Cost-effectiveness of the CNIC-Polypill versus separate monocomponents in cardiovascular secondary prevention in Spain.

INTRODUCTION AND OBJECTIVES: Despite advances in treatment, cardiovascular disease is the second leading cause of death in Spain. The objective of this study was to determine the cost-effectiveness of the CNIC-Polypill strategy (acetylsalicylic acid 100 mg, atorvastatin 20/40 mg, ramipril 2.5/5/10 mg) compared with the same separate monocomponents for the secondary prevention of recurrent cardiovascular events in adults in Spain. MATERIALS AND METHODS: A Markov cost-utility model was adapted considering 4 health states (stable, subsequent major adverse cardiovascular event, subsequent ischemic stroke and death) and the SMART risk equation over a lifetime horizon from the perspective of the Spanish National Healthcare System. The CNIC-Polypill strategy was compared with monocomponents in a hypothetical cohort of 1000 secondary prevention patients. Effectiveness, epidemiological, cost and utilities data were obtained from the NEPTUNO study, official databases and literature. Outcomes were costs (in 2021 euros) per life-year (LY) and quality-adjusted LY (QALY) gained. A 3% discount rate was applied. Deterministic one-way and probabilistic sensitivity analyses evaluated the robustness of the model. RESULTS: The CNIC-Polypill strategy in secondary prevention results in more LY (13.22) and QALY (11.64) gains at a lower cost than monocomponents. The CNIC-Polypill is dominant and saves є280.68 per patient compared with monocomponents. The probabilistic sensitivity analysis shows that 82.4% of the simulations are below the threshold of є25,000 per QALY gained. CONCLUSIONS: The CNIC-Polypill strategy in secondary cardiovascular prevention is cost-effective compared with the same separate monocomponents, resulting in a cost-saving strategy to the Spanish National Healthcare System.

[The natriuretic peptides in the diagnosis of heart failure in primary care setting]. / Los péptidos natriuréticos en el diagnóstico de la insuficiencia cardíaca en atención primaria.

Heart failure (HF) is a clinical syndrome characterized by symptoms and signs caused by structural and/or functional abnormalities of the heart that cause reduced cardiac output and/or elevated intracardiac pressures at rest or during exercise. Its prevalence and incidence are increasing and it is the leading cause of hospitalization in people over 65years of age. The new American and European guidelines for the management of HF emphasize that the measurement of natriuretic peptide (NP) concentrations constitutes a cornerstone of the diagnostic management of HF, and that the history, physical examination, electrocardiogram, and chest X-ray, complete the beginning of the HF diagnostic process. All these actions and diagnostic tests can be performed and requested from the primary care office. The authors of this document, on behalf of the SEMERGEN Hypertension and Cardiovascular Disease Working Group, have reviewed the most recent scientific evidence related to the preventive diagnostic management of NP in patients with HF in primary care setting.

Evaluation of prophylaxis in primary prevention with acetylsalicylic acid in people with diabetes: A scoping review.

BACKGROUND: The efficacy and safety of acetylsalicylic acid (ASA) prophylaxis for the primary prevention of atherosclerotic cardiovascular disease (ACVD) remain controversial in people with diabetes (DM) without ACVD, because the possible increased risk of major bleeding could outweigh the potential reduction in the risk of mortality and of major adverse cardiovascular events (MACE) considered individually or together. OBJECTIVE: To evaluate the overall risk-benefit of ASA prophylaxis in primary prevention in people with DM and to compare the recommendations of the guidelines with the results of the meta-analyses (MA) and systematic reviews (SR). MATERIAL AND METHODS: We searched Medline, Google Scholar, Embase, and the Cochrane Library for SR and MA published from 2009 to 2020 which compared the effects of ASA prophylaxis versus placebo or control followed up for at least one year in people with DM without ACVD. Heterogeneity among the randomized clinical trials (RCT) included in the SR and MA was assessed. Cardiovascular outcomes of efficacy (all-cause mortality [ACM], cardiovascular mortality [CVM], myocardial infarction [MI], stroke and MACE) and of safety (major bleeding events [MBE], major gastrointestinal bleeding events [MGIBE], and intracranial and extracranial bleeding) were shown. RESULTS: The recommendations of 12 guidelines were evaluated. The results of 25 SR and MA that included a total of 20 RCT were assessed. None of the MA or SR showed that ASA prophylaxis decreased the risk of ACM, CVM or MI. Only two of the 19 SR and MA that evaluated ischemic stroke showed a decrease in the stroke risk (mean 20.0% [SD±5.7]), bordering on statistical significance. Almost half of the MA and SR showed, bordering on statistical significance, a risk reduction for the MACE composite endpoint (mean 10.5% [SD±3.3]). The significant increases in MGIBE risk ranged from 35% to 55%. The significant increases in the risk of MBE and extracraneal bleeding were 33.4% (SD±14.9) and 54.5% (SD±0.7) respectively. CONCLUSION: The overall risk-benefit assessment of ASA prophylaxis in primary prevention suggests that it should not be applied in people with DM.

[Oral Findings in Patients With COVID-19]. / Hallazgos bucales en pacientes COVID-19.

The aim of this study was to describe oral lesions in a group of patients with COVID-19. We recruited 55 patients, 25 women (45.5%) and 30 men (54.5%), aged between 1 and 89 years with confirmed COVID-19 at different stages of severity. After obtaining informed consent, we examined their mouths and recorded clinical findings. Forty percent of the patients had at least 1 oral lesion. The most common lesions were candidiasis and ulcers (7 patients each); 2 patients had enanthems. Geographic tongue and caviar tongue were also observed. Altered taste, dry mouth, and painful/burning mouth were noted in 60%, 27.3%, and 36.4% of patients, respectively. Oral mucosal alterations and lesions were prevalent in this series of COVID-19 patients. Altered taste and a painful/burning mouth were common symptoms.

Comprehensive management of risk factors in peripheral vascular disease. Expert consensus.

INTRODUCTION: There is currently a degree of divergence among the main clinical practice guidelines on the management of risk factors for peripheral arterial disease (PAD). This project aims to gain understanding of the management of PAD risk factors in clinical practice and to reach a multidisciplinary consensus on the strategies to be followed in order to optimize its identification, treatment, and follow-up. METHODOLOGY: A multidisciplinary consensus following the Delphi methodology. RESULTS: Professionals (n = 130) with extensive experience in PAD participated in this consultation. The results suggest that in order to optimize the control of risk factors, efforts should be aimed at: (1) promoting the involvement and awareness of all specialists in the identification of and screening for the disease; (2) guaranteeing the possibility of evaluating the ankle-brachial index (ABI) in all the medical specialties involved; (3) promoting strategies for patients to quit smoking through the use of drugs, programs, or referrals to specialized units; (4) promoting an appropriate Mediterranean-based diet and the prescription of daily exercise; (5) raising awareness of the importance of ensuring LDL cholesterol values below 70 mg/dL, especially in symptomatic but also in asymptomatic patients (<55 mg/dL following the publication of the ESC/EAS guide); (6) recommending the use of antiplatelet therapy in asymptomatic patients with diabetes mellitus (DM) and/or a pathological ABI; and (7) protocolizing the annual evaluation of ABI in high-risk patients. CONCLUSION: This document presents the 22 agreed-upon strategies which are intended to help professionals optimize multidisciplinary management of PAD risk factors.

[SEMERGEN positioning on approaching chronic heart failure in primary care]. / Posicionamiento SEMERGEN en el abordaje de la insuficiencia cardíaca crónica en atención primaria.

Heart failure (HF) is a public health problem that generates a large healthcare burden both in hospitals and in Primary Care (PC). The publication of numerous studies about HF in recent years has led to a paradigm shift in the approach to this syndrome, in which the work of PC teams is gaining greater prominence. The recent guidelines published by the European Society of Cardiology have fundamentally introduced changes in the management of patients with HF. The new proposed strategy, with drugs that reduce hospitalizations and slow the progression of the disease, should now be a priority for all professionals involved. This position document analyzes a proposal for an approach based on multidisciplinary teams with the leadership of family doctors, key to providing quality care throughout the entire process of the disease, from its prevention to the end of the life.

Oral Findings in Patients With COVID-19.

The aim of this study was to describe oral lesions in a group of patients with COVID-19. We recruited 55 patients, 25 women (45.5%) and 30 men (54.5%), aged between 1 and 89 years with confirmed COVID-19 at different stages of severity. After obtaining informed consent, we examined their mouths and recorded clinical findings. Forty percent of the patients had at least 1 oral lesion. The most common lesions were candidiasis and ulcers (7 patients each); 2 patients had enanthems. Geographic tongue and caviar tongue were also observed. Altered taste, dry mouth, and painful/burning mouth were noted in 60%, 27.3%, and 36.4% of patients, respectively. Oral mucosal alterations and lesions were prevalent in this series of COVID-19 patients. Altered taste and a painful/burning mouth were common symptoms.

El propósito de este trabajo fue caracterizar las alteraciones orales en un grupo de pacientes COVID-19. Para ello se evaluaron 55 pacientes hospitalizados, confirmados COVID-19 en distintos estadios de severidad. Previo consentimiento informado, se examinó la cavidad oral y se registraron los hallazgos clínicos. El grupo de estudio estuvo conformado por 25 mujeres (45,5%) y 30 hombres (54,5%), con edades comprendidas entre 1 y 89 años. Un 40% de los pacientes mostraron alguna lesión bucal. Las lesiones más comunes fueron candidiasis y ulceraciones (7 pacientes cada uno) y en dos pacientes se observó enantema. También se encontraron alteraciones de la normalidad como glositis migratoria y varicosidades linguales. Asimismo, se registraron alteraciones del gusto, xerostomía y dolor/ardor bucal en el 60%, 27,3% y 36,4% respectivamente. En los pacientes COVID-19 se observaron con frecuencia alteraciones y lesiones en la mucosa bucal. Finalmente, la disgeusia y el dolor y/o el ardor oral fueron síntomas comunes en estos pacientes.

Telemedicine, ethics, and law in times of COVID-19. A look towards the future.

The health emergency in Spain caused by COVID-19 was of such a magnitude that on March 14, 2020, a state of alarm was declared that lasted for more than three months. This ongoing pandemic has affected a vast number of people. Among the measures taken to reduce the risk of contagion, visits to health centers have been reduced and virtual consultations have increased. Once the pandemic ends, it will be necessary to consider whether telemedicine should be limited to periods of health crises or whether it could become a new way of practicing medicine. Telemedicine lacks specific regulations and has loopholes that leave physicians with a considerable degree of insecurity. This article analyzes the limits, precautions, and legal standards of the use of telemedicine.

[Telemedicine, ethics, and law in times of COVID-19. A look towards the future]. / Telemedicina, ética y derecho en tiempos de COVID-19. Una mirada hacia el futuro.

The health emergency in Spain caused by COVID-19 was of such a magnitude that on March 14, 2020, a state of alarm was declared that lasted for more than three months. This ongoing pandemic has affected a vast number of people. Among the measures taken to reduce the risk of contagion, visits to health centers have been reduced and virtual consultations have increased. Once the pandemic ends, it will be necessary to consider whether telemedicine should be limited to periods of health crises or whether it could become a new way of practicing medicine. Telemedicine lacks specific regulations and has loopholes that leave physicians with a considerable degree of insecurity. This article analyzes the limits, precautions, and legal standards of the use of telemedicine.

Management of patients with heart failure treated in cardiology consultations: IC-BERG Study. / Manejo de los pacientes con insuficiencia cardiaca atendidos en la consulta de cardiología: Estudio IC-BERG.

OBJECTIVE: To determine the perception and management of heart failure with reduced ejection fraction (HFrEF) by clinical cardiologists and to establish a consensus with recommendations. METHODS: We employed the modified Delphi method among a panel of 150 experts who answered a questionnaire that included three blocks: definition and perception of patients with «stable¼ HFrEF (15 statements), management of patients with «stable¼ HFrEF (51 statements) and recommendations for optimising the management and follow-up (9 statements). The level of agreement was assessed with a Likert 9-point scale. RESULTS: A consensus of agreement was reached on 49 statements, a consensus of disagreement was reached on 16, and 10 statements remained undetermined. There was consensus regarding the definition of «stable¼ HF (82%), that HFrEF had a silent nature that could increase the mortality risk for mildly symptomatic patients (96%) and that the drug treatment should be optimised, regardless of whether a patient with HFrEF remains stable in the same functional class (98.7%). In contrast, there was a consensus of disagreement regarding the notion that treatment with an angiotensin receptor-neprilysin inhibitor is justified only when the functional class worsens (90.7%). CONCLUSIONS: Our current understanding of «stable¼ HF is insufficient, and the treatment needs to be optimised, even for apparently stable patients, to decrease the risk of disease progression.

Quality of life, adherence and satisfaction of patients with auricular fibrillation treated with dabigatran or vitamin K antagonists. / Calidad de vida, adherencia y satisfacción en pacientes con fibrilación auricular tratados con dabigatrán o antagonistas de la vitamina K.

OBJECTIVE: To analyse the quality of life, adherence and satisfaction of patients with nonvalvular auricular fibrillation (NVAF) treated with dabigatran versus vitamin K antagonists (VKA) in cardiology consultations in Spain. METHODS: We conducted an observational, comparative, prospective and multicentre study of patients with NVAF treated in cardiology departments, who started treatment with dabigatran or VKA in the month prior to the baseline visit. The follow-up lasted 6 months. We analysed quality of life (using the validated AF-QoL 18 questionnaire [0, minimum; 100, maximum]), adherence (using the Morisky-Green test) and the cardiologist's perception (using a specific questionnaire [0, completely dissatisfied; 10, completely satisfied]). RESULTS: We analysed 1015 patients (mean age, 73.3±9.4 years; 57% men; CHA2DS2VASc, 3.4±1.5; HAS-BLED, 1.5±1.0) who were treated with dabigatran (74.7%) or with VKA (25.3%). The total quality-of-life scores remained constant throughout the follow-up (47.9±23.5 and 48.6±24.4 at baseline and at 6 months, respectively; P=NS) but were higher at 6 months for the dabigatran group (50.6±24.7 vs. 42.8±22.5; P<.001). Treatment adherence was high during the study but greater with dabigatran at 6 months (89.2% vs. 81.1%; P=.001). There was a better perception of the cardiologist regarding the satisfaction of the patients treated with dabigatran at 6 months (9.0±1.2 vs. 6.6±2.2; P<.001). CONCLUSIONS: For patients with NVAF and high thromboembolic risk treated in cardiology consultations, the adherence, satisfaction and quality of life were higher for the patients treated with dabigatran than for those treated with VKA.

A novel approach to childhood obesity: circulating chemokines and growth factors as biomarkers of insulin resistance.

BACKGROUND: Insulin resistance (IR) in children with obesity constitutes a risk factor that should be precisely diagnosed to prevent further comorbidities. OBJECTIVE: Chemokines were evaluated to identify novel predictors of IR with clinical application. METHODS: We analysed the levels of cytokines (tumour necrosis factor [TNF] α and interleukins [ILs] 1ß, 4, 6 and 10), chemokines (stromal cell derived factor 1α, monocyte chemoattract protein [MCP] 1, eotaxin and fractalkine) and growth factors (brain-derived neurotrophic factor, pro-fibrotic platelet-derived growth factor [PDGF-BB] and insulin-like growth factor 1) in serum of prepubertal children with obesity (61 girls/59 boys, 50% IR and 50% non-IR) and 32 controls. Factor analysis, correlation, binary logistic regression and receiver operating characteristic analysis of combined biomarkers were used to validate their capability for preventive interventions of IR. RESULTS: Changes in MCP1, eotaxin, IL1ß and PDGF-BB were observed in IR children with obesity. Bivariate correlation between stromal cell derived factor 1α, MCP1, eotaxin, TNFα, brain-derived neurotrophic factor and/or PDGF-BB explained the high variance (65.9%) defined by three components related to inflammation and growth that contribute towards IR. The combination of leptin, triglyceride/high-density lipoprotein, insulin-like growth factor 1, TNFα, MCP1 and PDGF-BB showed a sensitivity and specificity of 93.2% for the identification of IR. The percentage of correct predictions was 89.6. CONCLUSIONS: Combined set of cytokines, adipokines and chemokines constitutes a model that predicts IR, suggesting a potential application in clinical practice as biomarkers to identify children with obesity and hyperinsulinaemia.

[Failure Mode and Effects Analysis (FMEA) method applied to anticoagulation of patients with non-valvular atrial fibrillation]. / El método AMFE (Análisis Modal de Fallos y Efectos) aplicado a la anticoagulación de pacientes con fibrilación auricular no valvular.

OBJECTIVES: To contribute to the improvement of the process of anticoagulation in patients with nonvalvular atrial fibrillation (NVAF) through awareness and training activities for Primary Care Physicians. MATERIALS AND METHODS: A total of 38 focus groups, sequenced according to an adaptation of the Failure Mode and Effects Analysis (FMEA) method. Each meeting was driven by «brainstorming¼ methodology. The geographical representation was homogeneous, with a total of 482 national. physicians (444 Primary Care Physicians, and 38 cardiologists). The meetings were held between March 28 and June 20, 2017. RESULTS: The main unsafe actions that can lead to a haemorrhagic or thrombotic event are incorrect anticoagulation or lack of patient follow-up. These events are mainly caused by training deficiencies in the management of NVAF, or by not taking into account possible interactions with vitamin K antagonist drugs. The main recommendations to alleviate these failures were focused on a good follow-up of patients with NVAF, on creating or updating the protocols or clinical practice guidelines, and on promoting the continuous training of physicians who usually manage patients with non-valvular AF treated with oral anticoagulants. CONCLUSIONS: A significant percentage of patients with NVAF are not correctly anticoagulated. Specific actions are required to alleviate this problem. Among them, the importance of a general anticoagulation training was emphasised, and particularly, the use of direct oral anticoagulants.

Experimental data in support of characterization of the CePO4 dispersion into transparent PMMA/PU IPNs by the sequential route.

This article is focused on the complementary data referring to the article "Dispersion of upconverting nanostructures of CePO4 using rod and semi-spherical morphologies into transparent PMMA/PU IPNs by the sequential route". It contains the XPS data of CePO4, photographs and DSC thermograms of transparent PMMA/PU IPNs as well as with CePO4 dispersed in different wt.%, Confocal laser scanning micrographs, transmission electron microscopy (TEM), optical images of surface, and visual inspection (photographs) before and after aging of hybrid materials.

[Management of heart failure in cardiology and primary care (MICCAP) program: Improving the management of patients with heart failure]. / Programa MICCAP (Manejo de la Insuficiencia Cardiaca en Cardiología y en Atención Primaria): mejorando el manejo del paciente con insuficiencia cardiaca.

Despite current treatments, morbidity and mortality of patients with heart failure remain high. The late diagnosis of heart failure, the insufficient heart failure treatment (i.e. not using the appropriate drugs, prescribing lower doses of drugs than recommended, etc.), and a poor coordination between different health care levels, may explain, at least in part, these figures. The Management of Heart Failure in Cardiology and Primary Care (MICCAP) program has been developed with the aim of optimising the integrated management of patients with heart failure between Primary Care and Cardiology, through the improvement of coordination between both health care levels. This includes continuous medical education to reinforce the diagnostic and therapeutic skills of general practitioners in the field of heart failure. The rationale and objectives of the MICCAP program are summarised in this article.

[Optimal cholesterol levels in patients in real-life. A systematic review]. / Niveles óptimos de colesterol en los pacientes con dislipemia. Revisión sistemática de la evidencia.

Dyslipidaemia is one of the main risk factors for the development of atherosclerosis. Different studies have demonstrated that the lower the LDL cholesterol, the better. Current evidence shows that the LDL cholesterol targets recommended by the clinical practice guidelines are beneficial and safe. However, consistent data show that higher reductions might provide additional cardiovascular beneficial effects, without an increase in side effects. Unfortunately, the current control of dyslipidaemia is very poor. Although statins are the treatment of choice in the majority of patients with dyslipidaemia, the current therapeutic armamentarium has different alternatives that effectively reduce LDL cholesterol levels, and that alone, or in combination, help to achieve LDL cholesterol targets in the majority of patients.

Metabolomics allows the discrimination of the pathophysiological relevance of hyperinsulinism in obese prepubertal children.

BACKGROUND/OBJECTIVES: Insulin resistance (IR) is the cornerstone of the obesity-associated metabolic derangements observed in obese children. Targeted metabolomics was employed to explore the pathophysiological relevance of hyperinsulinemia in childhood obesity in order to identify biomarkers of IR with potential clinical application. SUBJECTS/METHODS: One hundred prepubertal obese children (50 girls/50 boys, 50% IR and 50% non-IR in each group), underwent an oral glucose tolerance test for usual carbohydrate and lipid metabolism determinations. Fasting serum leptin, total and high molecular weight-adiponectin and high-sensitivity C-reactive protein (CRP) levels were measured and the metabolites showing significant differences between IR and non-IR groups in a previous metabolomics study were quantified. Enrichment of metabolic pathways (quantitative enrichment analysis) and the correlations between lipid and carbohydrate metabolism parameters, adipokines and serum metabolites were investigated, with their discriminatory capacity being evaluated by receiver operating characteristic (ROC) analysis. RESULTS: Twenty-three metabolite sets were enriched in the serum metabolome of IR obese children (P<0.05, false discovery rate (FDR)<5%). The urea cycle, alanine metabolism and glucose-alanine cycle were the most significantly enriched pathways (PFDR<0.00005). The high correlation between metabolites related to fatty acid oxidation and amino acids (mainly branched chain and aromatic amino acids) pointed to the possible contribution of mitochondrial dysfunction in IR. The degree of body mass index-standard deviation score (BMI-SDS) excess did not correlate with any of the metabolomic components studied. In the ROC analysis, the combination of leptin and alanine showed a high IR discrimination value in the whole cohort (area under curve, AUCALL=0.87), as well as in boys (AUCM=0.84) and girls (AUCF=0.91) when considered separately. However, the specific metabolite/adipokine combinations with highest sensitivity were different between the sexes. CONCLUSIONS: Combined sets of metabolic, adipokine and metabolomic parameters can identify pathophysiological relevant IR in a single fasting sample, suggesting a potential application of metabolomic analysis in clinical practice to better identify children at risk without using invasive protocols.

Healthcare resources and needs in anticoagulant therapy for patients with nonvalvular atrial fibrillation. SAMOA Study. / Recursos y necesidades asistenciales en el tratamiento anticoagulante de los pacientes con fibrilación auricular no valvular. Estudio SAMOA.

INTRODUCTION AND OBJECTIVES: To determine, in the various medical specialties, the healthcare process for anticoagulated patients with nonvalvular atrial fibrillation, to determine the available and necessary resources and to identify potential areas of improvement in the care of these patients. METHODS: We performed a cross-sectional survey of primary care and specialised physicians involved in the care of anticoagulated patients. The questionnaires referred to the healthcare process, the indication and prescription of anticoagulant therapy and the barriers and deficiencies present for these patients. RESULTS: A total of 893 physicians participated in the study, 437 of whom worked in primary care and 456 of whom were specialists (mostly cardiologists). Forty-two percent of the family doctors indicated that they assessed and prescribed anticoagulant therapy, and 66% performed the regular follow-up of these patients. In both healthcare settings, the physicians noted the lack of standardised protocols. There was also a lack of quality control in the treatment. CONCLUSIONS: The role of primary care in managing anticoagulated patients has grown compared with previous reports. The responses of the participating physicians suggest marked gaps in the standardisation of the healthcare process and several areas for improvement in these patients' follow-up. The promotion of training in direct-acting anticoagulant drugs remains pivotal.