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INTRODUCTION: This study characterizes patients receiving evolocumab in clinical practice and assesses treatment effectiveness, safety and persistence outcomes across five countries. METHODS: This retrospective and prospective observational study enrolled patients initiated on evolocumab during August 2017 to July 2019 at 49 sites across Canada, Mexico, Colombia, Saudi Arabia and Kuwait. Medical records data were extracted within 6 months prior to (baseline) and every 3 months for 12 months post evolocumab initiation and reported as available. RESULTS: A total of 578 patients were enrolled (40.1% female, median age 60 [interquartile range (IQR) 51-68] years); 83.7% had atherosclerotic cardiovascular disease and/or familial hypercholesterolemia. Median low-density lipoprotein cholesterol (LDL-C) at baseline was 3.4 (IQR 2.7-4.2) mmol/L (131.5 [IQR 104.4-162.4] mg/dL), with 75.6% of patients receiving a statin (59.2% high intensity). Compared to baseline, the median lowest LDL-C was reduced by 70.2% and remained stable over 12 months of treatment. Guideline-recommended LDL-C thresholds < 1.8, < 1.4 and < 1.0 mmol/L (< 70, < 55 and < 40 mg/dL) were achieved by 75.3%, 63.6% and 47.4% of patients. LDL-C outcomes were consistent across high- and very high-risk patients. Background lipid-lowering therapy remained relatively stable. No serious treatment-emergent adverse events were reported, and persistence to evolocumab was 90.2% at 12 months. CONCLUSION: These findings provide real-world evidence that evolocumab use is in accordance with its international guideline-recommended place in dyslipidemia therapy, as well as confirmation of its effectiveness and safety in a heterogeneous population. Evolocumab can address a healthcare gap in the management of dyslipidemia by increasing the proportion of patients achieving LDL-C goals recommended to lower cardiovascular risk.
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Resumen Introducción: Los pacientes con enfermedad aterosclerótica establecida requieren tratamiento con estatinas para reducir la probabilidad de nuevos eventos. Objetivo: Identificar el porcentaje de pacientes con enfermedad coronaria aterosclerótica establecida que logran niveles de cLDL (colesterol LDL) inferiores a 70mg/dl y describir su distribución en tres grupos terapéuticos: estatinas, otros hipolipemiantes y sin tratamiento. Métodos: Estudio observacional descriptivo de corte transversal, en el que se seleccionaron pacientes de tres hospitales de alta complejidad, mayores de 18 años, con enfermedad aterosclerótica diagnosticada a partir del año 2017. El registro del perfil lipídico corresponde al realizado al menos tres meses después del diagnóstico. Resultados: Se incluyeron en total 746 pacientes con enfermedad coronaria aterosclerótica, con un promedio de edad de 65,3±10,9 años y predominio del sexo masculino (75,5%). Del total de los pacientes evaluados se prescribieron un 97,8% de terapia con al menos una estatina, 0,7% de otros hipolipemiantes y 1,5% no presentaron tratamiento. Los pacientes con niveles de cLDL inferior a 70mg/dl corresponden al 56%. Conclusiones: La extensa divulgación de guías de práctica clínica para dislipidemias en adultos en Colombia, y la incorporación de estatinas de alta intensidad, demuestran una mejoría en la proporción del cumplimiento en metas de cLDL para pacientes con enfermedad aterosclerótica establecida. Sin embargo, una alta proporción aún persiste fuera de metas, lo cual constituye una oportunidad de optimización del uso de terapias disponibles y recientemente desarrolladas.
Abstract Introduction: Patients with established atherosclerotic disease require treatment with statins in order to reduce the probability of new events. Objective: To identify the percentage of patients with established atherosclerotic coronary disease that achieve cLDL (LDL - cholesterol) levels less than 70mg/dL, and to describe its distribution in three treatment groups: statins, other lipid lowering drugs, and without treatment. Methods: A cross-sectional, descriptive observational study was conducted on patients diagnosed with atherosclerotic disease from 2017 and over 18-years-old from 3 tertiary hospitals. A record was made of the lipid profile that was performed at least three months after the diagnosis. Results: A total of 746 patients with atherosclerotic coronary disease were included. The mean age was 65.3±10.9 years and the majority (75.5%) were males. Of the total number of patients evaluated, 97.8% were prescribed a therapy with at least one statin, 0.7% with other lipid-lowering drugs, and 1.5% had no treatment. Just over half (56%) of the patients had cLDL levels of less than 70mg/dL. Conclusions: The widespread use of clinical practice guidelines for dyslipidaemias in adults in Colombia, and the incorporation of high-intensity statins, has led to an improvement in the proportion of patients with established atherosclerotic disease achieving cLDL targets. However, a high percentage still does not reach the targets, which suggests a need for an improving of the use of available and recently developed therapies.
