differ at any time points. Serious adverse events were more frequent in Epo-treated patients as compared with controls (22.6% vs. 14.9%; p = 0.03), particularly thrombotic complications (12.4% vs. 5.8%; p = 0.01). CONCLUSIONS: In patients resuscitated from an OHCA of presumed cardiac cause, early administration of erythropoietin plus standard therapy did not confer a benefit, and was associated with a higher complication rate. (High Dose of Erythropoietin Analogue After Cardiac Arrest [Epo-ACR-02]; NCT00999583).


Assuntos
Epoetina alfa/administração & dosagem , Hematínicos/administração & dosagem , Parada Cardíaca Extra-Hospitalar/tratamento farmacológico , Idoso , Intervenção Médica Precoce , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego
20.
Clin Ther ; 38(8): 1778-88, 2016 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-27473384

RESUMO

PURPOSE: The purpose of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) equivalence of single 100 U/kg subcutaneous doses of Epoetin Hospira and Epogen in healthy male subjects as part of an overall program to demonstrate biosimilarity of Epoetin Hospira to the reference product Epogen. METHODS: This single-center, open-label, randomized, 2-period, crossover study was conducted in 81 healthy male subjects. Subjects were randomized to Sequence 1, in which they received 100 U/kg of Epoetin Hospira or to sequence 2, in which they received 100 U/kg Epogen subcutaneously in the first study period and the alternative treatment in the second study period. Blood was collected for determination of baseline-adjusted epoetin concentrations (BAECs) for pharmacokinetics and for determination of reticulocyte percentage of total erythrocytes for pharmacodynamics throughout both study periods. The primary PK end points were the geometric mean ratios (GMRs) of the 2 treatments for AUC0-t and Cmax based on the BAEC, and the primary PD end points were the GMRs of the 2 treatments for AUC0-t and Cmax for reticulocyte percentage. FINDINGS: The GMRs of Epoetin Hospira to Epogen for the BAEC-derived PK parameters were 1.05 for AUC0-t with a 90% CI of 1.01 to 1.11, and 1.09 for Cmax with a 90% CI of 1.01 to 1.18, with both 90% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. The GMRs (Epoetin Hospira/Epogen) for the reticulocyte percentage-derived PD parameters were 1.01 for AUC0-t with a 95% CI of 0.98 to 1.05, and 1.02 for Cmax with a 95% CI of 0.98 to 1.06, with both 95% CIs contained within the prespecified equivalence margin of 0.80 to 1.25. Overall, the adverse events were of similar frequency (11.7% and 13.9% for Epoetin Hospira and Epogen, respectively) and severity between treatments. One subject had a positive anti- recombinant human erythropoietin antibody result by radioimmunoprecipitation assay before dosing and throughout the conduct of the study with negative neutralizing antibodies and with no evidence of clinical deterioration or impact on the pharmacokinetics, pharmacodynamics, or safety. IMPLICATIONS: The results of this study established the PK and PD equivalence of single 100 U/kg subcutaneous doses of the proposed biosimilar Epoetin Hospira to the reference product Epogen in healthy male subjects and support the overall demonstration of biosimilarity of Epoetin Hospira and Epogen.


Assuntos
Epoetina alfa/administração & dosagem , Proteínas Recombinantes/administração & dosagem , Adolescente , Adulto , Anticorpos Neutralizantes/imunologia , Estudos Cross-Over , Epoetina alfa/farmacocinética , Epoetina alfa/farmacologia , Humanos , Masculino , Pessoa de Meia-Idade , Proteínas Recombinantes/farmacocinética , Proteínas Recombinantes/farmacologia , Adulto Jovem
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