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

Moving towards compulsory vaccination: The Italian experience

Vaccine hesitancy is a phenomenon that has increased widely in the last few years, in the Europe and in the USA, giving its consequences on vaccine coverage rates. The decrease in those rates caused an enormous spread of preventable infections that were quite rare in the past years, or, at least, presented mild consequences. Since immunization is an issue of coverage rates, the European Council prompted the National Health Authorities to face the challenge of reaching the target of 95% of the population, set by European Centre for Disease Prevention and Control (ECDC), through the implementation of effective vaccination policies. In Italy, coverage rates have been decreasing in the last few years. In 2016, the following coverage rates at 24 months for birth cohort 2014 have been reported by Italian..

Cohort study of electronic cigarette use: effectiveness and safety at 24 months

OBJECTIVE: To evaluate the safety and effectiveness of e-cigarettes, by comparing users of only e-cigarettes, smokers of only tobacco cigarettes and dual users. DESIGN: Prospective cohort study. We update previous 12-month findings and report the results of the 24-month follow-up. DATA SOURCES: Direct contact and questionnaires by phone or via internet. METHODS: Adults (30-75 years) were classified as: (1) tobacco smokers, if they smoked ≥1 tobacco cigarette/day, (2) e-cigarette users, if they inhaled ≥50 puffs/week of any type of e-cigarette and (3) dual users, if they smoked tobacco cigarettes and also used e-cigarettes. Carbon monoxide levels were tested in 50% of those declaring tobacco smoking abstinence. Hospital discharge data were used to validate possibly related serious adverse events in 46.0% of the sample. MAIN OUTCOME MEASURES: Sustained abstinence from tobacco cigarettes and/or e-cigarettes after 24 months, the difference in the number of tobacco cigarettes smoked daily between baseline and 24 months, possibly related serious adverse events. RESULTS: Data at 24 months were available for 229 e-cigarette users, 480 tobacco smokers and 223 dual users (overall response rate 68.8%). Of the e-cigarette users, 61.1% remained abstinent from tobacco (while 23.1% and 26.0% of tobacco-only smokers and dual users achieved tobacco abstinence). The rate (18.8%) of stopping use of either product (tobacco and/or e-cigarettes) was not higher for e-cigarette users compared with tobacco smokers or dual users. Self-rated health and adverse events were similar between all groups. Among those continuing to smoke, there were no differences in the proportion of participants reducing tobacco cigarette consumption by 50% or more, the average daily number of cigarettes and the average self-rated health by baseline group. Most dual users at baseline abandoned e-cigarettes and continued to smoke tobacco. Those who continued dual using or converted from tobacco smoking to dual use during follow-up experienced significant improvements in the 3 outcomes compared with those who continued or switched to only smoking tobacco (p<0.001). CONCLUSIONS: E-cigarette use alone might support tobacco quitters remaining abstinent from smoking. However, dual use did not improve the likelihood of quitting tobacco or e-cigarette use, but may be helpful to reduce tobacco consumption. Adverse event data were scarce and must be considered preliminary. TRIAL REGISTRATION NUMBER: NCT01785537

Which competences and what managerial training for the health professions

The process of passage to be e-profit and loss organization following the reform of the Italian health system, especially in a context of fiscal federalism and administered competition among the public and private producers, causes implications on the competences of whom develops his/her own professional activity. The aim of the paper is to give some inputs for discussion about the training of manager: starting from the meaning of the word ?management? and using the model elaborated by Mintzberg and Simon with the purpose to identify who is involved in such training, trying to make explicit that the analysis of the organizational positions and the profile of the resource that will go to occupy it is a forced passage for building the training package and to make clear characteristics and contents of the training offer

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