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Systematic assessment of blood pressure (BP) control rates may help to improve the clinical management of hypertension in clinical practice. This approach had limited application in Europe over the last three decades and only recently has been implemented in some countries. The present study is aimed at evaluating hypertension prevalence and control among adult outpatients followed by a large, representative sample of general practitioners (GPs) in Italy. We retrospectively analysed the data derived from the GP Health Search-CSD database in 2013. Hypertension prevalence and control were estimated within the overall population sample and in hypertensive outpatients, respectively, according to age and gender. Hypertension diagnosis was defined according to the International Classification of Diseases 9. Clinic BP levels were measured according to the European guidelines. BP control was defined as systolic/diastolic BP <140/90 mm Hg. Data from 911 753 individuals (52.2% females) were scrutinized. Hypertension was diagnosed in 236 377 (25.9%) patients, being higher in male aged <70 years than age-matched female. Hypertension control was recorded in 60.6% of hypertensive patients, being higher in female than male individuals aged <70 years. Our current analysis demonstrates that about 26% of adult outpatients followed in the GP setting had hypertension and that about 61% had controlled BP levels. Both prevalence and control of hypertension appear to be higher when compared with the data reported from the analysis of the same database in 2005, thus confirming a positive trend in BP control in the GP clinical setting in Italy.

Summary Aims Allopurinol is used as long‐term therapy to reduce the occurrence of gout flares. This study estimated the impact of patient adherence to allopurinol on hyperuricaemia (serum uric acid levels, sUA > 6 mg/dl) and the identification of non‐adherence predictors. Methods The Italian Health Search‐CSD Longitudinal Patient Database was accessed to identify outpatients aged ≥ 18 years with gout and prescribed with allopurinol during the years 2002–2011. Patients with a proportion of days covered ≥ 80% were considered adherent to allopurinol. Data on sUA levels over the first year of therapy were categorised in three time‐windows (30–89; 90–149; 150–365 days). Logistic regressions were used to estimate the association between adherence and hyperuricaemia, as well as non‐adherence predictors. Results A total of 3727 patients were included. In the interval 0–29 days, the proportion of patients adherent to allopurinol was 45.9%, while up to 89, 149 and 365 days the percentages were 16.7%, 10.0% and 3.2%, respectively. The proportions of hyperuricaemic patients for each time‐window were 43.1%, 42.4%, 32.6% and 59.0%, 64.0%, 66.4% among adherent and non‐adherent patients, respectively. In the multivariable analysis, adherence was associated with a significant lower risk of hyperuricaemia. The adjusted ORs were 0.49 (95% CI: 0.33–0.73), 0.40 (95% CI: 0.24–0.67) and 0.23 (95% CI: 0.15–0.34) for the first, second and third time‐window, respectively. Patients with hypertension (adjusted OR = 0.64, 95% CI: 0.42–0.99) and history of gout flares (adjusted OR = 0.55, 95% CI: 0.32–0.95) were significantly adherent to allopurinol. Conclusions Adherence monitoring in patients with gout is pivotal to ensure the effectiveness of therapy. To gain a better patient adherence, the communication between physicians and patients should be improved.

The use of aspirin in the primary prevention of cardiovascular events remains controversial. We aimed to assess the efficacy and safety of aspirin versus placebo in patients with a moderate estimated risk of a first cardiovascular event. ARRIVE is a randomised, double-blind, placebo-controlled, multicentre study done in seven countries. Eligible patients were aged 55 years (men) or 60 years (women) and older and had an average cardiovascular risk, deemed to be moderate on the basis of the number of specific risk factors. We excluded patients at high risk of gastrointestinal bleeding or other bleeding, or diabetes. Patients were randomly assigned (1:1) with a computer-generated randomisation code to receive enteric-coated aspirin tablets (100 mg) or placebo tablets, once daily. Patients, investigators, and others involved in treatment or data analysis were masked to treatment allocation. The primary efficacy endpoint was a composite outcome of time to first occurrence of cardiovascular death, myocardial infarction, unstable angina, stroke, or transient ischaemic attack. Safety endpoints were haemorrhagic events and incidence of other adverse events, and were analysed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT00501059. Between July 5, 2007, and Nov 15, 2016, 12 546 patients were enrolled and randomly assigned to receive aspirin (n=6270) or placebo (n=6276) at 501 study sites. Median follow-up was 60 months. In the intention-to-treat analysis, the primary endpoint occurred in 269 (4·29%) patients in the aspirin group versus 281 (4·48%) patients in the placebo group (hazard ratio [HR] 0·96; 95% CI 0·81–1·13; p=0·6038). Gastrointestinal bleeding events (mostly mild) occurred in 61 (0·97%) patients in the aspirin group versus 29 (0·46%) in the placebo group (HR 2·11; 95% CI 1·36–3·28; p=0·0007). The overall incidence rate of serious adverse events was similar in both treatment groups (n=1266 [20·19%] in the aspirin group vs n=1311 [20·89%] in the placebo group. The overall incidence of adverse events was similar in both treatment groups (n=5142 [82·01%] vs n=5129 [81·72%] in the placebo group). The overall incidence of treatment-related adverse events was low (n=1050 [16·75%] vs n=850 [13·54%] in the placebo group; p<0·0001). There were 321 documented deaths in the intention-to-treat population (n=160 [2·55%] vs n=161 [2·57%] of 6276 patients in the placebo group). The event rate was much lower than expected, which is probably reflective of contemporary risk management strategies, making the study more representative of a low-risk population. The role of aspirin in primary prevention among patients at moderate risk could therefore not be addressed. Nonetheless, the findings with respect to aspirin's effects are consistent with those observed in the previously published low-risk primary prevention studies. Bayer.

BACKGROUND Subclinical cardiac damage has recently emerged as a potential predictor of adverse renal outcome. We therefore retrospectively evaluated the effect of left-ventricular hypertrophy (LVH), diagnosed electrocardiographically, on the renal outcome of hypertensive patients managed in primary care. METHODS From a historical cohort of 39,525 hypertensive individuals evaluated in 2005, we retrieved 5-year data of the 18,510 surviving subjects for whom renal follow-up was available. RESULTS The baseline prevalences of chronic kidney disease (CKD) and LVH in the study cohort were 25.6% and 5.6%, respectively. During the 5-year follow-up, 1.4% of patients with LVH and 0.5% of those without LVH progressed to end-stage renal disease (ESRD) requiring dialysis (P < 0.01). Moreover, 25.6% of patients with LVH and 17% without LVH progressed from each stage of CKD to a more advanced stage (P < 0.01), whereas 0.9% of patients with LVH and 0.4% without LVH reached stage 5 CKD (P < 0.01). Multivariate Cox regression analysis showed that besides estimated glomerular filtration rate (eGFR) and male gender, LVH was the most significant modifiable predictor of progression to dialysis (hazard ratio (HR), 1.82; 95% CI, 1.05-3.17; P = 0.03). Multivariate logistic regression analysis also revealed LVH as a significant predictor of the risk of progression from each stage of CKD to a more advanced stage (OR, 1.24; 95% CI, 1.07-1.45; P < 0.01), as well as of progression to stage 5 CKD (OR, 1.86; 95% CI, 1.17-2.95; P < 0.01). CONCLUSIONS Left-ventricular hypertrophy proved to be a significant predictor of adverse renal outcome in hypertensive patients managed with primary care, and systematic screening for LVH should be adopted for assessing renal risk in these patients.

Background The aim of this study was to describe population and primary care morbidity and to examine how the differences vary across the diseases and are influenced by patients' demographic characteristics. Methods A comparison of the prevalence of four chronic conditions for 432 747 patients from the Health Search Database (HSD) and 119 799 individuals from a Health Interview Survey was carried out. A linear regression was performed to study the associations between age and difference in morbidity. Results Similar prevalence was found for diabetes and hypertension, whereas for chronic obstructive pulmonary disease (COPD) and gastroduodenal ulcer lower HSD prevalence was reported. Among females, age was always associated with morbidity difference. Among males, significant associations were found only for COPD (R² = 0.81; p = 0.001) and gastroduodenal ulcer (R² = 0.93; p <0.001 ). Conclusions The difference between population and primary care morbidity is affected by disease under investigation and patients' demographic characteristics. Therefore, in choosing the more cost-effective approach to collect data such evidence should be taken into account, and results should be interpreted with great caution.

To evaluate whether an electronic reminder integrated into a routine computer system increases the use of antiplatelet drugs for diabetic patients among Italian general practitioners (GPs). A randomized controlled trial was carried out among 300 GPs and their patients selected from the Health Search Database. Among these, 150 GPs (intervention group) received instructions to activate an electronic reminder plus a letter summarizing the beneficial effects of antiplatelet drugs in diabetic patients with at least one additional cardiovascular risk factor (\"high risk\"), whereas the other 150 GPs (control group) received only the letter. The electronic reminder, integrated into a standard software system for the management of the daily clinical practice, was displayed when every participating GP opened the medical record of diabetic patients aged > or =30 years. Only high-risk diabetic patients were included in the analysis. Patients were considered under antiplatelet treatment if they received two or more prescriptions at baseline and during the follow-up. We selected 15,343 high-risk diabetic patients, 7,313 belonging to GPs of the control group and 8,030 belonging to GPs of the intervention group. Overall, 1,672 patients (22.9%) of the control group and 1,886 (23.5%) patients of the intervention group received antiplatelet drugs at baseline (P = N.S.). At the end of the follow-up, the number of treated patients was significantly increased in the intervention group (odds ratio 1.99, 95% CI 1.79-2.22) versus the control group. The effect of the electronic reminder was more relevant among those patients with one or more cardiovascular risk factors but without previous cardiovascular diseases (CVDs), compared with those with CVDs. These findings provide evidence for the effect of an electronic reminder in affecting the prescriptive behavior of GPs.

Background Data from national surveys and general practitioner databases has shown an increasing prevalence of gout in several countries. However there is no data regarding the epidemiology of gout in Italy in the last decade. Objectives To assess both prevalence and incidence of gout in Italy between 2005 and 2009. Methods Data was obtained from the Italian primary care database (Health Search/Longitudinal Patient Database) which comprises about one million adults (>18 years) from all around the Country. Rates together with 95% Confidence Interval (CI) have been measured overall and stratified by age, gender and calendar year. Characteristics of patients with newly diagnosed gout and hyperuricemia have been explored Results Calculated prevalence of symptomatic gout increased from 6.7 per 1,000 adults in 2005 to 9.1 in 2009, whilst incidence remained stable (0.93 per 1,000 Person Years (PYs) in 2005 and 0.95 in 2009). Prevalence increases with age and is 4 times higher in males. A similar trend was observed for hyperuricemia whose prevalence is about ten times higher than that of symptomatic gout (66.3 per 1,000 adults in 2005 and 92.1 in 2009) in our population. Therefore during the study period, the prevalence of gout and hyperuricemia appears to be always slightly higher in the Northern Italy than in the Central and Southern Italy (e.g. year 2009: gout=9.3 vs. 8.6 vs. 9.0 per 1,000 inhabitants; hyperuricemia=95.3 vs. 92.7 vs. 88.0 per 1,000 inhabitants. Recurrent gout attacks were observed in 19.1% cases within one year following the first attack and in 23.1% cases within five years. Conclusions This is the first study regarding the epidemiology of gout in Italy. The overall prevalence of both gout and hyperuricemia is remarkably lower than that reported in similar population-based investigations carried out in other western countries, namely the US, UK and Germany. This difference might in part be related to country specific diet; in fact the typical Italian diet (i.e. Mediterranean diet) is associated with low levels of serum urate. Interestingly, the prevalence of gout and, to a lesser extent, of hyperuricemia is quite different across Italian geographic areas, with the higher figures observed in the Northern Italy. This finding is likely to be attributed to different dietary habits as the adherence to Mediterranean diet is higher in Central and Southern than Northern Italy High recurrence of attacks was observed during the first year following the first episode. References Roddy E, Doherty M. Arthritis Res Ther 2010;12:R223 Cea Soriano L, et al. Arthritis Res Ther 2011;13:R39 Zhu Y, et al. Arthritis Rheum 2011;63:3136-41 Annemans L, et al. Ann Rheum Dis 2008;67:960-6 Disclosure of Interest None Declared

Introduction In 2020, the restrictions adopted to control the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic led to an unprecedented reduction in influenza-related burden. As such, the reduced chance to characterize the circulating virus strains might have increased the risk of vaccine mismatch for the forthcoming winter seasons. The role of an effective influenza vaccination campaign might therefore assume even more value, especially for frail and multimorbid older individuals. Methodological concerns on confounding by indication are always debated in vaccine effectiveness studies and it might be instrumental to give a pragmatic message on an individual's responsibility to receive the influenza vaccine. We therefore investigated the role of specific confounders to explain the association between influenza vaccine and mortality among older adults. Methods Using a primary care database, we formed a cohort of patients aged 65 years or older who were actively registered with their general practitioner (GP) at the beginning of each of nine influenza seasons through to the 2018/2019 season. The study index date was the related seasons' starting date. Exposure to the influenza vaccine was operationally defined in the 2 months preceding the index date up to 2 weeks before the exit date. Cox regression models were estimated to calculate hazard ratios (HRs) and their 95% confidence intervals (CI) of death between vaccinated and unvaccinated patients in a time-dependent fashion. The potential confounders sequentially entered the model based on their increasing effect size observed in univariate analyses. Results Over the 10 years under study, the influenza vaccine showed a significant protective effect in terms of mortality, reaching 13% reduction (HR 0.87, 95% CI 0.80-0.95) in the 2018/2019 influenza season. When we estimated the multivariate model by sequentially adding the potential confounders, there was an inversion of HR (below the unit) that was significantly explained by the covariates coding for a prior history of lower respiratory tract infections and the presence of the pneumococcal vaccine. Conclusion In the current pandemic scenario, we cannot divert attention to proper use of face masks, social distancing, and hand hygiene, which are important measures to prevent influenza and other respiratory viral infections. Nonetheless, their effectiveness might be negligible without acceptable coverage for influenza vaccine, especially in older patients with a history of lower respiratory tract infections, which appears to be the main source of confounding by indication.

Background The exploitation of routinely collected clinical health information is warranted to optimize the case detection and diagnostic workout of Alzheimer’s disease (AD). We aimed to derive an AD prediction score based on routinely collected primary care data.Methods We built a cohort selecting 199,978 primary care patients 60 + part of the Health Search Database between January 2002 and 2009, followed up until 2019 to detect incident AD cases. The cohort was randomly divided into a derivation and validation sub-cohort. To identify AD and non-AD cases, we applied a clinical algorithm that involved two clinicians. According to a nested case–control design, AD cases were matched with up to 10 controls based on age, sex, calendar period, and follow-up duration. Using the derivation sub-cohort, 32 potential AD predictors (sociodemographic, clinical, drug-related, etc.) were tested in a logistic regression and selected to build a prediction model. The predictive performance of this model was tested on the validation sub-cohort by mean of explained variation, calibration, and discrimination measurements.ResultsWe identified 3223 AD cases. The presence of memory disorders, hallucinations, anxiety, and depression and the use of NSAIDs were associated with future AD. The combination of the predictors allowed the production of a predictive score that showed an explained variation (pseudo-R2) for AD occurrence of 13.4%, good calibration parameters, and an area under the curve of 0.73 (95% CI: 0.71–0.75). In accordance with this model, 7% of patients presented with a high-risk score for developing AD over 15 years.Conclusion An automated risk score for AD based on routinely collected clinical data is a promising tool for the early case detection and timely management of patients by the general practitioners.