Uso de agentes hipolipemiantes y cumplimiento de metas terapéuticas en pacientes de alto riesgo cardiovascular en la República Argentina / Use of Lipid-Lowering Agents and Therapeutic Goal Achievement in Cardiovascular High-Risk Patients in Argentina

RESUMEN Introducción: Uno de los pilares fundamentales para la reducción del riesgo cardiovascular en pacientes en prevención secundaria es el correcto manejo del tratamiento hipolipemiante. Las estatinas en altas dosis, el ezetimibe, y más recientemente los inhibidores de PCSK9 (iPCSK9) son las principales herramientas farmacológicas con las que contamos para que estos pacientes cumplan metas terapéuticas de colesterol LDL (C-LDL). A pesar de la contundente evidencia a favor de estas terapéuticas, existe una gran subutilización de las mismas a nivel mundial, con bajos niveles de adherencia e inercia terapéutica. En Argentina existe escasa evidencia sobre la calidad del tratamiento hipolipemiante, y qué porcentaje de pacientes en prevención secundaria se encuentran con un perfil lipídico controlado acorde a guías nacionales e internacionales. Material y métodos: Diseñamos un estudio de corte transversal en pacientes en prevención secundaria de eventos cardiovasculares incluidos de forma prospectiva, consecutiva y multicéntrica en hospitales de la República Argentina que poseen sistema de Residencia Médica afiliados al Consejo Argentino de Residentes de Cardiología (CONAREC). Se realizó la recolección de datos durante los meses de marzo a agosto del año 2020. Se relevó el tratamiento hipolipemiante que recibían, los motivos detrás de la no utilización de estatinas en dosis adecuadas, y los valores de perfil lipídico en caso de contar con un registro en los últimos 6 meses previos a la inclusión. Resultados: Se incluyeron 1000 pacientes consecutivos de 24 centros, correspondientes a 11 provincias. Un 85,9% se encontraba bajo tratamiento con estatinas; un 4,8%, con ezetimibe; un 2,4% con fibratos; y un 13%, sin tratamiento. De aquellos pacientes en tratamiento con estatinas, un 67% recibía estatinas en altas dosis (58% del total de pacientes). Un total de 509 pacientes presentaban medición del C-LDL dentro de los últimos 6 meses. El valor promedio de C-LDL fue de 94 (90,6-97,8) mg/dL; el de C-LDL, 41 (40,7-42,6) mg/dL; y el de triglicéridos, 151 (142,9-159,8) mg/dL. Un 30% se encontraba con valores por debajo del corte de 70 mg/dL. Un 16% se encontraba con valores por debajo de 55 mg/dL. Un 37% de los pacientes presentaba C-LDL >100 mg/dL. Conclusiones: En este estudio multicéntrico de pacientes en prevención secundaria desarrollado en la República Argentina, poco más de la mitad presentaba tratamiento con estatinas en altas dosis, con una escasa utilización de ezetimibe. El subtratamiento se reflejó en los valores de C-LDL, con más de dos tercios de los pacientes fuera de rango terapéutico y, por lo tanto, lejos de las recomendaciones de las guías clínicas.

ABSTRACT Background: The correct management of lipid-lowering treatment is one of the key factors for the reduction of cardiovascular risk in secondary prevention patients. High-dose statins, ezetimibe, and more recently PCSK9 inhibitors (PCSK9i) are the main tools available to meet LDL cholesterol (LDL-C) therapeutic goals in these patients. Despite the overwhelming evidence in their favor, these therapies are greatly underutilized worldwide, with low levels of adherence and therapeutic inertia. In Argentina, there is scarce evidence on the quality of lipid-lowering treatment and the rate of patients in secondary prevention with a controlled lipid profile according to national and international guidelines. Methods: A prospective, multicenter, cross-sectional study including consecutive patients in secondary prevention for cardiovascular events from hospitals of Argentina with a Medical Residency system affiliated to CONAREC, was carried out from March to August 2020. Data was collected on the lipid-lowering treatment received, the reasons behind the non-use of statins in adequate doses and the lipid profile levels in case of having a record from the last 6 months prior to inclusion. Results: Among 1000 consecutive patients included from 24 centers corresponding to 11 provinces, 85.9% was treated with statins, 4.8% with ezetimibe, 2.4% with fibrates, and 13% was without treatment. In the case of patients treated with statin therapy, 67% was receiving high-dose statins (58% of the total number of patients). A total of 509 patients presented LDL-C assessment within the last 6 months. Mean LDL-C was 94 (90.6-97.8) mg/dl, HDL cholesterol 41 (40.7-42.6) mg/dl, and triglycerides 151 (142.9-159.8) mg/dl. In 30% of cases, LDL-C was below the cut-off value of 70 mg/dl and in 16% below 55 mg/ dl. In 37% of patients, LDL-C was >100 mg/dl. Conclusions: In this multicenter secondary prevention study performed in Argentina, just over half of the patients presented high-dose statin treatment, with scarce use of ezetimibe. Undertreatment was reflected in LDL-C values, with more than two-thirds of patients outside the therapeutic range, and therefore far from clinical guideline recommendations.

Risco Cardiovascular e Elegibilidade Para Estatina na Prevenção Primária: Comparação Entre a Diretriz Brasileira e a Diretriz da AHA/ACC / Cardiovascular Risk and Statin Eligibility in Primary Prevention: A Comparison between the Brazilian and the AHA/ACC Guidelines

Resumo Fundamento Diferenças entre as versões atualizadas da Diretriz Brasileira de Dislipidemias e da Diretriz de Colesterol da American Heart Association (AHA)/American College of Cardiology (ACC) quanto à estratificação de risco cardiovascular e à elegibilidade para a terapia com estatina não são conhecidas. Objetivos Comparar a categorização de risco cardiovascular e a elegibilidade à terapia com estatina estabelecidas segundo a diretriz brasileira ou a diretriz da AHA/ACC em pacientes em prevenção primária. Métodos Nós avaliamos retrospectivamente indivíduos com idade entre 40 e 74 anos sem condições de alto risco, com LDL-c 70 -< 190 mg/dL, sem tratamento com agentes hipolipemiantes, e que passaram por avaliação clínica de rotina. O risco cardiovascular foi estratificado de acordo com a diretriz brasileira e a da AHA/ACC. Os indivíduos foram considerados elegíveis para estatina se os níveis de LDL-c estivessem no mínimo 30 mg/dL acima da meta para o risco cardiovascular (diretriz brasileira) ou se o risco em 10 anos para doença cardiovascular aterosclerótica fosse ≥ 7,5% (diretriz da AHA/ACC). Um valor de p < 0,05 foi considerado estatisticamente significativo. Resultados A amostra do estudo consistiu 18525 indivíduos (69% homens, idade 48 ± 6 anos). Entre os indivíduos considerados de risco intermediário ou alto segundo a diretriz brasileira, mais de 80% seriam classificados em uma categoria de risco mais baixo segundo a diretriz da AHA/ACC. Entre os homens, 45% e 16% seriam considerados elegíveis para a terapia com estatina segundo as diretrizes brasileira e da AHA/ACC, respectivamente (p < 0,001). Entre as mulheres, as respectivas proporções seriam 16% e 1% (p < 0,001). Oitenta e dois porcento das mulheres e 57% dos homens elegíveis para estatina com base no critério da diretriz brasileira não seriam considerados elegíveis para estatina segundo o critério da AHA/ACC. Conclusões Em comparação à diretriz da AHA/ACC, a diretriz brasileira classifica uma maior proporção dos pacientes em prevenção primária em categorias de risco mais alto e aumenta substancialmente a elegibilidade para estatina. (Arq Bras Cardiol. 2020; 115(3):440-449)

Abstract Background Differences between the updated versions of the Brazilian Guideline on Dyslipidemias and the American Heart Association (AHA)/American College of Cardiology (ACC) Cholesterol Guideline regarding cardiovascular risk stratification and statin eligibility are unknown. Objectives To compare cardiovascular risk categorization and statin eligibility based on the Brazilian guideline with those based on the AHA/ACC guideline in primary prevention patients. Methods We retrospectively analyzed individuals aged 40-74 years without high-risk conditions, with LDL-c 70 to < 190 mg/dL, not on lipid-lowering drugs, who underwent routine clinical assessment. Cardiovascular risk was stratified according to the Brazilian and the AHA/ACC guidelines. Subjects were considered eligible for statin therapy if LDL-c was at least 30 mg/dL above the target for the cardiovascular risk (Brazilian guideline) or the 10-year atherosclerotic cardiovascular disease risk was ≥7.5% (AHA/ACC guideline). A p-value < 0.05 was considered statistically significant. Results The study sample consisted of 18,525 subjects (69% male, age 48 ± 6 years). Among subjects considered at intermediate or high risk by the Brazilian guideline, over 80% would be in a lower risk category by the AHA/ACC guideline. Among men, 45% and 16% would be statin eligible by the Brazilian and the AHA/ACC guidelines criteria, respectively (p < 0.001). Among women, the respective proportions would be 16% and 1% (p < 0.001). Eighty-two percent of women and 57% of men eligible for statins based on the Brazilian guideline criterion would not be eligible according to the AHA/ACC guideline criterion. Conclusions Compared with the AHA/ACC guideline, the Brazilian guideline classifies a larger proportion of primary prevention patients into higher-risk categories and substantially increases statin eligibility. (Arq Bras Cardiol. 2020; 115(3):440-449)

The effects of Atorvastatin calcium on the incidence of macular edema after phacoemulsification in diabetic patients / 中华眼底病杂志

Objective To investigate the effects of Atorvastatin calcium on the incidence of macular edema after phacoemulsification in diabetic patients.Methods Forty two eyes of 42 cataract patients with diabetes and hypercholesterolemia who underwent phacoemulsification surgery were divided into interventional group (23 patients) and non-interventional group (19 patients) by random number table methods.The blood glucose and pressure of patients in two groups was controlled strictly before and after surgery.10 mg Atorvastatin calcium per day was delivered one day after cataract surgery for the patients of interventional group and used for 24 weeks.No lipid-lowing agent was provided to the patients of non-interventional group.The main outcome measures included the best corrected visual acuity (BCVA),central retina thickness (CRT),total cholesterol (TC),low density lipoprotein cholesterol (LDL-C) and high density lipoprotein cholesterol (HDL-C).No significant difference was shown in the BCVA,CRT,TC,LDL-C and HDL-C in two groups before phacoemulsification surgery (t=1.251,1.257,1.031,1.042,1.461;P＞0.05).At the end of the 24 weeks after surgery,the efficacy evaluation and comparative analysis were performed.The analysis included the BCVA,the incidence of macular edema,CRT,TC,LDL-C and HDL-C.Results The BCVA was no significantly different between two groups one day after surgery (t=1.523,P＞0.05).But 4,12,24 weeks after phacoemulsification surgery,the BCVA in interventional group was better than that in non-interventional group(t=3.920,3.012,7.025;P＜0.05).24 weeks after the operation,macular edema was occurred in 2 eyes (8.69％) in interventional group and 4 eyes (21.05 ％) in non-interventional group.Significance difference was found between two groups (x2 =4.896,P＜0.05).There was no significance different of the CRT between two groups one day after operation (t=1.501,P＞0.05).Whereas,the significance difference of the CRT was occurred in two groups 4,12,24 weeks after surgery(t=4.673,7.583,9.035;P＜0.05).Comparing with that in non-interventional group,the level of TC (t =7.043,7.930,8.611) and LDL-C (t =9.374,9.554,10.856) in interventional group was significantly decreased 4 to 24 weeks after operation (P＜0.05).But no significance different of HDL-C was shown in two groups 4,12 and 24 weeks after surgery (t=1.057,1.127,1.295;P＞ 0.05).Conclusion The treatment of Atorvastatin calcium effectively reduced the incidence rate of macular edema in hypercholesterolemia patients with good glycemic and hypertension control after phacoemulsification surgery.