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Background: There are no studies on prevalence, incidence and comorbidities of Parkinson's disease (PD) in the Italian population., Methods: The database of 700 Italian general practitioners (population, 923,356) was investigated. All patients with International Classification of Diseases Ninth Revision - Clinical Modification (ICD-9-CM) diagnosis of PD during the period 2002-2012 were included. Parkinsonisms were excluded. Clinical conditions preceding PD were identified through ICD-9-CM codes. The Charlson Comorbidity Index was used. PD crude and standardized prevalence and annual incidence were calculated. Crude and adjusted hazard ratios were calculated for comorbidities., Results: A total of 2,204 patients (1,140 men, 1,064 women, age 22-95 years) were included. The crude prevalence of PD was 239/100,000. Prevalence increased exponentially with age. Standardized prevalence was 233 (95% CI 232-235). One hundred ninety-four patients were newly diagnosed, giving a crude incidence of 22/100,000 and a standardized incidence of 23.1/100,000 (95% CI 22.9-23.2). Incidence increased steadily until age 75-84 years and then decreased. Older age, cardiovascular and gastrointestinal disorders, diabetes, and restless-legs syndrome were associated with increased PD risk and smoking and hypersomnia with decreased PD risk. The Charlson Comorbidity Index was associated with PD risk with a documented gradient., Conclusions: Prevalence and incidence of PD in Italy are in line with studies with the highest case ascertainment. PD risk varies with the number and type of comorbidities., (© 2016 S. Karger AG, Basel.)

Purpose: To examine patterns of outpatient and community antibiotic use among adults in five European countries., Methods: We used healthcare data of 28.8 million adults from six population-based ARITMO project databases to ascertain information on systemic antibiotic use in Denmark (2000-2008), the Netherlands (1999-2010), Italy (2000-2010), the UK (1996-2009), and Germany (2004-2008). We estimated overall, and age-group and sex specific antibiotic use as defined daily doses (DDD) per 1000 inhabitants per day. We computed annual age- and sex-standardized population prevalence of antibiotic use per 1000 persons-years (p-y) and the mean duration (in days) of antibiotic use., Results: The overall antibiotic use varied from 8.7 DDD per 1000 inhabitants per day in the UK to 18.1 DDD in Denmark, representing a 2.1-fold geographical variation. In all countries, prescribing was relatively high among individuals aged 15-19 years; lower in those aged 20-50 years; and then increased steadily reaching 41.8 DDD per 1000 inhabitants per day in individuals ≥ 85 years in Denmark. After age- and sex-standardization, prevalence of antibiotic use varied threefold from 160.2/1000 p-y in the UK to 421.1/1000 p-y in Italy. The ratio of broad- to narrow-spectrum penicillin, cephalosporin, and macrolide use varied from 0.6 in Denmark to 120.2 in Italy. Women used more antibiotics than men did in all countries. Across countries, the mean duration of antibiotic use varied 1.3 to 21.1-fold for different antibiotics., Conclusions: Antibiotic use is high in women and the elderly. Prescribing patterns vary substantially across European countries, both according to overall consumption, user prevalence, duration, and narrow- versus broad-spectrum antibiotics.

Background and Objectives: Rising prevalence of CKD requires active involvement of general practitioners to limit ESRD and mortality risk. However, the outcomes of patients with CKD exclusively managed by general practitioners are ill defined., Design, Setting, Participants, & Measurements: We prospectively evaluated 30,326 adult patients with nondialysis CKD stages 1-5 who had never received consultation in tertiary nephrology care recruited from 700 general practitioner offices in Italy during 2002 and 2003. CKD stages were classified as stages 1 and 2 (GFR ≥ 60 ml/min per 1.73 m(2) and either albuminuria or an International Classification of Diseases, Ninth Revision, Clinical Modification code for kidney disease), stage 3a (GFR=59-45), stage 3b (GFR=44-30), stage 4 (GFR=29-15), and stage 5 (GFR<15). Primary outcome was the risk of ESRD (dialysis or transplantation) or all-cause death., Results: Overall 64% of patients were in stage 3a, and 4.5% of patients were in stages 3b-5. Patients with stages 1 and 2 were younger, were predominantly men, more frequently had diabetes, and had lower prevalence of previous cardiovascular disease than patients with stages 3a-5. Hypertension was frequent in all CKD stages (80%-94%), whereas there was a lower prevalence of dyslipidemia, albuminuria, and obesity associated with more advanced CKD. During the follow-up (median=7.2 years; interquartile range=4.7-7.7), 6592 patients died and 295 started ESRD. Compared with stages 1 and 2 (reference), mortality risk (hazard ratio, 95% confidence interval) was higher in stages 3b-5 (1.66, 1.49-1.86, 2.75, 2.41-3.13 and 2.54, 2.01-3.22, respectively) but not stage 3a (1.11, 0.99-1.23). Similarly, ESRD risk (hazard ratio, 95% confidence interval) was not higher at stage 3a (1.44, 0.79-2.64) but was greater in stages 3b-5 (11.0, 6.3-19.5, 91.2, 53.2-156.2 and, 122.8, 67.9-222.0, respectively). Among modifiable risk factors, anemia and albuminuria significantly predicted either outcome, whereas hypertension only predicted mortality., Conclusions: In patients with CKD not referred to nephrology, risks of ESRD and mortality were higher in those with CKD stages 3b-5., (Copyright © 2014 by the American Society of Nephrology.)

Background: Despite the high use of antidepressants (ADs) among the elderly, there is limited information about the prescribing pattern of these drugs in the Italian elderly population. The aim of this study was to analyze the trend in the use of ADs in the Italian elderly patients in the years 2003-2009, and specifically, to evaluate rates and predictors of AD treatment discontinuation in depressed older patients., Methods: The nationwide general practice Health Search Database (HSD) was used to identify AD users aged 65 years old and over from 2003 to 2009. ADs were categorized as (1) selective serotonin reuptake inhibitors (SSRIs); (2) serotonin-norepinephrine reuptake inhibitors (SNRIs); (3) tricyclic antidepressants (TCAs); (4) noradrenergic and specific serotonergic antidepressants (NaSSAs); and (5) other ADs. Incidence and prevalence of AD use per 1,000 inhabitants was calculated by drug class and single compound. We also measured rates and predictors of AD discontinuation (i.e., treatment gap ≥ 60 days) during the first year of therapy., Results: Overall, 39,557 AD users ≥65 years (17 % of the total HSD elderly population) were included in the study. SSRIs were increasingly and most frequently prescribed ADs (102.7-195.3 per 1,000 over seven years). The most common indications for AD use were depression and anxiety. Overall, 14 % of AD users continued their AD medication without treatment gaps, 27 % were intermittent AD users and 58 % discontinued their ADs during the first year of follow-up. Specific AD classes such as TCAs and 'other ADs were found to be predictors of discontinuation. In depressed patients, the use of NaSSas, TCAs and 'other ADs as well the concomitant use of >5 drugs (other than ADs) and living in Southern Italy were more likely to predict discontinuation., Conclusion: ADs, especially SSRIs, are widely and increasingly prescribed in elderly Italian patients in recent years. The observed high AD discontinuation rates are likely to impact the achievement of a therapeutic endpoint in depressed patients. Patients who are at high risk of AD discontinuation such as those receiving multi-drug therapy or living in Southern Italy should be monitored more closely to improve benefits of AD treatments.

Objectives: To estimate the prevalence and incidence of epilepsy in Italy using a national database of general practitioners (GPs)., Methods: The Health Search CSD Longitudinal Patient Database (HSD) has been established in 1998 by the Italian College of GPs. Participants were 700 GPs, representing a population of 912,458. For each patient, information on age and sex, EEG, CT scan, and MRI was included. Prevalent cases with a diagnosis of 'epilepsy' (ICD9CM: 345*) were selected in the 2011 population. Incident cases of epilepsy were identified in 2011 by excluding patients diagnosed for epilepsy and convulsions and those with EEG, CT scan, MRI prescribed for epilepsy and/or convulsions in the previous years. Crude and standardized (Italian population) prevalence and incidence were calculated., Results: Crude prevalence of epilepsy was 7.9 per 1,000 (men 8.1; women 7.7). The highest prevalence was in patients <25 years and ≥75 years. The incidence of epilepsy was 33.5 per 100,000 (women 35.3; men 31.5). The highest incidence was in women <25 years and in men 75 years or older., Conclusions: Prevalence and incidence of epilepsy in this study were similar to those of other industrialized countries. HSD appears as a reliable data source for the surveillance of epilepsy in Italy., (© 2014 S. Karger AG, Basel.)

Objective: To assess the epidemiology of gout and hyperuricaemia in the Italian general population during the years 2005-2009., Methods: Using the Italian primary care database (Health Search/CSD Longitudinal Patient Database), the prevalence, incidence and recurrence rates of gout and/or hyperuricaemia (serum urate level >360 mmol/l (6 mg/dl)) in outpatients aged ≥18 years during the years 2005-2009 were estimated. Rates together with 95% CI were measured overall and stratified by age, gender and calendar year. The characteristics of patients with newly diagnosed gout and hyperuricaemia were investigated and compared with the general population., Results: The prevalence of gout increased from 6.7 per 1000 inhabitants in 2005 to 9.1 per 1000 inhabitants in 2009. It increased with advancing age and was fourfold higher in men. A similar trend was observed for asymptomatic hyperuricaemia (85.4 per 1000 inhabitants in 2005 vs 119.3 per 1000 inhabitants in 2009). The incidence of gout remained stable during the observation years (0.93 per 1000 person years in 2005 vs 0.95 in 2009). Recurrent episode rate was 19.1% during the first year following the first gout attack and 31.6% during the following 5 years. Advanced age, increased levels of uric acid, nephrolithiasis and concomitant use of ciclosporin were the main predictors of recurrence of gout attacks., Conclusion: The prevalence of gout and hyperuricaemia increased in Italy from 2005 to 2009. A high recurrence rate for gout attack was observed during the first year following the first episode. Early management of hyperuricaemia in patients at higher risk of recurrent gout attack should be considered in primary care.

The practice of prostate-specific antigen (PSA) screening has been increasing in Italy despite uncertain scientific evidence and contrary recommendations from most scientific societies. In 2002, a survey of PSA screening diffusion among general practices was performed, looking for screening frequency and age pattern of screened individuals. The objective of this study was to assess whether the features of PSA screening did change after 6 years in the same considered setting. Using the data obtained from 500 Italian general practitioners providing information to the Health Search/CSD Patient database, we selected, for the study purpose 351,091 male individuals. We assumed PSA prescriptions performed during 2005-2008 in individuals without prostate cancer, or benign prostate disease, or urological symptoms history to have a screening purpose. Screening frequency was analyzed in the overall series, by year and by patient's age. Exposure to PSA screening (at least on PSA test in the considered period) of males aged over 50 years raised from 31.4% (confidence interval 95% 31.08-31.70%) during 2002 to 46.4% (confidence interval 95% 46.19-46.68%) during 2008. The highest yearly exposure to PSA screening (55%) and the highest frequency of repeat testing was observed in the 70-79 age range. PSA screening practice has continued to increase in Italy and is often performed in elderly people without any scientific rationale.

Objectives: The risk of venous thrombotic events (VTE) among medical outpatients is still not clear and it remains to be clarified whether medical diseases involve the same risk if managed at home or in hospital. The aim of this study was to evaluate in the setting of outpatient family medicine the relationship between VTE and medical conditions known to be at risk during a hospital stay., Design and Setting: The study involved a nationwide retrospective observation according to a nested case-control method; 400 general practitioners throughout Italy constituted the network for data collection. Between 2001 and 2004, all cases recorded as having VTE were entered; ten control patients without VTE, matched by sex, physician, and age, were selected from the database for each case., Results: The eligible population comprised 372,000 patients and 1,624 incident VTE were recorded. Univariate analysis indicated hospitalization (OR 5.02; 95% CI 4.01-6.29), cancer (OR 3.06; 95% CI 2.47-3.79), acute infectious disease (OR 2.93; 95% CI 1.94-4.43), neurological disease (OR 2.60; 95% CI 1.56-4.33), congestive heart failure (CHF) (OR 2.48; 95% CI 1.68-3.69), paralysis (OR 1.87; 95% CI 1.51-2.32), COPD (OR 1.58; 95% CI 1.29-1.95), stroke (OR 1.62; 95% CI 1.24-2.12), superficial venous thrombosis (OR 1.51; 95% CI 1.11-2.04, and rheumatic diseases (OR 1.49; 95% CI 1.28-1.74) as significantly associated with an increased risk for VTE. After adjustment, only transient or definitive paralysis, cancer, acute infectious disease, congestive heart failure, neurological diseases, and previous hospitalization remained associated., Conclusions: This large study indicates that VTE outpatients seen by general practitioners in Italy have a high prevalence of the same medical diseases associated with VTE among patients treated in hospital., (Copyright © 2010 Elsevier Ltd. All rights reserved.)

Background: Pharmacological preventive therapy after acute myocardial infarction (AMI) is strictly recommended because of its great efficacy. Little is known about long-term utilization of drugs related to cardiovascular secondary prevention in everyday practice., Design: A population-based cohort study on the basis of an Italian general practice database., Methods: Searching a large primary-care Italian database (Health Search), we selected five cohorts of patients with first occurrence of AMI from 2001 to 2005, respectively, and analyzed prescriptions of antithrombotic agents, beta-blockers, statins and angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs) from 2001 to 2006 (follow-up ranging from 1 to 5 years)., Results: We identified 4764 patients (mean age 67; 35% female) discharged from hospital after first-ever AMI. The prescription rate in the first year after AMI was suboptimal (beta-blockers 35.1%, aspirin or warfarin 75.0%, ACE-inhibitors or ARBs 61.6%, statins 52.8%) but showed a continuous improvement from 2001 to 2005. The prescription rate decreased slightly during the follow-up, but showed a complex pattern with a variable but significant number of patients discontinuing or resuming the therapy., Conclusions: The prescription of recommended drugs after AMI has increased from 2001 to 2006 in Italy, but the prescription rate remains largely unsatisfactory. Therapeutic continuity is also suboptimal.

Background: One third to two thirds of people with schizophrenia have persistent psychotic symptoms despite clozapine treatment. Under real-world circumstances, the need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine has been cited as the most common reason for simultaneously prescribing a second antipsychotic drug in combination treatment strategies. In a clinical area where the pressing need of providing therapeutic answers has progressively increased the occurrence of antipsychotic polypharmacy, despite the lack of robust evidence of its efficacy, we sought to implement a pre-planned protocol where two alternative therapeutic answers are systematically provided and evaluated within the context of a pragmatic, multicentre, independent randomised study., Methods/design: The principal clinical question to be answered by the present project is the relative efficacy and tolerability of combination treatment with clozapine plus aripiprazole compared with combination treatment with clozapine plus haloperidol in patients with an incomplete response to treatment with clozapine over an appropriate period of time. This project is a prospective, multicentre, randomized, parallel-group, superiority trial that follow patients over a period of 12 months. Withdrawal from allocated treatment within 3 months is the primary outcome., Discussion: The implementation of the protocol presented here shows that it is possible to create a network of community psychiatric services that accept the idea of using their everyday clinical practice to produce randomised knowledge. The employed pragmatic attitude allowed to randomly allocate more than 100 individuals, which means that this study is the largest antipsychotic combination trial conducted so far in Western countries. We expect that the current project, by generating evidence on whether it is clinically useful to combine clozapine with aripiprazole rather than with haloperidol, provides physicians with a solid evidence base to be directly applied in the routine care of patients with schizophrenia.

Background: Sudden cardiac death (SCD) is a major cause of death in western countries, with coronary heart disease (CHD) being the basis of over 70% of SCD. Incidence in high-CHD risk countries has already been studied, but this information is not available for Mediterranean low-CHD risk countries. Incidence is of paramount importance when cost-effectiveness rate of actions against SCD must be estimated., Methods: We estimated the incidence of SCD and its potential risk associated with clinical variables, by a means of a case-control study in a general practice setting. The enrolled general practitioners (GPs) provided data about the total number of their patients, and identified all their patients who suffered an out-of-hospital SCD during the previous 365 days. Two age-matched and gender-matched controls visiting GPs office after the SCD selection were also selected. We used a structured questionnaire to obtain information about potential risk factors for SCD. Covariates that were univariately associated with SCD were included in the multivariate regression analyses., Results: In a population of 297 340 (age greater than 14 years), a total of 230 cases were identified (0.77 per 1000 individuals), mostly occurring at home and among persons with known high cardiovascular risk. In the multivariate analysis only CHD (OR: 1.67; 95% CI: 1.09-2.58), arrhythmia (OR: 2.2; 95% CI: 1.3-3.9), obesity (OR: 2.3; 95% CI: 1.5-3.6), alcohol abuse (OR: 1.8; 95% CI: 1.2-2.7), and family history of CHD (OR 3.1; 95% CI: 1.8-5.3) resulted in a significant association with SCD., Conclusions: The incidence of SCD in Italy is lower than that reported in high-CHD risk population, most of the cases occurring at home and among persons with known high cardiovascular risk. Implementing recommendations for these patients seems to be the most effective strategy to reduce the incidence of SCD.

Objectives: To explore the antibiotic prescribing pattern for cystitis and the patient-related variables associated with prescription during a 4 year period among Italian general practitioners (GPs)., Methods: We obtained information from the 'Health Search Database' (HSD), an Italian general practice research database. From a total sample of 457 672 eligible patients aged >16 years registered up to December 2002, we included those whose diagnoses could be classified as acute (uncomplicated and complicated) and recurrent cystitis. Patients' features and prevalence of antibiotic users were assessed., Results: Of 35 129 cases diagnosed during the period 1999-2002, 96.0% of them were acute cystitis (39.2% recorded as uncomplicated). The prevalence of cases with acute complicated and uncomplicated cystitis slightly increased during the 4 year period, whereas it remained stable for recurrent cystitis. Most of the cystitis cases reported no diagnostic tests. More than 70% of patients were prescribed with at least one antibiotic, with a 4-fold increased risk of antibiotic use for acute cystitis throughout the study period. The prevalence of antibiotic users reached 86.2% for both acute uncomplicated and complicated cystitis in 2002, and 81.5% for recurrent cystitis. Fluoroquinolones represented the most common antibiotics being prescribed although they markedly decreased during these years. Fosfomycin trometamol use increased dramatically, becoming the first choice for any type of cystitis., Conclusions: Data indicate an evident rise in antibiotic use mostly related to fosfomycin trometamol. They also indicate that such a prescriptive trend finds confirmation from the available evidence for acute uncomplicated cystitis, although the management of recurrent cystitis could be further improved.

Unlabelled: BACKGROUND; Heart failure (HF) represents an important health issue in western countries, especially for the elderly, frail population. A number of HF patients must usually be assisted at home. No information is available about the usual care of HF patients in Italy. The aim of this study was to describe the characteristics of HF patients receiving homecare in the Italian general practice., Methods: A questionnaire was sent to 320 general practitioners (GPs) involved in the Health Search project. Among these, 148 (46.2%) answered and 376 home-ridden HF patients (60.3% women, median age 85 years) were identified., Results: 257 (57%) patients were in NYHA class III or IV. Multiple relevant concomitant diseases occurred in 326 (86.7%) subjects. Only 140 (37.2%) patients were able to take their pills without any help; caregivers, mainly family members, were required 24 hours a day in 78.7% of cases. The length of homecare was > 1 year in 84.5% of cases., Conclusions: According to our data, thousands of HF patients are usually assisted at home for long periods in Italy. This is a very old group of subjects with heavy co-morbidity and a high need for continuous, prolonged assistance. Studies specifically aimed at the care of HF patients are needed.