Análisis del programa de apoyo al paciente de evolocumab (Repatha®) para pacientes con enfermedades cardiovasculares en Colombia / Analysis of the evolocumab (Repatha®) patient support program for patients with cardiovascular disease in Colombia

Antecedentes: Las enfermedades cardiovasculares son la principal causa de muerte a nivel mundial. El objetivo es describir las características demográficas, los patrones de tratamiento, cumplimiento terapéutico y continuidad del tratamiento y explorar las variables relacionadas con la falta de adherencia de los pacientes inscritos en un programa de apoyo al paciente (PSP, por sus siglas en inglés) cardiovascular para al tratamiento con evolocumab en Colombia. Métodos: Estudio observacional-retrospectivo del registro de datos de los pacientes que ingresaron al programa PSP de evolocumab. Resultados: El análisis incluyó a 930 pacientes inscritos en el PSP (2017-2021). La edad media fue de 65,1 años (DE±1,1) y el 49,1% eran mujeres. La tasa media de cumplimiento del tratamiento con evolocumab fue del 70,5% (DE±21,8). Un total de 367 pacientes (40,5%) reportaron una tasa de cumplimiento superior al 80%. El análisis de continuidad incluyó a 739 pacientes (81,5%); el 87,8% de estos pacientes fueron considerados persistentes en el tratamiento. Un total de 871 pacientes (93,7%) reportaron al menos un evento adverso durante el período de seguimiento (en su mayoría no graves). Conclusión: Este es el primer estudio de la vida real sobre el tratamiento para la dislipidemia en un programa de apoyo a pacientes en Colombia. La adherencia encontrada fue superior al 70%, cifra similar a los hallazgos de otros estudios de vida real. Entre las causas del bajo cumplimiento se destacan las barreras administrativas y médicas para la suspensión o abandono del tratamiento con evolocumab. (AU)

Background: Cardiovascular diseases are considered the leading cause of death globally. This study describes the demographic characteristics, treatment patterns, self-reported compliance and persistence, and to explore variables related to non-adherence of patients enrolled in the cardiovascular patient support program (PSP) for evolocumab treatment in Colombia. Methods: This retrospective observational of the data registry of patients who entered the evolocumab PSP program. Results: The analysis included 930 patients enrolled in the PSP (2017-2021). Mean age was 65.1 (SD±13.1) and49.1% patients were female. The mean compliance rate to evolocumab treatment was 70.5% (SD±21.8). A total of 367 patients (40.5%) reported compliance higher than 80%. Persistence analysis included 739 patients (81.5%) where 87.8% of these patients were considered persistent to treatment. A total of 871 patients (93.7%) reported the occurrence of at least one adverse event during the follow-up period (mostly non-serious). Conclusion: This is the first real-life study describing patient characteristics, compliance and continuity of treatment for dyslipidemia in a patient support program in Colombia. The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab. (AU)

Analysis of the evolocumab (Repatha®) patient support program for patients with cardiovascular disease in Colombia. / Análisis del programa de apoyo al paciente de evolocumab (Repatha®) para pacientes con enfermedades cardiovasculares en Colombia.

BACKGROUND: Cardiovascular diseases are considered the leading cause of death globally. This study describes the demographic characteristics, treatment patterns, self-reported compliance and persistence, and to explore variables related to non-adherence of patients enrolled in the cardiovascular patient support program (PSP) for evolocumab treatment in Colombia. METHODS: This retrospective observational of the data registry of patients who entered the evolocumab PSP program. RESULTS: The analysis included 930 patients enrolled in the PSP (2017-2021). Mean age was 65.1 (SD±13.1) and49.1% patients were female. The mean compliance rate to evolocumab treatment was 70.5% (SD±21.8). A total of 367 patients (40.5%) reported compliance higher than 80%. Persistence analysis included 739 patients (81.5%) where 87.8% of these patients were considered persistent to treatment. A total of 871 patients (93.7%) reported the occurrence of at least one adverse event during the follow-up period (mostly non-serious). CONCLUSION: This is the first real-life study describing patient characteristics, compliance and continuity of treatment for dyslipidemia in a patient support program in Colombia. The overall adherence found was higher than 70%; similar to findings reported in other real-life studies with iPCSK9. However, the reasons for low compliance were different, highlighting the high number of administrative and medical reasons for suspension or abandonment of treatment with evolocumab.

Use of antibiotics in Paediatric Primary Health Care before and during the COVID-19 pandemic.

INTRODUCTION: Consumption of antibiotics is high in Spain, primarily in children. Excessive use of then contributes to the development of antimicrobial resistance. The aim of our study is to analyse the evolution of antibiotic consumption at the Primary Health Care in the paediatric population of Asturias, Spain, from 2014 to 2021, and to evaluate the impact of COVID-19 pandemic on it. METHODS: Retrospective and observational study using data about antibacterial agents for systemic use dispensed for official prescriptions to children under 14 years in Primary Care. Antibiotic consumption is expressed as defined daily dose (DDD) per 1000 inhabitants per day (DID). RESULTS: The antibiotic consumption rate dropped from 13.9 DID in 2014 to 4.0 in 2021 (ß=-1,42, p=0,002), with and inflection point in 2019. From 2019 to 2020 antibiotic use dropped by 47.1%. Antibiotic consumption remained very low from April 2020 to September 2021, and then moderately increased from October 2021. Prevalence of antibiotic use dropped from 39.9% in 2014 to 17.5% in 2021 (ß=-3,64, p=0,006). Relative consumption of amoxicillin/clavulanic acid decreased, while those of amoxiciline and third-generation cephalosporins increased. CONCLUSIONS: Paediatric antibiotic consumption collapsed in Asturias in 2020, coinciding with COVID-19 pandemic. Monitoring of antimicrobial usage indicators will allow to check if these changes are sustained over time.

Antibiotic consumption in secondary and tertiary hospitals in Colombia: national surveillance from 2018-2020 / Consumo de antibióticos en hospitales de segundo y tercer nivel en Colombia: vigilancia nacional entre 2018 y 2020 / Consumo de antibióticos em hospitais secundários e terciários da Colômbia: vigilância nacional de 2018 a 2020

ABSTRACT Objective. To assess the compliance in secondary and tertiary level hospitals with monthly reporting of antibiotic consumption to the Colombian National Public Health Surveillance System (SIVIGILA-INS), and to describe reported antibiotic consumption during 2018-2020. Methods. This study involved a secondary analysis of antibiotic consumption data reported to SIVIGILA-INS. Frequency of hospital reporting was assessed and compared against expected reports, disaggregated by intensive care units (ICU)/non-ICU wards and geographical regions. Consumption was expressed as defined daily dose (DDD) per 100 occupied beds for seven antibiotics. Results. More than 70% of hospitals reported antibiotic consumption at least once in each of the three years (79% in ICU and 71% in non-ICU wards). Of these, ICU monthly reporting was complete (12 monthly reports per year) for 59% in the period 2018-2019 but only 4% in 2020. Non-ICU reporting was complete for 52% in 2019 and for 2% in 2020. Most regions had an overall decrease in reporting in 2020. Analysis of antibiotic consumption showed an increase for piperacillin/tazobactam, ertapenem, and cefepime from 2019 to 2020. Conclusions. There were gaps in the consistency and frequency of reporting. Efforts are needed to improve compliance with monthly reporting, which declined in 2020, possibly due to the COVID-19 pandemic. Non-compliance on reporting and data quality issues should be addressed with the hospitals to enable valid interpretation of antibiotic consumption trends.

RESUMEN Objetivo. Evaluar el cumplimiento de los hospitales de segundo y tercer nivel en la presentación mensual de información sobre el consumo de antibióticos en el Sistema Nacional de Vigilancia en Salud Pública de Colombia (SIVIGILA-INS) y describir el consumo de antibióticos reportado en el período 2018-2020. Métodos. Este estudio incluyó un análisis secundario de los datos del consumo de antibióticos reportado en SIVIGILA-INS. Se evaluó la frecuencia de los informes hospitalarios y se comparó con los informes esperados, desglosados por unidad de cuidados intensivos (UCI) y otros servicios distintos a la UCI, y por región geográfica. El consumo se expresó en dosis diaria definida (DDD) por 100 camas ocupadas para siete antibióticos. Resultados. Más del 70% de los hospitales notificaron el consumo de antibióticos al menos una vez en cada uno de los tres años (79% en la UCI y 71% en los servicios distintos a la UCI). De estos, el 59% de las UCI completaron los informes mensuales (12 informes en un año) entre el 2018 y el 2019, pero solo el 4% en el 2020. El 52% de los servicios distintos a la UCI completó los informes en el 2019 y el 2% en el 2020. En la mayoría de las regiones hubo una disminución general de la notificación en el 2020. El análisis del consumo de antibióticos mostró un aumento de piperacilina/tazobactam, ertapenem y cefepima del 2019 al 2020. Conclusiones. Se encontraron disparidades en la coherencia y en la frecuencia de la presentación de informes. Es necesario destinar esfuerzos para mejorar el cumplimiento de la notificación mensual, que disminuyó en el 2020 posiblemente debido a la pandemia de COVID-19. La falta de cumplimiento en la presentación de los reportes y los problemas de calidad de los datos deben abordarse con los hospitales para facilitar la interpretación válida de las tendencias de consumo de antibióticos.

RESUMO Objetivo. Avaliar o cumprimento da exigência de notificar mensalmente o consumo de antibióticos em hospitais secundários e terciários ao Sistema Nacional de Vigilância em Saúde Pública da Colômbia (SIVIGILA-INS) e descrever o consumo informado de antibióticos de 2018 a 2020. Métodos. Este estudo envolveu uma análise secundária dos dados de consumo de antibióticos enviados para o SIVIGILA-INS. A frequência de notificação pelos hospitais foi avaliada e comparada com a frequência esperada. Os dados foram desagregados entre unidades de terapia intensiva (UTIs) e enfermarias gerais e por regiões geográficas. O consumo foi expresso como dose diária definida (DDD) por 100 leitos ocupados para sete antibióticos. Resultados. Mais de 70% dos hospitais notificaram consumo de antibióticos pelo menos uma vez em cada um dos três anos (79% na UTI e 71% nas enfermarias gerais). Entre eles, 59% dos hospitais enviaram todas as notificações relativas a UTIs (12 notificações mensais) no período de 2018 a 2019, mas apenas 4% o fizeram em 2020. No caso das enfermarias gerais, 52% dos hospitais enviaram todas as notificações em 2019 e 2% o fizeram em 2020. A maioria das regiões teve uma diminuição geral no número de notificações enviadas em 2020. A análise do consumo de antibióticos revelou um aumento no uso de piperacilina/tazobactam, ertapeném e cefepima de 2019 para 2020. Conclusões. Houve lacunas na uniformidade e frequência das notificações. São necessários esforços para melhorar o cumprimento da exigência de notificações mensais, que, possivelmente devido à pandemia de COVID‑19, diminuiu em 2020. Problemas relacionados ao não cumprimento da exigência de notificação e à qualidade dos dados devem ser resolvidos junto aos hospitais para permitir uma interpretação válida das tendências de consumo de antibióticos.

Consumo de antibióticos en atención primaria en población adulta de Asturias durante el periodo 2014-2020 / Antibiotic consumption in primary care in the adult population of Asturias during 2014–2020 period

Objetivo: Estudiar la evolución del consumo de antibióticos en población adulta en el ámbito de Atención Primaria (AP) del Servicio de Salud del Principado de Asturias (SESPA) durante 2014-2020.DiseñoEstudio observacional retrospectivo.EmplazamientoAP del SESPA.ParticipantesPoblación de la base de datos de Tarjeta Sanitaria Individual.IntervencionesSe recogieron datos de prescripción de antibióticos, realizada en las consultas de medicina de familia, dispensados en las oficinas de farmacia con cargo al SESPA. Se analizaron variables de uso y consumo de antibióticos mediante modelos de regresión lineal.Mediciones principalesPrevalencia de uso de antibióticos (porcentaje población); tasa de consumo de antibióticos de uso sistémico (DTD), consumo relativo de antibióticos de espectro reducido (porcentaje DDD).ResultadosLa prevalencia media del uso de antibióticos del periodo 2014-2019 fue de 32,2% y 23,9% en 2020. La tasa de consumo de antibióticos de uso sistémico pasó de 21,4 DTD en 2014 a 12,7 DTD en 2020. El consumo de antibióticos de espectro reducido se mantuvo estable (19,4% DDD en 2014 y 19,3% DDD en 2020) (IC95: -0,10, 0,26). En el periodo de marzo a diciembre de 2020, el consumo de antibióticos se redujo un 28,6% respecto al mismo periodo de 2019.ConclusionesEn 2014-2020 el consumo de antibióticos disminuyó, especialmente a partir de la pandemia por COVID-19, con estabilización del consumo de antibióticos de espectro reducido respecto al total. Existe variabilidad en el consumo por subgrupos terapéuticos.

Trend study of the consumption of systemic antibiotics in the adult population in of Primary Care of the Health Service of the Principality of Asturias (SESPA) during the period 2014̶2020. Retrospective observational study. SESPA, Primary Care. Population from the Individual Health Card database. Data were collected on the prescription of antibiotics, carried out in the family medicine consultations, dispensed in the pharmacy offices with charge of SESPA. Antibiotic use and consumption variables were analyzed using linear regression models. Prevalence of antibiotic use (population percentage); consumption rate of systemic antibiotics (DTD), relative consumption of narrow-spectrum antibiotics (percentage DDD). The average prevalence of the use of antibiotics for the 2014̶2019 period was 32.2% and 23.9% in 2020. The rate of consumption of systemic antibiotics decreased from 21.4 DTD in 2014 to 12.7 DTD in 2020. The consumption of narrow-spectrum antibiotics remained stable (19.4% DDD in 2014 and 19.3% DDD in 2020) (CI95: −0.10, 0.26). In the period from March to December 2020, the consumption of antibiotics decreased by 28.6% compared to the same period in 2019. In 2014̶2020, the consumption of antibiotics decreased, especially since the COVID-19 pandemic, with stabilization of the consumption of narrow-spectrum antibiotics compared to the total. There is variability in consumption by therapeutic subgroups.

[Antibiotic consumption in primary care in the adult population of Asturias during 2014-2020 period]. / Consumo de antibióticos en atención primaria en población adulta de Asturias durante el periodo 2014-2020.

Trend study of the consumption of systemic antibiotics in the adult population in of Primary Care of the Health Service of the Principality of Asturias (SESPA) during the period 2014̶2020. Retrospective observational study. SESPA, Primary Care. Population from the Individual Health Card database. Data were collected on the prescription of antibiotics, carried out in the family medicine consultations, dispensed in the pharmacy offices with charge of SESPA. Antibiotic use and consumption variables were analyzed using linear regression models. Prevalence of antibiotic use (population percentage); consumption rate of systemic antibiotics (DTD), relative consumption of narrow-spectrum antibiotics (percentage DDD). The average prevalence of the use of antibiotics for the 2014̶2019 period was 32.2% and 23.9% in 2020. The rate of consumption of systemic antibiotics decreased from 21.4 DTD in 2014 to 12.7 DTD in 2020. The consumption of narrow-spectrum antibiotics remained stable (19.4% DDD in 2014 and 19.3% DDD in 2020) (CI95: -0.10, 0.26). In the period from March to December 2020, the consumption of antibiotics decreased by 28.6% compared to the same period in 2019. In 2014̶2020, the consumption of antibiotics decreased, especially since the COVID-19 pandemic, with stabilization of the consumption of narrow-spectrum antibiotics compared to the total. There is variability in consumption by therapeutic subgroups.