SPIRIT: Assessing Clinical Parameters Associated with Using IDegLira in Patients with Type 2 Diabetes in a Real-World Setting in Colombia.

INTRODUCTION: Insulin degludec/liraglutide (IDegLira) is a fixed-ratio combination of insulin degludec (a basal insulin) and liraglutide (a glucagon-like peptide-1 receptor agonist [GLP-1RA]). This study aimed to investigate clinical outcomes in people with type 2 diabetes mellitus (T2DM) after initiating IDegLira treatment in a real-world setting in Colombia. METHODS: SPIRIT is a non-interventional, single-arm, retrospective chart review study to assess clinical outcomes in people with T2DM. Participating patients were switched from a treatment regimen of basal insulin (with or without oral antidiabetics [OADs]) and started on treatment with IDegLira a minimum of 26 ± 6 weeks before the data collection start date. Data were collected from the medical records of 175 patients in ten clinical centers across Colombia. RESULTS: Compared with baseline, there was a significant reduction in glycated hemoglobin (HbA1c) (1.3%; 95% confidence interval [CI] - 1.6 to - 1.0; p < 0.0001) after 26 ± 6 weeks of follow-up. The mean HbA1c at baseline and at the end of the study was 9.1% and 7.8%, respectively. In addition, IDegLira significantly reduced absolute body weight by 1 kg (95% CI - 1.5 to - 0.5; p < 0.0001), from a mean of 76.1 kg at baseline to 75.1 kg after follow-up. The mean IDegLira dose at the end of the study was 21.3 U, and no severe hypoglycemic events were observed during the follow-up period. CONCLUSION: In real-world practice, initiating IDegLira in patients with T2DM previously treated with basal insulin (± OAD) was associated with improved glycemic control, reduced body weight and reduced risk of hypoglycemia. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT05324462.

Cost-utility analysis of palivizumab for preventing respiratory syncytial virus in preterm neonates and infants in Colombia.

AIM: Palivizumab has proven effective in reducing hospitalizations, preventing severe illness, improving health outcomes, and reducing healthcare costs for infants at risk of respiratory syncytial virus (RSV) infection. We aim to assess the value of palivizumab in preventing RSV infection in high-risk infants in Colombia, where RSV poses a significant threat, causing severe respiratory illness and hospitalizations. METHODS: We conducted a decision tree analysis to compare five doses of palivizumab with no palivizumab. The study considered three population groups: preterm neonates (≤ 35 weeks gestational age), infants with bronchopulmonary dysplasia (BPD), and infants with hemodynamically significant congenital heart disease (CHD). We obtained clinical efficacy data from IMpact-RSV and Cardiac Synagis trials, while we derived neonatal hospitalization risks from the SENTINEL-1 study. We based hospitalization and recurrent wheezing management costs on Colombian analyses and validated them by experts. We estimated incremental cost-effectiveness ratios and performed 1,000 Monte Carlo simulations for probabilistic sensitivity analyses. RESULTS: Palivizumab is a dominant strategy for preventing RSV infection in preterm neonates and infants with BPD and CHD. Its high efficacy (78% in preventing RSV in preterm infants), the substantial risk of illness and hospitalization, and the high costs associated with hospitalization, particularly in neonatal intensive care settings, support this finding. The scatter plots and willingness-to-pay curves align with these results. CONCLUSION: Palivizumab is a cost-saving strategy in Colombia, effectively preventing RSV infection in preterm neonates and infants with BPD and CHD by reducing hospitalizations and lowering healthcare costs.

A cost-effectiveness analysis of pneumococcal conjugate vaccines in infants and herd protection in older adults in Colombia.

BACKGROUND: Pneumococcal diseases have a clinical and economic impact on the population. Until this year, a 10-valent pneumococcal vaccine (PCV10) used to be applied in Colombia, which does not contain serotypes 19A, 3, and 6A, the most prevalent in the country. Therefore, we aimed to assess the cost-effectiveness of the shift to the 13-valent pneumococcal vaccine (PCV13). RESEARCH DESIGN AND METHODS: A decision model was used for newborns in Colombia between 2022-2025 and adults over 65 years. The time horizon was life expectancy. Outcomes are Invasive Pneumococcal Diseases (IPD), Community-Acquired Pneumonia (CAP), Acute Otitis Media (AOM), their sequelae, Life Gained Years (LYGs), and herd effect in older adults. RESULTS: PCV10 covers 4.27% of serotypes in the country, while PCV13 covers 64.4%. PCV13 would avoid in children 796 cases of IPD, 19,365 of CAP, 1,399 deaths, and generate 44,204 additional LYGs, as well as 9,101 cases of AOM, 13 cases of neuromotor disability and 428 cochlear implants versus PCV10. In older adults, PCV13 would avoid 993 cases of IPD and 17,245 of CAP, versus PCV10. PCV13 saves $51.4 million. The decision model shows robustness in the sensitivity analysis. CONCLUSION: PCV13 is a cost-saving strategy versus PCV10 to avoid pneumococcal diseases.

Calidad de vida de pacientes con diabetes tipo 2 en Colombia. Revisión sistemática y metaanálisis acumulativo / Quality of Life of Patients with Type 2 Diabetes in Colombia. Systematic Review and Cumulative Meta-analysis

Resumen Antecedentes: La calidad de vida (CV) relacionada con la salud es un indicador de desempeño de los sistemas sanitarios; no obstante, se desconoce su estado en personas con diabetes tipo 2, lo que limita la implementación y evaluación de intervenciones dirigidas a mejorar su salud. Objetivo: Identificar los dominios más afectados en la CV de pacientes con diabetes tipo 2. Método: Búsqueda sistemática en las bases de datos LILACS, Pubmed, Embase y Google Académico, de estudios observacionales que midieron de manera cuantitativa la CV de pacientes con diabetes tipo 2, sin importar la comorbilidad o estado funcional, en el contexto ambulatorio u hospitalario en Colombia. Para identificar los dominios más afectados se realizó un metaanálisis acumulativo de estudios observacionales que midieron la CV con los Cuestionarios de Salud SF-36 (Short Form-36) y SF-8 (Short Form-8), y se realizó un modelo de efectos aleatorios que permitió la estimación de las medias como medida de efecto combinado. Resultados: Se identificaron siete artículos, de los cuales cuatro fueron incluidos en la síntesis cuantitativa. Los dominios de la CV de los pacientes con diabetes tipo 2 más afectados según los Cuestionarios SF-36 y SF-8 fueron salud general 49,7 (IC 95%: 37,3 a 62,0), rol físico 53,6 (IC 95%: 35,6 a 71,6) y función física 53,8 (IC 95%: 34,8 a 72,8). Conclusión: Los programas preventivos y de atención a personas con diabetes tipo 2 deben enfocarse en un manejo integral que contribuya al mejoramiento de su CV relacionada con su salud.

Abstract Background: The quality of life related to health is an indicator performance of health system; however, its condition in people with type 2 diabetes is unknown, which limits the implementation and evaluation of interventions aimed at improving their health. Objectives: To identify the most affected domains in the quality of life in people with 2 type diabetes. Methods: Systematic search in LILACS, Pubmed, Embase and Google Scholar data bases for observational studies that measure quantitatively the quality of life for patients with diabetes type 2, despite comorbidity or functional status, in the ambulatory or hospital setting in Colombia. In order to identify the most affected domains, it was carried out a cumulative meta-analysis of observational studies aimed to measure life quality through the Health Questionnaires SF-36 (Short Form-36) and SF-8 (Short Form-8), and also, a Random effects model was conducted, which allowed the average as a measure of combined effect. Results: Seven articles were identified, of which four were included in the quantitative synthesis, the most affected domains according to SF-36 and SF-8 were general health 49.7 (95% CI: 37.3 to 62.0), physical role 53.6 (95% CI: 35.6 to 71.6), physical function 53.8 (95% CI: 34.8 to 72.8). Conclusion: Preventive and care programs for people with type 2 diabetes should focus on comprehensive management that contributes to quality of life improvement concerned health. It is still required to expand the investigation to account for the results in people's health.

Cost-effectiveness analysis of iStent trabecular micro-bypass stent for patients with open-angle glaucoma in Colombia.

OBJECTIVE: To estimate the cost-effectiveness of trabecular micro bypass stent vs laser trabeculoplasty or medications only, for patients with open-angle glaucoma in a setting of the Colombian System Health. METHODS: This is a cost-effectiveness analysis that based its assumptions in external data sources, used to extrapolate the quality-of-life related to health, survival, and costs. A Markov model, with stages from 0 (ocular hypertension without glaucoma) to 5 and bilateral blindness, was developed inclusive of Colombians older than 40 years in 2018, from a societal perspective, comparing trabecular micro-bypass stents vs laser trabeculoplasty, timolol + dorzolamide + brimonidine, timolol + dorzolamide + latanoprost, or timolol + dorzolamide + brimatoprost, in terms of clinical and economic outcomes over a lifetime horizon. Both costs and health outcomes had an annual rate discount of 5%. Health outcomes were evaluated in terms of QALYs related with loss of visual acuity. Trabecular micro-bypass costs include the joint use of timolol, and the costs of laser trabeculoplasty include the combined use of timolol + dorzolamide. RESULTS: Trabecular micro-bypass stents were estimated to have 127,971 more discounted QALYs vs laser trabeculoplasty; 405,982 vs timolol + dorzolamide + brimonidine; and 378,287 vs timolol + dorzolamide + latanoprost or timolol + dorzolamide + brimatoprost. Cumulative costs with trabecular micro-bypass stents at 40 years was $13,252,318 lower than laser trabeculoplasty; $6,403,534, lower than timolol + dorzolamide + brimonidine; $22,311,064, lower than timolol + dorzolamide + latanoprost; and $29,156,113 lower than timolol + dorzolamide + brimatoprost. CONCLUSIONS: The trabecular micro-bypass stent is a highly cost-saving strategy due to more QALYs related to a lower rate of the population with loss of visual acuity in the long-term, and because the costs associated with additional medications and complications are lower with trabecular micro-bypass stents.

Cost-effectiveness analysis of the available pneumococcal conjugated vaccines for children under five years in Colombia.

BACKGROUND: Pneumococcal diseases in children under five years are common and preventable. In Colombia there are two pneumococcal conjugate vaccines (PCV) that have proved clinical efficacy. The aim was to estimate the cost-effectiveness of 13-valent PCV (PCV13) and 10-valent PCV (PCV10) in terms of prevention of Invasive Pneumococcal Diseases (IPD), radiologically-confirmed pneumonia, and their related mortality, as well as, acute otitis media (AOM) in a cohort of newborns in Colombia. METHODS: We developed an analytical decision tree model with national data including the distribution of pneumococcal serotypes in Colombia between 2009 and 2013. A simulation of vaccination of 90% of newborns in Colombia took place with a time horizon of 5 years. The analysis was done from the Colombian health system perspective. Vaccines efficacy parameters were measured as life-years gained (LYG) and avoided morbidity by pneumococcal diseases; they were determined by a systematic review of literature. A health insurance company provided the costs. A probabilistic and a univariate sensitivity analysis for epidemiological, efficacy and cost parameters were done. RESULTS: After 5 years projection, PCV13 would prevent 437 deaths due to pneumococcal infections versus 321 that would be prevented by PCV10, compared to no vaccination. PCV13 would generate 25 396 LYG, and PCV10 would generate 18 708 LYG. Medical costs avoided would be US$ 19 479 395 for PCV13 and US$ 13 703 271 for PCV10. Compared to no vaccination, PCV13 and PCV10 were cost-effective, with an incremental cost-effectiveness ratio (ICER) of US$ 489.26 and US$ 813.41 per additional LYG, respectively; besides, PCV13 was dominant over PCV10 due to lower costs and better outcomes. CONCLUSION: PCV13 is a cost-saving strategy compared with PCV10, as part of a universal coverage vaccination program in Colombian children under one year. PCV13 is expected to lead to a greater decrement in infant mortality from pneumococcal diseases, and a higher cost saving by preventing more pneumococcal diseases compared with PCV10 in a 5 years projection.

Cost-effectiveness analysis of pneumococcal conjugate vaccine 13-valent in older adults in Colombia.

BACKGROUND: Nowadays, there are two vaccination strategies in Colombia to prevent pneumococcal diseases in people over 50 years. Our aim is to estimate cost-effectiveness of pneumococcal conjugate vaccine 13-valent (PCV13) versus pneumococcal polysaccharide vaccine 23-valent (PPSV23) to prevent pneumococcal diseases and their related mortality in people over 50 years old in Colombia. METHODS: A Markov model was developed with national data, including pneumococcal serotypes distribution in Colombia between 2005 and 2010. Vaccination of a cohort was simulated and a five year time horizon was assumed. Analysis was done from a perspective of a third party payer. Direct costs were provided by a national insurance company; sensitive univariate and probabilistic analysis were done for epidemiological and clinical effectiveness parameters and costs. RESULTS: PCV13 avoids 3 560 deaths by pneumococcal infections versus PPSV23 and 4 255 deaths versus no vaccine. PCV13 prevents 79 633 cases by all-cause pneumonia versus PPSV23 and 81 468 cases versus no vaccine. Total costs (healthcare and vaccines costs) with PCV13 would be U.S. $ 97,587,113 cheaper than PPSV23 and it would save U.S. $ 145,196,578 versus no vaccine. CONCLUSION: PCV13 would be a cost-saving strategy in the context of a mass vaccination program in Colombia to people over 50 years old because it would reduce burden of disease and specific mortality by pneumococcal diseases, besides, it saves money versus PPSV23.

Supervivencia en niños de muy bajo peso al nacimiento, 1996-2004 / Survival in Children with Low Birth Weights, 1996 – 2004

El objetivo de esta investigación fue establecer la probabilidad de supervivencia y la morbilidad de los neonatos con muy bajo peso al nacimiento, en un hospital de tercer nivel de Colombia. Para este fin se evaluaron todos los neonatos nacidos vivos con peso inferior a 1500g en el Hospital General de Medellín, entre 1996 y 2004. Resultados: durante el período de estudio ingresaron 1443 neonatos. 54 por cien de las madres recibió esteroides antenatales y 17.1 por cien de los neonatos recibió surfactante pulmonar. La media del tiempo de supervivencia de los neonatos con peso inferior a 1000g fue menor a un día. Ningún neonato de 23 semanas o menos egresó vivo. La probabilidad de ingresar a la Unidad de Cuidado Intensivo Neonatal fue significativamente menor entre los neonatos menores de 1000g, que entre los neonatos de 1000 a 1490 g, y el RR = 0.54 (IC95 por cien: 0.44-0.65). La mortalidad de este grupo fue mayor de manera estadísticamente significativa, que entre los de 1000 a 1490 g, y el RR = 3.8 (IC 95 por cien=3.3-4.3). La fracción atribuible en la población (Raptor cien) debida al extremo bajo peso al nacer fue de 47.8 por cien. Conclusiones: hay menor probabilidad de ingreso a la Unidad de Cuidado Intensivo Neonatal en los neonatos con peso inferior a 1000 g, lo cual afecta la probabilidad de sobrevivir de esta población. La alta probabilidad de morir debido al extremo bajo peso al nacimiento debe llamar la atención de las autoridades sanitarias, porque esto evalúa de manera indirecta la calidad de atención obstétrica que reciben las pacientes. Deben diseñarse estudios de cohorte en esta población, con el fin de evaluar el pronóstico a largo plazo que permitan diseñar políticas de atención materna y neonatal.