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Venous thromboembolism (VTE) is an important cause of morbidity and mortality following major orthopaedic surgery. However, the incidence of VTE and the role of additional risk factors have not yet been well explored in Italian clinical practice. The objective of the study is to estimate the incidence of VTE in the 3 months following elective hip and knee replacement (HR, KR) in a large cohort of patients, and the association between some selected risk factors and the occurrence of VTE. A large cohort study based on the record linkage between automated archives of the National Health System was analysed. In particular, all the residents in the Lombardy Region (Italy) who underwent HR and KR between 2005 and 2008 were followed for 3 months after surgery. The odds ratio (OR) of VTE associated with selected known risk factors was estimated by multivariate logistic regression. Amongst the 69,770 patients included in the study, 2,393 experienced at least one VTE event during the follow-up; the overall risk of VTE after HR or KR was 3. 4%. The adjusted odds of experiencing a VTE event was higher in male patients (OR 1. 11; 95% confidence interval 1. 01-1. 21), aged 60 years or older (1. 30; 1. 00-1. 68), undergoing KR (1. 47; 1. 35-1. 61), with previous deep vein thrombosis (1. 96; 1. 20-3. 19), pulmonary embolism (3. 25; 1. 84-5. 75) or cancer (1. 21; 1. 00-1. 46). In conclusion, the incidence of VTE after elective HR and KR in the Italian clinical practice is high. Our results suggest the need of optimising the management of thromboprophylaxis to further reduce postoperative VTE. © 2011 SIMI.

SummaryThe aims of this study were to investigate trends in the incidence of diagnosed atrial fibrillation (AF), and to identify factors associated with the prescription of antithrombotics (ATs) and to identify the persistence of patients with oral anticoagulant (OAC) treatment in primary care. Data were obtained from 400 Italian primary care physicians providing information to the Health Search/Thales Database from 2001 to 2004. The age-standardised incidence of AF was: 3.9–3.0 cases, and 3.6–3.0 cases per 1,000 person-years in males and females, respectively. During the study period, 2,016 (37.2%) patients had no prescription, 1,663 (30.7%) were prescribed an antiplatelet (AP) agent, 1,440 (26.6%) were prescribed an OAC and 301 (5.5%) had both prescriptions. The date of diagnosis (p = 0.0001) affected the likelihood of receiving an OAC. AP, but not OAC, use significantly increased with a worsening stroke risk profile using the CHADS2 risk score. Older age increased the probability (p < 0.0001) of receiving an AP, but not an OAC. Approximately 42% and 24% of patients persisted with OAC treatment at one and two years, respectively, the remainder interrupted or discontinued their treatment. Underuse and discontinuation of OAC treatment is common in incident AF patients. Risk stratification only partially influences AT management.

The aim of this review was to summarize recent findings on patients’ adherence and persistence to antihypertensive (AHT) therapy. A literature search was performed using MEDLINE for original studies published in the English language between April 2003 and July 2008. According to selection criteria, the review included 47 papers classified into the following groups: (i) studies assessing overall behaviour towards treatment; (ii) studies differentiating among AHT classes; and (iii) studies comparing specific AHTs. It was not possible to perform a meta-analysis due to the wide variety of study designs, objectives and definitions. However, some strong messages emerged: non-adherent patients have higher blood pressure (BP) values, which lead to a higher risk of cardiovascular events; angiotensin II type 1 receptor antagonists (angiotensin receptor blockers) are the AHTs with the best patient adherence and persistence to treatment; better treatment adherence is observed in patients using fixed versus extemporaneous AHT combinations. Improving BP control is pivotal to reduce cardiovascular events, allowing for a better use of healthcare resources, and

Aims and background Data on kidney cancer incidence and prevalence are not available on a national and regional level. We provided estimates of the number of incident and prevalent cases of kidney and renal cell cancer in Italy overall and in various regions in 2002 and gave projections for the years 2007 and 2012. Methods We derived annual numbers of incident cases combining mortality data provided by the World Health Organization and information on relative survival from kidney cancer and we subsequently derived 5-year prevalence by combining incidence with information on survival. We provided different projection estimates for the years 2007 and 2012 for incidence and prevalence, on the basis of various hypothetical scenarios, i.e., stable rates over time or steady falls by 1% per year. Results In 2002, there were about 8000 incident cases and 26,800 prevalent cases of kidney cancer in Italy. Of these, approximately 6800 and 22,750 were incident and prevalent cases of renal cell cancer, respectively. The most reliable estimate of incident kidney cancer cases in Italy over the period 2007–2012 is likely to range between 7000 and 9000. Of these, between 6000 and 8000 are renal cell cancer cases. The best estimate of prevalence of kidney cancer is between 20,000 and 34,000 cases and that of renal cell cancer between 17,000 and 29,000 cases. Conclusions Incidence and prevalence of renal cell cancer are likely to remain approximately stable between 2002 and 2007. Increased diagnostic attention due to widespread use of echography and other diagnostic techniques may, however, lead to earlier detection of kidney neoplasms and consequently to an apparent increase in the incidence of renal cell cancer.

New therapeutic options have modified the natural history and health care costs of multiple sclerosis (MS). An epidemiological 25 years-long model-based cost-utility analysis was performed following the Italian National Health Service (INHS) and societal perspectives to compare costs and quality-adjusted life years of treatment with Interferon beta-1b (IFNB-1b) from diagnosis of clinically isolated syndrome (CIS) versus treating at subsequent conversion to clinically definite MS (CDMS). Among patients treated (untreated) with IFNB-1b from CIS diagnosis, 40,420 (43,700) converted to CDMS after 25 years; the estimated cumulative probability of converting to CDMS during the first 3 years was 72.90% (84.94%) (P0.0001). Early treatment with IFNB-1b is highly cost-effective for the INHS (incremental cost-effectiveness ratio: Euros 2,574.94) and dominant from the societal viewpoint. Sensitivity analyses confirmed the base case findings. Early treatment with IFNB-1b delays conversion to CDMS in CIS patients and might be a "good value for money" health care programme.

Vascular dementia (VaD) is a heterogeneous pathology currently regarded as the result of a variety of causes. Different types of VaD can be identified according to different criteria. This heterogeneity might be one of the causes of the controversial results observed, up to now, in clinical trials. Recently, the 10th revision of the International Classification of Diseases (ICD-10) explicitly identified subcortical VaD as a welldefined subgroup. Abnormalities of white matter are clearly detectable with computed tomography or magnetic resonance scans. The clinicoradiological association of dementia, blood hypertension, and other vascular risk factors, extensive white matter lesions, and small subcortical infarcts might be considered as a clinical univocal entity. Following the encouraging results of a preliminary pilot study, the above-mentioned criteria were followed to define a population of patients to be enrolled in a double-blind, parallel- groups, placebo-controlled clinical trial with nimodipine, which has been proposed as a drug that can improve cognitive functions in patients with VaD. The paper discusses the protocol design of this ongoing trial and its main entry criteria, with particular emphasis on the definition of the population to be enrolled. Implication for future trials in subcortical VaD are discussed further.

INTRODUCTION:Metastatic castration-resistant prostate cancer (mCRPC) is an incurable disease and represents a significant clinical, economic, and social burden. The therapeutic scenario of mCRPC has completely changed over the last years with the approval of several treatments (1). Radium-223 is a new target-alpha therapy showing a significant survival benefit in mCRPC patients (2,3). The study aimed to evaluate the introduction of radium-223 in Italy using Health Technology Assessment methodology.METHODS:To assess epidemiological, clinical, economic, organizational, social, and ethical aspects, a literature review was carried out. A cost-effectiveness and a budget impact analysis were performed from the National Health Service (NHS) perspective to compare radium-223 with other treatments and determine the budgetary impact of the utilization of radium-223 for the treatment of mCRPC.RESULTS:In Italy, prostate cancer represents the most diagnosed cancer in men and the third in the whole population. When the disease becomes metastatic, approximately 80 percent of patients develop bone metastases, commonly associated to skeletal-related events (SREs) with a significant impact on survival, quality of life, and costs (1). Radium-223 is a novel alpha particle emitting therapeutic agent which targets new bone growth surrounding bone metastases. Different from other radiopharmaceuticals, radium-223 prolongs overall survival with a favorable safety profile (2,3). In order to optimize patient outcome, the management of radium-223 should be viewed in a multidisciplinary context. The administration is quite simple and requires only basal shielding. Currently it can be administered in hospital inpatient settings and in some regions the outpatient usage is allowed. Finally, radium-223 showed a favorable budget impact profile and cost-effectiveness when compared with best supportive care and new therapeutic agents (abiraterone, enzalutamide, cabazitaxel) (1).CONCLUSIONS:The introduction of radium-223 allows provision of a new therapy, offering a valid alternative to patient with mCRPC without any increase of costs for the NHS.

To analyse the relation between number of sexual partners, selected sexual habits and the risk of human immunodeficiency virus (HIV) infection.We conducted a case-control study nested in a cross-sectional survey conducted among subjects attending sexually transmitted diseases (STD) clinics in Northern Italy. Eligible for the study were 1711 subjects (1259 males, 452 females) who referred themselves for the first time between September 1988 and March 1993 to three STD clinics in Northern Italy for suspected STD or STD treatment. A total of 145 subjects (113 males and 32 females) were HIV positive.In comparison with subjects reporting no or one sexual partner over the 3 years before the interview, the estimated odds ratios (OR) of HIV serum positivity were 1.2 (95% confidence interval [CI]: 0.6-2.3), 0.8 (95% CI: 0.4-1.8) and 0.3 (95% CI: 0.4-2.5) in subjects reporting 2-3, 4-5, andor = 6 partners, respectively. The results were similar considering separately males and females and in men reporting only homosexual partners. Regular condom use decreased the risk of HIV infection: in comparison with subjects reporting no or occasional use of condoms, the OR of HIV infection was 0.5 (95% CI: 0.4-0.8) for regular users. Considering men only, compared with men with no homosexual intercourse, the OR of HIV infection was 2.3 (95% CI: 1.4-3.9) in those reporting bisexual intercourse and 2.2 (95% CI: 1.2-4.2) in men reporting only homosexual intercourse (among homosexuals). There was no relation between HIV infection risk and receptive anal sex.The risk of HIV infection does not increase linearly with the number of sexual partners in this population. This is reasonable, as the prevalence of HIV infection in this population is essentially determined by drug use. Caution is needed in the interpretation of these results since the analysis of role of number of sexual partners in male intravenous drug users is impaired by low statistical power.It remains to be clearly established how multiple sex partners affect the risk of HIV infection. Northern Italy is a region where the prevalence of HIV infection is high mainly among IV drug users. The authors conducted a case-control study nested in a cross-sectional survey among subjects attending three STD clinics in Bergamo, Brescia, and Verona with the goal of analyzing the relationship between the number of sex partners, selected sex practices, and the risk of HIV infection. The study population was comprised of 1259 males and 452 females who referred themselves for the first time between September 1988 and March 1993 to the clinics for suspected STD or STD treatment. The men were of median age 30 years in the range of 16-70, while the women were of median age 28 years in the range of 16-61. 113 males and 32 females were HIV-seropositive. In comparison with subjects reporting no or one sex partner over the three years before the interview, the estimated odds ratio (OR) of HIV serum positivity were 1.2, 0.8, and 0.3 in subjects reporting 2-3, 4-5, and 6 or more partners, respectively. The risk of HIV infection therefore does not increase linearly with the number of sex partners in this population. These results were similar considering separately males and females and among the 91 men reporting only homosexual partners. 165 men reported themselves as being bisexual. Regular condom use decreased the risk of HIV infection such that the OR of HIV infection was 0.5 for regular users compared to subjects who reported no or occasional use of condoms. Considering men only, compared with men with no homosexual intercourse, the OR of HIV infection was 2.3 among those reporting bisexual intercourse and 2.2 among men reporting only homosexual intercourse. There was no relation between HIV infection risk and receptive anal sex. IV drug use was strongly associated with HIV-seropositivity, while a history of STD was more frequently reported by HIV-positive subjects than by HIV-negative subjects.

Background: Aspirin is recommended as preventive therapy in patients with cardiovascular diseases (CVD), diabetes mellitus, and high cardiovascular risk due to multiple risk factors. However, the benefits of aspirin might be affected by its inappropriate use. Real-life information on aspirin use is therefore needed as an audit tool aimed to maximize the benefits and minimize the risks. Design: Retrospective cross-sectional and cohort study. Methods: Primary care data were obtained from 400 Italian general practitioners (GPs) providing information to the Health Search/CDS Longitudinal Patients Database. Prevalence of use was assessed in individuals aged 18 years and older, registered in the GP's list at the beginning of the observation period (year 2005). As potential correlates of aspirin use, clinical and demographic variables were also recorded. Logistic regression analysis was conducted to assess the relationship between such covariates and aspirin use. Persistence to aspirin treatment was examined among newly prescribed aspirin users during the years 2000-04. Results: On a total sample of 540,984 patients, 45,271 (8.3%) were prescribed at least once with aspirin. On 35,473 patients with previous CVD, 51.7% were treated with aspirin, whereas only 15.2% of 151,526 eligible patients free of CVD received an aspirin prescription. In primary prevention, prevalence of aspirin use was significantly associated with the increased number of cardiovascular risk factors either among diabetic (p

We assessed prevalence and risk factors for human immunodeficiency virus (HIV) infection in 637 patients (506 men, 131 women; median age 30 years, range 17-64) attending between September 1988 and July 1989 for the first time two sexually transmitted disease (STD) clinics in Northern Italy, for suspected or STD treatment. A total of 44 subjects (6.9%, 95% confidence interval, (Cl): 4.9-8.9) were seropositive for HIV antibodies. The prevalence of HIV infection decreased with age, from 9% in patients aged 24 years or less to 3% in those aged 45 years or more (chi 21 trend 4.97, p less than 0.05). Women tended to have a lower prevalence of infection than men (5.3% versus 7.3%) but this was not statistically significant. Compared with men reporting no homosexual intercourse, HIV infection risk was about 50% higher in those reporting bisexual intercourse (age- and sex-adjusted odds ratio (OR) 1.5,95% Cl: 0.6-3.6) and about fourfold in those reporting only homosexual intercourse (OR 3.8, 95% Cl: 1.7-8.5). No clear trend in risk was observed with number of sexual partners both in men and in women. Intravenous drug users had an increased risk of HIV infection; compared with non-users, the OR was 5.6 (95% Cl: 3.0-10.5) in users, and the point estimates increased with frequency of use, from 3.3 (95% Cl: 0.8-11.5) in occasional users to 6.4 (95% Cl: 3.2-12.8) in regular users. The risk of HIV infection was 2.2 (95% Cl: 1.1-4.3) in patients reporting a history of STD, and 1.6 (95% Cl: 0.8-3.3) in those reporting syphilis.(ABSTRACT TRUNCATED AT 250 WORDS)

CONCLUSIONS: Rivaroxaban is a cost-effective alternative to VKA and is cost-saving for the SSN in the treatment of NVAF patients at highest unmet medical need.

In Western countries, vascular dementia (VaD) is the most common form of cognitive deterioration after Alzheimer’s disease. Therapeutic trials in VaD have so far failed to yield satisfactory results. One explanation of this failure may be the etiological and clinical heterogeneity of the included patients. Patients with subcortical VaD, defined on a clinical and radiological basis, may constitute a more homogeneous group. Thus, we conducted a post-hoc subgroup analysis of the Scandinavian Multi-Infarct Dementia Trial that evaluated the efficacy and safety of oral nimodipine administered for 6 months in 259 patients. The original patients sample was divided on the basis of head CT in those with subcortical VaD ( n =92, 45 nimodipine, 47 placebo) and those with multi-infarct dementia ( n =167, 83 nimodipine, 84 placebo). While in the total trial population a treatment effect could not be proved, in this subgroup analysis, the subcortical VaD patients treated with nimodipine performed better on the majority of neuropsychological tests and functional scales in comparison with patients on placebo. No trend could be evidenced in the multi-infarct dementia patients. Treatment efficacy was in particular suggested for the Zahlen-Verbindungs-Test, Fuld-Object-Memory Evaluation, Word Fluency, and for the Instrumental Activities of Daily Living scale. The results did not reach statistical significance in this small sample. Our study preliminarily indicates that nimodipine could be effective in patients with small vessel subcortical VaD and supports the rationale for a further controlled and adequately powered trial to test nimodipine in patients with subcortical VaD.

Vascular dementia is a major cause of mental and physical disability in Western countries. Treatment of vascular dementia is currently based on the recognition and control of vascular risk factors, while specific drugs have not been approved yet. The aim of the present multinational, double-blind, placebo-controlled study was to evaluate the safety and efficacy of nimodipine administered for as long as 26 weeks in improving cognition or slowing cognitive deterioration in patients defined as having multi-infarct dementia (DSM-III-R criteria). Two hundred and fifty-nine patients were included (128 nimodipine, 131 placebo), and 251 were available for the intention-to-treat analysis. No significant difference between drug-treated and placebo patients was noted on the Gottfries-Brane-Steen scale score (primary efficacy criterion), the remaining neuropsychological tests (Zahlen-Verbindungs-Test, Fuld-Object-Memory Evaluation, Word Fluency Test, Digit Span, Mini-Mental State Examination), and the functional scales (index of Activity of Daily Living, Instrumental Activity of Daily Living, Rapid Disability Scale, Clinical Dementia Rating), although the majority of changes were in favor of the active drug group. A lower incidence of cerebrovascular and cardiac events was observed in the nimodipine-treated patients in comparison with the placebo group. This study failed to show a significant effect of nimodipine on cognitive, social or global assessments in patients defined as affected by multi-infarct dementia according to the DSM-III-R criteria. A post-hoc analysis (presented in an accompanying paper) suggests that nimodipine may have a favorable effect in the subgroup of patients defined as affected by subcortical (small vessel) vascular dementia.

Owing to the involvement of Italian Centres in a multicentre, German-Italian therapeutical trial with Alzheimer’s dementia patients, to be assessed with the Alzheimer’s Disease Assessment Scale (ADAS), it was decided that the Italian centres would use an Italian version of the scale, derived from that used by the German centres. However, the lists of words for exploring verbal memory are not merely translated from the German version, but are composed of selective Italian words chosen according to linguistic criteria. This Italian version was validated following the same procedure adopted for validating the German version. We submitted this Italian version to an interrater reliability, test-retest reliability, concurrent validity, internal consistency and sensitivity evaluation, using demented patients. Based on the results of these tests this Italian version of the ADAS proved valid and reliable. Moreover, the results were strikingly comparable to those from the validation of the German version. Our work supports the validity, reliability and transnational comparability of national versions of the ADAS constructed following definite linguistic criteria.

Goal of the study was to analyze the relationship between anticardiolipin antibodies, lupus anticoagulant and the risk of intrauterine late fetal death.A case-control study was conducted in a network of general and teaching hospitals in northern Italy. Cases studied were 99 women (median age 27 years), without clinical evidence of systemic lupus erythematosus or other immunological disorders who had an 'unexplained' intrauterine fetal death at or after the 20 weeks of gestation. The control subjects were 85 women (median age 28 years) who gave birth at term (37 weeks gestation) to healthy infants on randomly selected days at the same hospitals where cases had been identified.The presence of lupus anticoagulant was detected in four of the 99 cases (4%, 95% confidence interval 2%-15%) and none of the 85 controls. A total of 10 out of the 89 cases (11%, 95 confidence interval 6%-23%), but none of the 79 controls for whom anticardiolipin antibodies value was available had elevated anticardiolipin antibodies; this difference was statistically significant (chi 2(1) = 9.38, p0.01).

STUDY OBJECTIVE--To investigate the relationship between alcohol consumption and the risk of acute myocardial infarction in women. DESIGN--This was a hospital based, case-control study carried out between 1983 and 1990. Main outcome measures were average daily number of drinks of various alcoholic beverages consumed and corresponding multivariate relative risk estimates and 95% confidence intervals (CI). SETTING--A network including major teaching and general hospitals in northern Italy. SUBJECTS--Cases were 298 women with acute myocardial infarction but no history of ischaemic heart disease and controls 685 women admitted to hospital for acute conditions, unrelated to alcohol consumption or to known or suspected risk factors for ischaemic heart disease. MEASUREMENTS AND MAIN RESULTS--Compared with non-drinkers, the estimated relative risks (RR) were 0.7 (95% CI 0.5, 1.0) for one drink or less per day, 0.8 (95% CI 0.6, 1.2) for more than one to two drinks per day, 1.4 (95% CI 0.8, 2.3) for more than two to three, and 2.6 (95% CI 1.5, 4.6) for more than three drinks per day. These estimates were consistent across strata of selected covariates, including age, education, and smoking. Allowance for major identified risk factors for myocardial infarction did not materially modify the risk estimate for light drinkers (RR 0.7, 95% CI 0.5, 1.1), but reduced the RR in heavy drinkers to 1.8 (95% CI 0.9, 3.5). CONCLUSIONS--This study indicates that women who do not drink alcohol have a risk of myocardial infarction that is higher than that of light drinkers, although the protection of light drinking was not significant. Among drinkers, however, there was a significant direct trend in risk with dose. The raised risks in heavy drinkers may reflect a real association or result from other unfavourable characteristics or habits associated with high alcohol consumption.

The relation between cigarette smoking and risk of bladder cancer was analysed in a case-control study in Northern Italy of 337 cases of histologically confirmed invasive bladder cancer and 392 controls admitted to the same network of hospitals with acute, non-neoplastic, non-urological conditions. Compared with never-smokers, the multivariate relative risk (RR) was 1.9 (95% confidence interval, CI 1.2-3.1) for ex-smokers and 3.3 (95% CI 2.2-5.0) for current smokers. The risk was directly and significantly related to duration of smoking (RR 3.5 for 30 years or more) and dose (RR 3.9 for 20 cigarettes per day or more), and consistent among strata of sex and age (though the RRs were systematically higher at older ages). Smokers of black tobacco only had a RR of 3.7, compared with 2.6 for smokers of blond cigarettes or mixed types. The interaction between tobacco and several occupations associated with bladder cancer risk fitted an additive rather than a multiplicative model: compared with non-exposed never-smokers, RR was 2.5 for exposed non-smokers, 2.8 for non-exposed smokers and 3.7 for occupationally exposed smokers.

Aims and background Data on liver cancer incidence and prevalence in Italy are not available on a national and regional level. Methods We provided estimates of the number of incident and prevalent cases for hepatocellular carcinoma in Italy overall and in various regions in 2002 and gave projections for the years 2007 and 2012. We obtained annual numbers of incident cases of hepatocellular carcinoma by combining mortality data provided by the World Health Organization and information on survival for liver cancer, and subsequently derived five-year prevalence for hepatocellular carcinoma by combining incidence with information on survival. Results In 2002, there were about 5800 incident cases and 4300 prevalent cases of hepatocellular carcinoma in Italy. The most reliable estimate of hepatocellular carcinoma incident cases in Italy in 2007 is between 5500 and 6000, and this figure is likely to decline to 5000–5500 in 2012. The best estimate of prevalence is about 4000 cases in 2007, which is likely to decline to 3700 in 2012. Conclusions Incidence and prevalence of hepatocellular carcinoma are likely to remain approximately stable between 2002 and 2007 and slightly decrease in the subsequent quinquennia. These projections are, however, subject to large uncertainties because of the problems in diagnosis and death certification for this neoplasm, particularly for the elderly.

The easy access to the pelvis of infertile women by laparoscopy favours early diagnosis of endometriosis in an increasing number of subjects with minimal and mild disease. These initial forms have been associated with and considered as the cause of infertility despite the absence of relevant scientific evidence. Various hormone therapies, some with severe side-effects and high costs, have been used by numerous authors. However, no study comparing medically treated with untreated women has ever shown any drug to be more effective than expectant management. The possible explanations of treatment failures are reviewed.