Cost-effectiveness of direct acting oral anticoagulants in the prevention of thromboembolic complications : limits and concerns of economic evaluations

Economic evaluations have a widespread application in many areas of clinical research and play a key role in the clinical decision-making process. However, economic analyses have been sometimes used to produce new 'evidence' that is not adequately tested in the target population. This is the case of data arising from a systematic review of clinical trials evaluating the use of direct acting oral anticoagulants for the prevention of stroke in patients with atrial fibrillation. Taking into account this example, here we discuss the concerns raised by the improper interpretation of the results. Our conclusions are three-fold. Data from economic analyses should not be shifted to a clinical recommendation. Simulation models should not be used to generate new 'evidence' that is not supported by experimental data and is misleading. Clinical judgment is therefore pivotal to interpret results emerging from economic analyses

Risk of atrial fibrillation among bisphosphonate users: a multicenter, population-based, Italian study

Summary: Bisphosphonate treatment is used to prevent bone fractures. A controversial association of bisphosphonate use and risk of atrial fibrillation has been reported. In our study, current alendronate users were associated with a higher risk of atrial fibrillation as compared with those who had stopped bisphosphonate (BP) therapy for more than 1 year.Introduction: Bisphosphonates are widely used to prevent bone fractures. Controversial findings regarding the association between bisphosphonate use and the risk of atrial fibrillation (AF) have been reported. The aim of this study was to evaluate the risk of AF in association with BP exposure.Methods: We performed a nested case-control study using the databases of drug-dispensing and hospital discharge diagnoses from five Italian regions. The data cover a period ranging from July 1, 2003 to December 31, 2006. The study population comprised new users of bisphosphonates aged 55 years and older. Patients were followed from the first BP prescription until an occurrence of an AF diagnosis (index date, i.e., ID), cancer, death, or the end of the study period, whichever came first. For the risk estimation, any AF case was matched by age and sex to up to 10 controls from the same source population. A conditional logistic regression was performed to obtain the odds ratio with 95 % confidence intervals (CI). The BP exposure was classified into current (<90 days prior to ID), recent (91–180), past (181–364), and distant past (≥365) use, with the latter category being used as a reference point. A subgroup analysis by individual BP was then carried out.Results: In comparison with distant past users of BP, current users of BP showed an almost twofold increased risk of AF: odds ratio (OR) = 1.78 and 95 % CI = 1.46–2.16. Specifically, alendronate users were mostly associated with AF as compared with distant past use of BP (OR, 1.97; 95 % CI, 1.59–2.43).Conclusion: In our nested case-control study, current users of BP are associated with a higher risk of atrial fibrillation as compared with those who had stopped BP treatment for more than 1 year

Pleural mesothelioma risk in the construction industry: a case-control study in Italy, 2000-2018

Objectives Workers in the construction industry have been exposed to asbestos in various occupations. In Italy, a National Mesothelioma Registry has been implemented more than 20 years ago. Using cases selected from this registry and exploiting existing control data sets, we estimated relative risks for pleural mesothelioma (PM) among construction workers. DesignCase-control study. SettingCases from the National Mesothelioma Registry (2000-2018), controls from three previous case-control studies. MethodsWe selected male PM incident cases diagnosed in 2000-2018. Population controls were taken from three studies performed in six Italian regions within two periods (2002-2004 and 2012-2016). Age-adjusted and period-adjusted unconditional logistic regression models were fitted to estimate odds ratios (OR) for occupations in the construction industry. We followed two approaches, one (primary) excluding and the other (secondary) including subjects employed in other non-construction blue collar occupations for &gt;5 years. For both approaches, we performed an overall analysis including all cases and, given the incomplete temporal and geographic overlap of cases and controls, three time or/and space restricted sensitivity analyses. ResultsThe whole data set included 15 592 cases and 2210 controls. With the primary approach (4797 cases and 1085 controls), OR was 3.64 (2181 cases) for subjects ever employed in construction. We found elevated risks for blue-collar occupations (1993 cases, OR 4.52), including bricklayers (988 cases, OR 7.05), general construction workers (320 cases, OR 4.66), plumbers and pipe fitters (305 cases, OR 9.13), painters (104 cases, OR 2.17) and several others. Sensitivity analyses yielded very similar findings. Using the secondary approach, we observed similar patterns, but ORs were remarkably lower. ConclusionsWe found markedly increased PM risks for most occupations in the construction industry. These findings are relevant for compensation of subjects affected with mesothelioma in the construction industry

MF59®-Adjuvanted H5N1 Vaccine Induces Immunologic Memory and Heterotypic Antibody Responses in Non-Elderly and Elderly Adults

Pathogenic avian influenza virus (H5N1) has the potential to cause a major global pandemic in humans. Safe and effective vaccines that induce immunologic memory and broad heterotypic response are needed.Healthy adults aged 18-60 and > 60 years (n = 313 and n = 173, respectively) were randomized (1:1) to receive two primary and one booster injection of 7.5 microg or 15 microg doses of a subunit MF59-adjuvanted H5N1 (A/Vietnam/1194/2004) (clade 1) vaccine. Safety was monitored until 6 months after booster. Immunogenicity was assessed by hemagglutination inhibition (HI), single radial hemolysis (SRH) and microneutralization assays (MN). Mild injection-site pain was the most common adverse reaction. No serious adverse events relating to the vaccine were reported. The humoral immune responses to 7.5 microg and 15 microg doses were comparable. The rates for seroprotection (HI>40; SRH>25 mm(2); MN > or = 40) after the primary vaccination ranged 72-87%. Six months after primary vaccination with the 7.5 microg dose, 18% and 21% of non-elderly and elderly adults were seroprotected; rates increased to 90% and 84%, respectively, after the booster vaccination. In the 15 microg group, seroprotection rates among non-elderly and elderly adults increased from 25% and 62% after primary vaccination to 92% and 88% after booster vaccination, respectively. A heterologous immune response to the H5N1/turkey/Turkey/05 strain was elicited after second and booster vaccinations.Both formulations of MF59-adjuvanted influenza H5N1 vaccine were well tolerated. The European Union requirement for licensure for pre-pandemic vaccines was met by the lower dose tested. The presence of cross-reactive antibodies to a clade 2 heterologous strain demonstrates that this vaccine may be appropriate for pre-pandemic programs.(ClinicalTrials.gov) NCT00311480

On Nontrival Equilibria in Finitely Repeated Games

Background: Data on the effect of oral bisphosphonates (BPs) on risk of upper gastrointestinal complications (UGIC) are conflicting. We conducted a large population-based study from a network of Italian healthcare utilization databases aimed to assess the UGIC risk associated with use of BPs in the setting of secondary prevention of osteoporotic fractures.Methods: A nested case-control study was carried out within a cohort of 68,970 patients aged 45 years or older, who have been hospitalized for osteoporotic fracture from 2003 until 2005. Cases were the 804 patients who experienced hospitalization for UGIC until 2007. Up to 20 controls were randomly selected for each case. Conditional logistic regression model was used to estimate odds ratio (OR) associated with current and past use of BPs (i.e. for drug dispensation within 30 days and over 31 days prior the outcome onset, respectively) after adjusting for several covariates.Results: Compared with patients who did not use BPs, current and past users had OR (and 95% confidence interval) of 0.86 (0.60 to 1.22) and 1.07 (0.80 to 1.44) respectively. There was no difference in the ORs estimated according with BPs type (alendronate or risedronate) and regimen (daily or weekly), nor with co-therapies and comorbidities.Conclusions: Further evidence that BPs dispensed for secondary prevention of osteoporotic fractures are not associated with increased risk of severe gastrointestinal complications is supplied from this study. Further research is required to clarify the role BPs and other drugs of co-medication in inducing UGI

Attitudes and Beliefs towards Rotavirus Vaccination in a Sample of Italian Women: A Cross-Sectional Study

(1) Background: Rotavirus is the leading cause of severe diarrhea and dehydration in infants and young children worldwide. Despite the proven benefits of vaccination, vaccine hesitancy and refusal remains a significant barrier to achieving high vaccination coverage in many countries, such as Italy. (2) Methods: An online survey was conducted among women aged between 18 and 50 years from Abruzzo Region, Italy. The survey was composed of two main sections: demographic characteristics and attitudes and knowledge about rotavirus vaccination, based on a five-point Likert scale. Logistic regression analysis was performed to evaluate factors associated with willingness to get the rotavirus vaccination. (3) Results: A total of 414 women were enrolled in the study. Women who were unaware of rotavirus more frequently had a lower education level (university degree 62.5% vs. 78.7%, p = 0.004) and reported having no children (p p < 0.001). (4) Conclusions: The present study showed low levels of knowledge and attitudes towards rotavirus vaccination. These results highlight the need for developing and improving additional public education programs for parents

Reduction in Hospital Admissions for Cardiovascular Diseases (CVDs) during the Coronavirus Disease 2019 (COVID-19) Pandemic: A Retrospective Study from a Southern Italian Region in the Year 2020

(1) Background: The COVID-19 pandemic has indirect consequences for healthcare for other diseases, known as collateral damage. This situation heavily affects healthcare systems, causing changes in patterns of hospital admission. During the peak of the coronavirus disease 2019 pandemic, numerous studies reported a reduction in admissions for acute coronary syndrome. The aim of this study was to evaluate the incidence of admissions for cardiovascular diseases in Abruzzo, a region of Southern Italy, in the year 2020 and compare it to the two previous years (2018&ndash;2019). (2) Methods: This retrospective study was conducted in Abruzzo, Italy. The monthly number of admissions in the year 2020 was compared to a control period made from the average number of events that occurred in the previous two years (2018&ndash;2019). (3) Results: A global reduction in hospital admissions for all the cardiovascular diseases (CVDs) considered was observed. In particular, compared to the control period, in 2020, the number of admissions for ST-segment elevation myocardial infarction (STEMI) was lower by 34 (hospitalization rate ratio, HRR, 0.93; p &lt; 0.001), the number of non-ST-segment-elevation myocardial infarctions (N-STEMI) was lower by 154.5 (HRR 0.89; p &lt; 0.001), the number for acute coronary syndrome (ACS) was 340 lower (HRR 0.90; p &lt; 0.001) and the number for heart failure (HF) was 1424.5 lower than during the control period (HRR 0.73; p &lt; 0.001). (4) Conclusions: The results of this study show the impact of COVID-19 on admissions for CVDs, suggesting the need for strategic measures to overcome the burden of hospitalizations in future years

The Impact of COPD on Hospitalized Patients with Diabetes: A Propensity Score Matched Analysis on Discharge Records

(1) Background: Type 2 diabetes is a common comorbidity of chronic obstructive pulmonary disease. Despite the lack of knowledge of the pathophysiological link between diabetes and chronic obstructive pulmonary disease, the presence of diabetes among those with chronic obstructive pulmonary disease is associated with worse outcomes, such as mortality and hospitalization. The aim of this study was to evaluate the impact of chronic obstructive pulmonary disease on in-hospital mortality and prolonged length of stay (PLOS) among patients with diabetes. (2) Methods: The study considered all hospital admissions of patients with diabetes aged over 65 years performed from 2006 to 2015 in Abruzzo, Italy. To compare outcomes between patients with and without chronic obstructive pulmonary disease, a propensity score matching procedure was performed. (3) Results: During the study period, 140,556 admissions of patients with diabetes were performed. After matching, 18,379 patients with chronic obstructive pulmonary disease and 18,379 controls were included in the analyses. Logistic regression analyses showed as chronic obstructive pulmonary disease was associated with in-hospital mortality (OR: 1.10; p = 0.036) and PLOS (OR: 1.18; p = 0.002). (4) Conclusions: In a cohort of Italian patients, diabetic patients with chronic obstructive pulmonary disease were associated with in-hospital mortality and PLOS. The definition of the causes of these differences aims to implement public health surveillance and policies