Final Stage of Chronic Kidney Disease with Conservative Kidney Management or Renal Replacement Therapy: A Primary-Care Population Study.

BACKGROUND: Studies focus on the incidence and risk factors (RFs) associated with reaching the final stage of chronic kidney disease (CKD-G5) and receiving kidney replacement therapy (KRT). Analysis of those related to reaching CKD-G5 while receiving conservative kidney management (CKM) has been neglected. METHODS: Retrospective cohort study analysing electronic health records of individuals aged ≥ 50 with eGFR < 60 mL/min/m2. Cumulative incidence rates of CKD-G5, with and without KRT, were calculated. Multinomial regression models determined odds ratios (ORs) for CKD-G5 progression with KRT, CKM, or death. RESULTS: Among 332,164 patients, the cumulative incidence of CKD-G5 was 2.79 cases per 100 person-years. The rates were 1.92 for CKD-G5 with KRT and 0.87 for CKD-G5 with CKM. Low eGFR and albuminuria were the primary RFs. Male gender and uncontrolled blood pressure had a greater impact on KRT (OR = 2.63 CI, 1.63) than on CKD-G5 with CKM (OR = 1.45 CI, 1.31). Increasing age and rurality reduced the probability of KRT but increased the probability of CKD-G5 with CKM. Higher incomes decreased the likelihood of developing CKD-G5 with and without KRT (OR = 0.49 CI). CONCLUSION: One-third of CKD-G5 cases receive CKM. Those are typically older, female, rural residents with lower incomes and with lesser proteinuria or cardiovascular RF. The likelihood of receiving KRT is influenced by location and socioeconomic disparities.

Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trial.

Background: Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. Methods: We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. ClinicalTrials.gov registry: NCT04847141. Findings: 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, -3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; -9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Interpretation: Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19. Funding: Grifols.

Cardiovascular events and mortality in chronic kidney disease in primary care patients with previous type 2 diabetes and/or hypertension. A population-based epidemiological study (KIDNEES).

BACKGROUND: Chronic Kidney Disease (CKD), Type 2 Diabetes (T2D) and Hypertension (HTN) are frequently associated with adverse outcomes. We aimed to estimate the impact of a prior diagnosis of T2D and/or HTN on clinical characteristics, cardiovascular events (CVE) and all-cause mortality (ACM) of patients with CKD. METHODS: We conducted a retrospective cohort study based on primary care electronic health records of people without atherosclerotic cardiovascular disease, aged 18-90 years with incident CKD between January 1, 2007, and December 31, 2017. The association between CKD groups classified according to prior diagnosis of T2D and/or HTN and risk of ACM and CVE at follow-up was evaluated with Cox and Fine-Gray regression models, respectively. RESULTS: 398,477 patients were included. Median age was 74 years and 55.2% were women. Individuals were classified as CKD with HTN (51.9%), CKD with T2D (3.87%), CKD with HTN/T2D (31.4%) and CKD without HTN/T2D (12.9%). In the multivariate analysis, with the CKD without HTN/T2D group as reference, the ACM Hazard Ratio (HR) was 0.74 (95%CI 0.72-0.75) for the CKD with HTN group, 0.81 (95%CI 0.79-0.83) for CKD with HTN/T2D and 1.14 (95%CI 1.10-1.19) for the CKD with T2D group. The sub distribution HRs for CVE were 1.40 (95%CI 1.34-1.47), 1.70 (95%CI 1.61-1.80) and 1.37 (95%CI 1.26-1.48), respectively. CONCLUSION: In patients with CKD, the risk of ACM and CVE differed in patients with previous HTN and/or T2D. These comorbidities can help identify individuals at higher risk of adverse outcomes and improve the management of patients with CKD in primary care.

Evaluating the controlled reopening of nightlife during the COVID-19 pandemic: a matched cohort study in Sitges, Spain, in May 2021 (Reobrim Sitges).

OBJECTIVES: To assess the impact of relaxing the state of alarm restrictions on SARS-CoV-2 infections at 14 days among people attending reopened nightclub venues. DESIGN: Matched cohort study with a paired control group (1:5 ratio). SETTING: Five small nightclubs with indoor areas and outdoor terraces, in a nightlife-restricted area in Sitges, Spain, on 20 May 2021. Wearing masks was mandatory, drinking was allowed and social distance was not required. PARTICIPANTS: Volunteers were selected through a convenience sampling. To attend the event, participants were required to be older than 17 years, with a negative rapid antigen diagnostic test (Ag-RDT) on the same afternoon, without a positive reverse-transcription PCR (RT-PCR) or Ag-RDT and/or symptoms associated with COVID-19 in the previous 7 days, to not having knowingly been in close contact with someone infected in the previous 10 days and to not have knowingly had close contact with someone with a suspicion of COVID-19 in the previous 48 hours. A control group was paired by exact age, gender, residence municipality, socioeconomic index, previous SARS-CoV-2-confirmed infection and vaccination status, in a 1:5 ratio, from the primary care electronic health records. PRIMARY OUTCOME: Evidence of infection at electronic health records by SARS-CoV-2 at 14-day follow-up. RESULTS: Among the 391 participants (median age 37 years; 44% (n=173) women), no positive SARS-CoV-2 cases were detected at 14 days, resulting in a cumulative incidence estimation of 0 (95% CI 0 to 943) per 100 000 inhabitants. In the control group, two cases with RT-PCR test were identified, resulting in a cumulative incidence of 102.30 (12.4 to 369) per 100 000 inhabitants. CONCLUSIONS: Nightlife attendance under controlled conditions and with a requirement for a negative Ag-RDT was not associated with increased transmissibility of SARS-CoV-2 in a pandemic context of low infection rates. In such circumstances, secure opening of the nightlife sector was possible, under reduced capacity and controlled access by Ag-RDT, and environments where compliance with sanitary measures are maintainable.

Monitoring of SARS-CoV-2 seroprevalence among primary healthcare patients in the Barcelona Metropolitan Area: the SeroCAP sentinel network protocol.

INTRODUCTION: SARS-CoV-2 seroprevalence studies are currently being recommended and implemented in many countries. Forming part of the COVID-19 monitoring and evaluation plan of the Catalan Government Health Department, our network aims to initiate a primary healthcare sentinel monitoring system as a surrogate of SARS-CoV-2 exposure in the Barcelona Metropolitan Area. METHODS AND ANALYSIS: The seroCAP is a serial cross-sectional study, which will be performed in the Barcelona Metropolitan Area to estimate antibodies against SARS-CoV-2. From February 2021 to March 2022, the detection of serum IgG antibodies against SARS-CoV-2 trimeric spike protein will be performed on a monthly basis in blood samples collected for diverse clinical purposes in three reference hospitals from the three Barcelona healthcare areas (BCN areas). The samples (n=2588/month) will be from patients attended by 30 primary healthcare teams at 30 basic healthcare areas (BHA). A lab software algorithm will systematically select the samples by age and sex. Seroprevalence will be estimated and monitored by age, sex, BCN area and BHA. Descriptive and cluster analysis of the characteristics and distribution of SARS-CoV-2 infections will be performed. Sociodemographic, socioeconomic and morbidity-associated factors will be determined using logistic regression. We will explore the association between seroprevalence, SARS-CoV-2 confirmed cases and the implemented measures using interrupted time series analysis. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University Institute Foundation for Primary Health Care Research Jordi Gol i Gurina ethics committee. An informed consent is not required regarding the approval of the secondary use of biological samples within the framework of the COVID-19 pandemic. A report will be generated quarterly. The final analysis, conclusions and recommendations will be shared with the stakeholders and communicated to the general public. Manuscripts resulting from the network will be submitted for publication in peer-reviewed journals.

Double-blind placebo-controlled randomized clinical trial to assess the efficacy of montelukast in mild to moderate respiratory symptoms of patients with long COVID: E-SPERANZA COVID Project study protocol.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic continues to affect the globe. After 18 months of the SARS-CoV-2 emergence, clinicians have clearly defined a subgroup of patients with lasting, disabling symptoms. While big strides have been made in understanding the acute phase of SARS-CoV-2 infection, the pathophysiology of long COVID is still largely unknown, and evidence-based, effective treatments for this condition remain unavailable. OBJECTIVES: To evaluate the efficacy of 10 mg oral montelukast every 24 h versus placebo in improving quality of life associated with mild to moderate respiratory symptoms in patients with long COVID as measured with the COPD Assessment Test (CAT) questionnaire. The secondary objectives will evaluate the effect of montelukast versus placebo on improving exercise capacity, COVID-19 symptoms (asthenia, headache, mental confusion or brain fog, ageusia, and anosmia), oxygen desaturation during exertion, functional status, and mortality. METHODS AND ANALYSIS: Phase III, randomized, double-blind clinical trial. We will include 18- to 80-year-old patients with SARS-CoV-2 infection and mild to moderate respiratory symptoms lasting more than 4 weeks. Participants will be randomly allocated in a 1:1 ratio to the intervention (experimental treatment with 10 mg/day montelukast) or the control group (placebo group), during a 28-day treatment. Follow-up will finish 56 days after the start of treatment. The primary outcome will be health-related quality of life associated with respiratory symptoms according to the COPD Assessment Test 4 weeks after starting the treatment. The following are the secondary outcomes: (a) exercise capacity and oxygen saturation (1-min sit-to-stand test); (b) Post-COVID-19 Functional Status Scale; (c) other symptoms: asthenia, headache, mental confusion (brain fog), ageusia, and anosmia (Likert scale); (d) use of healthcare resources; (e) mortality; (f) sick leave duration in days; and (g) side effects of montelukast. ETHICS AND DISSEMINATION: This study has been approved by the Clinical Research Ethics Committee of the IDIAPJGol (reference number 21/091-C). The trial results will be published in open access, peer-reviewed journals and explained in webinars to increase awareness and understanding about long COVID among primary health professionals. TRIAL REGISTRATION: ClinicalTrials.gov NCT04695704 . Registered on January 5, 2021. EudraCT number 2021-000605-24. Prospectively registered.

Riesgo cardiovascular en la disminución leve-moderada de la tasa de filtrado glomerular, diabetes y enfermedad coronaria en un área del sur de Europa / Cardiovascular risk in mild to moderately decreased glomerular filtration rate, diabetes and coronary heart disease in a southern European region

INTRODUCCIÓN Y OBJETIVOS: Se considera que los individuos con disminución leve-moderada de la tasa de filtrado glomerular estimada (TFGe, 30-59ml/min/1,73 m2) están en alto riesgo de enfermedad cardiovascular (ECV). Ningún estudio ha comparado este riesgo con TFGe 30-59, diabetes mellitus (DM) y enfermedad coronaria (EC) en regiones con baja incidencia de EC. MÉTODOS: Se realizó un estudio de cohortes retrospectivo en 122.443 individuos de 60-84 años de una región de baja incidencia de EC con creatinina determinada entre el 1 de enero de 2010 y 31 de diciembre de 2011. Se identificaron los ingresos por EC (infarto de miocardio, angina de pecho) o ECV (EC, accidente cerebrovascular o accidente isquémico transitorio) hasta el 31 de diciembre de 2013 según registros electrónicos. Se estimaron las tasas de incidencia y la subdistribution hazard ratio (sHR) ajustadas mediante regresión de Cox considerando los riesgos competitivos en individuos con TFGe 30-59, DM y EC o combinaciones, respecto a individuos sin estas afecciones. RESULTADOS: La mediana de seguimiento fue de 38,3 [intervalo intercuartílico, 33,8-42,7] meses. Las sHR de EC de los individuos con TFGe 30-59, DM, TFGe 30-59 más DM, EC previa, EC más DM y EC más TFGe 30-59 más DM fueron, respectivamente, 1,34 (IC95%, 1,04-1,74), 1,61 (IC95%, 1,36-1,90), 1,96 (IC95%, 1,42-2,70), 4,33 (IC95%, 3,58-5,25), 7,05 (IC95%, 5,80-8,58) y 7,72 (IC95%, 5,72-10,41), y las sHR de ECV, 1,25 (IC95%, 1,06-1,46), 1,56 (IC95%, 1,41-1,74), 1,83 (IC95%, 1,50-2,23), 2,86 (IC95%, 2,48-3,29), 4,54 (IC95%, 3,93-5,24) y 5,33 (IC95%, 4,31-6,60). CONCLUSIONES: Los individuos de 60-84 años con TFGe 30-59, de modo similar que la DM, presentaron un riesgo de ingreso por EC y ECV un 50% inferior que aquellos con EC previa. Una TFGe 30-59 no aparece como equivalente de riesgo coronario. Debe priorizarse un tratamiento más intensivo del riesgo cardiovascular de los individuos con EC y DM o TFGe 30-59 más DM

INTRODUCTION AND OBJECTIVES: Individuals with mild to moderately decreased estimated glomerular filtration rate (eGFR=30-59 mL/min/1.73 m2) are considered at high risk of cardiovascular disease (CVD). No studies have compared this risk in eGFR=30-59, diabetes mellitus (DM), and coronary heart disease (CHD) in regions with a low incidence of CHD. METHODS: We performed a retrospective cohort study of 122 443 individuals aged 60-84 years from a region with a low CHD incidence with creatinine measured between January 1, 2010 and December 31, 2011. We identified hospital admissions due to CHD (myocardial infarction, angina) or CVD (CHD, stroke, or transient ischemic attack) from electronic medical records up to December 31, 2013. We estimated incidence rates and Cox regression adjusted subdistribution hazard ratio (sHR) including competing risks in patients with eGFR=30-59, DM and CHD, or combinations, compared with individuals without these diseases. RESULTS: The median follow-up was 38.3 [IQR, 33.8-42.7] months. Adjusted sHR for CHD in individuals with eGFR=30-59, DM, eGFR=30-59 plus DM, previous CHD, CHD plus DM, and CHD plus eGFR=30-59 plus DM, were 1.34 (95%CI, 1.04-1.74), 1.61 (95%CI, 1.36-1.90), 1.96 (95%CI, 1.42-2.70), 4.33 (95%CI, 3.58-5.25), 7.05 (5.80-8.58) and 7.72 (5.72-10.41), respectively. The corresponding sHR for CVD were 1.25 (95%CI, 1.06-1.46), 1.56 (95%CI, 1.41-1.74), 1.83 (95%CI, 1.50-2.23), 2.86 (95%CI, 2.48-3.29), 4.54 (95%CI, 3.93-5.24), and 5.33 (95%CI, 4.31-6.60). CONCLUSIONS: In 60- to 84-year-olds with eGFR=30-59, similarly to DM, the likelihood of being admitted to hospital for CHD and CVD was about half that of individuals with established CHD. Thus, eGFR=30-59 does not appear to be a coronary-risk equivalent. Individuals with CHD and DM, or eGFR=30-59 plus DM, should be prioritized for more intensive risk management

Cardiovascular risk in mild to moderately decreased glomerular filtration rate, diabetes and coronary heart disease in a southern European region.

INTRODUCTION AND OBJECTIVES: Individuals with mild to moderately decreased estimated glomerular filtration rate (eGFR=30-59 mL/min/1.73 m2) are considered at high risk of cardiovascular disease (CVD). No studies have compared this risk in eGFR=30-59, diabetes mellitus (DM), and coronary heart disease (CHD) in regions with a low incidence of CHD. METHODS: We performed a retrospective cohort study of 122 443 individuals aged 60-84 years from a region with a low CHD incidence with creatinine measured between January 1, 2010 and December 31, 2011. We identified hospital admissions due to CHD (myocardial infarction, angina) or CVD (CHD, stroke, or transient ischemic attack) from electronic medical records up to December 31, 2013. We estimated incidence rates and Cox regression adjusted subdistribution hazard ratio (sHR) including competing risks in patients with eGFR=30-59, DM and CHD, or combinations, compared with individuals without these diseases. RESULTS: The median follow-up was 38.3 [IQR, 33.8-42.7] months. Adjusted sHR for CHD in individuals with eGFR=30-59, DM, eGFR=30-59 plus DM, previous CHD, CHD plus DM, and CHD plus eGFR=30-59 plus DM, were 1.34 (95%CI, 1.04-1.74), 1.61 (95%CI, 1.36-1.90), 1.96 (95%CI, 1.42-2.70), 4.33 (95%CI, 3.58-5.25), 7.05 (5.80-8.58) and 7.72 (5.72-10.41), respectively. The corresponding sHR for CVD were 1.25 (95%CI, 1.06-1.46), 1.56 (95%CI, 1.41-1.74), 1.83 (95%CI, 1.50-2.23), 2.86 (95%CI, 2.48-3.29), 4.54 (95%CI, 3.93-5.24), and 5.33 (95%CI, 4.31-6.60). CONCLUSIONS: In 60- to 84-year-olds with eGFR=30-59, similarly to DM, the likelihood of being admitted to hospital for CHD and CVD was about half that of individuals with established CHD. Thus, eGFR=30-59 does not appear to be a coronary-risk equivalent. Individuals with CHD and DM, or eGFR=30-59 plus DM, should be prioritized for more intensive risk management.

Heart failure admission across glomerular filtration rate categories in a community cohort of 125,053 individuals over 60 years of age.

A reduced estimated glomerular filtration rate (eGFR) has been described as a predictor of heart failure (HF). However, the increased risk across eGFR categories has not been fully evaluated, which is especially relevant in older individuals in whom both the prevalence of HF and decreased eGFR are higher. Furthermore, this association has not been studied in Mediterranean populations, where coronary heart disease (CHD), a frequent cause of HF, has a low prevalence. We performed a retrospective cohort study using the electronic medical records from primary and hospital settings in northeastern Spain. We included 125,053 individuals ≥60 years old with the determination of creatinine and without diagnosis or previous admission due to HF. The eGFR was calculated according to the CKD-EPI formula and classified by clinical categories. The association between eGFR, as a continuous and categorical variable, and the risk of admission due to HF was assessed by Cox proportional risk analysis, considering death as a competitive risk. During a median follow-up of 38.8 months, 2,176 individuals (1.74%) were hospitalized due to HF. The unadjusted admission rates were 4.02, 13.0, 26.0, and 48.6 per 1000 person-years for eGFR > 60, 45-59, 30-44, and 15-29 ml/min/1.73 m2, respectively. The corresponding hazard ratios (95% confidence interval; reference eGFR 60-89) were 1.38 (95% CI 1.23-1.55), 2.02 (95% CI 1.76-2.32) and 3.46 (95% CI 2.78-4.31). In this Mediterranean community-based cohort of individuals ≥60 years old without previous HF, the risk of admission due to HF gradually increased with decreasing eGFR.

Effectiveness of Statins as Primary Prevention in People With Gout: A Population-Based Cohort Study.

BACKGROUND: Cardiovascular guidelines do not give firm recommendations on statin therapy in patients with gout because evidence is lacking. AIM: To analyze the effectiveness of statin therapy in primary prevention of coronary heart disease (CHD), ischemic stroke (IS), and all-cause mortality in a population with gout. METHODS: A retrospective cohort study (July 2006 to December 2017) based on Information System for the Development of Research in Primary Care (SIDIAPQ), a research-quality database of electronic medical records, included primary care patients (aged 35-85 years) without previous cardiovascular disease (CVD). Participants were categorized as nonusers or new users of statins (defined as receiving statins for the first time during the study period). Index date was first statin invoicing for new users and randomly assigned to nonusers. The groups were compared for the incidence of CHD, IS, and all-cause mortality, using Cox proportional hazards modeling adjusted for propensity score. RESULTS: Between July 2006 and December 2008, 8018 individuals were included; 736 (9.1%) were new users of statins. Median follow-up was 9.8 years. Crude incidence of CHD was 8.16 (95% confidence interval [CI]: 6.25-10.65) and 6.56 (95% CI: 5.85-7.36) events per 1000 person-years in new users and nonusers, respectively. Hazard ratios were 0.84 (95% CI: 0.60-1.19) for CHD, 0.68 (0.44-1.05) for IS, and 0.87 (0.67-1.12) for all-cause mortality. Hazard for diabetes was 1.27 (0.99-1.63). CONCLUSIONS: Statin therapy was not associated with a clinically significant decrease in CHD. Despite higher risk of CVD in gout populations compared to general population, patients with gout from a primary prevention population with a low-to-intermediate incidence of CHD should be evaluated according to their cardiovascular risk assessment, lifestyle recommendations, and preferences, in line with recent European League Against Rheumatism recommendations.

Efectos a largo plazo de una intervención intensiva sobre cambios en los estilos de vida en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado-alto / Long-term effects of intensive intervention on changes in lifestyle in patients with hyperfibrinogenaemia and moderate-high cardiovascular risk

OBJETIVOS: Evaluar si persiste el beneficio sobre los factores de riesgo cardiovascular (FRCV) a los 5 años de una intervención intensiva en estilos de vida (EV) que duró 2 años, en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado o alto. DISEÑO: Estudio observacional prospectivo multicéntrico. Emplazamiento: Trece Centros de Atención Primaria de Barcelona y Baix Llobregat. PARTICIPANTES: Un total de 300 pacientes que finalizaron el estudio EFAP (146 del grupo intervención y 154 del control). INTERVENCIONES: El estudio EFAP, realizado con pacientes con cifras de colesterol normal y fibrinógeno elevado, mostró que las intervenciones sobre el estilo de vida son eficaces en la reducción de FRCV. Finalizado el estudio EFAP, los 2 grupos siguieron los controles habituales. Pasados 5 años evaluamos los 2 grupos. Mediciones principales: Edad, sexo, FRCV (diabetes, dislipidemia, hipertensión arterial, obesidad), analítica (fibrinógeno, glucosa, hemograma, colesterol, triglicéridos), presión arterial, peso, talla, índice de masa corporal (IMC), hábitos tóxicos (tabaco y alcohol), REGICOR. RESULTADOS: A los 5 años, el grupo intervención presentó respecto al control menor perímetro abdominal (98 y 101 cm, respectivamente; p = 0,043), menor peso (76,30 y 75,04kg, respectivamente; p < 0,001) e IMC (29,5 y 30, 97 kg/m2; p = 0,018). El nivel de fibrinógeno fue inferior en el grupo intervención (330,33 y 320,27 mg/dl respectivamente; p < 0,001), y riesgo REGICOR también fue inferior en el grupo intervención (5,65 y 5,59 respectivamente; p < 0,06). CONCLUSIÓN: El beneficio de una intervención intensiva en EV durante 2 años para reducir los FRCV persiste a los 5 años, pero disminuye su intensidad con el tiempo. Se recomienda repetir periódicamente las intervenciones para mantener el efecto beneficioso sobre los EV

OBJECTIVES: To determine whether the benefit on cardiovascular risk factors (CVRF) persists 5 years after an intensive intervention in lifestyle (LS) that lasted 2 years, in patients with hyperfibrinogenaemia and moderate or high cardiovascular risk. DESIGN: multicentre prospective observational study. LOCATION: 13 Primary Care Centres in Barcelona and Baix Llobregat. PARTICIPANTS: A total of 300 patients who completed the EFAP study (146 intervention group, 154 control group). INTERVENTIONS: The EFAP study, conducted on patients with normal cholesterol and elevated fibrinogen showed that lifestyle interventions are effective in reducing CVRF. After the EFAP study, the 2 groups followed the usual controls, and re-assessed after 5 years. MAIN MEASUREMENTS: Age, gender, cardiovascular diseases (CVD) (diabetes, dyslipidaemia, hypertension, obesity), laboratory parameters (fibrinogen, glucose, full blood count, cholesterol, triglycerides), blood pressure, weight, height, body mass index (BMI), tobacco and alcohol use, REGICOR. RESULTS: At 5 years, the intervention group had a lower abdominal circumference (98 and 101cm, respectively, P = .043), a lower weight (76.30 and 75.04 kg, respectively, P < .001), and BMI (29.5 and 30.97 kg/m2, P = .018). Fibrinogen level was lower in the intervention group (330.33 and 320.27 mg/dl respectively, P < .001), and REGICOR risk was also lower in the intervention group (5.65 and 5.59 respectively, P < .06). CONCLUSION: The benefit of an intensive intervention in LS for 2 years to reduce CVRF persists at 5 years, but decreases its intensity over time. It is recommended to repeat the interventions periodically to maintain the beneficial effect on LS

Tasa de filtrado glomerular estimada, eventos cardiovasculares y mortalidad por grupos de edad en individuos de 60 o más años del sur de Europa / Estimated glomerular filtration rate, cardiovascular events and mortality across age groups among individuals older than 60 years in Southern Europe

Introducción y objetivos: Los individuos con tasa de filtrado glomerular estimada (TFGe) disminuida tienen mayor riesgo de muerte por todas las causas (MT) y cardiovascular; se debate si los sujetos mayores con TFGe entre 45 y 59 ml/min/1,73 m2 también tienen un riesgo aumentado. Se evaluó la asociación entre la TFGe y la MT y los eventos cardiovasculares (ECV) en individuos de edad 60-74 y ≥ 75 años en un área de baja incidencia de enfermedad coronaria. Métodos: Se realizó un estudio retrospectivo de cohortes utilizando registros electrónicos de atención primaria y hospital. Se incluyó a 130.233 individuos de 60 o más años con una determinación de creatinina entre el 1 de enero de 2010 y el 31 de diciembre de 2011 y una TFGe según la fórmula de la Chronic Kidney Disease Epidemiology Collaboration. Las asociaciones independientes entre la TFGe y la MT y el ingreso por ECV se evaluaron mediante modelos de regresión de Cox y Fine-Gray respectivamente. Resultados: Media de edad, 70 años; el 56,1% eran mujeres. El 13,5% tenía una TFGe < 60 (el 69,7%, TFGe 45-59). Durante una mediana de seguimiento de 38,2 meses, 6.474 participantes fallecieron y 3.746 presentaron ECV. Tanto para la MT como para los ECV, las HR ajustadas de los participantes de 75 o más años fueron significativas con TFGe < 60. Con TFGe 45-59, para MT fueron HR = 1,61; IC95%, 1,37-1,89 y HR = 1,19; IC95%, 1,10-1,28 en los grupos de edad de 60-74 y ≥ 75 años respectivamente, y para ECV, HR = 1,28; IC95%, 1,08-1,51 y HR = 1,12; IC95%, 0,99-1,26. Conclusiones: En un área de baja incidencia de enfermedad coronaria, el riesgo de muerte y ECV fue de mayor a menor TFGe. A edades ≥ 75 años, la categoría de TFGe 45-59, en el límite significativo de ECV, incluyó a muchos individuos sin riesgo adicional significativo

Introduction and objectives: Individuals with a decreased estimated glomerular filtration rate (eGFR) are at increased risk of all-cause (ACM) and cardiovascular mortality; there is ongoing debate about whether older individuals with eGFR 45 to 59 mL/min/1.73 m2 are also at increased risk. We evaluated the association between eGFR and ACM and cardiovascular events (CVE) in people aged 60 to 74 and ≥ 75 years in a population with a low coronary disease incidence. Methods: We conducted a retrospective cohort study by using primary care and hospital electronic records. We included 130 233 individuals aged ≥ 60 years with creatinine measurement between January 1, 2010 and December 31, 2011; eGFR was estimated by using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation. The independent association between eGFR and the risk of ACM and hospital admission due to CVE were determined with Cox and Fine-Gray regressions, respectively. Results: The median was age 70 years, and 56.1% were women; 13.5% had eGFR < 60 (69.7% eGFR 45-59). During a median follow-up of 38.2 months, 6474 participants died and 3746 had a CVE. For ACM and CVE, the HR in older individuals became significant at eGFR < 60. Fully adjusted HR for ACM in the eGFR 45 to 59 category were 1.61; 95%CI, 1.37-1.89 and 1.19; 95%CI, 1.10-1.28 in 60- to 74-year-olds and ≥ 75-year-olds, respectively; for CVE HR were 1.28; 95%CI, 1.08-1.51 and 1.12; 95%CI, 0.99-1.26. Conclusions: In a region with low coronary disease incidence, the risk of death and CVE increased with decreasing eGFR. In ≥ 75-year-olds, the eGFR 45 to 59 category, which had borderline risk for CVE, included many individuals without significant additional risk

Insuficiencia cardiaca en atención primaria: actitudes, conocimientos y autocuidado / Heart failure in primary care: Attitudes, knowledge and self-care

OBJETIVO: Conocer actitudes, conocimientos y prácticas en autocuidado en pacientes con insuficiencia cardiaca (IC) atendidos en atención primaria, e identificar factores asociados a mayor autocuidado. DISEÑO: Estudio transversal multicéntrico. Emplazamiento: Atención primaria. PARTICIPANTES: Individuos mayores de 18 años con diagnóstico activo de IC a 1 de diciembre de 2011 en 10 centros de salud del Área Metropolitana de Barcelona. Medidas principales: Se realizó entrevista y revisión de historia clínica para obtención de datos sociodemográficos, clínicos y tests de actitudes (Self-efficacy Managing Chronic Disease Scale), conocimientos (Patient Knowledge Questionnaire), autocuidado (European Heart Failure Self-care Behaviour Scale), grado autonomía (Barthel) y cribado ansiedad-depresión (test Goldberg). Se analizaron las variables asociadas a autocuidado mediante modelo de regresión lineal múltiple de efectos mixtos jerarquizado por centros. RESULTADOS: n = 295 individuos (77,6%), edad media 75,6años (DE: 11), 56,6% mujeres, 62% sin estudios primarios. Se obtuvo una media global de autocuidado de 28,65 (DE: 8,22) puntos. Un 25% de los pacientes presentaron puntuaciones inferiores a 21 puntos. En el modelo multivariante final (n = 282; R2 condicional = 0,3382), un mayor autocuidado se relacionó con mejores conocimientos sobre la IC (coeficiente -1,37; intervalo de confianza 95%: -1,85 a -0,90) y el diagnóstico de cardiopatía isquémica (-2,41; -4,36: -0,46). CONCLUSIONES: El grado de prácticas en autocuidado es moderado. La asociación de mejor autocuidado y mayor nivel de conocimientos sobre la IC, potencialmente modificables, subraya la oportunidad de implementar estrategias para su mejora adaptadas a las características diferenciales de los pacientes con IC atendidos de atención primaria

OBJECTIVE: To determine the attitudes, knowledge, and self-care practices in patients with heart failure (HF) in Primary Care, as well as to identify factors associated with better self-care. DESIGN: Cross-sectional and multicentre study. SETTING: Primary Care. PARTICIPANTS: Subjects over 18 years old with HF diagnosis, attended in 10 Primary Health Care Centres in the Metropolitan Area of Barcelona. MAIN MEASUREMENTS: Self-care was measured using the European Heart Failure Self-Care Behaviour Scale. Sociodemographic and clinical characteristics, tests on attitudes (Self-efficacy Managing Chronic Disease Scale), knowledge (Patient Knowledge Questionnaire), level of autonomy (Barthel), and anxiety and depression screening (Goldberg Test), were also gathered in an interview. A multivariate mixed model stratified by centre was used to analyse the adjusted association of covariates with self-care. RESULTS: A total of 295 subjects (77.6%) agreed to participate, with a mean age of 75.6 years (SD: 11), 56.6% women, and 62% with no primary education. The mean self-care score was 28.65 (SD: 8.22), with 25% of patients scoring lower than 21 points. In the final stratified multivariate model (n = 282; R2 conditional = 0.3382), better self-care was associated with higher knowledge (coefficient, 95% confidence interval: -1.37; -1.85 to -0.90), and coronary heart disease diagnosis (-2.41; -4.36: -0.46). CONCLUSION: Self-care was moderate. The correlation of better self-care with higher knowledge highlights the opportunity to implement strategies to improve self-care, which should consider the characteristics of heart failure patients attended in Primary Care

Estimated Glomerular Filtration Rate, Cardiovascular Events and Mortality Across Age Groups Among Individuals Older Than 60 Years in Southern Europe.

INTRODUCTION AND OBJECTIVES: Individuals with a decreased estimated glomerular filtration rate (eGFR) are at increased risk of all-cause (ACM) and cardiovascular mortality; there is ongoing debate about whether older individuals with eGFR 45 to 59mL/min/1.73 m2 are also at increased risk. We evaluated the association between eGFR and ACM and cardiovascular events (CVE) in people aged 60 to 74 and ≥ 75 years in a population with a low coronary disease incidence. METHODS: We conducted a retrospective cohort study by using primary care and hospital electronic records. We included 130 233 individuals aged ≥ 60 years with creatinine measurement between January 1, 2010 and December 31, 2011; eGFR was estimated by using the Chronic Kidney Disease Epidemiology Collaboration creatinine equation. The independent association between eGFR and the risk of ACM and hospital admission due to CVE were determined with Cox and Fine-Gray regressions, respectively. RESULTS: The median was age 70 years, and 56.1% were women; 13.5% had eGFR < 60 (69.7% eGFR 45-59). During a median follow-up of 38.2 months, 6474 participants died and 3746 had a CVE. For ACM and CVE, the HR in older individuals became significant at eGFR < 60. Fully adjusted HR for ACM in the eGFR 45 to 59 category were 1.61; 95%CI, 1.37-1.89 and 1.19; 95%CI, 1.10-1.28 in 60- to 74-year-olds and ≥ 75-year-olds, respectively; for CVE HR were 1.28; 95%CI, 1.08-1.51 and 1.12; 95%CI, 0.99-1.26. CONCLUSIONS: In a region with low coronary disease incidence, the risk of death and CVE increased with decreasing eGFR. In ≥ 75-year-olds, the eGFR 45 to 59 category, which had borderline risk for CVE, included many individuals without significant additional risk.

Association between chronic immune-mediated inflammatory diseases and cardiovascular risk.

OBJECTIVE: To examine the association between chronic immune-mediated diseases (rheumatoid arthritis, systemic lupus erythematosus or the following chronic immune-mediated inflammatory diagnoses groups: inflammatory bowel diseases, inflammatory polyarthropathies, systemic connective tissue disorders and spondylopathies) and the 6-year coronary artery disease, stroke, cardiovascular disease incidence and overall mortality; and to estimate the population attributable fractions for all four end-points for each chronic immune-mediated inflammatory disease. METHODS: Cohort study of individuals aged 35-85 years, with no history of cardiovascular disease from Catalonia (Spain). The coded diagnoses of chronic immune-mediated diseases and cardiovascular diseases were ascertained and registered using validated codes, and date of death was obtained from administrative data. Cox regression models for each outcome according to exposure were fitted to estimate HRs in two models 1 : after adjustment for sex, age, cardiovascular risk factors and 2 further adjusted for drug use. Population attributable fractions were estimated for each exposure. RESULTS: Data were collected from 991 546 participants. The risk of cardiovascular disease was increased in systemic connective tissue disorders (model 1: HR=1.38 (95% CI 1.21 to 1.57) and model 2: HR=1.31 (95% CI 1.15 to 1.49)), rheumatoid arthritis (HR=1.43 (95% CI 1.26 to 1.62) and HR=1.31 (95% CI 1.15 to 1.49)) and inflammatory bowel diseases (HR=1.18 (95% CI 1.06 to 1.32) and HR=1.12 (95% CI 1.01 to 1.25)). The effect of anti-inflammatory treatment was significant in all instances (HR=1.50 (95% CI 1.24 to 1.81); HR=1.47 (95% CI 1.23 to 1.75); HR=1.43 (95% CI 1.19 to 1.73), respectively). The population attributable fractions for all three disorders were 13.4%, 15.7% and 10.7%, respectively. CONCLUSION: Systemic connective tissue disorders and rheumatoid arthritis conferred the highest cardiovascular risk and population impact, followed by inflammatory bowel diseases.

[Heart failure in primary care: Attitudes, knowledge and self-care]. / Insuficiencia cardiaca en atención primaria: actitudes, conocimientos y autocuidado.

OBJECTIVE: To determine the attitudes, knowledge, and self-care practices in patients with heart failure (HF) in Primary Care, as well as to identify factors associated with better self-care. DESIGN: Cross-sectional and multicentre study. SETTING: Primary Care. PARTICIPANTS: Subjects over 18 years old with HF diagnosis, attended in 10 Primary Health Care Centres in the Metropolitan Area of Barcelona. MAIN MEASUREMENTS: Self-care was measured using the European Heart Failure Self-Care Behaviour Scale. Sociodemographic and clinical characteristics, tests on attitudes (Self-efficacy Managing Chronic Disease Scale), knowledge (Patient Knowledge Questionnaire), level of autonomy (Barthel), and anxiety and depression screening (Goldberg Test), were also gathered in an interview. A multivariate mixed model stratified by centre was used to analyse the adjusted association of covariates with self-care. RESULTS: A total of 295 subjects (77.6%) agreed to participate, with a mean age of 75.6 years (SD: 11), 56.6% women, and 62% with no primary education. The mean self-care score was 28.65 (SD: 8.22), with 25% of patients scoring lower than 21 points. In the final stratified multivariate model (n=282; R2 conditional=0.3382), better self-care was associated with higher knowledge (coefficient, 95% confidence interval: -1.37; -1.85 to -0.90), and coronary heart disease diagnosis (-2.41; -4.36: -0.46). CONCLUSION: Self-care was moderate. The correlation of better self-care with higher knowledge highlights the opportunity to implement strategies to improve self-care, which should consider the characteristics of heart failure patients attended in Primary Care.

[Long-term effects of intensive intervention on changes in lifestyle in patients with hyperfibrinogenaemia and moderate-high cardiovascular risk]. / Efectos a largo plazo de una intervención intensiva sobre cambios en los estilos de vida en pacientes con hiperfibrinogenemia y riesgo cardiovascular moderado-alto.

OBJECTIVES: To determine whether the benefit on cardiovascular risk factors (CVRF) persists 5 years after an intensive intervention in lifestyle (LS) that lasted 2 years, in patients with hyperfibrinogenaemia and moderate or high cardiovascular risk. DESIGN: multicentre prospective observational study. LOCATION: 13 Primary Care Centres in Barcelona and Baix Llobregat. PARTICIPANTS: A total of 300 patients who completed the EFAP study (146 intervention group, 154 control group). INTERVENTIONS: The EFAP study, conducted on patients with normal cholesterol and elevated fibrinogen showed that lifestyle interventions are effective in reducing CVRF. After the EFAP study, the 2 groups followed the usual controls, and re-assessed after 5 years. MAIN MEASUREMENTS: Age, gender, cardiovascular diseases (CVD) (diabetes, dyslipidaemia, hypertension, obesity), laboratory parameters (fibrinogen, glucose, full blood count, cholesterol, triglycerides), blood pressure, weight, height, body mass index (BMI), tobacco and alcohol use, REGICOR. RESULTS: At 5 years, the intervention group had a lower abdominal circumference (98 and 101cm, respectively, P=.043), a lower weight (76.30 and 75.04kg, respectively, P<.001), and BMI (29.5 and 30.97kg/m2, P=.018). Fibrinogen level was lower in the intervention group (330.33 and 320.27 mg/dl respectively, P < .001), and REGICOR risk was also lower in the intervention group (5.65 and 5.59 respectively, P < .06). CONCLUSION: The benefit of an intensive intervention in LS for 2 years to reduce CVRF persists at 5 years, but decreases its intensity over time. It is recommended to repeat the interventions periodically to maintain the beneficial effect on LS.

The association between education and cardiovascular disease incidence is mediated by hypertension, diabetes, and body mass index.

Education and cardiovascular disease (CVD) are inversely associated but the mediating factors have not been totally elucidated. Our aim was to analyze the mediating role of modifiable risk factors. Cohort study using the REGICOR population cohorts. Participants without previous CVD were included (n = 9226). Marginal structural models were used to analyze the association between education and CVD incidence at 6 years of follow-up. Mediation by modifiable risk factors (diabetes, dyslipidemia, hypertension, smoking, body mass index, and physical activity) was assessed using the counterfactual framework. Participants with a university degree had a CVD incidence hazard ratio (HR) of 0.51 (95% confidence interval (CI) = 0.30, 0.85), compared to those with primary or lower education. Only hypertension, BMI, and diabetes mediated the association between education and CVD incidence, accounting for 26% of the association (13.9, 6.9, and 5.2%, respectively). Sensitivity analyses showed that hypertension was the strongest mediator (average causal mediation effect [95% CI] = increase of 2170 days free of CVD events [711, 4520]). The association between education and CVD incidence is partially mediated by hypertension, BMI, and diabetes. Interventions to decrease the prevalence of these risk factors could contribute to diminish the CVD inequalities associated with educational level.

Enfermedad renal crónica en individuos hipertensos mayores o iguales a 60 años atendidos en Atención Primaria / Chronic kidney disease in hypertensive subjects Greater than or equal to 60 years treated in Primary Care

Antecedentes: La hipertensión arterial (HTA) es la segunda causa de insuficiencia renal. En hipertensos con enfermedad renal crónica (ERC) el control de la presión arterial (PA) es la intervención más importante para minimizar la progresión. Para el diagnóstico de ERC se recomienda la determinación estandarizada de creatinina y filtrado glomerular estimado (FGe) según CKD-EPI. Objetivos: Describir la prevalencia y los factores asociados a la disminución moderada del FGe (según CKD-EPI) y el control de PA en individuos con HTA. Métodos: Estudio descriptivo transversal en individuos ≥60 años incluidos en la base de datos SIDIAP plus con HTA y registro de creatinina sérica estandarizada y PA en últimos 2años. Criterios de exclusión: FGe<30, diálisis o trasplante renal, enfermedad cardiovascular previa, atención domiciliaria. Variable principal: FGe según CKD-EPI. Covariables: datos demográficos, exploración, factores de riesgo cardiovascular, diagnósticos de insuficiencia cardiaca y fibrilación auricular y fármacos (antihipertensivos con acción sobre función renal, antiagregantes, hipolipidemiantes). Criterio de control de la PA: ≤130/80mmHg en individuos con albuminuria, ≤140/90 en el resto. Resultados: Prevalencia FGe<60: 18,8%. Factores asociados: edad, sexo, insuficiencia cardiaca, cociente albúmina/creatinina, fibrilación auricular, hábito tabáquico, dislipidemia, diabetes y obesidad. Control de la PA: 66,14 y 63,24% en FGe≥60 y FGe<60 respectivamente (p<0,05). La exposición a fármacos fue superior en FGe<60. Conclusiones: Uno de cada 5hipertensos sin enfermedad cardiovascular ≥60 años en atención primaria presentó disminución moderada del FGe. Además de la edad y el sexo, la albuminuria y la insuficiencia cardiaca fueron los principales factores asociados. A pesar de la mayor exposición a fármacos, el control de la PA fue inferior en ERC (AU)

Background: Hypertension (HT) is the second leading cause of kidney failure. In hypertensive patients with chronic kidney disease (CKD), blood pressure (BP) control is the most important intervention to minimise progression. For CKD diagnosis, standardised creatinine and estimated glomerular filtration rate (eGFR) testing by CKD-EPI is recommended. Objectives: To describe the prevalence and factors associated with a moderate decrease in eGFR (by CKD-EPI) and BP control in subjects with HT. Methods: Cross-sectional descriptive study in subjects ≥ 60 years included in the SIDIAP plus database with hypertension and standardised serum creatinine and BP tests in the last 2years. Exclusion criteria: eGFR<30, dialysis or kidney transplantation, prior cardiovascular disease, home care. Primary endpoint: eGFR by CKD-EPI formula. Covariates: demographic data, examination, cardiovascular risk factors, heart failure and auricular fibrillation diagnosis, and drugs (antihypertensive agents acting on renal function, antiplatelet and lipid lowering agents). BP control criteria: ≤130/80mmHg in individuals with albuminuria, ≤140/90 in all other subjects. Results: Prevalence of eGFR <60=18.8%. Associated factors: age, gender, heart failure, albumin/creatinine ratio, auricular fibrillation, smoking, dyslipidaemia, diabetes and obesity. BP control: 66.14 and 63.24% in eGFR≥60 and eGFR <60, respectively (P<.05). Exposure to drugs was higher in eGFR<60. Conclusion: One in 5hypertensive patients without cardiovascular disease ≥60 years in primary care presented with a moderate decrease in eGFR. In addition to age and sex, albuminuria and heart failure were the main associated factors. Despite the increased exposure to drugs, BP control was lower in CKD (AU)