Consenso sobre definición de criterios diagnósticos, terapéuticos y de seguimiento de la acromegalia en pacientes colombianos

Contexto: la acromegalia es una enfermedad rara en la población general y habitualmente tiene una evolución clínica insidiosa, lo cual genera un reto para diagnosticar al paciente a partir de la sospecha clínica y posterior confirmación con las ayudas diagnósticas. La mayoría de pacientes con acromegalia tienen como origen de la enfermedad un tumor hipofisario secretor de hormona del crecimiento y en consecuencia el tratamiento debe estar dirigido a lograr el control bioquímico y la reducción de la masa tumoral. Finalmente, el seguimiento del paciente resulta clave para lograr el control de la enfermedad y detectar las comorbilidades asociadas. Objetivo: definir criterios para el diagnóstico, tratamiento y seguimiento de la acromegalia en pacientes colombianos. Materiales y métodos: se realizó un consenso tipo Delphi modificado. Participaron 10 expertos en el manejo del paciente con acromegalia (endocrinólogos y neurocirujanos) y un grupo desarrollador. Los resultados fueron analizados y discutidos. A partir de este ejercicio, se presentaron las recomendaciones en los diferentes apartados. Resultados: se obtuvieron recomendaciones acerca del seguimiento al paciente colombiano con acromegalia y el abordaje del paciente desde el sistema de salud local, la sospecha clínica, el diagnóstico bioquímico e imagenológico, el tratamiento mediante intervención quirúrgica, el tratamiento farmacológico y la radioterapia. Conclusiones: en Colombia es importante el fortalecimiento del conocimiento médico desde la atención primaria hasta el especialista en el correcto diagnóstico, manejo y seguimiento del paciente con acromegalia para lograr la detección temprana de la enfermedad y disminuir la progresión de las comorbilidades asociadas

Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P = 0.98). There were no significant between-group differences in rates of acute pancreatitis (P = 0.07) or pancreatic cancer (P = 0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events

Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

Relación costo-efectividad del abastecimiento de dantroleno desde el punto de vista del prestador de servicios de salud

8 páginasIntroduction: Malignant hyperthermia is an acute syndrome triggered by certain anesthetic medications. Dantrolene is the only specific treatment for malignant hyperthermia crises. Without treatment, lethalitymay be as high as 80%. In Colombia, it is not mandatory to keep dantrolene supplies in stock. Objective: To establish the cost-benefit ratio, from the perspective of healthcare institutions, of keeping dantrolene supplies in stock in the operating theater. Methods: Using a decision tree, a Monte Carlo simulation was run with 10 thousand scenarios to determine the median annual cost of keeping full or partial stocks (36 or 12 vials 20mg, respectively) of dantrolene. For the option of not keeping supplies in stock, the cost threshold was calculated where the expected value of both alternatives of the decision tree is equalized. Indifference curves were constructed for complete and partial supplies. Results: The median annual cost was estimated at 6.6 million Colombian pesos (COP) for full dantrolene supplies, and at COP 2.2 million for partial supplies. The median economic consequence threshold for one death due to the unavailability of dantrolene was estimated at COP 18.5 million for full supplies, and at COP 57.0 million for partial supplies. Conclusion: If, as a result of the unavailability of dantrolene, the economic consequences of a death due to malignant hyperthermia exceed the threshold of COP 57.0 or COP 18.5 million, the purchase of full or partial stocks, respectively, is justified.Introduccion: La hipertermia maligna (HM) es un síndrome agudo desencadenado por algunos medicamentos anestésicos. El dantroleno es el unico tratamiento especí fico para las crisis de HM. Sin tratamiento puede tener una letalidad cercana al 80%. En Colombia, el abastecimiento de dantroleno no es obligatorio. Objetivo: Establecer la relacion costo-efectividad, desde el punto de vista de las instituciones prestadoras de servicios de salud, de mantener un abastecimiento de dantroleno en quirofanos. Métodos: Mediante un árbol de decisiones se realizo una simulacion Monte Carlo con 10 mil escenarios para determinar la mediana del costo anual de un abastecimiento completo o parcial (36 o 12 viales de 20mg, respectivamente) de dantroleno. Para la alternativa de no tener abastecimiento, se calculo el umbral de costo, donde se iguala el valor esperado de ambas alternativas del árbol de decisiones. Se construyeron curvas de indiferencia para el abastecimiento completo y parcial. Resultados: La mediana del costo anual del abastecimiento completo de dantroleno se estimo en $6.6 millones de pesos colombianos (COP), y el del abastecimiento parcial en$2.2 millones COP. La mediana del umbral de consecuencias economicas por una muerte sin disponibilidad de dantroleno se estimo en 18.5 millones COP para el abastecimiento completo, y en 57.0 millones COP para el abastecimiento parcial. Conclusion: Si por no disponer de dantroleno las consecuencias economicas de una muerte por HM superan el umbral de $57.0 o$18.5 millones COP, se justifica la compra de un abastecimiento completo o parcial, respectivamente

Relación costo-efectividad del abastecimiento de dantroleno desde el punto de vista del prestador de servicios de salud

8 páginasIntroduction: Malignant hyperthermia is an acute syndrome triggered by certain anesthetic medications. Dantrolene is the only specific treatment for malignant hyperthermia crises. Without treatment, lethalitymay be as high as 80%. In Colombia, it is not mandatory to keep dantrolene supplies in stock. Objective: To establish the cost-benefit ratio, from the perspective of healthcare institutions, of keeping dantrolene supplies in stock in the operating theater. Methods: Using a decision tree, a Monte Carlo simulation was run with 10 thousand scenarios to determine the median annual cost of keeping full or partial stocks (36 or 12 vials 20mg, respectively) of dantrolene. For the option of not keeping supplies in stock, the cost threshold was calculated where the expected value of both alternatives of the decision tree is equalized. Indifference curves were constructed for complete and partial supplies. Results: The median annual cost was estimated at 6.6 million Colombian pesos (COP) for full dantrolene supplies, and at COP 2.2 million for partial supplies. The median economic consequence threshold for one death due to the unavailability of dantrolene was estimated at COP 18.5 million for full supplies, and at COP 57.0 million for partial supplies. Conclusion: If, as a result of the unavailability of dantrolene, the economic consequences of a death due to malignant hyperthermia exceed the threshold of COP 57.0 or COP 18.5 million, the purchase of full or partial stocks, respectively, is justified.Introduccion: La hipertermia maligna (HM) es un síndrome agudo desencadenado por algunos medicamentos anestésicos. El dantroleno es el unico tratamiento especí fico para las crisis de HM. Sin tratamiento puede tener una letalidad cercana al 80%. En Colombia, el abastecimiento de dantroleno no es obligatorio. Objetivo: Establecer la relacion costo-efectividad, desde el punto de vista de las instituciones prestadoras de servicios de salud, de mantener un abastecimiento de dantroleno en quirofanos. Métodos: Mediante un árbol de decisiones se realizo una simulacion Monte Carlo con 10 mil escenarios para determinar la mediana del costo anual de un abastecimiento completo o parcial (36 o 12 viales de 20mg, respectivamente) de dantroleno. Para la alternativa de no tener abastecimiento, se calculo el umbral de costo, donde se iguala el valor esperado de ambas alternativas del árbol de decisiones. Se construyeron curvas de indiferencia para el abastecimiento completo y parcial. Resultados: La mediana del costo anual del abastecimiento completo de dantroleno se estimo en $6.6 millones de pesos colombianos (COP), y el del abastecimiento parcial en$2.2 millones COP. La mediana del umbral de consecuencias economicas por una muerte sin disponibilidad de dantroleno se estimo en 18.5 millones COP para el abastecimiento completo, y en 57.0 millones COP para el abastecimiento parcial. Conclusion: Si por no disponer de dantroleno las consecuencias economicas de una muerte por HM superan el umbral de $57.0 o$18.5 millones COP, se justifica la compra de un abastecimiento completo o parcial, respectivamente

Evaluación del nivel de competitividad de las empresas que elaboran subproductos derivados de la hoja de Coca. caso de estudio empresa: Coca Nasa

La hoja de coca es utilizada para la elaboración de diferentes productos dentro de la industria legal como una opción para mejorar el desarrollo económico y al mismo tiempo la conservación de las costumbres de las comunidades indígenas del país; respaldadas estas últimas por normatividad internacional como el convenio 169 de 1989 sobre pueblos indígenas tribales de la Organización Internacional del Trabajo OIT y el numeral 2º del artículo 14 de la ley 67 de 1993 de la Convención de las Naciones Unidas, que hablan sobre el respeto a los usos tradicionales lícitos de la hoja de coca que estén soportados por la evidencia histórica y que puedan ser incluidos dentro del concepto de patrimonio cultural inmaterial; adicionalmente, teniendo en cuenta el marco de transformación de la legalidad de los cultivos de la hoja de coca en la región y a su vez el impacto social y ambiental de la elaboración de productos ilícitos a partir de la misma, vislumbramos el fomento a la industria de los alimentos y bebidas elaborados con la hoja de coca como una actividad económica viable y diferenciada del cultivo destinado al proceso de alcaloides. Es así, como apoyados en el caso de la empresa Coca Nasa del resguardo de la comunidad nasa del departamento del Cauca, consideramos importante evaluar el nivel de competitividad de las empresas que elaboran subproductos derivados de la hoja de coca, con el fin de establecer el impacto socio económico de dichas empresas, su situación actual desde el reconocimiento de los derechos como organización de etnias indígenas, su diferenciación en el mercado, los posibles mercados estratégicos, el valor agregado de sus productos y su nivel de aceptación. Adicionalmente, consideramos importante resaltar que para el desarrollo de esta investigación, tomamos como referente el trabajo “el caso coca nasa, análisis jurídico de la política del estado colombiano en materia de comercialización de alimentos y bebidas derivados de hoja de coca producidos por comunidades indígenas” del Grupo de investigación “Justicia y Conflicto” de la Escuela de Derecho de la Universidad EAFIT.The coca leaf is used to make different products within the legal industry as an option to improve economic development and at the same time preserve the customs of the country's indigenous communities; supported by international regulations such as Convention 169 of 1989 on tribal indigenous peoples of the International Labor Organization ILO and the numeral 2 of article 14 of Law 67 of 1993 of the United Nations Convention, which speak on respect for the traditional licit uses of the coca leaf that are supported by historical evidence and that can be included within the concept of intangible cultural heritage; additionally, taking into account the framework of transformation of the legality of coca leaf crops in the region and in turn the social and environmental impact of the production of illicit products from it, we envision the promotion of the industry of Food and beverages made with coca leaf as a viable and differentiated economic activity of the crop destined for the alkaloid process. Thus, as supported in the case of the Coca Nasa company of the nasa community's shelter in the department of Cauca, we consider it important to assess the level of competitiveness of the companies that produce by-products derived from the coca leaf, in order to establish the socio-economic impact of these companies, their current situation from the recognition of rights as an organization of indigenous ethnic groups, their differentiation in the market, the possible strategic markets, the added value of their products and their level of acceptance. Additionally, we consider it important to highlight that for the development of this research, we take as reference the work “the coca nasa case, legal analysis of the Colombian state's policy regarding the commercialization of food and beverages derived from coca leaf produced by indigenous communities” of the “Justice and Conflict” Research Group of the EAFIT University School of Law