The CNIC polypill (Acetylsalicylic acid + Atorvastatin + Rampril) in secondary prevention of cardiovascular disease in patients with type 2 diabetes: A comparative analysis with alternative therapeutic approaches.

BACKGROUND: Patients with type 2 DM (T2DM) and established cardiovascular disease (CVD) are at high risk of recurrent CV events. We analysed the use of the CNIC-polypill (acetylsalicylic acid, ramipril, and atorvastatin) compared with other therapeutic strategies in patients with T2DM and CVD from the retrospective NEPTUNO study. METHODS: Patients were stratified into four therapeutic approaches: CNIC-polypill, its monocomponents as loose medications, equipotent medications, and other therapies. Outcomes included the 2-year cumulative incidence and risk of recurrent major adverse CV events (MACE) and CV death, risk factors control, medication persistence, and utilisation of healthcare resources and costs. RESULTS: After two years, T2DM patients treated with Monocomponents, Equipotent drugs, or Other therapies had increased recurrent MACE risk compared to CNIC-polypill (11 %, 23 %, and 44 %, respectively; P < 0.05) and shorter median time to CV events (305-377 vs. 396 days; P < 0.05). The CNIC-polypill group achieved a significant 11.2 % increase in patients reaching LDL-c targets <70 mg/dL, outperforming other strategies. It also exhibited superior triglyceride control and a higher proportion achieving the <130/80 mmHg blood pressure goal. The CNIC-polypill cohort displayed significantly higher 24-month persistence (71.5 % vs. 54.7 %-58.3 %, p < 0.05) and lower mean adjusted costs per patient (€5083 vs. €6000-€6523; p < 0.05). In a comparative analysis, T2DM patients had lower baseline LDL-c and total cholesterol levels than non-T2DM counterparts yet experienced a higher incidence of recurrent MACE over two years. CONCLUSION: The CNIC-polypill (ASA, atorvastatin and ramipril) emerged as a promising treatment for patients with CVD, particularly those with T2DM, offering improved clinical outcomes and economic efficiency.

A Complex Interplay: Navigating the Crossroads of Tobacco Use, Cardiovascular Disease, and the COVID-19 Pandemic: A WHF Policy Brief.

The Coronavirus Disease 2019, commonly referred to as COVID-19, is responsible for one of the deadliest pandemics in human history. The direct, indirect and lasting repercussions of the COVID-19 pandemic on individuals and public health, as well as health systems can still be observed, even today. In the midst of the initial chaos, the role of tobacco as a prognostic factor for unfavourable COVID-19 outcomes was largely neglected. As of 2023, numerous studies have confirmed that use of tobacco, a leading risk factor for cardiovascular and other diseases, is strongly associated with increased risks of severe COVID-19 complications (e.g., hospitalisation, ICU admission, need for mechanical ventilation, long COVID, etc.) and deaths from COVID-19. In addition, evidence suggests that COVID-19 directly affects multiple organs beyond the respiratory system, disproportionately impacting individuals with comorbidities. Notably, people living with cardiovascular disease are more prone to experiencing worse outcomes, as COVID-19 often inherently manifests as thrombotic cardiovascular complications. As such, the triad of tobacco, COVID-19 and cardiovascular disease constitutes a dangerous cocktail. The lockdowns and social distancing measures imposed by governments have also had adverse effects on our lifestyles (e.g., shifts in diets, physical activity, tobacco consumption patterns, etc.) and mental well-being, all of which affect cardiovascular health. In particular, vulnerable populations are especially susceptible to tobacco use, cardiovascular disease and the psychological fallout from the pandemic. Therefore, national pandemic responses need to consider health equity as well as the social determinants of health. The pandemic has also had catastrophic impacts on many health systems, bringing some to the brink of collapse. As a result, many health services, such as services for cardiovascular disease or tobacco cessation, were severely disrupted due to fears of transmission and redirection of resources for COVID-19 care. Unfortunately, the return to pre-pandemic levels of cardiovascular disease care activity has stagnated. Nevertheless, digital solutions, such as telemedicine and apps, have flourished, and may help reduce the gaps. Advancing tobacco control was especially challenging due to interference from the tobacco industry. The industry exploited lingering uncertainties to propagate misleading information on tobacco and COVID-19 in order to promote its products. Regrettably, the links between tobacco use and risk of SARS-CoV-2 infection remain inconclusive. However, a robust body of evidence has, since then, demonstrated that tobacco use is associated with more severe COVID-19 illness and complications. Additionally, the tobacco industry also repeatedly attempted to forge partnerships with governments under the guise of corporate social responsibility. The implementation of the WHO Framework Convention on Tobacco Control could address many of the aforementioned challenges and alleviate the burden of tobacco, COVID-19, and cardiovascular disease. In particular, the implementation of Article 5.3 could protect public health policies from the vested interests of the industry. The world can learn from the COVID-19 pandemic to better prepare for future health emergencies of international concern. In light of the impact of tobacco on the COVID-19 pandemic, it is imperative that tobacco control remains a central component in pandemic preparedness and response plans.

[Effectiveness of the CNIC polypill in secondary cardiovascular prevention in the subgroup of patients of the NEPTUNO study using atorvastatin doses of 20 mg]. / Efectividad de la polipíldora CNIC en prevención cardiovascular secundaria en el subgrupo de pacientes del estudio NEPTUNO con dosis de atorvastatina de 20 mg.

Objective: To analyse the incidence and risk of recurrent major adverse cardiovascular events (MACE), level of risk factor control, treatment persistence and cost of the CNIC polypill version containing acetylsalicylic acid (ASA) 100 mg, atorvastatin 20 mg (A20), and ramipril 2.5, 5.0 or 10 mg in secondary cardiovascular prevention patients. Method: Subanalysis of the observational, retrospective, multicentre, NEPTUNO study in patients treated for two years with the CNIC polypill A20, the same monocomponents as single drugs, equipotent drugs, and other therapies. Results: 922 patients were included in each group. The risk of recurrent MACE was lower among CNIC A20 polypill users than all others (21%, 23% and 26% increased risk among the monocomponents, equipotent or other therapy cohorts, respectively; p < 0.05). The magnitude of the mean change in low-density lipoprotein cholesterol and blood pressure, as well as the increase in the proportion of patients achieving target goals, was also greater among patients treated with the CNIC A20 polypill than in any of the other cohorts (all p < 0.001). Treatment persistence was significantly higher in patients treated with the CNIC A20 polypill (p < 0.001) and was a less costly strategy than any other therapeutic option. Conclusions: In patients in secondary cardiovascular prevention, the CNIC A20 polypill (ASA 100 mg, atorvastatin 20 mg, and ramipril 2.5, 5.0 or 10 mg) constitutes a valid therapeutic option with similar benefits and outcomes to the version of the polypill with atorvastatin 40 mg.

Objetivo: Analizar la incidencia y el riesgo de eventos adversos cardiovasculares mayores (MACE) recurrentes, el nivel de control de factores de riesgo, la persistencia al tratamiento y el coste de la versión de la polipíldora CNIC que contiene 100 mg de ácido acetilsalicílico (AAS), 20 mg de atorvastatina (A20) y 2.5/5.0 ó 10 mg de ramipril en pacientes en prevención cardiovascular secundaria. Método: Subanálisis del estudio observacional, retrospectivo y multicéntrico NEPTUNO en pacientes tratados durante 2 años con la polipíldora CNIC A20, los mismos monocomponentes por separado, medicamentos equipotentes uotras terapias. Resultados: Se incluyeron 922 pacientes en cada grupo. El riesgo de sufrir un MACE recurrente en el grupode polipíldora CNIC A20 fue menor que en todas las demás cohortes (21%, 23% y 26% de aumento del riesgo en las cohortesde monocomponentes, equipotentes u otras terapias, respectivamente; p < 0.05). La magnitud del cambio en el colesterol unidoa lipoproteínas de baja densidad y la presión arterial, así como el incremento en la proporción de pacientes que alcanzaron losobjetivos establecidos, fueron mayores en los pacientes tratados con la polipíldora CNIC A20 que en cualquiera de las otrascohortes (p < 0.001). La persistencia al tratamiento fue mayor en los pacientes tratados con la polipíldora CNIC A20 (p < 0.001)y esta estrategia resultó ser menos costosa que cualquier otra opción terapéutica. Conclusiones: En pacientes en prevencióncardiovascular secundaria, la polipíldora CNIC A20 (AAS 100 mg; atorvastatina 20 mg; ramipril 2.5/5.0 ó 10 mg) constituye unaopción terapéutica válida con beneficios y resultados similares a la versión de la polipíldora con 40 mg de atorvastatina.

The CNIC-polypill (acetylsalicylic acid, atorvastatin, and ramipril), an effective and cost-saving secondary prevention strategy compared with other therapeutic options in patients with ischaemic heart disease.

Aims: The retrospective NEPTUNO study evaluated the effectiveness of the Centro Nacional de Investigaciones Cardiovasculares (CNIC)-polypill (including acetylsalicylic acid, ramipril, and atorvastatin) vs. other therapeutic approaches in secondary prevention for cardiovascular (CV) disease. In this substudy, the focus was on the subgroup of patients with ischaemic heart disease (IHD). Methods and results: Patients on four strategies: CNIC-polypill, its monocomponents as loose medications, equipotent medications, and other therapies. The primary endpoint was the incidence of recurrent major adverse CV events (MACEs) after 2 years. After matching, 1080 patients were included in each cohort. The CNIC-polypill cohort had a significantly lower incidence of recurrent MACE compared with monocomponents, equipotent drugs, and other therapies cohorts (16.1 vs. 24, 24.4, and 24.3%, respectively; P < 0.001). The hazard ratios (HRs) for recurrent MACE were higher in monocomponents (HR = 1.12; P = 0.042), equipotent drugs (HR = 1.14; P = 0.031), and other therapies cohorts (HR = 1.17; P = 0.016) compared with the CNIC-polypill, with a number needed to treat of 12 patients to prevent a MACE. The CNIC-polypill demonstrated a greater reduction in LDL cholesterol (LDL-c; -56.1 vs. -43.6, -33.3, and -33.2% in the monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) and systolic blood pressure (-13.7 vs. -11.5, -10.6, and -9.1% in the CNIC-polypill, monocomponents, equipotent drugs, and other therapies, respectively; P < 0.001) compared with other cohorts. The CNIC-polypill intervention was less costly and more effective than any other therapeutic option, with €2317-€2407 cost savings per event prevented. Conclusion: In IHD, the CNIC-polypill exemplifies a guideline-recommended secondary prevention treatment linked to better outcomes and cost saving compared with other therapeutic options.

Nicotine and Cardiovascular Health: When Poison is Addictive - a WHF Policy Brief.

Nicotine is universally recognized as the primary addictive substance fuelling the continued use of tobacco products, which are responsible for over 8 million deaths annually. In recent years, the popularity of newer recreational nicotine products has surged drastically in many countries, raising health and safety concerns. For decades, the tobacco industry has promoted the myth that nicotine is as harmless as caffeine. Nonetheless, evidence shows that nicotine is far from innocuous, even on its own. In fact, numerous studies have demonstrated that nicotine can harm multiple organs, including the respiratory and cardiovascular systems. Tobacco and recreational nicotine products are commercialized in various types and forms, delivering varying levels of nicotine along with other toxic compounds. These products deliver nicotine in profiles that can initiate and perpetuate addiction, especially in young populations. Notably, some electronic nicotine delivery systems (ENDS) and heated tobacco products (HTP) can deliver concentrations of nicotine that are comparable to those of traditional cigarettes. Despite being regularly advertised as such, ENDS and HTP have demonstrated limited effectiveness as tobacco cessation aids in real-world settings. Furthermore, ENDS have also been associated with an increased risk of cardiovascular disease. In contrast, nicotine replacement therapies (NRT) are proven to be safe and effective medications for tobacco cessation. NRTs are designed to release nicotine in a slow and controlled manner, thereby minimizing the potential for abuse. Moreover, the long-term safety of NRTs has been extensively studied and documented. The vast majority of tobacco and nicotine products available in the market currently contain nicotine derived from tobacco leaves. However, advancements in the chemical synthesis of nicotine have introduced an economically viable alternative source. The tobacco industry has been exploiting synthetic nicotine to circumvent existing tobacco control laws and regulations. The emergence of newer tobacco and recreational nicotine products, along with synthetic nicotine, pose a tangible threat to established tobacco control policies. Nicotine regulations need to be responsive to address these evolving challenges. As such, governments should regulate all tobacco and non-medical nicotine products through a global, comprehensive, and consistent approach in order to safeguard tobacco control progress in past decades.

Mortality Attributable to Environmental Tobacco Smoke Exposure in Spain in 2020.

INTRODUCTION AND OBJECTIVES: Exposure to environmental tobacco smoke (ETS) is associated with increased mortality and morbidity. The objective of this study was to estimate the impact of ETS exposure in Spain on mortality in 2020 in the population aged 35 years and over. METHODS: A method of estimating attributable mortality (AM) based on the prevalence of ETS exposure was applied. Prevalence data were obtained from a representative study conducted in Spain and the relative risks were derived from a meta-analysis. AM point estimates are presented along with 95% confidence intervals (95% CI), calculated using a bootstrap naive procedure. AM, both overall and by smoking habit, was estimated for each combination of sex, age group, and cause of death (lung cancer and ischemic heart disease). A sensitivity analysis was performed. RESULTS: A total of 747 (95% CI 676-825) deaths were attributable to ETS exposure, of which 279 (95% CI 256-306) were caused by lung cancer, and 468 (95% CI 417-523) by ischemic heart disease. Three-quarters (75.1%) of AM occurred in men and 60.9% in non-smokers. When chronic obstructive pulmonary disease and cerebrovascular disease are included, the burden of AM is estimated at 2242 deaths. CONCLUSIONS: ETS exposure is associated with 1.5% of all deaths from lung cancer and ischemic heart disease in the population aged 35 and over. These data underline the need for health authorities to focus on reducing exposure to ETS in all settings and environments.

The CNIC-Polypill reduces recurrent major cardiovascular events in real-life secondary prevention patients in Spain: The NEPTUNO study.

BACKGROUND: To evaluate the effectiveness of a cardiovascular polypill including aspirin, ramipril and atorvastatin (CNIC-Polypill), on the incidence of recurrent major cardiovascular events (MACE) and risk factor control in patients with established atherosclerotic cardiovascular disease (ASCVD) vs different pharmacological therapeutic strategies. METHODS: Retrospective, observational study using data from electronic-health records. Patients were distributed into 4 different cohorts: CNIC-Polypill (case cohort) vs 3 control cohorts: same monocomponents taken separately (Monocomponents), equipotent drugs (Equipotent) and other drugs not included in the previous cohorts (Other therapies). Patients were followed for 2 years or until MACE or death. RESULTS: After propensity score matching, a total of 6456 patients (1614 patients per cohort) were analysed. After 2 years, the risk of recurrent MACE was lower in the CNIC-Polypill cohort compared to the control groups (22%; p = 0.017, 25%; p = 0.002, 27%; p = 0.001, higher in the Monocomponents, Equipotent and Other therapies cohorts, respectively). The incremental proportion of patients who achieved blood pressure (BP) and low-density lipoprotein cholesterol (LDLc) control from baseline was higher in the CNIC-Polypill cohort vs control cohorts (BP controlled patients: +12.5% vs + 6.3%; p < 0.05, +2.2%; p < 0.01, +2.4%; p < 0.01, LDLc controlled patients: +10.3% vs + 4.9%; p < 0.001, +5.7%; p < 0.001, +4.9%; p < 0.001, respectively). Medication persistence was higher in patients treated with the CNIC-Polypill (72.1% vs 62.2%, 60.0% and 54.2%, respectively; p < 0.001) at study end. CONCLUSIONS: In secondary prevention patients, compared with control groups, treatment with the CNIC-Polypill was associated with significant reductions in the accumulated incidence of recurrent MACE, improved BP and LDLc control rates, and increased medication persistence.

E-Cigarettes: A New Threat to Cardiovascular Health - A World Heart Federation Policy Brief.

Tobacco is widely recognized as a leading cause of cardiovascular morbidity and mortality, accounting for approximately seventeen percent of all cardiovascular disease deaths globally. Electronic nicotine delivery systems such as e-cigarettes have been developed and advertised as safer alternatives to traditional tobacco cigarettes. Aggressive marketing strategies, as well as misleading claims by manufacturers, have largely contributed to the belief that e-cigarettes are harmless. In reality, e-cigarettes are far from innocuous. E-cigarette solutions and aerosols generally contain harmful substances that are commonly found in tobacco cigarette emissions. A growing body of literature suggests that e-cigarettes are associated with an increased risk of cardiovascular morbidity and mortality. In addition, the effectiveness of e-cigarettes as smoking cessation tools has yet to be determined. Concerningly, most smokers do not give up on tobacco cigarettes and eventually become dual users. Unregulated, e-cigarettes constitute a serious threat to established tobacco control policies. Fortunately, many countries have demonstrated that strong regulations were effective in protecting their populations from the dangers of e-cigarettes. The World Heart Federation recommends applying the precautionary principle and a set of measures to protect vulnerable populations, prevent exposure to second-hand smoking, and address misleading claims. In this regard, we recommend that governments, policymakers, and other relevant stakeholders enact or support the following measures, among others: Prohibit the sale and distribution of e-cigarettes to minors, as well as the use of flavouring agents.Prohibit the use of e-cigarettes anywhere tobacco cigarettes have been banned.Prohibit marketing, advertising, and misleading claims regarding e-cigarettes.Apply excise taxes on e-cigarettes.Conduct more research regarding the long-term effects of e-cigarettes on cardiovascular health. Lastly, countries that have banned the commercialization of e-cigarettes should maintain these measures.

Stratification and management of cardiovascular risk in cancer patients. A consensus document of the SEC, FEC, SEOM, SEOR, SEHH, SEMG, AEEMT, AEEC, and AECC.

Both cancer treatment and survival have significantly improved, but these advances have highlighted the deleterious effects of vascular complications associated with anticancer therapy. This consensus document aims to provide a coordinated, multidisciplinary and practical approach to the stratification, monitoring and treatment of cardiovascular risk in cancer patients. The document is promoted by the Working Group on Cardio Oncology of the Spanish Society of Cardiology (SEC) and was drafted in collaboration with experts from distinct areas of expertise of the SEC and the Spanish Society of Hematology and Hemotherapy (SEHH), the Spanish Society of Medical Oncology (SEOM), the Spanish Society of Radiation Oncology (SEOR), the Spanish Society of General and Family Physicians (SEMG), the Spanish Association of Specialists in Occupational Medicine (AEEMT), the Spanish Association of Cardiovascular Nursing (AEEC), the Spanish Heart Foundation (FEC), and the Spanish Cancer Association (AECC).

Recomendaciones para el manejo de la comorbilidad en la práctica clínica en pacientes con espondiloartritis axia / Recommendations for the Management of Comorbidity in Patients With Axial Spondyloarthritis in Clinical Practice

Objetivos: Identificar las comorbilidades prioritarias en la espondiloartritis axial (EspAx) y recomendar cómo hacer su seguimiento desde una perspectiva eminentemente práctica. Métodos: Se seleccionó a un grupo multidisciplinar (10 reumatólogos [6 expertos en EspAx], 2 médicos de familia, una internista, una cardióloga, una gastroenteróloga y una psicóloga). En una primera reunión de discusión, se establecieron el alcance y los usuarios, y se votó una lista de comorbilidades sobre la base de la frecuencia y el impacto. Los panelistas debían defender con argumentos consistentes la inclusión de cada comorbilidad/ítem en el documento. Cuatro panelistas y 2 metodólogos, desarrollaron revisiones sistemáticas en temas controvertidos. En una segunda reunión se presentaron los resultados de las revisiones y los argumentos de todos los ítems a incluir. Tras esta reunión se redactó el documento final. Resultados: El documento final incluye 2 listas de comprobación (checklist), una para profesionales sanitarios y otra para pacientes, que recogen: riesgo cardiovascular, comorbilidad renal, riesgo gastrointestinal, estilo de vida, riesgo de infecciones y vacunación, afectación pulmonar, medicación concomitante, trastornos psicoafectivos, osteoporosis y riesgo de fractura. Además, el documento refleja los argumentos para incluir cada ítem y la manera de recoger los ítems. Asimismo, el panel consideró oportuno establecer unas «prácticas a evitar» aplicables a la comorbilidad de la EspAx. Conclusiones: Se generaron 2 listas de comprobación y un listado de escenarios a evitar para facilitar el manejo de las comorbilidades de la EspAx. En pasos posteriores probaremos su utilidad y su aceptación por un grupo amplio de usuarios que incluya médicos, pacientes y enfermeras

Objectives: To identify priorities among comorbidities in axial spondyloarthritis (AxSpA) and recommend how to follow them from an eminently practical perspective. Methods: A multidisciplinary group was selected (10 rheumatologists-six of them experts in AxSpA-, 2 general practitioners, an internist, a cardiologist, a gastroenterologist and a psychologist). In a first discussion meeting, the scope and users were established and a list of comorbidities was voted based on frequency and impact. The panelists had to defend the inclusion of each comorbidity/item in the document with consistent arguments. Four panelists and two methodologists developed systematic reviews on controversial topics. In a second meeting, the results of the reviews and the arguments concerning the items to be included were presented. After the meeting, the final document was drafted. Results: The final document includes two checklists, one for health professionals and another for patients; they incorporate cardiovascular risk, renal comorbidities, gastrointestinal risk, lifestyle, risk of infections and vaccinations, pulmonary involvement, concomitant medication, psycho-affective disorders, osteoporosis, and risk of fracture. In addition, the document reflects the arguments favoring the inclusion of each item and how to record the items for subsequent collection. The panel considered it also appropriate to likewise establish «practices to avoid» applicable to comorbidity in AxSpA. Conclusions: Two checklists and a list of situations to avoid were generated to facilitate the management of comorbidities in AxSpA. In a future step, their utility and acceptance will be tested by a broad group of users that includes doctors, patients and nurses

Recommendations for the Management of Comorbidity in Patients With Axial Spondyloarthritis in Clinical Practice. / Recomendaciones para el manejo de la comorbilidad en la práctica clínica en pacientes con espondiloartritis axial.

OBJECTIVES: To identify priorities among comorbidities in axial spondyloarthritis (AxSpA) and recommend how to follow them from an eminently practical perspective. METHODS: A multidisciplinary group was selected (10 rheumatologists-six of them experts in AxSpA-, 2 general practitioners, an internist, a cardiologist, a gastroenterologist and a psychologist). In a first discussion meeting, the scope and users were established and a list of comorbidities was voted based on frequency and impact. The panelists had to defend the inclusion of each comorbidity/item in the document with consistent arguments. Four panelists and two methodologists developed systematic reviews on controversial topics. In a second meeting, the results of the reviews and the arguments concerning the items to be included were presented. After the meeting, the final document was drafted. RESULTS: The final document includes two checklists, one for health professionals and another for patients; they incorporate cardiovascular risk, renal comorbidities, gastrointestinal risk, lifestyle, risk of infections and vaccinations, pulmonary involvement, concomitant medication, psycho-affective disorders, osteoporosis, and risk of fracture. In addition, the document reflects the arguments favoring the inclusion of each item and how to record the items for subsequent collection. The panel considered it also appropriate to likewise establish «practices to avoid¼ applicable to comorbidity in AxSpA. CONCLUSIONS: Two checklists and a list of situations to avoid were generated to facilitate the management of comorbidities in AxSpA. In a future step, their utility and acceptance will be tested by a broad group of users that includes doctors, patients and nurses.

Small airway dysfunction in smokers with stable ischemic heart disease.

BACKGROUND: A higher prevalence of airflow limitation (AL) has been described in patients with ischemic heart disease (IHD). Although small airway dysfunction (SAD) is an early feature of AL, there is little information about its occurrence in IHD patients. Our objective was to describe the prevalence of SAD in IHD patients, while comparing patient-related outcomes and future health risk among IHD patients with AL, SAD and normal lung function. METHODS: In 118 consecutive smoking patients with stable IHD, comorbidities, utilization of healthcare resources, current treatment, blood biochemistry and health status were recorded. SAD was evaluated by impulse oscillometry, and pre- and post-bronchodilator spirometry was performed. RESULTS: The prevalence of AL and SAD were 20.3 (95% CI, 13.1-27.6%) and 26.3% (95% CI, 18.3-34.2%), respectively. Compared to the normal lung function group, patients with SAD and without AL had lower spirometric values, poorer quality of life and higher levels of C-reactive protein (CRP), as well as increased cardiovascular risk and more vascular age. In patients with normal spirometry, the presence of SAD was independently associated with pack-years, HDL-cholesterol and CRP levels. CONCLUSION: In patients with IHD, the presence of SAD is common and that it is associated with reduced health status and increased future cardiac risk.

Una historia resumida. La inhibición de la PCSK9 y su desarrollo clínico / A brief history. PCSK9 inhibition and its clinical development

La hipercolesterolemia es uno de los más importantes factores de riesgo de enfermedades cardiovasculares, y no siempre es posible controlarla con los tratamientos convencionales: dieta, ejercicio y fármacos hipolipemiantes. La inhibición de la proteína PCSK9 mediante anticuerpos monoclonales aumenta el número de receptores de colesterol unido a lipoproteínas de baja densidad (cLDL) en el hepatocito y, por lo tanto, contribuye a su destrucción. Con estos fármacos, empleados solos o añadidos a estatinas o ezetimiba, se ha observado una reducción del colesterol muy importante que permite mantener las cifras de cLDL de la mayoría de los pacientes en lo recomendado por las guías de práctica clínica. Para averiguar su eficacia clínica, se han diseñados 3 estudios multicéntricos de morbimortalidad con alirocumab, evolocumab y bococizumab. En el estudio del evolocumab, un anticuerpo monoclonal 100% humano, se demostró una reducción significativa del objetivo primario de eficacia, que incluía mortalidad cardiovascular, infarto agudo de miocardio, ictus, angina inestable o revascularización miocárdica. Por el contrario, en el estudio con bococizumab, un anticuerpo humanizado, no 100% humano, no se observó beneficio clínico, lo que se atribuye a una disminución de la eficacia secundaria a la creación de anticuerpos contra el fármaco. Esta nueva opción terapéutica ya está disponible en la práctica clínica y supone un nuevo avance en la prevención de las enfermedades cardiovasculares (AU)

Hypercholesterolaemia is one of the major cardiovascular risk factors; however, conventional treatment with diet, exercise and cholesterol-lowering drugs are insufficient to control low-density lipoprotein (LDL) cholesterol in a significant number of patients. Inhibition of the PCSK9 protein by using specific monoclonal antibodies increases the number of LDL cholesterol receptors in the hepatocyte, contributing to LDL destruction. The use of these drugs, whether as monotherapy or in combination with statins and ezetimibe, significantly reduces LDL cholesterol, allowing LDL cholesterol levels in most patients to be maintained within limits recommended by clinical practice guidelines. To determine their clinical efficacy, 3 multicenter trials of morbidity and mortality have been conducted with alirocumab, evolocumab and bococizumab. The trial involving evolocumab, a fully human monoclonal antibody, demonstrated a significant reduction of the primary efficacy endpoint, including cardiovascular mortality, myocardial infarction, stroke, unstable angina or myocardial revascularisation. However, no clinical benefit was observed with bococizumab (a humanised but not fully human monoclonal antibody), probably due to a decrease in efficacy secondary to the formation of anti-drug antibodies. This new therapeutic option is already used in clinical practice and is considered a new advance in the prevention of cardiovascular disease (AU)

Avances en el control lipídico, de la teoría a la práctica. El reto de la medicina traslacional / Advances in lipid control, from theory to practice. The challenge of translational medicine

El control lipídico es uno de los pilares de la prevención secundaria pero, a pesar de la múltiple evidencia que demuestra la reducción del riesgo de nuevos eventos cardiovasculares cuanto menor sea la concentración de colesterol unido a lipoproteínas de baja densidad, esta sigue siendo el factor de riesgo de los pacientes que peor se controla. La aparición de nuevos fármacos como los inhibidores de PCSK9 ayudará a mejorar este control, pero también pueden resultar de gran importancia programas que mejoren la comunicación entre cardiología y atención primaria y con los pacientes, ya que, aunque se disponga de excelentes fármacos, si no se prescriben o si los pacientes no los utilizan, no se alcanzarán los objetivos. A pesar del gran desarrollo clínico de las terapias hipolipemiantes en los últimos años, con evidencia que en gran parte se refleja en las principales guías clínicas, existe una brecha importante entre la evidencia generada y la incorporación de las nuevas terapias a la práctica. Esta brecha contribuye a que una proporción importante de pacientes con enfermedad cardiovascular establecida no alcancen los objetivos de control lipídico y por ello estén expuestos a un riesgo aumentado de eventos recurrentes. Reducir esta brecha obliga a analizar de manera crítica las principales barreras y afrontar nuevos retos para solventarlas. Investigadores básicos y clínicos, médicos especialistas y de atención primaria, otros profesionales sanitarios, sociedades científicas y autoridades sanitarias deben encontrar la sinergia que permita finalmente reducir esta brecha y mejorar los resultados en salud cardiovascular (AU)

Lipid control is one of the pillars of secondary prevention, but despite multiple evidence showing that the risk of new cardiovascular events decreases with lower low-density lipoprotein cholesterol (LDL-C) levels, this remains the most poorly controlled risk factor in our patients. The development of new drugs, such as PCSK9 inhibitors, will help us to improve this problem, but programmes that improve the continuity of care between cardiologists and primary care physicians are also very important. Although good drugs are available, lipid goals will not be achieved unless they are used in our patients. Despite the clinical development of lipid-lowering therapies in the last few years, there is currently an important gap between the evidence generated by many clinical trials, reflected in the clinical practice guidelines, and its clinical application in our patients, contributing to the fact that a significant number of patients with established cardiovascular disease do not achieve lipid control targets, and consequently continue to be at high risk or have recurrent events. To narrow this gap, it seems necessary to critically analyse the main barriers and to develop strategies to solve these problems. Basic and clinical investigators, cardiologists and primary care physicians, other health professionals, scientific societies and health authorities working together will contribute to close the gap and to improve cardiovascular health outcomes (AU)

Indicadores de calidad en cardiología. Principales indicadores para medir la calidad de los resultados (indicadores de resultados) y parámetros de calidad relacionados con mejores resultados en la práctica clínica (indicadores de práctica asistencial). INCARDIO (Indicadores de Calidad en Unidades Asistenciales del Área del Corazón): Declaración de posicionamiento de consenso de SEC/SECTCV / Quality markers in cardiology. Main markers to measure quality of results (outcomes) and quality measures related to better results in clinical practice (Performance Metrics). INCARDIO ( Indicadores de Calidad en Unidades Asistenciales del Área del Corazón): a SEC/SECTCV consensus position paper

La práctica clínica cardiológica requiere una organización compleja que influya en los resultados globales y puede diferir sustancialmente entre distintos hospitales y comunidades. El objetivo de este documento de consenso es definir indicadores de calidad en cardiología, incluidos los indicadores para medir la calidad de los resultados (indicadores de resultados) y los parámetros de calidad relacionados con mejores resultados en la práctica clínica (indicadores de práctica asistencial). El documento está destinado principalmente al sistema de asistencia sanitaria de España y puede servir de base para documentos similares en otros países (AU)

Cardiology practice requires complex organization that impacts overall outcomes and may differ substantially among hospitals and communities. The aim of this consensus document is to define quality markers in cardiology, including markers to measure the quality of results (outcomes metrics) and quality measures related to better results in clinical practice (performance metrics). The document is mainly intended for the Spanish health care system and may serve as a basis for similar documents in other countries (AU)

Quality Markers in Cardiology. Main Markers to Measure Quality of Results (Outcomes) and Quality Measures Related to Better Results in Clinical Practice (Performance Metrics). INCARDIO (Indicadores de Calidad en Unidades Asistenciales del Área del Corazón): A SEC/SECTCV Consensus Position Paper.

Cardiology practice requires complex organization that impacts overall outcomes and may differ substantially among hospitals and communities. The aim of this consensus document is to define quality markers in cardiology, including markers to measure the quality of results (outcomes metrics) and quality measures related to better results in clinical practice (performance metrics). The document is mainly intended for the Spanish health care system and may serve as a basis for similar documents in other countries.

El cardiólogo ante el cigarrillo electrónico / Cardiologists and electronic cigarettes

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