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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.

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

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.

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.

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.

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.