Carga económica de la hipercolesterolemia en población con alto riesgo cardiovascular en México / Economic burden of hypercholesterolemia in high risk of cardiovascular disease population in Mexico

Resumen Objetivo: Se estimó la carga económica directa e indirecta de la hipercolesterolemia en población con alto riesgo de presentar un evento cardiovascular. Para ello se definieron específicamente cinco grupos de pacientes: 1) aquellos con hipercolesterolemia familiar; 2, 3 y 4) personas con hipercolesterolemia más el antecedente de diabetes, infarto o evento vascular cerebral; 5) pacientes con hipercolesterolemia más diabetes y antecedente de infarto agudo de miocardio (definidos como pacientes de muy alto riesgo cardiovascular). Los cálculos se hicieron desde la perspectiva de las instituciones de salud pública en México. Método: Para la estimación de los costos directos se incluyó la atención ambulatoria, el tratamiento farmacológico, la atención hospitalaria y las intervenciones quirúrgicas relacionadas con las enfermedades cardiovasculares. Para la carga económica indirecta, se consideraron las muertes reportadas específicamente por causa de hipercolesterolemia, en un momento anterior al final de la edad productiva (muerte prematura). Resultados: La carga económica directa de las cinco categorías de pacientes en riesgo consideradas es de MXN $39,601,464,154 (USD $1,987,526,432), mientras que la carga económica indirecta asciende a MXN $121,646,689 (USD $6,105,229). Conclusiones: El impacto económico de la hipercolesterolemia en población con alto riesgo cardiovascular correspondía a $39,723,110,843 en 2020 (equivalente a USD $1,993,631,661), equivalente al 0.16% del PIB nacional.

Abstract Objective: To estimate the direct and indirect economic burden of hypercholesterolemia in patients with high risk of a cardiovascular event, specifically there were defined 5 groups of patients: 1) familial hypercholesterolemia; 2, 3 and 4) patients with hypercholesterolemia and background of diabetes, myocardial infarction or stroke; 5) diabetes, myocardial infarction and hypercholesterolemia (very high-risk patients) from the Mexican public healthcare institutions. Methods: For the estimation of the direct costs the items included correspond to: outpatient care, pharmacological treatment, inpatient hospital care, and surgical procedures. For indirect economic burden, death certificates, before the end of the productive age due to hypercholesterolemia were calculated (premature mortality). Results: The direct economic burden for the 5 groups of patients at risk is MXN $39,601,464,154 (USD $1,987,526,432), while the indirect economic burden amounts to MXN $121,646,689 (USD $6,105,229). Conclusions: The economic impact of hypercholesterolemia in patients with high cardiovascular risk is $39,723,110,843 (equivalent to USD $1,993,631,661) and corresponds to the 0.16% of GDP.

Economic burden of hypercholesterolemia in high risk of cardiovascular disease population in Mexico.

OBJECTIVE: To estimate the direct and indirect economic burden of hypercholesterolemia in patients with high risk of a cardiovascular event, specifically there were defined 5 groups of patients: 1) familial hypercholesterolemia; 2, 3 and 4) patients with hypercholesterolemia and background of diabetes, myocardial infarction or stroke; 5) diabetes, myocardial infarction and hypercholesterolemia (very high-risk patients) from the Mexican public healthcare institutions. METHODS: For the estimation of the direct costs the items included correspond to: outpatient care, pharmacological treatment, inpatient hospital care, and surgical procedures. For indirect economic burden, death certificates, before the end of the productive age due to hypercholesterolemia were calculated (premature mortality). RESULTS: The direct economic burden for the 5 groups of patients at risk is MXN $39,601,464,154 (USD $1,987,526,432), while the indirect economic burden amounts to MXN $121,646,689 (USD $6,105,229). CONCLUSIONS: The economic impact of hypercholesterolemia in patients with high cardiovascular risk is $39,723,110,843 (equivalent to USD $1,993,631,661) and corresponds to the 0.16% of GDP.

OBJETIVO: Se estimó la carga económica directa e indirecta de la hipercolesterolemia en población con alto riesgo de presentar un evento cardiovascular. Para ello se definieron específicamente cinco grupos de pacientes: 1) aquellos con hipercolesterolemia familiar; 2, 3 y 4) personas con hipercolesterolemia más el antecedente de diabetes, infarto o evento vascular cerebral; 5) pacientes con hipercolesterolemia más diabetes y antecedente de infarto agudo de miocardio (definidos como pacientes de muy alto riesgo cardiovascular). Los cálculos se hicieron desde la perspectiva de las instituciones de salud pública en México. MÉTODO: Para la estimación de los costos directos se incluyó la atención ambulatoria, el tratamiento farmacológico, la atención hospitalaria y las intervenciones quirúrgicas relacionadas con las enfermedades cardiovasculares. Para la carga económica indirecta, se consideraron las muertes reportadas específicamente por causa de hipercolesterolemia, en un momento anterior al final de la edad productiva (muerte prematura). RESULTADOS: La carga económica directa de las cinco categorías de pacientes en riesgo consideradas es de MXN $39,601,464,154 (USD $1,987,526,432), mientras que la carga económica indirecta asciende a MXN $121,646,689 (USD $6,105,229). CONCLUSIONES: El impacto económico de la hipercolesterolemia en población con alto riesgo cardiovascular correspondía a $39,723,110,843 en 2020 (equivalente a USD $1,993,631,661), equivalente al 0.16% del PIB nacional.

Guía de práctica clínica mexicana para el diagnóstico y tratamiento de las dislipidemias y enfermedad cardiovascular aterosclerótica.

ANTECEDENTES: Las enfermedades cardiovasculares son la principal causa mundial de mortalidad y México no es la excepción. Los datos epidemiológicos obtenidos en 1990 mostraron que los padecimientos cardiovasculares representaron el 19.8% de todas las causas de muerte en nuestro país; esta cifra se incrementó de manera significativa a un 25.5% para 2015. Diversas encuestas nacionales sugieren que más del 60% de la población adulta tiene al menos un factor de riesgo para padecer enfermedades cardiovasculares (obesidad o sobrepeso, hipertensión, tabaquismo, diabetes, dislipidemias). Por otro lado, datos de la Organización Panamericana de la Salud han relacionado el proceso de aterosclerosis como la primer causa de muerte prematura, reduciendo la expectativa de vida de manera sensible, lo que tiene una enorme repercusión social. OBJETIVO: Este documento constituye la guía de práctica clínica (GPC) elaborada por iniciativa de la Sociedad Mexicana de Cardiología en colaboración con la Sociedad Mexicana de Nutrición y Endocrinología, A.C., Asociación Nacional de Cardiólogos de México, A.C., Asociación Mexicana para la Prevención de la Aterosclerosis y sus Complicaciones, A.C., Comité Normativo Nacional de Medicina General, A.C., Colegio Nacional de Medicina Geriátrica, A.C., Colegio de Medicina Interna de México, A.C., Sociedad Mexicana de Angiología y Cirugía Vascular y Endovenosa, A.C., Instituto Mexicano de Investigaciones Nefrológicas, A.C. y la Academia Mexicana de Neurología, A.C.; con el apoyo metodológico de la Agencia Iberoamericana de Desarrollo y Evaluación de Tecnologías en Salud, con la finalidad de establecer recomendaciones basadas en la mejor evidencia disponible y consensuadas por un grupo interdisciplinario de expertos. El objetivo de este documento es el de brindar recomendaciones basadas en evidencia para ayudar a los tomadores de decisión en el diagnóstico y tratamiento de las dislipidemias en nuestro país. MATERIAL Y MÉTODOS: Este documento cumple con estándares internacionales de calidad, como los descritos por el Instituto de Medicina de EE.UU., el Instituto de Excelencia Clínica de Gran Bretaña, la Red Colegiada para el Desarrollo de Guías de Escocia y la Red Internacional de Guías de Práctica Clínica. Se integró un grupo multidisciplinario de expertos clínicos y metodólogos con experiencia en revisiones sistemáticas de la literatura y el desarrollo de guías de práctica clínica. Se consensuó un documento de alcances, se establecieron las preguntas clínicas relevantes, se identificó de manera exhaustiva la mejor evidencia disponible evaluada críticamente en revisiones sistemáticas de la literatura y se desarrollaron las recomendaciones clínicas. Se utilizó la metodología de Panel Delphi modificado para lograr un nivel de consenso adecuado en cada una de las recomendaciones contenidas en esta GPC. RESULTADOS: Se consensuaron 23 preguntas clínicas que dieron origen a sus respectivas recomendaciones clínicas. CONCLUSIONES: Esperamos que este documento contribuya a la mejor toma de decisiones clínicas y se convierta en un punto de referencia para los clínicos y pacientes en el manejo de las dislipidemias y esto contribuya a disminuir la morbilidad y mortalidad derivada de los eventos cardiovasculares ateroscleróticos en nuestro país. BACKGROUND: Cardiovascular diseases are the leading cause of mortality worldwide and Mexico is no exception. The epidemiological data obtained in 1990 showed that cardiovascular diseases represented 19.8% of all causes of death in our country. This figure increased significantly to 25.5% for 2015. Some national surveys suggest that more than 60% of the adult population has at least one risk factor for cardiovascular disease (obesity or overweight, hypertension, smoking, diabetes, dyslipidemias). On the other hand, data from the Pan American Health Organization have linked the process of atherosclerosis as the first cause of premature death, significantly reducing life expectancy, which has enormous social repercussions. OBJECTIVE: This document constitutes the Clinical Practice Guide (CPG) prepared at the initiative of the Mexican Society of Cardiology in collaboration with the Mexican Society of Nutrition and Endocrinology, AC, National Association of Cardiologists of Mexico, AC, Mexican Association for the Prevention of Atherosclerosis and its Complications, AC, National Normative Committee of General Medicine, AC, National College of Geriatric Medicine, AC, College of Internal Medicine of Mexico, AC, Mexican Society of Angiology and Vascular and Endovenous Surgery, AC, Mexican Institute of Research Nephrological, AC and the Mexican Academy of Neurology, A.C.; with the methodological support of the Ibero-American Agency for the Development and Evaluation of Health Technologies, in order to establish recommendations based on the best available evidence and agreed upon by an interdisciplinary group of experts. The objective of this document is to provide evidence-based recommendations to help decision makers in the diagnosis and treatment of dyslipidemias in our country. MATERIAL AND METHODS: This document complies with international quality standards, such as those described by the Institute of Medicine of the USA, the Institute of Clinical Excellence of Great Britain, the Scottish Intercollegiate Guideline Network and the Guidelines International Network. A multidisciplinary group of clinical experts and methodologists with experience in systematic reviews of the literature and the development of clinical practice guidelines was formed. A scope document was agreed upon, relevant clinical questions were established, the best available evidence critically evaluated in systematic literature reviews was exhaustively identified, and clinical recommendations were developed. The modified Delphi Panel methodology was used to achieve an adequate level of consensus in each of the recommendations contained in this CPG. RESULTS: 23 clinical questions were agreed upon which gave rise to their respective clinical recommendations. CONCLUSIONS: We consider that this document contributes to better clinical decision-making and becomes a point of reference for clinicians and patients in the management of dyslipidemias and this contributes to reducing the morbidity and mortality derived from atherosclerotic cardiovascular events in our country.

Comparative assessment of LDL-C and VLDL-C estimation in familial combined hyperlipidemia using Sampson's, Martin's and Friedewald's equations.

BACKGROUND: Sampson et al. developed a novel method to estimate very low-density lipoprotein cholesterol (VLDL-C) and low-density lipoprotein cholesterol (LDL-C) in the setting of hypertriglyceridemia. Familial Combined Hyperlipidemia (FCHL) is a common primary dyslipidemia in which lipoprotein composition interferes with LDL-C estimation. This study aimed to evaluate performance of LDL-C using this new method (LDL-S) compared with LDL-C estimated by Friedewald's and Martin eq. (LDL-F, LDL-M) in FCHL. METHODS: Data were collected from 340 subjects with confirmed FCHL. Concordance for VLDL-C measured by ultracentrifugation and LDL-C estimated using these measures compared to Sampson's, Martin's and Friedewald's equations was performed using correlation coefficients, root mean squared error (RMSE) and bias. Also, concordance of misclassified metrics according to LDL-C (< 70 and < 100 mg/dL) and Apo B (< 80 and < 65 mg/dL) thresholds were assessed. RESULTS: Sampson's equation was more accurate (RMSE 11.21 mg/dL; R2 = 0.88) compared to Martin's (RMSE 13.15 mg/dL; R2 = 0.875) and the Friedewald's equation (RMSE 13.7 mg/dL; R2 = 0.869). When assessing performance according to LDL-C, Sampson's had highest correlation and lowest RMSE compared to other equations (RMSE 19.99 mg/dL; R2 = 0.840). Comparing performance strength across triglyceride levels, Sampson's showed consistently improved correlations compared to Martin's and Friedewald's formulas for increasing triglycerides and for the FCHL phenotype of mixed dyslipidemia. Sampson's also had improved concordance with treatment goals. CONCLUSIONS: In FCHL, VLDL-C and LDL-C estimation using Sampson's formula showed higher concordance with lipid targets assessed using VLDL-C obtained by ultracentrifugation compared with Friedewald's and Martin's equations. Implementation of Sampson's formula could improve treatment monitoring in FCHL.

Reducing the Clinical and Public Health Burden of Familial Hypercholesterolemia: A Global Call to Action.

Importance: Familial hypercholesterolemia (FH) is an underdiagnosed and undertreated genetic disorder that leads to premature morbidity and mortality due to atherosclerotic cardiovascular disease. Familial hypercholesterolemia affects 1 in 200 to 250 people around the world of every race and ethnicity. The lack of general awareness of FH among the public and medical community has resulted in only 10% of the FH population being diagnosed and adequately treated. The World Health Organization recognized FH as a public health priority in 1998 during a consultation meeting in Geneva, Switzerland. The World Health Organization report highlighted 11 recommendations to address FH worldwide, from diagnosis and treatment to family screening and education. Research since the 1998 report has increased understanding and awareness of FH, particularly in specialty areas, such as cardiology and lipidology. However, in the past 20 years, there has been little progress in implementing the 11 recommendations to prevent premature atherosclerotic cardiovascular disease in an entire generation of families with FH. Observations: In 2018, the Familial Hypercholesterolemia Foundation and the World Heart Federation convened the international FH community to update the 11 recommendations. Two meetings were held: one at the 2018 FH Foundation Global Summit and the other during the 2018 World Congress of Cardiology and Cardiovascular Health. Each meeting served as a platform for the FH community to examine the original recommendations, assess the gaps, and provide commentary on the revised recommendations. The Global Call to Action on Familial Hypercholesterolemia thus represents individuals with FH, advocacy leaders, scientific experts, policy makers, and the original authors of the 1998 World Health Organization report. Attendees from 40 countries brought perspectives on FH from low-, middle-, and high-income regions. Tables listing country-specific government support for FH care, existing country-specific and international FH scientific statements and guidelines, country-specific and international FH registries, and known FH advocacy organizations around the world were created. Conclusions and Relevance: By adopting the 9 updated public policy recommendations created for this document, covering awareness; advocacy; screening, testing, and diagnosis; treatment; family-based care; registries; research; and cost and value, individual countries have the opportunity to prevent atherosclerotic heart disease in their citizens carrying a gene associated with FH and, likely, all those with severe hypercholesterolemia as well.

Cost-Effectiveness of Insulin Degludec vs. Insulin Glargine U100 in Type 1 and Type 2 Diabetes Mellitus in a UK Setting.

BACKGROUND: Understanding which therapeutic innovations in diabetes represent the best value requires rigorous economic evaluation. Data from randomised controlled trials and observational studies indicate that insulin degludec has a hypoglycemia advantage versus insulin glargine 100 units/mL (glargine U100), the most widely prescribed basal insulin analogue in the UK. This analysis was done to more rigorously assess cost-effectiveness in a UK setting. METHODS: Data from two double-blinded, randomised, two-period crossover trials in type 1 (SWITCH 1) and type 2 (SWITCH 2) diabetes mellitus were used to assess the cost-effectiveness of degludec vs. glargine U100 with an economic model. Cost-effectiveness was analysed over a 1-year time horizon based on the different rates of hypoglycaemia and actual doses of insulin used, rather than glycaemic control due to the treat-to-target trial design. RESULTS: In type 1 diabetes mellitus, degludec was highly cost-effective compared with glargine U100, with an incremental cost-effectiveness ratio of £984 (increased costs of only £23/year and improvement in participant health of 0.0232 quality-adjusted life-years (QALYs)). In type 2 diabetes mellitus, it was estimated that quality of life was improved (0.0065 QALYs gain) with degludec compared with glargine U100 at an increased annual cost of £117 (incremental cost-effectiveness ratio, £17,939). One-way sensitivity analyses showed that the results were robust to changes in parameters in both type 1 and type 2 diabetes mellitus. CONCLUSIONS: The rigorous design of the SWITCH trials, coupled with a representative patient population and a definition of hypoglycaemia that is relevant for real-world patients, makes the results of these trials highly generalisable. The within-trial analysis has the added value of being able to include doses and event rates directly from the trials. This short-term economic analysis estimated that IDeg would be cost-effective relative to IGlar U100 in both type 1 and type 2 diabetes mellitus in the UK. TRIAL REGISTRATION: SWITCH 1 (NCT02034513); SWITCH 2 (NCT02030600). FUNDING: Novo Nordisk, Søborg, Denmark.