Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study.

OBJECTIVE: Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. PATIENTS AND METHODS: We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. RESULTS: We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2-60.1) in UC, and 50.0 months (40.9-60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. CONCLUSIONS: SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM.

Correlations between ankle circumference, symptoms, and quality of life demonstrate the clinical relevance of minimal leg swelling reduction: results of a study in 1,036 Argentinean patients.

BACKGROUND: Clinical classification (C) of patients suffering from chronic venous disorders according to the Clinical, Etiology, Anatomy, and Pathophysiology Classification takes into account signs and symptoms, but the C3 (venous edema) class has been identified as poorly specific. Patients in whom physicians fail to observe significant edema (sign) frequently report a feeling of swelling (symptom). Previous studies of venoactive drugs have demonstrated significant reduction in leg volume, but the correlation with a clinical improvement was lacking. OBJECTIVE: To describe the clinical status of a sample of Argentinean patients presenting with venous symptoms and signs. To demonstrate the relationship between the reduction of leg swelling and the improvement of symptoms of chronic venous disorders (CVDs) and quality of life (QoL) in patients with CVD. MATERIALS AND METHODS: One thousand thirty-six patients were included prospectively and submitted to medical interrogation and examination and specific and generic self-questionnaires. Patients included were reassessed using the same tools after phlebotropic treatment (Ruscus+hesperidin+ascorbic acid), the prescription of which was expected to induce variations in clinical status. RESULTS: Significant correlations were observed between ankle circumference reduction and improvement of all symptoms in C2 to C3 patients: heaviness, pain, paraesthesia, and cramps. Such correlations were found in C0 to C1 patients. There was a correlation between improvement attained in QoL and the physical dimension of the Chronic Venous Insufficiency Questionnaire. CONCLUSIONS: Our results demonstrate the relevance of moderate ankle swelling, which is not usually described clinically as edema and is probably a typical symptom of chronic venous disorders. Future studies should focus on this insufficiently analyzed clinical feature and put to better use more specific QoL questionnaires.

Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study / Respuesta subóptima a los antagonistas del factor de necrosis tumoral en la enfermedad inflamatoria intestinal en Latinoamérica: Estudio EXPLORE LATAM

Objective Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. Patients and methods We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. Results We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2–60.1) in UC, and 50.0 months (40.9–60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. Conclusions SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM (AU)

Objetivo Los datos sobre tratamiento con antagonistas del factor de necrosis tumoral (anti-TNF) y su respuesta subóptima (RSO) en las enfermedades inflamatorias intestinales (EII) en América Latina (LATAM) son escasos. Se evaluaron la incidencia e indicadores de RSO a anti-TNF en pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) de Argentina, Colombia y México. Pacientes y métodos Se realizó un análisis retrospectivo de datos del estudio EXPLORE LATAM (NCT03090139), incluyendo pacientes adultos con EII que iniciaron anti-TNF entre marzo de 2010 a marzo de 2015. Se evaluó la incidencia acumulada de RSO a los anti-TNF en primera línea. Además, se realizó una encuesta a especialistas sobre las barreras del tratamiento con anti-TNF. Resultados Se incluyeron 185 pacientes con EII (CU/EC: 99/86) tratados con anti-TNF en primera línea de Argentina (38 CU; 40 EC), Colombia (21 CU; 25 EC) y México (40 CU; 21 EC); 36,4% de los pacientes con CU y 46,5% de los pacientes con EC experimentaron RSO a anti-TNF durante la mediana (intervalo intercuartílico) de 49 meses (37,2-60,1) en CU y 50 meses (40,9-60,1) en EC. El indicador más común de RSO fue el aumento del tratamiento no biológico (CU: 41,7%; EC: 35,0%). La accesibilidad y la derivación tardía a centros especializados fueron las barreras más comunes para el tratamiento con anti-TNF. Conclusiones La RSO a anti-TNF fue frecuente en pacientes con EII de LATAM, el aumento del tratamiento no biológico representó el indicador más frecuente de RSO. Nuestros hallazgos contribuyen a la evidencia actual sobre las necesidades insatisfechas asociadas a los anti-TNF en LATAM (AU)

Uso de fármacos antihipertensivos en pediatría: ¿Existe evidencia suficiente? / Use of antihypertensive agents in pediatrics: Do we have enough evidence?

El informe del Segundo Grupo de Tareas sobre el control de la presión arterial en los niños estableció guías para el diagnóstico y tratamiento de la hipertensión infantil. Estas recomiendan un enfoque individualizado para la terapéutica apropiada encada caso e incluyen la elección de los fármacos más pertinentes. En este artículo se presenta un análisis de las bases racionales para la selección de un fármaco antihipertensivo en pediatría. En general, la terapéutica antihipertensiva en niños se caracteriza por la ausencia de estudios clínicos controlados aleatorizados con buen diseño. Por lo tanto, la evidencia disponible es escasa y de baja calidad. No obstante ello, las nuevas regulaciones están alentando a las compañías farmacéuticas a llevar acabo estudios en niños para desarrollar fármacos con indicaciones pediátricas