The use of phytosterols (or plant sterols) for the control of plasma cholesterol concentrations has recently gained traction because their efficacy is acknowledged by scientific authorities and leading guidelines. Phytosterols, marketed as supplements or functional foods, are formally classified as food in the European Union, are freely available for purchase, and are frequently used without any health professional advice; therefore, they are often self-prescribed, either inappropriately or in situations in which no significant advantage can be obtained. For this reason, a panel of experts with diverse medical and scientific backgrounds was convened by NFI—Nutrition Foundation of Italy—to critically evaluate and summarize the literature available on the topic, with the goal of providing medical doctors and all health professionals useful information to actively govern the use of phytosterols in the context of plasma cholesterol control. Some practical indications to help professionals identify subjects who will most likely benefit from the use of these products, optimizing the therapeutic outcomes, are also provided. The panel concluded that the use of phytosterols as supplements or functional foods to control Low Density Lipoprotein (LDL) cholesterol levels should be preceded by the assessment of some relevant individual characteristics: cardiovascular risk, lipid profile, correct understanding of how to use these products, and willingness to pay for the treatment.

Background: Falls are a common cause of morbidity and functional impairment in the elderly and represent a significant health problem. General practitioners (GPs) are the first point of contact for health issues and may provide preventive services. The randomized clinical trial PREMIO was conducted by GPs to evaluate the effects of a multicomponent intervention for the prevention of falls in older adults aged ≥ 65 years at high risk of falling. Methods: 117 GPs enrolled 1757 patients (1116 F, 641 M) and randomized them into 2 groups (intervention and control). The intervention group received medical and behavioral counseling, home risk-factor assessment, a physical-activity program and nutritional counseling. The control group received only the nutritional counseling. Both groups were followed for one year. The primary outcome was the rate of falls at home over 12 months. Results: 1225 patients completed the study. Subjects receiving the intervention had, on average, fewer falls at home (percentage change −31.2%, p < 0.02) and fewer total falls (−26.0%, p < 0.02), although the reduction in the number of fallers was small (−3.9%, p = 0.05). Among the secondary endpoints, rates of general hospital or emergency-department admission and GP visits showed slight improvements (not statistically significant), while the risk of fractures was unexpectedly increased in the intervention group compared to the controls (odds ratio 2.39, p = 0.023). Conclusions: Future studies and public-health interventions to prevent domestic falls among community-dwelling older people at high risk of falling could benefit from a multicomponent approach including medication review, physical exercise and home risk assessment and should include assessment of risk factors for fractures.

Introduction: The European regulatory landscape is undergoing a profound transformation with the entry into force of the new EU Regulation 2021/2282 on Health Technology Assessment (HTA), designed to harmonize HTA assessments and ensure equity of access to health technologies in different Member States. Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JCS), which allow developers to engage in prior discussion with the bodies responsible for HTA assessments, are key elements in this context where the need for collaborative and structured dialogue between companies and regulatory agencies is growing. The objective of the following work was to identify areas of improvement related to the dialogue between stakeholders and to find solutions for a more effective interaction.Methods: In the context of the Seventh Edition of “The Mogliano Veneto Seminars” held in Mogliano Veneto on September 26 and 27, 2024, a multidisciplinary Working Group composed of about 30 experts in different disciplines, including institutional and stakeholder subjects from different fields (Companies, clinicians, health economists, patients’ associations) discussed the interactions between AIFA and Companies.Conclusions: The key elements to be considered for a more effective interaction between the parties are timing, processes, and the tools to be used. According to what emerged during the discussion, three moments of interaction were identified (pre-submission to EMA, pre-submission to AIFA, and post-submission to AIFA), during which an active dialogue between Companies and AIFA should accelerate and streamline negotiations. The solutions proposed by the experts would bring tangible opportunities of improvement.

This document illustrates the results of the work of two interdisciplinary and multistakeholder panels (researchers, public institutions, and industry representatives) on drug territorialization and digitalization, organized as part of a residential seminar held on 30 September and 1st October 2021. Arising from some considerations about the demand for health and the provisions of the National Recovery and Resilience Plan (PNRR), the discussion touched various aspects of managing the transition from current to future management models. The importance of identifying criteria for prioritizing interventions in the area emerged: different methods of drug delivery, scientific information and measurement, re-evaluation of pathologies that can be managed in this area. Finally, the role of digitization within this change was explored. The opinions provided by the experts move towards making the most of the opportunities arising from PNRR, in terms of investments in healthcare and data application, with a view to improve health system efficiency, patient care and related outcomes.