RESUMOObjetivo: Revisar as evidências clínicas da estenose valvular aórtica em suas dimensões médica e econômica, analisando as alternativas de tratamento cirúrgico em pacientes de alto risco cirúrgico com foco na tecnologia do implante transcateter de válvula aórtica (TAVI). Métodos: Foi elaborada uma revisão narrativa das publicações relacionadas à estenose vascular aórtica e às metodologias de tratamento cirúrgico, assim como a comparação entre a metodologia TAVI e as abordagens convencionais (substituição cirúrgica de válvula aórtica por esternotomia, valvuloplastia por balão intra--aórtico e tratamento farmacológico), abordando ainda dados sobre algumas diferentes marcas e gerações de dispositivos de TAVI oferecidas no mercado brasileiro, avaliando a eficácia, a segurança e o custo de tratamento. Resultados: Em pacientes portadores de estenose aórtica grave sintomá-tica e inoperáveis pela abordagem convencional, o uso do TAVI mostrou ser uma alternativa mais segura, eficaz e econômica em comparação aos tratamentos convencionais. Estudos com robustez metodológica mostram que esse procedimento alcança taxas superiores a 80% de sobrevida em um ano e aproximadamente 30% em cinco anos, mesmo em pacientes de alto risco. No entanto, foram observadas diferenças significativas nos desfechos entre diferentes estudos, que podem ser atribuídas não apenas ao desenho e à amostragem, mas às diferenças entre as diversas opções de gerações e marcas de dispositivos para TAVI disponíveis no mercado. Essas opções diferem principalmente na estrutura, via de inserção e modo de expansão. As válvulas de terceira geração vêm apresentando os melhores resultados em termos de eficácia, segurança e facilidade no procedimento, que resultam em mais benefícios aos pacientes e equilibram os custos de tratamento em médio e longo prazos. Conclusões: Estudos com evidências robustas avaliando desfechos representativos para o tratamento da estenose aórtica grave e sintomática mostram que a tecnologia minimamente invasiva TAVI é eficaz, segura no tratamento de pacientes de alto risco ou inoperáveis, com melhorias significativas nos dispositivos de terceira geração. ABSTRACTObjective: To review the clinical evidences of aortic valve stenosis in its medical and economical settings, reviewing the surgical treatment alternatives in patients at high surgical risk focused on the transcatheter aortic valve implantation (TAVI) technology. Methods: A structured review of the publications related to the disease and to the surgical treatment methodologies was conducted, followed by a search for information about the TAVI methodology, with comparisons between this method and conventional approaches (surgical aortic valve replacement by means of sternotomy, valvuloplasty via intra-aortic balloon and pharmacological treatment) and comparisons between different brands and generations of TAVI devices, evaluating the treatment efficacy, safety and cost.
Background: Although pharmacoeconomic studies constitute a valuable tool for better managing drug consumption, the conditions under which such studies would be performed in Latin American countries have not been explored.Objectives: The aim of this paper is to evaluate the potential advantages of and pitfalls in doing pharmacoeconomic research in Latin America and to propose avenues to facilitate the development of this field in the region.Methods: The Canadian guidelines for the economic evaluation of pharmaceuticals served as a structured framework to assess, both prospectively and retrospectively, the conditions under which the pharmacoeconomic component of a clinical trial held in Mexico and Brazil would be and actually was conducted.Results: The conditions under which pharmacoeconomic evaluations are conducted must be improved if studies are to contribute to the better management of scarce resources across the entire health care system.Conclusions: The creation of a public funding agency, the reappraisal of administrative data as a management tool in both the public and the private sectors, and the establishment of national guidelines should be considered within the framework of reforms aimed at allowing healthcare systems to meet their objectives of efficiency and equity.
To assess physician beliefs on the relative benefits of pens vs. vials, prescribing drivers, and characteristics of patients newly initiated on basal insulin analog via pens vs. vials among elderly type 2 diabetes patients. METHODS: An online survey of 352 U.S. primary care physicians was used to collect retrospective patient chart data on 500 elderly type 2 diabetes patients who initiated on basal insulin analog in 2009. For each physician, patient chart selection was randomized among eligible patients. Data on physician characteristics, physicians' opinion on the impact of different routes of administration (ROA), main drivers for selecting a particular ROA for each patient, and patient characteristics were collected. RESULTS: The majority of physician respondents were part of a group practice (77.8%) and treated a mean of 235.5 (SDϭ185.0) type 2 patients Ն 65 years old in 2009. Patient characteristics were similar in terms of age and diabetes duration. However, significantly more Caucasians (p ϭ 0.011) and patients covered by Medicare only (pϭ0.015) were initiated on pens, whereas significantly more women (pϭ0.003), Black/African Americans (pϭ0.011), and dual eligible patients (Medicare ϩ Medicaid; pϭ0.008) were initiated on vials. Patients initiated on vials had higher median baseline HbA1c values (8.7 vs. 8.4, pϽ0.001).Survey findings suggested that physicians prescribed vials primarily due to patients' economic constraints (62.9% of vial users vs. only 2.4% for pen users), although a majority of physicians considered pens better than vials (89.2% in terms of adherence, 65.1% in terms of HbA1c control, and 55.4% in terms of resource utilization). CONCLUSIONS: Results from this retrospective chart extraction survey suggest that patient characteristics differed between patients initiated on pens vs. vials, and that despite insulin pens being perceived as having better outcomes by physicians, economic considerations play a dominant role in the choice of insulin vials.
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