Clinical and therapeutic characterisation of a multicentre cohort of patients with inflammatory bowel disease in Colombia. / Caracterización clínica y terapéutica de una cohorte multicéntrica de pacientes con enfermedad inflamatoria intestinal en Colombia.

INTRODUCTION: In Latin America and Colombia there are few studies about the clinical and therapeutic characteristics of patients with inflammatory bowel disease (IBD). The objective of this study is to obtain an approximation to these data from a sample of patients from different reference centres in Colombia. PATIENTS AND METHODS: Cross-sectional study in adult and paediatric patients, with IBD, attended ambulatory in 6 institutions in different cities, between 2017 and 2020 information was collected on different dates, about demographic, clinical, and therapeutic aspects. RESULTS: Six hundred and five subjects, 565 (93.4%) adults, mean age 43 years (SD 12.78), 64% with ulcerative colitis (UC). The age at diagnosis of UC was 41.9 years, while in Crohn's disease (CD) it was 47.9 years. In UC, there was greater left involvement (47.2%), and in CD, 42.8% ileocolonic (L3). More than 50% were in mild activity or clinical remission. In UC, the biologic requirement was 27.2%, while in CD, 78%. Overall hospitalisation requirement was 39.5%, and the need for surgery was 37.5% in UC and 62.5% in CD. Also, 40 pediatric patients, 90% female, with UC being more frequent (80%). In UC, 83.3% presented extensive colitis, and in CD, all with ileocolonic localization (L3). More than 95% were in mild activity or remission. Biologic therapy was required in 16.6% and 75% for UC and CD, respectively. The frequency of hospitalisations and surgery was 2.7%. CONCLUSIONS: This study shows some unique characteristics of patients with IBD in Colombia. An earlier diagnosis is required, with a better therapeutic approach.

Efficacy and safety of faricimab for neovascular age-related macular degeneration: a systematic review and network meta-analysis.

OBJECTIVE: To evaluate the efficacy and safety of faricimab compared with other anti-vascular endothelial growth factor (anti-VEGF) agents in treating neovascular age-related macular degeneration (nAMD) patients. METHODS AND ANALYSIS: A systematic review (SR) was conducted up to January 2023. Network meta-analyses (NMA) were performed, including sensitivity and subgroup analyses for naïve population. Outcomes included changes in visual acuity (Early Treatment of Diabetic Retinopathy Study [ETDRS] letters), anatomical changes, frequency of injections and adverse events. The Cochrane Collaboration guidelines and the Confidence in Network Meta-Analysis framework were used for the SR and the certainty of evidence, respectively. RESULTS: From 4128 identified records through electronic databases and complementary searches, 63 randomised controlled trials (RCTs) met the eligibility criteria, with 42 included in the NMA. Faricimab showed a significant reduction in the number of annual injections compared with most fixed and flexible anti-VEGF treatment regimens, while showing no statistically significant differences in visual acuity through ETDRS letter gain, demonstrating a comparable efficacy. Retinal thickness results showed comparable efficacy to other anti-VEGF agents, and inferior only to brolucizumab. Results also showed that more patients treated with faricimab were free from post-treatment retinal fluid compared with aflibercept every 8 weeks, and both ranibizumab and bevacizumab, in the fixed and pro re nata (PRN) assessed schedules. Faricimab showed a comparable safety profile regarding the risk of ocular adverse events and serious ocular adverse events (SOAE), except for the comparison with brolucizumab quarterly, in which faricimab showed a significant reduction for SOAE risk. CONCLUSION: Faricimab showed a comparable clinical benefit in efficacy and safety outcomes, with a reduction in annual injections compared with fixed and flexible anti-VEGF drug regimens, representing a valuable treatment option for nAMD patients. PROSPERO REGISTRATION NUMBER: CRD42023394226.

The short-term cost-effectiveness of once-weekly semaglutide versus once-weekly dulaglutide for the treatment of type 2 diabetes mellitus in Colombian adults.

Background: Type 2 Diabetes Mellitus (T2DM) is a highly prevalent disease worldwide and in Colombia, representing one of the main causes of death and placing a considerable burden on healthcare systems. 13 classes of drugs are approved for the treatment of T2DM, with Glucagon-like Peptide-1 (GLP-1) receptor agonists being a first-line treatment option for patients with or at high risk of certain cardiovascular diseases and chronic kidney disease. The objective of this study is to conduct a short-term cost-effectiveness analysis of once-weekly semaglutide versus once-weekly dulaglutide in Colombian adults with T2DM, from a third-party payer perspective. Methods: Numbers needed to treat were calculated for different single and composite endpoints of the SUSTAIN 7 trial, annual costs for once weekly semaglutide 1.0 mg and dulaglutide 1.5 mg were extracted from the public SISMED database. With these inputs a cost of control model was developed, to obtain the annual cost of bringing one T2DM patient to relevant clinical outcomes by using semaglutide or dulaglutide. Results: Semaglutide was considered cost-effective compared to dulaglutide across all pre-specified endpoints, even in the different scenarios evaluated in the sensitivity analyses, and in a particularly pronounced manner for weight loss outcomes. Semaglutide at a dose of 1.0 mg once-weekly was cost-effective compared to dulaglutide 1.5 mg across all outcomes in the short-term, making it an appropriate first-line choice in the treatment of T2DM when deciding between these two GLP-1 receptor agonists. Conclusions: This is the first short-term cost-effectiveness study of semaglutide and dulaglutide in T2DM Colombian patients. Our modeled results suggest that once-weekly semaglutide represents a cost-effective option for treating individuals with T2DM in Colombia who are not achieving glycaemia control with metformin, and it would be expected to improve HbA1C, promote greater weight loss and reduce costs from a third-payer perspective compared with treatment with dulaglutide.

Trends in the epidemiology of inflammatory bowel disease in Colombia by demographics and region using a nationally representative claims database and characterization of inflammatory bowel disease phenotype in a case series of Colombian patients.

ABSTRACT: The incidence of inflammatory bowel disease (IBD) is on the rise in Latin America. The aims of this study were to examine epidemiologic trends of IBD in Colombia by demographics, region, urbanicity, and to describe the IBD phenotype in a large well-characterized Colombian cohort.We used a national database of 33 million adults encompassing 97.6% of the Colombian population in order to obtain epidemiologic trends of IBD using International Classification of Diseases 10codes for adults with ulcerative colitis (UC) and Crohn disease (CD). We calculated the incidence and prevalence of UC and CD from 2010-2017 and examined epidemiologic trends by urbanicity, demographics, and region. We then examined the IBD phenotype (using Montreal Classification), prevalence of IBD-related surgeries, and types of IBD-medications prescribed to adult patients attending a regional IBD clinic in Medellin, Colombia between 2001 and 2017.The incidence of UC increased from 5.59/100,000 in 2010 to 6.3/100,000 in 2017 (relative risk [RR] 1.12, confidence interval (CI) (1.09-1.18), P < .0001). While CD incidence did not increase, the prevalence increased within this period. The Andes region had the highest incidence of IBD (5.56/100,000 in 2017). IBD was seen less in rural regions in Colombia (RR=.95, CI (0.92-0.97), p < .01). An increased risk of IBD was present in women, even after adjusting for age and diagnosis year (RR 1.06 (1.02-1.08), P = .0003). The highest IBD risk occurred in patients 40 to 59 years of age. In the clinic cohort, there were 649 IBD patients: 73.7% UC and 24.5% CD. Mean age of diagnosis in CD was 41.0 years and 39.9 years in UC. UC patients developed mostly pancolitis (43%). CD patients developed mostly ileocolonic disease and greater than a third of patients had an inflammatory, non-fistulizing phenotype (37.7%). A total of 16.7% of CD patients had perianal disease. CD patients received more biologics than UC patients (odds ratio: 3.20, 95% CI 2.19-4.69 P < .001).Using both a national representative sample and a regional clinic cohort, we find that UC is more common in Colombia and is on the rise in urban regions; especially occurring in an older age cohort when compared to Western countries. Future studies are warranted to understand evolving environmental factors explaining this rise.

Usefulness of Preoperative Anorectal Manometry for Ostomy Closure: A Cross-sectional Study / Utilidad de la manometría anorrectal prequirúrgica para el cierre de ostomías: un estudio de corte transversal

Abstract Introduction: For several reasons, a patient may be taken to a colostomy for closure as soon as possible. However, their treatment may vary, and predicting adequate continence after colostomy closure can be difficult. The objective is to characterize preoperative manometry because, in Colombia, few cases describe its usefulness. Methods: A descriptive cross-sectional study of adult patients treated in two gastroenterology centers in Colombia between 2018 and 2020. Results: Of 316 patients, 13 were indicated manometry before colostomy closure, predominantly women (69%), with an average age of 51.69 years (standard deviation: 24.18). When evaluating the basal pressures of the anal sphincter, we noted 68% hypotonia, 16% hypertonia, and 16% normal pressures. The voluntary contraction test was abnormal in 25%, and a pattern of dyssynergic defecation was observed in 30%, all with type III patterns. The inhibitory rectoanal reflex was present in 92%, with an abnormal balloon expulsion test in 100% of patients. More than 70% of patients persisted with the colostomy in situ after the first year of construction and 30% beyond 36 months. Conclusions: The present study posits questions about the cost-effectiveness of anorectal manometry before colostomy closure, which requires corroboration by studies with more patients and more robust methodological designs.

Resumen Introducción: Hay varias razones por las que un paciente puede ser llevado a una colostomía con el objetivo de cerrarla lo antes posible, pero su tratamiento puede variar, y predecir una adecuada continencia posterior al cierre de la colostomía puede ser difícil. Se plantea como objetivo realizar una caracterización de la manometría prequirúrgica debido a que en Colombia hay pocos casos que describan su utilidad. Metodología: Estudio observacional descriptivo de corte transversal en pacientes adultos atendidos en dos centros de gastroenterología en Colombia entre el 2018 y el 2020. Resultados: De 316 pacientes, 13 tenían indicación de manometría previo a cierre de colostomía, predominantemente mujeres (69%), con una edad promedio de 51,69 años (desviación estándar: 24,18). Al evaluar las presiones basales del esfínter anal, se evidenció 68% de hipotonía, 16% de hipertonía y 16% de presiones normales. La prueba de contracción voluntaria fue anormal en el 25%, se observó un patrón de disinergia defecatoria en el 30%, todas con patrón tipo III. El reflejo rectoanal inhibitorio estuvo presente en el 92%, con prueba de expulsión de balón anormal en el 100% de los pacientes. Más del 70% de los pacientes persistían con la colostomía in situ después del primer año de su construcción y 30% más allá de 36 meses. Conclusiones: El presente estudio genera cuestionamientos acerca la costo-efectividad de la manometría anorrectal previa al cierre de colostomía, lo cual requiere ser corroborado por estudios con una mayor cantidad de pacientes y diseños metodológicos más robustos.

Dyssynergic Defecation Concerning Proctalgia Fugax: An Observational Study

Introduction: There is no clarity about manometric findings in patients with proctalgia fugax; evidence shows different results. This study aims to evaluate dyssynergic defecation through anorectal manometry in Colombian patients in two gastroenterology centers in Bogotá, Colombia. Materials and methods: A cross-sectional descriptive observational study in adult patients with proctalgia fugax undergoing anorectal manometry and treated in two gastroenterology centers in Bogotá between 2018 and 2020. Results: 316 patients were included, predominantly women (65%), with a median age of 45.2 (range: 18-78; standard deviation [SD]: 28.3). Four percent of patients had hypertonicity, 50% were normotonic, and 46% were hypotonic. Regarding manometric parameters, 50% had normal pressure, and 46% had anal sphincter hypotonia; 76% had a normal voluntary contraction test. Dyssynergic defecation was documented in 5% of patients, and the most frequent was type I, followed by type III. A rectoanal inhibitory reflex was identified in all patients, 42% with altered sensory threshold and 70% with abnormal balloon expulsion. There was an agreement between the results of the anorectal manometry and the subjective report of the digital rectal exam by the head nurse who performed the procedure. Conclusions: The data obtained in the present study suggest that proctalgia is not related to the elevated and sustained basal contracture of the sphincter but neither to the alteration in voluntary contraction since most patients have typical values.

Introducción: Actualmente, no hay claridad acerca de los hallazgos manométricos en pacientes con proctalgia fugaz, y la evidencia muestra diferentes resultados. Se plantea como objetivo en el presente estudio evaluar la presencia de disinergia defecatoria con manometría anorrectal en pacientes colombianos en dos centros de gastroenterología en Bogotá, Colombia. Metodología: Estudio observacional descriptivo de corte transversal en pacientes adultos sometidos a manometría anorrectal con proctalgia fugaz y atendidos en dos centros de gastroenterología de la ciudad de Bogotá entre el 2018 y el 2020. Resultados: Se incluyó a 316 pacientes, predominantemente mujeres (65%), con mediana de edad 45,2 (rango: 18-78; desviación estándar [DE]: 28,3). El 4% de los pacientes presentaban hipertonicidad, el 50% eran normotónicos y el 46%, hipotónicos. En cuanto a parámetros manométricos, el 50% tenía presión normal y el 46%, hipotonía de esfínter anal. El 76% tuvo una prueba de contracción voluntaria normal. En 5% pacientes se documentó disinergia defecatoria, y la más frecuente fue el tipo I, seguido del tipo III. En todos los pacientes se identificó reflejo recto anal inhibitorio, 42% con alteración en umbral sensitivo y 70% con expulsión de balón anormal, y hubo concordancia entre los resultados de la manometría anorrectal y el reporte subjetivo del tacto rectal de la jefe de enfermería que realizó el procedimiento. Conclusiones: Los datos obtenidos en el presente estudio sugieren que la proctalgia no está relacionada con la contractura basal elevada y sostenida del esfínter, pero tampoco con la alteración en la contracción voluntaria, ya que la mayoría de los pacientes presentan valores normales.

Caracterización clínica y terapéutica de una cohorte multicéntrica de pacientes con enfermedad inflamatoria intestinal en Colombia / Clinical and therapeutic characterisation of a multicentre cohort of patients with inflammatory bowel disease in Colombia

Introducción: En Latinoamérica y Colombia hay pocos estudios acerca las características clínicas y terapéuticas de pacientes con enfermedad inflamatoria intestinal (EII). Se plantea como objetivo obtener una aproximación a dichos datos a partir de una muestra de pacientes de diferentes centros de referencia en Colombia. Pacientes y métodos: Estudio de corte transversal en pacientes adultos y pediátricos, con EII, atendidos ambulatoriamente en seis instituciones en diferentes ciudades, entre 2017-2020 se recolectó información en fechas distintas, acerca aspectos demográficos, clínicos y terapéuticos. Resultados: Seiscientos cinco sujetos, 565 (93,4%) adultos, edad promedio de 43 años (DE 12,78), 64% con colitis ulcerosa (CU). La edad de diagnóstico de CU fue 41,9 años, mientras en enfermedad de Crohn (EC) fue 47,9 años. En CU, mayor compromiso izquierdo (47,2%), y en EC, 42,8% ileocolónico (L3). Más de 50% en actividad leve o remisión clínica. En CU, el requerimiento de biológico fue de 27,2%. mientras en EC, 78%. Requerimiento global de hospitalización en 39,5%, y necesidad de cirugía, de 37,5% en CU y 62,5% en EC. También, 40 pacientes pediátricos, 90% mujeres, siendo CU más frecuente (80%). En CU, 83,3% presentaron colitis extensa, y en EC, todas con localización ileocolónica (L3). Más de 95% en actividad leve o remisión. Requerimiento de biológico, en 16,6 y 75%, para CU y EC, respectivamente. La frecuencia hospitalizaciones y cirugía fue 2,7%. Conclusiones: Este estudio muestra algunas características únicas de los pacientes con EII en Colombia. Se requiere de un diagnóstico más temprano, con un mejor enfoque terapéutico. (AU)

Introduction: In Latin America and Colombia there are few studies about the clinical and therapeutic characteristics of patients with inflammatory bowel disease (IBD). The objective of this study is to obtain an approximation to these data from a sample of patients from different reference centres in Colombia. Patients and methods: Cross-sectional study in adult and paediatric patients, with IBD, attended ambulatory in 6 institutions in different cities, between 2017 and 2020 information was collected on different dates, about demographic, clinical, and therapeutic aspects. Results: Six hundred and five subjects, 565 (93.4%) adults, mean age 43 years (SD 12.78), 64% with ulcerative colitis (UC). The age at diagnosis of UC was 41.9 years, while in Crohn's disease (CD) it was 47.9 years. In UC, there was greater left involvement (47.2%), and in CD, 42.8% ileocolonic (L3). More than 50% were in mild activity or clinical remission. In UC, the biologic requirement was 27.2%, while in CD, 78%. Overall hospitalisation requirement was 39.5%, and the need for surgery was 37.5% in UC and 62.5% in CD. Also, 40 pediatric patients, 90% female, with UC being more frequent (80%). In UC, 83.3% presented extensive colitis, and in CD, all with ileocolonic localization (L3). More than 95% were in mild activity or remission. Biologic therapy was required in 16.6% and 75% for UC and CD, respectively. The frequency of hospitalisations and surgery was 2.7%. Conclusions: This study shows some unique characteristics of patients with IBD in Colombia. An earlier diagnosis is required, with a better therapeutic approach. (AU)