[High frequency of endoluminal thrombus in patients with ischaemic stroke following COVID-19]. / Alta Frecuencia de Trombo Endoluminal en pacientes con ictus isquémico tras la infección por Coronavirus 2019.

BACKGROUND: Ischaemic stroke may be a major complication of SARS-CoV-2 infection.Studying and characterising the different aetiological subtypes, clinical characteristics, and functional outcomes may be valuable in guiding patient selection for optimal management and treatment. METHODS: Data were collected retrospectively on consecutive patients with COVID-19 who developed acute focal brain ischaemia (between 1 March and 19 April 2020) at a tertiary university hospital in Madrid (Spain). RESULTS: During the study period, 1594 patients were diagnosed with COVID-19. We found 22 patients with ischaemic stroke (1.38%), 6 of whom did not meet the inclusion criteria. The remaining 16 patients were included in the study (15 cases of ischaemic stroke and one case of transient ischaemic attack).Median baseline National Institutes of Health Stroke Scale score was 9 (interquartile range: 16), and mean (standard deviation) age was 73 years (12.8). Twelve patients (75%) were men. Mean time from COVID-19 symptom onset to stroke onset was 13 days. Large vessel occlusion was identified in 12 patients (75%).We detected elevated levels of D-dimer in 87.5% of patients and C-reactive protein in 81.2%. The main aetiology was atherothrombotic stroke (9 patients, 56.3%), with the predominant subtype being endoluminal thrombus (5 patients, 31.2%), involving the internal carotid artery in 4 cases and the aortic arch in one. The mortality rate in our series was 44% (7 of 16 patients). CONCLUSIONS: In patients with COVID-19, the most frequent stroke aetiology was atherothrombosis, with a high proportion of endoluminal thrombus (31.2% of patients). Our clinical and laboratory data support COVID-19-associated coagulopathy as a relevant pathophysiological mechanism for ischaemic stroke in these patients.

Similar biotherapeutic products: overview and reflections.

Biotherapeutic products (BPs) have revolutionized medicine, changing the way we treat several pathologies such as autoimmune diseases and cancer, among others. Herein, we present an overview of similar BPs (SBPs), also called biosimilars, including the manufacturing process and regulatory aspects involved. The objective of developing an SBP is to manufacture a molecule that is highly similar to a reference BP by conducting a comparability exercise (CE) that can demonstrate similar safety and efficacy. This CE consists of quality, as well as nonclinical and clinical evaluation. A case-by-case analysis approach guided by scientific and objective standards must be the foundation for the SBP approval process. The establishment of a balance between a comprehensive CE for SBPs and their reference BPs, and the design of costeffective strategies to provide better access to BPs, should be the key goal for national regulatory authorities.

Sobre la necesidad de la farmacoeconomía. Comenzar por los principios / On the need of pharmacoeconomics. Beginning by the principles

Los gastos en salud y el uso de medicamentos han aumentado de forma importante en los últimos años, lo que alerta a gobiernos y entes sanitarios y puede relacionarse con algunos fenómenos: prescripción médica poco estandarizada, ganancias exageradas de la industria farmacéutica, avances en biotecnología y desperdicio de recursos, falta de comunicación entre gestores públicos y médicos clínicos y ausencia de regulación en precios de fármacos. La importancia de la farmacoeconomía se fundamenta en varios aspectos: optimización de prescripción médica, papel crucial en la comercialización y la distribución de medicamentos, capacidad de mostrar un amplio panorama del impacto social y económico de las enfermedades, como de abrir perspectivas de investigación en varios campos del conocimiento. Dentro de los tipos de estudios farmacoeconómicos se encuentran los que expresan la unidad de ingreso (costos) en términos monetarios y los resultados en unidades monetarias, naturales o de utilidad: reducción de costos (costo minimización), costo beneficio, costo utilidad y costo efectividad, como también los que estudian el panorama global de las enfermedades (análisis costo de la enfermedad). Los costos en salud se distribuyen de la siguiente manera: costos directos (médicos y no médicos), indirectos (impacto en la sociedad como unidad productiva) e intangibles (relacionados con calidad de vida de pacientes y familiares). La farmacoeconomía permite una mejor práctica clínica, sistemas de salud más eficientes y un consumo de recursos más racional. El uso de estos estudios es necesario para estructurar programas de salud y tomar decisiones. Así mismo es recomendada la inclusión de conceptos de economía de la salud en programas de medicina y ciencias de la salud.

Health expenditures and medication usage have increased dramatically in last years, situation that alerts governments and health authorities, and than can be related with some facts: not standardized medical prescription, excessive gains of the pharmaceutical industry, recent advances in biotechnology related with resource wastefulness, lack of communication between public health entities and clinical physicians and lack of consistent regulatory policies about drug prices. The importance of pharmacoeconomics is based on some aspects: better medical prescription, important role in commercialization and distribution of medicines, capacity of showing a broad and complete scenario of the social and economic impact of diseases, as opening research perspectives in different scientific fields. Within pharmacoeconomical analyses we can found those that show incomes (costs) in monetary units and show outcomes in monetary, natural or utility units: cost minimization, cost benefit, cost utility and cost effectiveness, and also we can found those analyses that study the general panorama of diseases (cost of illness studies). Health costs can be divided into: direct costs (medical and not medical), indirect (economical impact on society) and intangible (related with quality of life of patients and their families). Pharmacoeconomics can lead to a better medical practice, to more efficient health systems and to a more rational usage of resources. These studies are necessary for a proper structure of health programs, as for decision making. The inclusion of health economics concepts within medical and health sciences curricula is also recommended.