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1.
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
2.
J Knee Surg ; 32(10): 995-1000, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30423590

RESUMO

Perioperative blood management is essential to minimize allogeneic blood transfusion in total knee replacement. The effect of preoperative administration of erythropoietin, intraoperative cell saver, tranexamic acid, and restrictive transfusion strategies on allogeneic transfusion is studied in total knee replacement. A retrospective comparative study of 106 patients who underwent total knee replacement in different time periods was performed. Group A (n 1 = 45) underwent restrictive strategies of transfusion between 2009 and 2010. Group B (n 2 = 24) includes patients where erythropoietin of either 10.000 IU or 20.000 IU was given preoperatively. Patients of Group C (n 3 = 21) underwent autologous washed erythrocytes transfusion through a cell saver. Lastly, in Group D (n 4 = 15) tranexamic acid dose of 1 gr IV was given intraoperatively. The preoperative and discharge hemoglobin together with total units of blood transfusion and creatinine levels was studied. Tranexamic acid noted the least units of blood transfusion (mean = 0.82 units/patient, p < 0.001, CI 95%) in contrast to the two regimens of erythropoietin (1.16 units/patient) OrthoPAT (1.43 units/patient) and restrictive strategies (1.92 units/patient). The mean preoperative hemoglobin was 13.37 g/dL with no statistical difference among the groups of patients. The postoperative mean hemoglobin was 10.59 with no statistical difference among the groups of patients too. Additionally, the mean creatinine level was 0.93 mg/dL; however, no statistical difference among the groups of patients was noted. Finally, tranexamic acid seemed to be the most cost-effective regime. In our study, tranexamic acid proved its superiority concerning the postoperative blood transfusion on patients undergoing total knee replacement, in comparison with the other existing methods of perioperative blood management. This is a Level III, retrospective comparative study.


Assuntos
Artroplastia do Joelho/métodos , Perda Sanguínea Cirúrgica/prevenção & controle , Eritropoetina/administração & dosagem , Fármacos Hematológicos/administração & dosagem , Recuperação de Sangue Operatório/métodos , Ácido Tranexâmico/administração & dosagem , Idoso , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/economia , Artroplastia do Joelho/economia , Transfusão de Sangue , Transfusão de Sangue Autóloga/economia , Transfusão de Sangue Autóloga/instrumentação , Transfusão de Sangue Autóloga/métodos , Análise Custo-Benefício , Eritropoetina/economia , Feminino , Hematínicos/administração & dosagem , Hematínicos/economia , Fármacos Hematológicos/economia , Hemoglobinas/análise , Humanos , Masculino , Pessoa de Meia-Idade , Recuperação de Sangue Operatório/economia , Assistência Perioperatória/economia , Assistência Perioperatória/métodos , Estudos Retrospectivos , Ácido Tranexâmico/economia
3.
Semin Dial ; 30(5): 398-402, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28608933

RESUMO

Low-level bacterial and endotoxin contamination of water used to generate dialysate propagates chronic inflammation in patients with a wide-range of potential adverse consequences, including erythropoietin hyporesponsiveness. Advancements in hemodialysis systems now allow for the generation of ultrapure dialysate that has lower bacterial and endotoxin levels than the standard dialysate. The cost associated with ultrapure dialysate is thought to be a major barrier to its widespread adoption. In this report, we conduct a cost-benefit analysis examining the excess cost of generating ultrapure dialysate and the potential cost saving from a lower erythropoietin dose requirement. Our analysis suggests a potential cost saving of approximately $371 to $425 million per year with full adoption of ultrapure dialysate in the United States.


Assuntos
Soluções para Hemodiálise/economia , Diálise Renal/economia , Análise Custo-Benefício , Eritropoetina/administração & dosagem , Eritropoetina/economia , Soluções para Hemodiálise/efeitos adversos , Soluções para Hemodiálise/química , Humanos , Diálise Renal/efeitos adversos , Estados Unidos
4.
Pharmacoeconomics ; 34(11): 1173-1186, 2016 11.
Artigo em Inglês | MEDLINE | ID: mdl-27412251

RESUMO

BACKGROUND: The expiry of patents for costly biologics is creating new momentum on the pharmaceutical market for biosimilars (copies of off-patent biologics) and paving the way for their development. However, little is known about the competitiveness of biosimilars versus their originators and other biologics belonging to the same therapeutic class. OBJECTIVE: The main goal of this study was to analyse the type of competition generated by the first biosimilars commercialised on key global biologic markets and to grasp their economic model. The secondary goal was to distinguish the main factors likely to influence the uptake of biosimilars on national markets. METHODS: To be included in this study, countries had to meet three conditions: the regulatory framework for the development of biosimilars closely resembled that in Europe, biosimilars were marketed in 2014, and the value of the biologics market was >US$3 billion. We analysed granulocyte colony-stimulating factors (GCSFs) and erythropoietins (EPOs) over the period 2007-2014 because these are the two main therapeutic classes that have been 'biosimilarised' and thus have many years of experience available. We assessed market sizes, retail/hospital distribution mixes, incentives for using biosimilars and price discounts for originators versus biosimilars. We conducted a linear regression analysis to assess the relationship between uptakes of biosimilars and the market shares of other biologics. RESULTS: The EU-5 (France, Germany, Italy, Spain and the UK) and Japanese GCSF and EPO markets are highly-country-specific. Uptake of biosimilars seems to depend on retail/hospital distribution mixes and on medical practice. Depending on the therapeutic class and the market sector (retail or hospital), biosimilars may compete with first-generation or second-generation products or both. Some incentives implemented to encourage the use of biosimilars had mixed results. Overall, discounts for biosimilars versus originators are not factors that determine global uptake of biosimilars. CONCLUSION: Unlike generics, there appears to be no unique economic model for biosimilars. Moreover, a new phenomenon occurs with biosimilars: sometimes, they are able to take market shares from subsequent generations of biologics.


Assuntos
Produtos Biológicos/economia , Medicamentos Biossimilares/economia , Indústria Farmacêutica/economia , Modelos Econômicos , Produtos Biológicos/administração & dosagem , Medicamentos Biossimilares/administração & dosagem , Desenho de Fármacos , Medicamentos Genéricos/economia , Competição Econômica , Eritropoetina/administração & dosagem , Eritropoetina/economia , Europa (Continente) , Fator Estimulador de Colônias de Granulócitos/administração & dosagem , Fator Estimulador de Colônias de Granulócitos/economia , Humanos , Japão , Modelos Lineares , Patentes como Assunto
5.
Consult Pharm ; 31(5): 271-81, 2016 May.
Artigo em Inglês | MEDLINE | ID: mdl-27178657

RESUMO

UNLABELLED: Anemia in the elderly is often related to a higher prevalence of chronic diseases such as chronic kidney failure, arthritis, and malignancy. Erythropoiesis-stimulating agents (ESAs) have been used for years to effectively treat anemia and when used appropriately can substantially improve the health status and quality of life of older adults. Following the 2008 recession in Greece, the government introduced ESA price control restrictions, but no prescribing restrictions, in an effort to reduce drug expenditure. OBJECTIVE: ESA prescribing patterns and treatment costs were analyzed to determine inappropriate or appropriate use of these agents and related health care resources in Greece. METHOD: A retrospective register-based drug utilization study was carried out using data from prescriptions dispensed at the public pharmacy of the largest social insurance fund (IKA-ETAM), for patients receiving ESAs over a six-month period. For each patient, demographic data, ESA dosage regimen, treatment indication and cost, prescriber specialty, and prescription origin were recorded. RESULTS: A total of 14,387 prescriptions from 6,074 patients (median age 74 years) were reviewed. A substantial number of patients (13.5%) were treated for off-label indications, for which the average cost per patient per indication was higher. ESA dosage/frequency of administration varied but was in accordance with recommendations. The percentage of patients who received innovator and biosimilar erythropoietin (EPO) was 88% and 12%, respectively. CONCLUSION: For the optimization of ESA utilization and the reduction of treatment costs, strict ESA prescription monitoring, development of registries, and criteria for off-label indications and biosimilar use in naive patients under the umbrella of risk-sharing agreements should be proposed.


Assuntos
Anemia/tratamento farmacológico , Hematínicos/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Qualidade de Vida , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Assistência Ambulatorial , Anemia/economia , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Medicamentos Biossimilares/uso terapêutico , Criança , Pré-Escolar , Relação Dose-Resposta a Droga , Custos de Medicamentos , Eritropoetina/administração & dosagem , Eritropoetina/economia , Eritropoetina/uso terapêutico , Feminino , Grécia , Hematínicos/administração & dosagem , Hematínicos/economia , Humanos , Masculino , Pessoa de Meia-Idade , Uso Off-Label/estatística & dados numéricos , Sistema de Registros , Estudos Retrospectivos , Adulto Jovem
6.
Pediatrics ; 137(3): e20153859, 2016 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-26908704

RESUMO

BACKGROUND: We previously reported improved neurodevelopmental outcomes at 2 years among infants treated with the erythropoiesis-stimulating agents (ESAs) darbepoetin alfa (darbepoetin) or erythropoietin. Here we characterize 4-year outcomes. METHODS: Former preterm infants randomly assigned to receive darbepoetin (10 µg/kg, once per week), erythropoietin (400 U/kg, 3 times/week), or placebo through 35 weeks' postconceptual age were evaluated at 3.5 to 4 years of age. For comparison, healthy children formerly delivered full term (term controls [TCs]) were also recruited. All participants were assessed by using measures of full-scale IQ (FSIQ) and general language from the Wechsler Preschool and Primary Scale of Intelligence, Third Edition, and an overall measure of executive function, on the basis of tests evaluating inhibitory control and spatial working memory. Rates of neurodevelopmental impairment were compared across groups. RESULTS: Multivariate analysis of variance compared children randomly assigned to ESAs (n = 39), placebo (n =14), and TCs (n = 24). FSIQ and performance IQ were significantly higher in the ESA group than in the placebo group (FSIQ: 91.1 ± 17.5 vs 79.2 ± 18.5, P = .036; performance IQ: 93.0 ± 17.0 vs 79.5 ± 19.5, P = .018). Follow-up analyses revealed that the children receiving ESAs performed better than those who received placebo on executive function tasks. The ESA group's performance was below that of TCs, but the results did not reach significance on executive function. The incidence of neurodevelopmental impairment was greater in the placebo group than in the ESA group. CONCLUSIONS: ESA-treated infants had better cognitive outcomes and less developmental impairment at 3.5 to 4 years of age compared with placebo-treated infants. ESAs show promise in improving long-term cognitive outcomes of infants born prematurely.


Assuntos
Desenvolvimento Infantil/efeitos dos fármacos , Cognição/efeitos dos fármacos , Darbepoetina alfa/administração & dosagem , Eritropoetina/administração & dosagem , Doenças do Prematuro/tratamento farmacológico , Recém-Nascido Prematuro , Transtornos do Neurodesenvolvimento/tratamento farmacológico , Pré-Escolar , Relação Dose-Resposta a Droga , Esquema de Medicação , Quimioterapia Combinada , Feminino , Seguimentos , Hematínicos/administração & dosagem , Humanos , Lactente , Recém-Nascido , Injeções Subcutâneas , Masculino , Transtornos do Neurodesenvolvimento/etiologia , Transtornos do Neurodesenvolvimento/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
7.
J Arthroplasty ; 31(1): 76-80, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26387037

RESUMO

We sought to compare the efficacy and cost of reinfusion drains vs tranexamic acid (TA) in primary total joint athroplasty (TJA) patients. We randomized 186 primary TJAs (71 hips, 115 knees) to standard drains (61/186), autologous reinfusion drains (60/186), or single dose (20 mg/kg) of TA (65/186). There was a statistically significant (P < .0001) less drop in hemoglobin levels (2.98 mg/dL; range, 0.5-6.10) in the TA group compared with standard drains (P < .0001) and reinfusion drains (P < .0061). There was no significant difference in transfusion rates. At $581.89, the unit cost of the reinfusion system is substantially higher than the standard drain ($7.56) and TA ($35.91/g). The results of this randomized controlled trial demonstrate that TA is more efficacious and provides cost savings compared with reinfusion drains as a blood management tool for TJA.


Assuntos
Antifibrinolíticos/administração & dosagem , Artroplastia de Quadril/métodos , Artroplastia do Joelho/métodos , Transfusão de Sangue Autóloga/métodos , Drenagem/métodos , Ácido Tranexâmico/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Eritropoetina/administração & dosagem , Feminino , Custos de Cuidados de Saúde , Hemoglobinas/análise , Humanos , Ferro/administração & dosagem , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos
8.
Am J Kidney Dis ; 65(1): 49-57, 2015 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-25115616

RESUMO

BACKGROUND: Erythropoiesis-stimulating agent (ESA)-hyporesponsive anemia is common in chronic kidney disease (CKD). Pentoxifylline shows promise as a treatment for ESA-hyporesponsive anemia, but has not been rigorously evaluated. STUDY DESIGN: Multicenter, double-blind, randomized, controlled trial. SETTING & PARTICIPANTS: 53 adult patients with CKD stage 4 or 5 (including dialysis) and ESA-hyporesponsive anemia (hemoglobin≤120g/L and ESA resistance index [calculated as weight-adjusted weekly ESA dose in IU/kg/wk divided by hemoglobin concentration in g/L]≥1.0IU/kg/wk/g/L for erythropoietin-treated patients and ≥0.005µg/kg/wk/g/L for darbepoetin-treated patients). INTERVENTIONS: Pentoxifylline (400mg/d; n=26) or matching placebo (control; n=27) for 4 months. PRIMARY OUTCOME: ESA resistance index at 4 months; secondary outcomes: hemoglobin concentration, ESA dose, blood transfusion requirement, serum ferritin level and transferrin saturation, C-reactive protein level, adverse events, quality of life, and health economics. RESULTS: There was no statistically significant difference in ESA resistance index between the pentoxifylline and control groups (adjusted mean difference, -0.39 [95%CI, -0.89 to 0.10] IU/kg/wk/g/L; P=0.1). Pentoxifylline significantly increased hemoglobin concentration relative to the control group (adjusted mean difference, 7.6 [95%CI, 1.7-13.5] g/L; P=0.01). There was no difference in ESA dose between groups (-20.8 [95%CI, -67.2 to 25.7] IU/kg/wk; P=0.4). No differences in blood transfusion requirements, adverse events, or quality of life were observed between groups. Pentoxifylline cost A$88.05 (US $82.94) per person over the trial and produced mean savings in ESA cost of A$1,332 (US $1,255). The overall economic impact over the trial period was a saving of A$1,244 (US $1,172) per person for the pentoxifylline group compared with controls. LIMITATIONS: Sample size smaller than planned due to slow recruitment. CONCLUSIONS: Pentoxifylline did not significantly modify ESA hyporesponsiveness, but increased hemoglobin concentration. Further studies are warranted to determine whether pentoxifylline therapy represents a safe strategy for increasing hemoglobin levels in patients with CKD with ESA-hyporesponsive anemia.


Assuntos
Anemia , Eritropoese/efeitos dos fármacos , Eritropoetina , Pentoxifilina , Insuficiência Renal Crônica , Adulto , Idoso , Anemia/sangue , Anemia/tratamento farmacológico , Anemia/etiologia , Redução de Custos , Método Duplo-Cego , Monitoramento de Medicamentos/métodos , Resistência a Medicamentos/efeitos dos fármacos , Sinergismo Farmacológico , Eritropoetina/administração & dosagem , Eritropoetina/efeitos adversos , Fármacos Hematológicos/administração & dosagem , Fármacos Hematológicos/efeitos adversos , Hemoglobinas/análise , Humanos , Pessoa de Meia-Idade , Pentoxifilina/administração & dosagem , Pentoxifilina/efeitos adversos , Qualidade de Vida , Insuficiência Renal Crônica/complicações , Insuficiência Renal Crônica/economia , Insuficiência Renal Crônica/psicologia , Vasodilatadores/administração & dosagem , Vasodilatadores/efeitos adversos
9.
Trials ; 15: 501, 2014 Dec 20.
Artigo em Inglês | MEDLINE | ID: mdl-25528574

RESUMO

BACKGROUND: The Erythropoietin in Traumatic Brain Injury (EPO-TBI) trial aims to determine whether the administration of erythropoietin to patients with moderate or severe traumatic brain injury improves patient-centred outcomes. METHODS: EPO-TBI is a multicentre, blinded, randomised, parallel groups, placebo-controlled, phase III superiority trial of erythropoietin in ICU patients with traumatic brain injury conducted in Australia and New Zealand, Saudi Arabia and Europe; 606 critically ill patients aged 15 to 65 years with moderate or severe acute traumatic brain injury will be enrolled. Trial patients will receive either 40,000 IU erythropoietin or placebo by subcutaneous injection administered weekly for up to three doses during their ICU admission. The primary outcome measure is the proportion of unfavourable neurological outcomes, comprising death or severe disability, observed at 6 months following randomisation utilizing the Extended Glasgow Outcome Scale. Secondary outcomes, also assessed at 6 months following randomisation, include the probability of an equal or greater Extended Glasgow Outcome Scale level, mortality, the proportions of patients with proximal deep venous thrombosis or with composite thrombotic vascular events, as well as assessment of quality of life and cost-effectiveness. The planned sample size will allow 90% power to detect a reduction from 50% to 36% in unfavourable neurological outcomes at a two-sided alpha of 0.05. DISCUSSION: A detailed analysis plan has been developed for EPO-TBI that is consistent with international guidelines. This plan specifies the statistical models for evaluation of primary and secondary outcomes, as well as defining covariates for adjusted analyses. Application of this statistical analysis plan to the forthcoming EPO-TBI trial will facilitate unbiased analyses of these important clinical data. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12609000827235 (22 September 2009). ClinicalTrials.gov: NCT00987454 (29 September 2009). European Drug Regulatory Authorities Clinical Trials: 2011-005235-22 (18 January 2012).


Assuntos
Lesões Encefálicas/tratamento farmacológico , Eritropoetina/administração & dosagem , Fármacos Neuroprotetores/administração & dosagem , Projetos de Pesquisa/estatística & dados numéricos , Adolescente , Adulto , Idoso , Austrália , Lesões Encefálicas/diagnóstico , Lesões Encefálicas/economia , Lesões Encefálicas/mortalidade , Protocolos Clínicos , Análise Custo-Benefício , Estado Terminal , Interpretação Estatística de Dados , Avaliação da Deficiência , Esquema de Medicação , Custos de Medicamentos , Eritropoetina/efeitos adversos , Eritropoetina/economia , Europa (Continente) , Feminino , Humanos , Injeções Subcutâneas , Escala de Gravidade do Ferimento , Masculino , Pessoa de Meia-Idade , Modelos Estatísticos , Fármacos Neuroprotetores/efeitos adversos , Fármacos Neuroprotetores/economia , Nova Zelândia , Estudos Prospectivos , Qualidade de Vida , Recuperação de Função Fisiológica , Arábia Saudita , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
10.
PLoS One ; 9(4): e95643, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24755676

RESUMO

Erythropoietin (EPO) has been recognized as a neuroprotective agent. In animal models of neonatal brain injury, exogenous EPO has been shown to reduce lesion size, improve structure and function. Experimental studies have focused on short course treatment after injury. Timing, dose and length of treatment in preterm brain damage remain to be defined. We have evaluated the effects of high dose and long-term EPO treatment in hypoxic-ischemic (HI) injury in 3 days old (P3) rat pups using histopathology, magnetic resonance imaging (MRI) and spectroscopy (MRS) as well as functional assessment with somatosensory-evoked potentials (SEP). After HI, rat pups were assessed by MRI for initial damage and were randomized to receive EPO or vehicle. At the end of treatment period (P25) the size of resulting cortical damage and white matter (WM) microstructure integrity were assessed by MRI and cortical metabolism by MRS. Whisker elicited SEP were recorded to evaluate somatosensory function. Brains were collected for neuropathological assessment. The EPO treated animals did not show significant decrease of the HI induced cortical loss at P25. WM microstructure measured by diffusion tensor imaging was improved and SEP response in the injured cortex was recovered in the EPO treated animals compared to vehicle treated animals. In addition, the metabolic profile was less altered in the EPO group. Long-term treatment with high dose EPO after HI injury in the very immature rat brain induced recovery of WM microstructure and connectivity as well as somatosensory cortical function despite no effects on volume of cortical damage. This indicates that long-term high-dose EPO induces recovery of structural and functional connectivity despite persisting gross anatomical cortical alteration resulting from HI.


Assuntos
Eritropoetina/farmacologia , Hipóxia-Isquemia Encefálica/tratamento farmacológico , Hipóxia-Isquemia Encefálica/patologia , Animais , Animais Recém-Nascidos , Astrócitos/patologia , Córtex Cerebral/metabolismo , Córtex Cerebral/patologia , Cicatriz/patologia , Imagem de Tensor de Difusão , Modelos Animais de Doenças , Eritropoetina/administração & dosagem , Potenciais Somatossensoriais Evocados , Feminino , Hipóxia-Isquemia Encefálica/metabolismo , Filamentos Intermediários/metabolismo , Masculino , Metaboloma , Metabolômica , Bainha de Mielina/metabolismo , Neurônios/patologia , Fármacos Neuroprotetores/administração & dosagem , Fármacos Neuroprotetores/farmacologia , Tamanho do Órgão , Espectroscopia de Prótons por Ressonância Magnética , Ratos , Fatores de Tempo
11.
Implement Sci ; 9: 48, 2014 Apr 23.
Artigo em Inglês | MEDLINE | ID: mdl-24755214

RESUMO

BACKGROUND: Despite evidence that erythropoietin and intra- and postoperative blood salvage are expensive techniques considered to be non-cost-effective in primary elective total hip and knee arthroplasties in the Netherlands, Dutch medical professionals use them frequently to prevent the need for allogeneic transfusion. To actually change physicians' practice, a tailored strategy aimed at barriers that hinder physicians in abandoning the use of erythropoietin and perioperative blood salvage was systematically developed. The study aims to examine the effectiveness, feasibility and costs of this tailored de-implementation strategy compared to a control strategy. METHODS/DESIGN: A cluster randomized controlled trial including an effect, process and economic evaluation will be conducted in a minimum of 20 Dutch hospitals. Randomisation takes place at hospital level. The hospitals in the intervention group will receive a tailored de-implementation strategy that consists of four components: interactive education, feedback in educational outreach visits, electronically sent reports on hospital performance (all aimed at orthopedic surgeons and anesthesiologists), and information letters or emails aimed at other involved professionals within the intervention hospital (transfusion committee, OR-personnel, pharmacists). The hospitals in the control group will receive a control strategy (i.e., passive dissemination of available evidence). Outcomes will be measured at patient level, using retrospective medical record review. This will be done in all hospitals at baseline and after completion of the intervention period. The primary outcome of the effect evaluation is the percentage of patients undergoing primary elective total hip or knee arthroplasty in which erythropoietin or perioperative blood salvage is applied. The actual exposure to the tailored strategy and users' experiences will be assessed in the process evaluation. In the economic evaluation, the costs of the tailored strategy and the control strategy in relation to the difference in their effectiveness will be compared. DISCUSSION: This study will show whether a systematically developed tailored strategy is more effective for de-implementation of non-cost-effective blood saving measures than the control strategy. This knowledge can be used in national and international initiatives to make healthcare more efficient. It also provides more generalized knowledge regarding de-implementation strategies. TRIAL REGISTRATION: This trial is registered at the Dutch Trial Register NTR4044.


Assuntos
Artroplastia de Quadril/métodos , Artroplastia do Joelho/métodos , Educação Médica Continuada/organização & administração , Recuperação de Sangue Operatório/métodos , Padrões de Prática Médica/estatística & dados numéricos , Transfusão de Sangue/métodos , Protocolos Clínicos , Custos e Análise de Custo , Procedimentos Cirúrgicos Eletivos/métodos , Eritropoetina/administração & dosagem , Medicina Baseada em Evidências , Conhecimentos, Atitudes e Prática em Saúde , Humanos , Motivação , Países Baixos , Recuperação de Sangue Operatório/economia , Padrões de Prática Médica/economia , Projetos de Pesquisa
12.
Int Urol Nephrol ; 46(2): 453-9, 2014 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-24448756

RESUMO

PURPOSE: Maintaining target hemoglobin (Hb) with minimal variability is a challenge in hemodialysis (HD) patients. The aim of this study is to compare the long- and short-acting erythropoietin-stimulating agents such as Aranesp and Eprex in achieving these targets. METHODS: Randomized, prospective, open-labeled study of 24 weeks includes stable patients on HD >3 months, age >18 years, and on Eprex for >3 months. Patients were randomized into two groups: A-(Aranesp group):HD patients on Eprex Q TIW or BIW were converted to Aranesp Q weekly, by using the conversion factor of 200:1 and those on Eprex Q weekly to Aranesp Q 2 weeks; B-(Eprex group):patients continued on Eprex treatment. Hemoglobin target was set at (105-125 g/l). Primary end points were percentage of patients achieving target Hb, hemoglobin variability, and number of dose changes in each group. RESULTS: This study consisted of 139 HD patients: 72 in the Aranesp and 67 in the Eprex-mean (SD) age 54 (16.2) years, 77 (55 %) males. About 46 % were diabetic. Target Hb achieved in 64.8 % of the Aranesp and 59.7 % in the Eprex (p = 0.006). Hb variability was less frequent in the Aranesp group (p = 0.2). Mean number of dose changes was 1.3 (0.87) in the Aranesp and 1.9 (1.2) in the Eprex (p < 0.001). There was 1 vascular access thrombosis in the Aranesp and 8 in the Eprex (p < 0.001). There was no difference in hospitalization and death number between the 2 groups. CONCLUSIONS: Aranesp Q weekly or every 2 weeks is more efficient in achieving target Hb, with less dose changes and minor vascular access complications.


Assuntos
Eritropoetina/análogos & derivados , Hematínicos/administração & dosagem , Hemoglobinas/metabolismo , Insuficiência Renal Crônica/sangue , Insuficiência Renal Crônica/tratamento farmacológico , Adulto , Idoso , Darbepoetina alfa , Preparações de Ação Retardada , Epoetina alfa , Eritropoetina/administração & dosagem , Eritropoetina/economia , Feminino , Hematínicos/economia , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Diálise Renal , Insuficiência Renal Crônica/terapia , Resultado do Tratamento
13.
Vox Sang ; 106(1): 83-91, 2014 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-23869647

RESUMO

BACKGROUND: Postoperative blood loss may be a risk factor for allogeneic blood transfusion (ABT) in patients undergoing subcapital hip fracture (SHF) repair. We investigated the utility and costs of using a low-vacuum reinfusion drain (Bellovac ABT) within a blood management protocol for reducing ABT requirements in consecutive SHF. METHODS: The blood management protocol consisted of the application of a restrictive transfusion trigger (Hb < 8 g/dl), the peri-operative administration of IV iron sucrose (3 × 200 mg/48 h) ± recombinant erythropoietin (1 × 40 000 IU sc) and the use of Bellovac ABT (Group 2, n = 117). An immediate previous SHF series managed without Bellovac ABT served as control (Group 1, n = 138). RESULTS: Overall, 72 out of 255 (28%) received at least one ABT unit (2·1 ± 1·0 U/transfused patient) without differences between groups. However, in the subgroup of patients with admission Hb < 13 g/dl, the use of Bellovac ABT reduced postoperative ABT rates (16% vs. 46%, for groups 2 and 1, respectively; P = 0·001), although only 3 were reinfused, and was cost-saving. The use of Bellovac ABT also resulted in fewer wound bleeding complications, but there were no differences in Hb at postoperative days 7 and 30 between groups. CONCLUSIONS: In SHF patients with admission Hb < 13 g/dl and managed with peri-operative IV iron ± recombinant erythropoietin plus restrictive transfusion indication, the use of Bellovac ABT was associated with reduced ABT requirements, without increasing postoperative complications, and cost-savings.


Assuntos
Transfusão de Sangue/métodos , Fraturas do Quadril/cirurgia , Hemorragia Pós-Operatória/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Eritropoetina/administração & dosagem , Feminino , Humanos , Ferro/administração & dosagem , Masculino , Sucção , Vácuo
14.
Am J Nephrol ; 40(6): 554-60, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-25592645

RESUMO

BACKGROUND: Epoetin therapy used to treat anemia among ESRD patients has cost Medicare ∼$40 billion. Since January 2011, epoetin has been reimbursed via a new bundled prospective payment system (PPS). Our aim was to determine changes in epoetin dosing and hematocrit levels in response to PPS by different types of dialysis providers. METHODS: Data from the USRDS were used to identify 187,591 and 206,163 Medicare-eligible ESRD patients receiving hemodialysis during January 2010 (pre-PPS) and December 2011 (post-PPS). Standardized weekly mean epoetin dose administered pre- and post-PPS and adjustment in dose (titration) based on previous hematocrit level in each facility was disaggregated by profit status, chain membership and size. RESULTS: Major declines in epoetin use, dosing and achieved hematocrit levels were observed after PPS. Among the three largest dialysis chains, the decline in standardized epoetin dose was 29% at Fresenius, 47% at DaVita, and 52% at DCI. The standardized weekly epoetin dose among profit and nonprofit facilities declined by 38 and 42%, respectively. Changes in titration patterns suggest that a new hematocrit target of 30-33% was in place after PPS, replacing the erstwhile 33-36% hematocrit target used before PPS. CONCLUSION: Historically, important differences in anemia management were evident by dialysis organizational status. However, the confluence of financial incentives bundling epoetin payments and mounting scientific evidence linking higher hematocrit targets and higher epoetin doses to adverse outcomes have culminated in lower access to epoetin and lower doses across all dialysis providers in the first year after PPS.


Assuntos
Instituições de Assistência Ambulatorial/organização & administração , Anemia/tratamento farmacológico , Eritropoetina/administração & dosagem , Hematínicos/administração & dosagem , Sistema de Pagamento Prospectivo , Diálise Renal/economia , Anemia/etiologia , Tratamento Farmacológico/economia , Tratamento Farmacológico/tendências , Epoetina alfa , Eritropoetina/economia , Hematínicos/economia , Hematócrito , Humanos , Falência Renal Crônica/complicações , Falência Renal Crônica/terapia , Medicare/economia , Propriedade/organização & administração , Sistema de Pagamento Prospectivo/economia , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Diálise Renal/efeitos adversos , Estados Unidos
15.
Am J Nephrol ; 38(6): 496-500, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-24334854

RESUMO

BACKGROUND/AIMS: A cost analysis of a conversion from intravenous (IV) to subcutaneous (SC) epoetin α in patients receiving chronic in-center hemodialysis (HD). METHODS: This retrospective analysis compared epoetin α drug costs during a 6-month period of IV usage (July to December 2010, period 1) to a 6-month period of SC usage (July to December 2011, period 2) in four large in-center HD units. Data were collected from quarterly counts of HD patients receiving epoetin α and monthly inventory billing records. RESULTS: 622 HD patients who received IV epoetin α (period 1) were compared to 609 HD patients who received SC epoetin α (period 2). A 12.6% decrease in dose was observed. The average weekly cost of epoetin α was USD 173.02 per patient during the IV period versus USD 151.20 per patient during the SC period. This equated to a yearly cost savings of USD 1,135 per patient with SC epoetin α. CONCLUSION: The switch from IV to SC epoetin α was successfully implemented in all four centers and realized significant cost savings.


Assuntos
Administração Intravenosa/economia , Eritropoetina/administração & dosagem , Eritropoetina/economia , Injeções Subcutâneas/economia , Diálise Renal/instrumentação , Epoetina alfa , Custos de Cuidados de Saúde , Hemoglobinas/análise , Humanos , Manitoba , Proteínas Recombinantes/administração & dosagem , Proteínas Recombinantes/economia , Estudos Retrospectivos , Resultado do Tratamento
17.
Rev Med Chil ; 141(5): 568-73, 2013 May.
Artigo em Espanhol | MEDLINE | ID: mdl-24089270

RESUMO

BACKGROUND: In July 2010 end stage renal disease anemia correction was incorporated to the program of explicit health guaranties of the Ministry of Health. The treatment plan included intravenous iron and erythropoietin. The prescription of these medications carne from the deriving health organizations. AIM: To describe the results of that program in 11 dialysis facilities belonging to Fresenius Medical Care (a private organization) distributed in the six Metropolitan Health Services (MHS) in Santiago, Chile. MATERIAL AND METHODS: We selected 328 patients who remained in dialysis treatment at least between June 2010 and March 2011 and had a packed red cell volume lower than 30%, representing the target of the Plan. The evolution of packed red cell volume and the proportion of anemic patients in the facilities from each MHS were evaluated. RESULTS: The two above mentioned variables began to improve only in December 2010. In no MHS, with the exception of the Eastern MHS, the mean hematocrit improved to higher than 30%, nor was the proportion of anemic patients reduced to lower than 50%. CONCLUSIONS: Treatment of anemia of end stage renal disease in dialysis, implemented by the explicit health guaranties program of the Ministry of Health, was ineffective in almost all MHS in Santiago.


Assuntos
Anemia Ferropriva/tratamento farmacológico , Eritropoetina/administração & dosagem , Ferro/administração & dosagem , Falência Renal Crônica/terapia , Diálise Renal , Anemia Ferropriva/sangue , Anemia Ferropriva/etiologia , Quimioterapia Combinada , Hematócrito , Humanos , Injeções Intravenosas , Falência Renal Crônica/complicações , Avaliação de Programas e Projetos de Saúde
20.
BMJ ; 346: f3830, 2013 Jun 14.
Artigo em Inglês | MEDLINE | ID: mdl-23771225

Assuntos
Corticosteroides/administração & dosagem , Corticosteroides/efeitos adversos , Autoria/normas , Viés , Conflito de Interesses , Indústria Farmacêutica , Medicina Baseada em Evidências , Fidelidade a Diretrizes , Guias de Prática Clínica como Assunto/normas , Sociedades Médicas/economia , Traumatismos da Medula Espinal/tratamento farmacológico , Padrão de Cuidado , Corticosteroides/economia , Anticolesterolemiantes/administração & dosagem , Anticolesterolemiantes/efeitos adversos , Anticolesterolemiantes/economia , Conflito de Interesses/economia , Conflito de Interesses/legislação & jurisprudência , Ensaios Clínicos Controlados como Assunto , Esquema de Medicação , Indústria Farmacêutica/economia , Término Precoce de Ensaios Clínicos , Eritropoetina/administração & dosagem , Eritropoetina/efeitos adversos , Eritropoetina/economia , Medicina Baseada em Evidências/economia , Medicina Baseada em Evidências/ética , Medicina Baseada em Evidências/normas , Medicina Baseada em Evidências/tendências , Medo , Fibrinolíticos/administração & dosagem , Fibrinolíticos/efeitos adversos , Fibrinolíticos/economia , Fidelidade a Diretrizes/tendências , Humanos , Imperícia/legislação & jurisprudência , National Institutes of Health (U.S.) , Publicações Periódicas como Assunto/normas , Padrão de Cuidado/normas , Padrão de Cuidado/tendências , Acidente Vascular Cerebral/tratamento farmacológico , Ativador de Plasminogênio Tecidual/administração & dosagem , Ativador de Plasminogênio Tecidual/efeitos adversos , Ativador de Plasminogênio Tecidual/economia , Confiança , Estados Unidos
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