The preferences of people with amyotrophic lateral sclerosis on riluzole treatment in Europe.

The Patient Preference Survey aims to understand unmet needs related to riluzole management in people with Amyotrophic Lateral Sclerosis (ALS) and to identify which characteristics of a new formulation could better match their preferences. The survey involved 117 people with ALS (PALS) treated with riluzole in four European countries. The dysphagic PALS were least satisfied with the riluzole tablet and oral suspension and with ease in self-administration; up to 68% of respondents postponed or missed the treatment due to swallowing difficulties and need of caregiver assistance. Overall, 51% of tablet and 53% of oral suspension users regularly crushed or mixed riluzole with beverages, respectively; PALS who always manipulated riluzole showed low satisfaction with the formulation and considered the risk of choking and pneumonia the most worrisome event. The survey evaluated the driving factors in choosing/switching the therapy: 67% of PALS declared a low risk of choking. The research finally evaluated which attributes of a new formulation would be preferred: the most relevant were ease of use (4.3/5), convenient/portable packaging (4.0/5) and oral-dissolving properties without tongue motility (3.9/5). The Patient Preference Survey suggests that patients have several unmet needs and preferences that could be addressed by a different formulation, e.g. using oral film technologies.

Venous thromboembolism after major orthopaedic surgery: a population-based cohort study.

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.

A national survey on aspirin patterns of use and persistence in community outpatients in Italy.

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 < 0.001) or non-diabetic (p < 0.001) patients. A negative association has been observed among patients with contraindication to aspirin use. Only 23.4% of patients at 1 year and 12.2% at 2 years remained persistent with aspirin use, although most of first-time users reported an intermittent use. CONCLUSION: Underuse and discontinuation of aspirin treatment is common among eligible patients. Increased cardiovascular risk only partially influences aspirin management. An effort aimed to improve appropriate aspirin use is likely to provide major benefits.

A national survey of the management of atrial fibrillation with antithrombotic drugs in Italian primary care.

The 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.

Estimates of the incidence and prevalence of renal cell carcinoma in Italy in 2002 and projections for the years 2007 and 2012.

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.

Estimates of the incidence and prevalence of hepatocellular carcinoma in Italy in 2002 and projections for the years 2007 and 2012.

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.

Economic evaluation of treating clinically isolated syndrome and subsequent multiple sclerosis with interferon beta-1b.

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%) (P < 0.0001). 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.