Time-varying association between herpes zoster infection and subsequent occurrence of stroke.

OBJECTIVES: The aim of this study was to investigate the shape of the time-varying relationship between herpes zoster infection, nominally shingles, and the occurrence of stroke. STUDY DESIGN: Retrospective cohort study. METHODS: Using the Italian Health Search Database, a cohort of patients aged ≥18 years who were registered between 2002 and 2021 was selected. In this cohort, a nested case-control analysis was used to model the time-varying distance (in months) between the dates of shingles and post-herpetic stroke, using a regression cubic spline, based on the odds of the occurrence of stroke compared with those without shingles. RESULTS: The dataset comprised 42,513 cases (51.1% males; mean age [stanndard deviation {SD}]: 71.0 [11.8] years) and 425,124 related controls (51.1% males; mean age [SD]: 70.9 [12] years). In the first 12 months following shingles diagnosis, a rapid increase in the risk of stroke was observed, reaching an odds ratio of 1.31 (95% confidence interval: 1.21-1.41); subsequently, there was some risk reduction and a new symmetric increase within the first 4.2 years of follow-up, thus shaping a bimodal distribution. Then, a new increase in the stroke risk was reported, although less steep, which was followed by a regular risk reduction (still 10% higher compared with those without shingles), resulting in a right-skewed relationship between the time from the shingles diagnosis and the occurrence of stroke. This association was no longer statistically significant 13.1 years after shingles diagnosis. CONCLUSIONS: This study demonstrated that the risk of post-herpetic stroke has a short- and long-term association according to a risk continuum relationship. These findings confirm the relevance of vaccination coverage for herpes zoster.

To support the use of NT-proBNP to better detect heart failure in patients with type 2 diabetes.

PURPOSE: Heart failure (HF) is a chronic disease that causes approximately 300,000 and 250,000 deaths per year in Europe and United States, respectively. Type 2 Diabetes Mellitus (T2DM) is one the major risk factors of HF, and the investigation of NT-proBNP might support the early identification of HF in T2DM sufferers. Nevertheless, this parameter is poorly investigated. Thus, we aimed to demographically and clinically characterize diabetic patients which were prescribed with NT-proBNP in the primary care setting. METHODS: Using a primary care database, we formed a cohort of patients aged ≥18 years diagnosed with T2DM between 2002 and 2021. A multivariate Cox model was adopted to assess the determinants associated with the prescription of NT-proBNP. RESULTS: Among 167,961 T2DM patients, 7558 (4.5%, 95% CI: 4.4-4.6) were prescribed with NT-proBNP. Males and increasing age were expectedly associated with a higher propensity to be prescribed with NT-proBNP. In addition, a significant association was found for those suffering from obesity, ischemic cardiomyopathy, stroke, atrial fibrillation, hypertension, and with a Charlson Index of 2+. CONCLUSION: These determinants might contribute to investigate the NT-proBNP in T2DM sufferers. A decision support system to appropriately ease the prescription of NT-proBNP might be therefore implemented in primary care settings.

LDL-cholesterol control in the primary prevention of cardiovascular diseases: An expert opinion for clinicians and health professionals.

AIMS: Although adequate clinical management of patients with hypercholesterolemia without a history of known cardiovascular disease is essential for prevention, these subjects are often disregarded. Furthermore, the scientific literature on primary cardiovascular prevention is not as rich as that on secondary prevention; finally, physicians often lack adequate tools for the effective management of subjects in primary prevention and have to face some unsolved relevant issues. This document aims to discuss and review the evidence available on this topic and provide practical guidance. DATA SYNTHESIS: Available algorithms and risk charts represent the main tool for the assessment of cardiovascular risk in patients in primary prevention. The accuracy of such an estimate can be substantially improved considering the potential contribution of some additional risk factors (C-reactive protein, lipoprotein(a), family history of cardiovascular disease) and conditions (environmental pollution, sleep quality, socioeconomic status, educational level) whose impact on the cardiovascular risk has been better understood in recent years. The availability of non-invasive procedures to evaluate subclinical atherosclerosis may help to identify subjects needing an earlier intervention. Unveiling the presence of these conditions will improve cardiovascular risk estimation, granting a more appropriate intervention. CONCLUSIONS: The accurate assessment of cardiovascular risk in subjects in primary prevention with the use of algorithms and risk charts together with the evaluation of additional factors will allow physicians to approach each patient with personalized strategies, which should translate into an increased adherence to therapy and, as a consequence, a reduced cardiovascular risk.

How many and who are patients with heart failure eligible to SGLT2 inhibitors? Responses from the combination of administrative healthcare and primary care databases.

BACKGROUND: Recent successful findings (i.e. DAPA-HF trial) in patients with heart failure (HF) with/without diabetes treated with sodium-glucose co-transporter inhibitors (SGLT2-I) have fostered real-world data analyses. Fondazione Ricerca e Salute's (ReSD) administrative and Health Search's (HSD) primary healthcare databases were combined in the ReS-HS DB Consortium, to identify and characterize HF-patients eligible to SGLT2-I, and assess their costs charged to the Italian National Health Service (INHS). METHODS AND RESULTS: Eligibility to SGLT2-I was HF diagnosis, age ≥ 18 years, reduced (≤40%) ejection fraction (HFrEF) and glomerular filtration rate (GFR) ≥30 ml/min. The HSD, including 13,313 HF-patients (1.5% of the total HSD population) was used to develop and test the algorithms for imputing HFrEF and GFR ≥ 30 ml/min, based on a set of covariates, to the ReSD, including 67,369 (1.5% of the total ReSD population). Subjects eligible to SGLT2-I were 2187 in HSD (61.1% of HFrEF); after the imputation, 15,145 in ReSD (58.8% of HFrEF). Prevalence of eligibility to SGLT2-I was higher in males then in females and increased with age; diabetic patients were 44.3% and 33.4% of HSD and ReSD populations eligible to SGLT2-I, respectively. Estimated from ReSD, the mean annual cost charged to the INHS per patient with HF eligible to SGLT2-I was €7122 (68% due to hospitalizations). CONCLUSIONS: Approximately 20% of patients with HF was eligible to SGLT2-I. Real-world data can identify, quantify and characterize patients eligible to SGLT2-Is and assess related costs for the health care system, thus providing useful information to Regulatory Decision makers.

Derivation and Validation of a Prediction Model for Venous Thromboembolism in Primary Care.

BACKGROUND: Most episodes of venous thromboembolism (VTE) occurred in primary care. To date, no score potentially able to identify those patients who may deserve an antithrombotic prophylaxis has been developed. AIM: The objective of this study is to develop and validate a prediction model for VTE in primary care. METHODS: Using the Health Search Database, we identified a cohort of 1,359,880 adult patients between 2002 and 2013. The date of the first General Practitioner's (GP) visit was the cohort entry date. All VTE cases (index date) observed up to December 2014 were identified. The cohort was randomly divided in a development and a validation cohort. According to nested case-cohort analysis, up to five controls were matched to their respective cases on month and year of cohort entry and duration of follow-up.The score was evaluated according to explained variance (pseudo R2) as a performance measure, ratio of predicted to observed cases as model calibration and area under the curve (AUC) as discrimination measure. RESULTS: The score was able to explain 27.9% of the variation for VTE occurrence. The calibration measure revealed a margin of error lower than 10% in 70% of the population. In terms of discrimination, AUC was 0.82 (95% confidence interval: 0.82-0.83). Results of sensitivity analyses substantially confirmed these findings. CONCLUSION: The present score demonstrated a very good accuracy in predicting the risk of VTE in primary care. This score may be therefore implemented in clinical practice so aiding GPs in making decision on patients potentially at risk of VTE.

Adherence to Triple-Free-Drug Combination Therapies Among Patients With Cardiovascular Disease.

Combination therapies are often needed to modify the concomitant risk factors for cardiovascular disease. Nonadherence to cardiovascular medications is a relevant concern, especially in polytherapy. We conducted a population-based, cohort study with the aim of quantifying the level of adherence and its related determinants in patients exposed to free 3-drug combination therapies, namely concurrent use of angiotensin-converting-enzyme inhibitor (ACEi), calcium channel blocker (CCB), and statin or of ACEi, statin, and low-dose aspirin. Within Health Search Database, we selected a cohort of adult patients concurrently prescribed with ACEi, CCB, and statin, as well as those prescribed with ACEi, statin and low-dose aspirin, from the January 1, 2002 to the December 31, 2014. Adherent patients were concurrent users of triple free pill regimen with a proportion of days covered ≥80% during 1-year follow-up; demographics and clinical determinants of 1-year adherence were identified by multivariate logistic regression. We found that more than half of patients prescribed with triple free drug combination therapy with ACEi plus CCB plus statin or ACEi plus statin plus low-dose aspirin, were found to be nonadherent to these treatments. Males and patients at high/very-high cardiovascular risk were more likely to be adherent, whereas depression and atrial fibrillation were associated with nonadherence. Our findings indicate that sex, cardiovascular risk, presence of atrial fibrillation, and depression can influence adherence to polytherapy. In conclusion, given that patients suffering from multiple cardiovascular risk factors are at higher risk of fatal events, strategies are needed to improve medication adherence to combination therapies.

[ANMCO/FADOI/SIAARTI/SIC/SIMG/SIMI/SIMEU consensus document: The clinical care pathway of acute heart failure patients from symptom onset to discharge from the emergency department]. / Documento di consenso ANMCO/FADOI/SIAARTI/SIC/SIMG/SIMI/SIMEU: Il percorso clinico-diagnostico e terapeutico del paziente con scompenso cardiaco acuto dal domicilio alla dimissione dal Pronto Soccorso/ Dipartimento di Emergenza-Accettazione.

Acute heart failure (AHF) represents a relevant burden for emergency departments worldwide. AHF patients have markedly worse long-term outcomes than patients with other acute cardiac diseases (e.g. acute coronary syndromes); mortality or readmissions rates at 3 months approximate 33%, whereas 1-year mortality from index discharge ranges from 25% to 50%.The multiplicity of healthcare professionals acting across the care pathway of AHF patients represents a critical factor, which generates the need for integrating the different expertise and competence of general practitioners, emergency physicians, cardiologists, internists, and intensive care physicians to focus on care goals able to improve clinical outcomes.This consensus document results from the cooperation of the scientific societies representing the different healthcare professionals involved in the care of AHF patients and describes shared strategies and pathways aimed at ensuring both high quality care and better outcomes. The document describes the patient journey from symptom onset to the clinical suspicion of AHF and home management or referral to emergency care and transportation to the hospital, through the clinical diagnostic pathway in the emergency department, acute treatment, risk stratification and discharge from the emergency department to ordinary wards or home. The document analyzes the potential role of a cardiology fast-track and Observation Units and the transition to outpatient care by general practitioners and specialist heart failure clinics.The increasing care burden and complex problems generated by AHF are unlikely to be solved without an integrated multidisciplinary approach. Efficient networking among emergency departments, intensive care units, ordinary wards and primary care settings is crucial to achieve better outcomes. Thanks to the joint effort of qualified scientific societies, this document aims to achieve this goal through an integrated, shared and applicable pathway that will contribute to a homogeneous care management of AHF patients across the country.

Nutraceuticals and functional foods for the control of plasma cholesterol levels. An intersociety position paper.

Current evidence shows that cholesterol management either reduces the likelihood of cardiovascular disease (CVD) or slows down its progression. Hence, it is important that all health professionals make appropriate use of all the available intervention strategies to control risk factors: from dietary improvement and positive lifestyle changes to the use of functional foods, food supplements, and drugs. This review examines the effect of the most frequently occurring cholesterol-lowering substances in functional foods or in supplements across Europe, namely plant sterols and stanols, monacolin K found in red yeast rice, berberine and beta-glucans. We conclude that currently available supplements and functional foods can effectively reduce plasma LDL cholesterol levels by about 5 to 25%, either alone or in combination. Suitable candidates for these products are mainly individuals at low absolute cardiovascular risk at a young age or according to classic algorithms. Of note, despite being freely available for purchase, these products should be used following shared agreement between the physician and the patient ("concordance").

ANMCO/ISS/AMD/ANCE/ARCA/FADOI/GICR-IACPR/SICI-GISE/SIBioC/SIC/SICOA/SID/SIF/SIMEU/SIMG/SIMI/SISA Joint Consensus Document on cholesterol and cardiovascular risk: diagnostic-therapeutic pathway in Italy.

Atherosclerotic cardiovascular disease still represents the leading cause of death in Western countries. A wealth of scientific evidence demonstrates that increased blood cholesterol levels have a major impact on the outbreak and progression of atherosclerotic plaques. Moreover, several cholesterol-lowering pharmacological agents, including statins and ezetimibe, have proved effective in improving clinical outcomes. This document focuses on the clinical management of hypercholesterolaemia and has been conceived by 16 Italian medical associations with the support of the Italian National Institute of Health. The authors discuss in detail the role of hypercholesterolaemia in the genesis of atherosclerotic cardiovascular disease. In addition, the implications for high cholesterol levels in the definition of the individual cardiovascular risk profile have been carefully analysed, while all available therapeutic options for blood cholesterol reduction and cardiovascular risk mitigation have been explored. Finally, this document outlines the diagnostic and therapeutic pathways for the clinical management of patients with hypercholesterolaemia.

Effectiveness of adherence to lipid lowering therapy on LDL-cholesterol in patients with very high cardiovascular risk: A real-world evidence study in primary care.

BACKGROUND AND AIMS: Despite management guidelines advocating statin/ezetimibe use in very high cardiovascular risk (CV) conditions, adherence to this therapy is still suboptimal and LDL-C target attainment unsatisfactory. We aimed to investigate the level of adherence to statin/ezetimibe and LDL-C target achievement rates in an unselected very high CV risk population in primary care setting in Italy. METHODS: We performed a retrospective population-based study using the Health Search IMS Health Longitudinal Patient Database (HSD), including adult patients at very high CV risk, newly treated with statin, ezetimibe or their combination, with 3 and 6 months of follow-up. RESULTS: Although the large majority of patients had previous major CV events (99.9%), only 61% and 55.14% resulted adherent (Proportion of Days Covered, PDC≥80%) after 3 and 6 months, respectively. High adherence entailed almost a three times higher probability to reach the therapeutic LDL-C target (3 months: OR = 2.26 [95% [CI]: 1.88 to 2.72]; 6-months: OR = 2.74 [95% CI: 2.27 to 3.31]). The odds to treat to LDL-C target was greater for simvastatin-ezetimibe fixed combination, simvastatin, atorvastatin and rosuvastatin, in decreasing order. Finally, poor adherence was slightly more prevalent among patients treated with less effective statins, and at both low and maximal dosage regimens. CONCLUSIONS: This population-based study showed that adherence to statin therapy is poor even among patients who have already experienced a CV event. Failure to achieve recommended LDL-C levels appears imputable to the use of moderate doses and low to standard efficacy statins.

The Burden of Chronic Heart Failure in Primary Care in Italy.

INTRODUCTION: Chronic heart failure (CHF) is a major public health concern. From a public health perspective, the epidemiology of CHF needs to be distinguished from that of its related acute form. Data stemming from primary care are crucial to better know and update the prevalence and incidence rates of CHF. AIM: To update the epidemiology of CHF in an Italian primary care setting and to describe socio-demographic, lifestyle, and clinical characteristics of these patients. METHODS: A population-based study was conducted among 800 Italian general practitioners collecting data in a dedicated database. Information was extracted from adult subjects with a diagnosis of CHF from 2002 to 2013, and the prevalence and incidence rate of CHF were calculated. The study population was described in terms of socio-demographic, lifestyle, and clinical characteristics. RESULTS: A total of 13,633 patients with CHF were identified. Overall, the prevalence of CHF was 1.25% (95% CI 1.23-1.27), and the incidence rate was 1.99 per 1000 person-years (95% CI 1.81-2.08). In this population, smoking, alcohol use, and obesity were present in 2.93, 0.45, and 10.80% of cases, respectively. Hypertension (58.40%), chronic kidney disease (51.36%), dyslipidaemia (44.62%), ischaemic heart disease (25.75%), and atrial fibrillation (25.32%) were the most represented comorbidities. CONCLUSION: This study provides an updated epidemiological scenario of CHF in a primary care setting in Italy. These data may be useful to weight the social and economic impact of CHF and to plan strategies for improving the clinical care of CHF in general practice.

Prevalence and Control of Hypertension in Different Macro-Areas in Italy: Analysis of a Large Database by the General Practice.

INTRODUCTION: Limited data are available on the impact of hypertension in the different regions or urban areas in Italy. AIM: To evaluate hypertension prevalence and control among adult outpatients followed by general practitioners (GPs) in different regions and macro-areas in our Country. METHODS: We retrospectively analysed data extracted in 2013 from the national GP Health Search-CSD database and stratified into three groups, depending on their own regions (North, Center and South). Hypertension prevalence was estimated within the overall population sample of adult individuals, whereas control was assessed in hypertensive outpatients. Hypertension diagnosis was defined according to International Classification of Diseases 9. Clinic blood pressure (BP) levels were measured according to European guidelines. BP control was defined as BP <140/90 mmHg. RESULTS: Data from 940,806 individuals (52.0 % female) were scrutinized, among whom 363,324 (38.6 %) subjects were residents in the North, 276,643 (29.4 %) in the Center and 300,839 (32.0 %) in the South. Overall hypertension prevalence was higher in North (36.8 %) compared to South (33.8 %) and Center (29.3 %). Controlled BP levels were more frequently registered in the South (66.3 %) compared to Center (60.7 %) and North (55.6 %). In all these areas, prevalence and control of hypertension were higher in female than in male individuals. CONCLUSIONS: The present analysis demonstrates relevant differences in hypertension prevalence and control among different macro-areas and regions in Italy. Such analysis may be useful for promoting strategies aimed at ameliorating hypertension control at local levels.

What is the actual epidemiology of familial hypercholesterolemia in Italy? Evidence from a National Primary Care Database.

BACKGROUND: There are some inconsistencies on prevalence estimates of familial hypercholesterolemia (FH) in general population across Europe due to variable application of its diagnostic criteria. We aimed to investigate the FH epidemiology in Italy applying the Dutch Lipid Clinical Network (DLCN) score, and two alternative diagnostic algorithms to a primary care database. METHODS: We performed a retrospective population-based study using the Health Search IMS Health Longitudinal Patient Database (HSD) and including active (alive and currently registered with their general practitioners (GPs)) patients on December 31, 2014. Cases of FH were identified by applying DLCN score. Two further algorithms, based on either ICD9CM coding for FH or some clinical items adopted by the DLCN, were tested towards DLCN itself as gold standard. RESULTS: We estimated a prevalence of 0.01% for "definite" and 0.18% for "definite" plus "probable" cases as per the DLCN. Algorithms 1 and 2 reported a FH prevalence of 0.9 and 0.13%, respectively. Both algorithms resulted in consistent specificity (1: 99.10%; 2: 99.9%) towards DLCN, but Algorithm 2 considerably better identified true positive (sensitivity=85.90%) than Algorithm 1 (sensitivity=10.10%). CONCLUSION: The application of DLCN or valid diagnostic alternatives in the Italian primary care setting provides estimates of FH prevalence consistent with those reported in other screening studies in Caucasian population. These diagnostic criteria should be therefore fostered among GPs. In the perspective of FH new therapeutic options, the epidemiological picture of FH is even more relevant to foresee the costs and to plan affordable reimbursement programs in Italy.

[Blood pressure: the lower the better? Maybe no]. / Pressione arteriosa: più bassa è, meglio è? Forse no.

Antihypertensive treatment is aimed at reducing as much as possible health outcomes in terms of morbidity and mortality. The main international guidelines and clinical trials showed different positions about blood pressure targets. At present, there is no common opinion about the benefits of an aggressive drug treatment; moreover it is not clear whether lower blood pressure values are related to increased morbidity and mortality. The recent randomized SPRINT trial has compared intensive vs standard drug therapy in a non-diabetic hypertensive population. The trial has shown benefits of intensive treatment in reducing important health outcomes, though results were not confirmed in several patient subsets. We examined the studies on hypertensive patients with comorbidities (i.e., chronic kidney disease, cardiovascular disease) to identify blood pressure targets recommended in these populations, but no strong evidence was found about the benefits of intensive treatment. In geriatric patients the "lower is better" paradigm cannot be entirely applied because of comorbidity, polypharmacy and frailty.

[ANMCO/ISS/AMD/ANCE/ARCA/FADOI/GICR-IACPR/SICI-GISE/SIBioC/SIC/SICOA/SID/SIF/SIMEU/SIMG/SIMI/SISA Consensus document. Hypercholesterolemia and cardiovascular risk: diagnostic and therapeutic pathways in Italy]. / Documento di consenso intersocietario ANMCO/ISS/AMD/ANCE/ARCA/FADOI/ GICR-IACPR/SICI-GISE/SIBioC/SIC/SICOA/ SID/SIF/SIMEU/SIMG/SIMI/SISA Colesterolo e rischio cardiovascolare: percorso diagnostico-terapeutico in Italia.

Atherosclerotic cardiovascular disease still represents the leading cause of death in western countries. A wealth of scientific evidence demonstrates that increased blood cholesterol levels have a major impact on the outbreak and progression of atherosclerotic plaques. Moreover, several cholesterol-lowering pharmacological agents, including statins and ezetimibe, have proven effective in improving clinical outcomes. This document is focused on the clinical management of hypercholesterolemia and has been conceived by 16 Italian medical associations with the support of the Italian National Institute of Health. The authors have considered with particular attention the role of hypercholesterolemia in the genesis of atherosclerotic cardiovascular disease. Besides, the implications of high cholesterol levels in the definition of the individual cardiovascular risk profile have been carefully analyzed, while all available therapeutic options for blood cholesterol reduction and cardiovascular risk mitigation have been considered. Finally, this document outlines the diagnostic and therapeutic pathways for the clinical management of patients with hypercholesterolemia.

Patient Adherence to Olmesartan/Amlodipine Combinations: Fixed Versus Extemporaneous Combinations.

BACKGROUND: Lack of adherence to prescribed therapies is often a cause of suboptimal blood pressure control in patients with hypertension. To enhance patients' adherence to treatment, fixed-dose combinations of active substances with complementary mechanisms of action have been developed. An angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker (ARB) is often combined with a calcium channel blocker. Olmesartan is the most used ARB in combination therapy. In Italy, in September 2011, a fixed-dose combination of olmesartan/amlodipine (olmesartan/amlodipine 20/5 mg, 40/5 mg, or 40/10 mg) was introduced to treat patients with hypertension for whom control of blood pressure is not reached with either olmesartan or amlodipine alone. Prior research on adherence to olmesartan/amlodipine combinations was carried out in local contexts (e.g., claims databases of Italian regions or local health authorities), and/or it was limited by the fact that adherence was assessed against monotherapies already known for their low compliance profile, such as diuretics. OBJECTIVE: To compare adherence with olmesartan/amlodipine fixed-dose combination (FDC) and extemporaneous combination in primary care in Italy. METHODS: A nationwide, population-based study was conducted by using the Health Search IMS Health Longitudinal Patient Database. Patients aged > 17 years, affected by hypertension and treated with the FDC or extemporaneous combination of olmesartan/amlodipine, were identified. Adherence to these 2 therapeutic regimens was estimated by calculating the proportion of days covered (PDC). Patients were classified into 3 levels of adherence: high (PDC ≥ 80%), intermediate (PDC = 40%-79%), or low (PDC < 40%). RESULTS: In the 6-month follow-up, FDC showed higher adherence compared with an extemporaneous combination (55.1% vs. 15.9%, P < 0.001). This difference was confirmed in a multivariable logistic regression model clustered on patient identifier (odds ratio = 6.65; 95% CI = 3.10-14.26; P < 0.001). The proportion of patients adherent to FDC varied from 60.4% for the 40/5 mg formulation to 47.5% for the 40/10 mg formulation. CONCLUSIONS: These findings suggest that higher adherence may be achieved with FDCs than with extemporaneous combinations. To improve the degree of adherence, general practitioners may consider prescribing fixed combinations of antihypertensive agents as soon as monotherapies fail to achieve the expected therapeutic objective.

[Natriuretic peptides for the management of patients with heart failure: a bridge between primary care and cardiology?]. / I peptidi natriuretici per la gestione dei pazienti con scompenso cardiaco: un ponte fra Medicina Generale e Cardiologia?

BACKGROUND: The increasing prevalence of heart failure (HF) mandates the establishment of shared strategies between primary care physicians (PCP) and cardiologists to offer patients continuity of care. Easily available, low-cost biomarkers hold potential to facilitate this process. Data on the diffusion of natriuretic peptides (NP), a major novelty in the HF field in the last decade, in primary care are scarce. METHODS: The Cardiovascular Area of the Italian General Practice Society led a web survey among its members to investigate knowledge, perceptions and use of NP for HF management among Italian PCP. RESULTS: Over 700 PCP took part in the survey, three out of four declared they never or only occasionally prescribed NP assays. Among participating PCP, 86% reported that PN values were not regularly mentioned in discharge summaries of their patients hospitalized for acute HF. Conversely, only 4% reported to receive regularly PN prescription by cardiologists for their outpatients with chronic HF. One of five respondents ignored whether the assay was reimbursed by the National Health Service. The high negative predictive value for HF of elevated NP levels, the strongest evidence-based indication of NP, was correctly pointed out only by 13% of PCP. CONCLUSIONS: In our PCP sample, we documented a marginal use of NP in the management of HF patients. This is likely, at least in part, linked to a perceived scarce indication of NP values in discharge summaries and limited prescription in HF outpatients by cardiologists. Overall, PCP knowledge of the evidence on NP assay use for diagnosis, risk stratification and guided therapy of HF was limited. Two expert cardiologists were asked to comment on these findings and on the controversial aspects of the current use of NP in HF patients to better define their role as a tool for shared care between cardiologists and PCP.

Concurrent Use of Low-Dose Aspirin and Omega-3 Fatty Acids and Risk of Upper Gastrointestinal Complications: A Cohort Study with Nested Case-Control Analysis.

The risk of upper gastrointestinal complications (UGIC) due to low-dose aspirin (LDA) can be further increased by the concurrent exposure to other antithrombotic agents. Little is known on the combined therapy with LDA and medications containing omega-3 (OM3) fatty acids, which also exert antiplatelet activity. The aim of this study was to investigate the risk of UGIC in patients exposed to LDA-OM3 combination. The Italian Health Search IMS Health Longitudinal Patients Database was used to perform a population-based cohort study. Patients aged ≥18 years with cardio- or cerebrovascular ischaemic disease recorded between 2002 and 2012 (cohort entry) were selected. All UGIC cases (index date) observed up to December 2013 were identified. According to a nested case-control analysis, up to 10 controls were matched to each case on age, sex and calendar period. The risk of UGIC was investigated among current (up to 30 days preceding index date), recent (31-60 days) and past users (61-365 days) of the LDA-OM3 combination. Exposure assessment was lagged by 30 days to minimize reverse causation. Additionally, a duration-response analysis was performed. Odds ratios (OR) and 95% confidence intervals (CI) were estimated using conditional logistic regression. Non-users of the LDA-OM3 combination were the reference category. Current (OR = 0.66; 95% CI: 0.44-1.00), recent (OR = 0.83; 95% CI: 0.52-1.33) and past users (OR = 0.81; 95% CI: 0.57-1.15) did not statistically significantly increase the risk of UGIC. No duration-response relationship was found. Our results suggest that LDA-OM3 combination therapy does not affect the UGIC risk in patients with cardio- or cerebrovascular ischaemic diseases. Given the novelty of these findings, further studies are needed.

Lifestyle counselling in primary care: long-term effects on cholesterol level.

OBJECTIVE: To evaluate the long-term effectiveness of lifestyle counselling for low-moderate cardiovascular (CV) risk subjects in primary care. DESIGN: Prospective comparison of baseline vs post-intervention, and comparison of enrolled patients vs control subjects extracted from a large primary care database. SETTING: 94 general practices in Italy. PARTICIPANTS: All the 20-70-year-old hypercholesterolaemic subjects who did not qualify for statin treatment according to the guidelines and who were seen on 12 predetermined working days; 713 patients; 94 general practitioners. INTERVENTION: Short (5-10 min) educational intervention (qualitative dietary advice, encouraging walking or other aerobic physical activities); handing out simple dietetic advice at physician discretion. MAIN OUTCOME MEASURES: Total cholesterol level and global CV risk calculated according to the Framingham equation. RESULTS: Total cholesterol and global CV risk (10 years) decreased by 0.31 mmol/l (p < 0.0001, 95% CI 0.23-0.40) and 1.35% (p < 0.01, 95% CI -1.73 to -0.97), respectively, after a 54-month follow-up. Enrolled patients showed a greater total cholesterol decrease than control patients: 2.24% (p < 0.05, 95% CI 0.58-3.91%). CONCLUSIONS: A simple, office-based, long-term, lifestyle counselling programme produces a small, but clinically significant reduction of total cholesterol and of global CV risk. This result should encourage GPs to systematically offer simple, unstructured lifestyle counselling to all their patients.

Global cardiovascular disease risk management in italian patients with metabolic syndrome in the clinical practice setting.

BACKGROUND: Metabolic syndrome is a highly prevalent condition in the Italian population. This study assesses the feasibility and efficacy of a multifactorial approach for primary prevention of cardiovascular disease risk assessment in patients with metabolic syndrome in the daily clinical practice setting. METHODS: 726 patients were enrolled (males : females = 7 : 3), their ages ranging from 26 to 70 years, with metabolic syndrome and cardiovascular death risk ≥5%, computed by means of the European Systematic COronary Risk Evaluation (SCORE) algorithm. The first phase (3 months) consisted of an improvement in lifestyle and, if necessary, the initial administration of an antihypertensive therapy (valsartan 160 mg/day for patients with blood pressure ≥140/90 mmHg and ≥130/80 mmHg for diabetic patients). During phase 2 (6 months), patients with systolic blood pressure (SBP) ≥140 mmHg and/or diastolic blood pressure (DBP) ≥90 mmHg (≥130/80 mmHg for diabetic patients) were administered valsartan 160 mg/day + hydrochlorothiazide 12.5 mg/day combined; those with total cholesterol levels ≥190 mg/dL (≥175 mg/dL for diabetic patients) started treatment with fluvastatin 80 mg prolonged release (XL), as prescribed in the guidelines. A control group was approached with another conventional treatment. RESULTS: After 9 months of monitoring, the SBP dropped by 27 mmHg in the valsartan-treated patients and by 11 mmHg in the control group, while the DBP dropped by 12 mmHg in the former group and 2 mmHg in the latter. Total cholesterolaemia was reduced by 47 mg/dL in patients undergoing fluvastatin and valsartan therapy, by 19 mg/dL in those treated with valsartan only and by 33 mg/dL in those administered another conventional treatment. Relative risk reduction observed after 9 months, compared with the beginning of the study, was almost 48% in the valsartan/valsartan + fluvastatin group, versus 28% observed with the other conventional treatment. The reduction of risk at 60 years of age was an average of 39% at 3 months and 48% at 9 months, compared with the beginning of the study. Therapeutic success was accomplished with 78% of the patients treated with valsartan/valsartan + fluvastatin, compared with 47% of patients in the conventional therapy group. CONCLUSION: The present study demonstrated that the normalization of the main cardiovascular risk factors in patients with metabolic syndrome may be easily achieved in standard clinical practice settings, by leading an adequate lifestyle and, if necessary, the administration of antihypertensive and/or lipid-lowering monotherapy at the usual doses.