Generic versus brand-name cardiovascular drugs: a remarkable update

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Countries, national alcohol limits and risk behaviours: results from the TEN D by Night project

Background: this paper re-analysed data from the international cross-sectional TEN-D survey to investigate the association between country or national alcohol limits and risk behaviours. Methods: data were collected on subjects aged 16-35 years owning a driving license and attending recreational sites during weekend nights in Belgium/Netherlands, Bulgaria, Italy, Poland and Spain. Each participant was administered a: questionnaire, driving simulation, breath alcohol concentration (BAC) and illegal drugs detection tests. Random-effect regression was used to identify independent predictors of 3 outcomes: high BAC (≥0.5 g/L); negative driving behaviours; self-reported illegal drug consumption. Results: the survey included 4 534 subjects (mean age 23.1±4.2 years; males 68.3%). Alcohol misuse was highest in Poland (65.1%) and Spain (83.7%), which also showed the highest frequency of negative driving behaviours (39.0%) and illegal drugs consumption (55.6%). Multivariate analysis confirmed country as a predictor of all outcomes, whereas no association was found with national alcohol limits. Conclusions: the absence of association between national alcohol limits and alcohol misuse or negative driving behaviours suggests that cultural factors might be predominant in explaining the differences across countries. Our findings are preliminary and further research is needed

Health Care Financing Reforms in Italy: Projects of Jefferson\u27s Center for Research in Medical Education and Health Care

No abstract available

Inhaled CO2 Concentration While Wearing Face Masks: A Pilot Study Using Capnography

Background: Face masks are recommended based on the assumption that they protect against SARS-CoV-2 transmission, however studies on their potential side effects are still lacking. We aimed to evaluate the inhaled air carbon dioxide (CO2) concentration, when wearing masks. Methods: We measured end-tidal CO2 using professional side-stream capnography, with water-removing tubing, (1) without masks, (2) wearing a surgical mask, and (3) wearing a FFP2 respirator (for 5 minutes each while seated after 10 minutes of rest), in 146 healthy volunteers aged 10 to 90 years, from the general population of Ferrara, Italy. The inhaled air CO2 concentration was computed as: ([mask volume × end-tidal CO2] + [tidal volume − mask volume] × ambient air CO2)/tidal volume. Results: With surgical masks, the mean CO2 concentration was 7091 ± 2491 ppm in children, 4835 ± 869 in adults, and 4379 ± 978 in the elderly. With FFP2 respirators, this concentration was 13 665 ± 3655 in children, 8502 ± 1859 in adults, and 9027 ± 1882 in the elderly. The proportion showing a CO2 concentration higher than the 5000 ppm (8-hour average) acceptable threshold for workers was 41.1% with surgical masks, and 99.3% with FFP2 respirators. Adjusting for age, gender, BMI, and smoking, the inhaled air CO2 concentration significantly increased with increasing respiratory rate (mean 10 837 ±3712 ppm among participants ⩾18 breaths/minute, with FFP2 respirators), and among the minors. Conclusion: If these results are confirmed, the current guidelines on mask-wearing should be reevaluated

Generic versus brand-name drugs used in cardiovascular diseases

This meta-analysis aimed to compare the efficacy and adverse events, either serious or mild/moderate, of all generic versus brand-name cardiovascular medicines. We searched randomized trials in MEDLINE, Scopus, EMBASE, Cochrane Controlled Clinical Trial Register, and ClinicalTrials.gov (last update December 1, 2014). Attempts were made to contact the investigators of all potentially eligible trials. Two investigators independently extracted and analyzed soft (including systolic blood pressure, LDL cholesterol, and others) and hard efficacy outcomes (including major cardiovascular adverse events and death), minor/moderate and serious adverse events. We included 74 randomized trials; 53 reported ≥1 efficacy outcome (overall sample 3051), 32 measured mild/moderate adverse events (n = 2407), and 51 evaluated serious adverse events (n = 2892). We included trials assessing ACE inhibitors (n = 12), anticoagulants (n = 5), antiplatelet agents (n = 17), beta-blockers (n = 11), calcium channel blockers (n = 7); diuretics (n = 13); statins (n = 6); and others (n = 3). For both soft and hard efficacy outcomes, 100 % of the trials showed non-significant differences between generic and brand-name drugs. The aggregate effect size was 0.01 (95 % CI -0.05; 0.08) for soft outcomes; -0.06 (-0.71; 0.59) for hard outcomes. All but two trials showed non-significant differences in mild/moderate adverse events, and aggregate effect size was 0.07 (-0.06; 0.20). Comparable results were observed for each drug class and in each stratified meta-analysis. Overall, 8 serious possibly drug-related adverse events were reported: 5/2074 subjects on generics; 3/2076 subjects on brand-name drugs (OR 1.69; 95 % CI 0.40-7.20). This meta-analysis strengthens the evidence for clinical equivalence between brand-name and generic cardiovascular drugs. Physicians could be reassured about prescribing generic cardiovascular drugs, and health care organization about endorsing their wider use

SARS-CoV-2 pandemic: An overview

By the end of May 2020, SARS-CoV-2 pandemic caused more than 350,000 deaths worldwide. In the first months, there have been uncertainties on almost any area: infection transmission route, virus origin and persistence in the environment, diagnostic tests, therapeutic approach, high-risk subjects, lethality, and containment policies. We provide an updated summary of the current knowledge on the pandemic, discussing the available evidence on the effectiveness of the adopted mitigation strategies

Gender health and policies: the state of the art from exposure to solutions

Objective. To synthesize the determinants of gender inequalities through a narrative review that: (i) describes gender related var- iables that can create different levels of health; (ii) describes key points that may assist in policy development and its reorientation towards gender differences; (iii) debates potential approaches in understanding gender issues. Methods. Review of the international literature through online databases (Pubmed), search engines, publications and documents from ?grey literature?. Inclusion criteria: publications from 1997, English language; keywords used: gender based analysis; gender and public policy; women?s health; gender differences; health policy; gender impact assessment. Among the 300 papers retrieved, 55 were selected for relevance. Results. We performed a narrative synthesis of the included literature, regarding: (i) gender differences and their determi-nants; (ii) elements for the changing; (iii) possible approaches; (iv) gender influences the pursuit of health and health care access through specific variables; (v) health policies can modify these variables only by a minimal percentage. These interventions should guarantee equity and allow efficient resources allocation. The gap between political announce- ments and real policy implementation remains unchanged. (vi) Standard approaches to the topic are not feasible due to the scarcity of a specific literature and the numerous cultural differences. Conclusions. Gender analysis of policies suggests they can dif- ferently affect women in comparison to men. However, reforms, strategies and interventions introduced in the last two decades, have achieved a limited success towards better gender equality in health. The main aim is to attack the structural sources of gender inequity in the society

Enhancing COVID-19 Vaccines Acceptance: Results from a Survey on Vaccine Hesitancy in Northern Italy

In March 2021, the coronavirus disease 2019 (COVID-19) pandemic still poses a threat to the global population, and is a public health challenge that needs to be overcome. Now more than ever, action is needed to tackle vaccine hesitancy, especially in light of the availability of effective and safe vaccines. A cross-sectional online survey was carried out on a representative random sample of 1011 citizens from the Emilia-Romagna region, in Italy, in January 2021. The questionnaire collected information on socio-demographics, comorbidities, past vaccination refusal, COVID-19-related experiences, risk perception of infection, and likelihood to accept COVID-19 vaccination. Multiple logistic regression analyses and classification tree analyses were performed to identify significant predictors of vaccine hesitancy and to distinguish groups with different levels of hesitancy. Overall, 31.1% of the sample reported hesitancy. Past vaccination refusal was the key discriminating variable followed by perceived risk of infection. Other significant predictors of hesitancy were: ages between 35 and 54 years, female gender, low educational level, low income, and absence of comorbidities. The most common concerns about the COVID-19 vaccine involved safety (54%) and efficacy (27%). Studying the main determinants of vaccine hesitancy can help with targeting vaccination strategies, in order to gain widespread acceptance-a key path to ensure a rapid way out of the current pandemic emergency

Maternal steroid therapy for fetuses with immune-mediated complete atrioventricular block: a systematic review and meta-analysis

INTRODUCTION: To explore the effect of maternal fluorinated steroid therapy on fetuses affected by immune-mediated complete atrio-ventricular block (CAVB) in utero. MATERIAL AND METHODS: Pubmed, Embase, Cinahl, and ClinicalTrials.gov databases were searched. Only studies reporting the outcome of fetuses with immune CAVB diagnosed on prenatal ultrasound without any cardiac malformations and treated with fluorinated steroids compared to those not treated were included. The primary outcome observed was the regression of CAVB; secondary outcomes were need for pacemaker insertion, overall mortality, defined as the occurrence of either intrauterine (IUD) or neonatal (NND) death, IUD, NND, termination of pregnancy (TOP). Furthermore, we assessed the occurrence of all these outcomes in hydropic fetuses compared to those without hydrops at diagnosis. Meta-analyses of proportions using random effect model and meta-analyses using individual data random-effect logistic regression were used to combine data. RESULTS: Eight studies (162 fetuses) were included. The rate of regression was 3.0% (95%CI 0.2-9.1) in fetuses treated and 4.3% (95%CI 0.4-11.8) in those not treated, with no difference between the two groups (odds ratio (OR): 0.9, 95%CI 0.1-15.1). Pacemaker at birth was required in 71.5% (95%CI 56.0-84.7) of fetuses-treated and 57.8% (95%CI 40.3-74.3) of those not treated (OR: 9, 95%CI 0.4-3.4). There was no difference in the overall mortality rate (OR: 0.5, 95%CI 0.9-2.7) between the two groups; in hydropic fetuses, mortality occurred in 76.2% (95%CI 48.0-95.5) of the treated and in 23.8% (95%CI 1.2-62.3) of the untreated group, while in those without hydrops the corresponding figures were 8.9% (95%CI 2.0-20.3) and 12% (95%CI 8.7-42.2), respectively. Improvement or resolution of hydrops during pregnancy occurred in 76.2% (95%CI 48.0-95.5) of cases treated and in 23.3% (95%CI 1.2-62.3) of those nontreated with fluorinated steroids. CONCLUSIONS: The findings from this systematic review do not suggest a potential positive contribution of antenatal steroid therapy in improving the outcome of fetuses with immune CAVB

COVID-19 vaccines reduce the risk of SARS-CoV-2 reinfection and hospitalization: Meta-analysis

The addictive protection against SARS-CoV-2 reinfection conferred by vaccination, as compared to natural immunity alone, remains to be quantified. We thus carried out a meta-analysis to summarize the existing evidence on the association between SARS-CoV-2 vaccination and the risk of reinfection and disease. We searched MedLine, Scopus and preprint repositories up to July 31, 2022, to retrieve cohort or case-control studies comparing the risk of SARS-CoV-2 reinfection or severe/critical COVID-19 among vaccinated vs. unvaccinated subjects, recovered from a primary episode. Data were combined using a generic inverse-variance approach. Eighteen studies, enrolling 18,132,192 individuals, were included. As compared to the unvaccinated, vaccinated subjects showed a significantly lower likelihood of reinfection (summary Odds Ratio-OR: 0.47; 95% CI: 0.42-0.54). Notably, the results did not change up to 12 months of follow-up, by number of vaccine doses, in studies that adjusted for potential confounders, adopting different reinfection definitions, and with different predominant strains. Once reinfected, vaccinated subjects were also significantly less likely to develop a severe disease (OR: 0.45; 95% CI: 0.38-0.54). Although further studies on the long-term persistence of protection, under the challenge of the new circulating variants, are clearly needed, the present meta-analysis provides solid evidence of a stronger protection of hybrid vs. natural immunity, which may persist during Omicron waves and up to 12 months