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Aim: Intraindividual body weight variability (BWV), that is, the degree of weight fluctuations over time, is associated with an increased risk of cardiovascular diseases (CVDs) in multiple settings. The impact of BWV on cardiovascular risk in type 1 diabetes (T1D) remains unclear, despite the issues relative to weight management in individuals with this condition. Materials and methods: Using data from the Swedish National Diabetes Register, we identified individuals with T1D and without CVD at baseline with at least three measurements of body weight taken over three consecutive years. We estimated BWV as quartiles of the standard deviation of weight measures and explored its longitudinal association with the incidence of CVD during a 12.7 ± 4.6 year follow‐up through adjusted Cox regression models. The primary endpoint was the composite of nonfatal myocardial infarction, nonfatal stroke and all‐cause mortality. We modelled the function of risk in relation to the magnitude of BWV, testing also whether weight trends, that is, increasing, stable or decreasing, age, sex and glycaemic control modified the association between BWV and the outcome. Results: Among the 36 333 individuals with T1D in the register, we identified 19 373 individuals with at least three measures of body weight and without CVD at baseline. Participants with the highest BWV had a 42% increased risk of reaching the primary endpoint compared to those with the lowest BWV (hazard ratio [HR] = 1.42, 95% confidence interval [CI]: 1.24–1.62). In addition, high BWV was significantly associated with a 51% increased risk of all‐cause mortality (HR = 1.51, 95% CI: 1.28–1.78), a 37% increased risk of peripheral artery disease (HR = 1.37, 95% CI: 1.06–1.77) and a 55% increased risk of hospitalization for heart failure (HR = 1.55, 95% CI: 1.20–2.01). BWV showed a quasi‐linear association with the primary endpoint. No interaction was observed when comparing subgroups for weight trends, sex or degree of glycaemic control. In the subgroup of elderly individuals, the association of BWV with the primary endpoint was no longer significant. Conclusions: High BWV is associated with an increased risk of CVD and all‐cause mortality in individuals with T1D, independently of canonical risk factors. Weight trends, sex and glycaemic control do not modify such association while older age attenuates it. [ABSTRACT FROM AUTHOR]

OBJECTIVE: The Metformin and Dietary Restriction to Prevent Age-Related Morbid Events in People With Metabolic Syndrome (MeMeMe) trial tested whether 1,700 mg/day metformin (MET) with or without a Mediterranean diet (MedDiet) intervention could reduce the cumulative incidence of major noncommunicable diseases in people with metabolic syndrome. RESEARCH DESIGN AND METHODS: A total of 1,442 participants were randomly assigned to one of four interventions: 1) MET (1,700 mg/day) plus MedDiet intervention (MET+MedDiet); 2) placebo plus MedDiet intervention; 3) MET (1,700 mg/day) alone; and 4) placebo alone. Participants were followed up for 3 years on average. The primary outcome was the cumulative incidence of major noncommunicable diseases (including type 2 diabetes, cardiovascular diseases, and cancer). Secondary outcomes were the incidence of type 2 diabetes and the changing prevalence of metabolic syndrome. RESULTS: The crude incidence of the major noncommunicable diseases was 6.7 cases per 100 person-years in theMET+MedDiet group, 6.9 in theMET alone group, 13.3 in the placebo plus MedDiet group, and 11.3 in the placebo group. The differences were fully explained by the reduction of type 2 diabetes, which was 80% and 92% lower in the MET andMET+MedDiet groups, respectively, compared with placebo. CONCLUSIONS: The use of 1,700 mg/day MET is effective to prevent diabetes in people selected on the basis of metabolic syndrome. [ABSTRACT FROM AUTHOR]

Venous blood collection systems (VBCSs) are combinations of in-vitro diagnostics and medical devices, usually available as integrated set. However, purchasing and using a combination of devices from different sets is considered by clinical laboratories as an option to achieve specific sampling tasks or reduce costs. This systematic review aimed to retrieve available evidence regarding safety, efficacy, and economic aspects of VBCSs, focusing on differences between integrated and combined systems. The literature review was carried out in PubMed. Cited documents and resources made available by scientific organisations were also screened. Extracted evidence was clustered according to Quality/Efficacy/Performance, Safety, and Costs/Procurement domains and discussed in the current European regulatory framework. Twenty documents published between 2010 and 2021 were included. There was no evidence to suggest equivalence between combined and integrated VBCSs in terms of safety and efficacy. Scientific society's consensus documents and product standards report that combined VBCS can impact operators' and patients' safety. Analytical performances and overall efficacy of combined VBCSs are not guaranteed without whole system validation and verification. EU regulatory framework clearly allocates responsibilities for the validation and verification of an integrated VBCS, but not for combined VBCSs, lacking information about the management of product nonconformities and post-market surveillance. Laboratory validation of combined VBCS demands risk-benefit and cost-benefit analyses, a non-negligible organisational and economic burden, and investment in knowledge acquisition. Implications in terms of laboratory responsibility and legal liability should be part of a comprehensive assessment of safety, efficacy, and cost carried out during device procurement. [ABSTRACT FROM AUTHOR]

Simple Summary: The global aging trend led to an increase in cancer diagnoses at a very old age, including breast cancer (BC). The BC treatment recommendations are based on clinical trials that do not include elderly patients, which still miss dedicated guidelines derived from prospective studies. To gain new insight, we performed a prospective monocentric study focused on the characteristics and outcomes of patients aged 80 years or older with a BC diagnosis. Most patients (84.1%) did not have advanced disease, and 69.3% were surgically treated. Systemic therapy was administered to 81.8%. Postsurgical therapy was omitted in 32% of eligible patients due to either comorbidities or patient choice. At the end of the 5-year follow-up period, 25.6% of patients experienced disease progression and the overall survival probability was 82.9. After 8.5 years, 48.9% of patients died, and BC was the cause of death in 32.6% of them. Many patients were lost to follow-up (27.3%). Our results emphasize the importance of tailored management strategies, considering both the biological behavior of BC in elderly patients and their overall health status since their life expectancy is not negligible. Background: The lengthening of the lifespan led to an increase in breast cancer (BC) diagnosed in very old age, but the treatment recommendations in this patient group usually lack evidence-based practice. We conducted a prospective observational monocentric study specifically targeting patients diagnosed with invasive BC at 80 years of age or older. Methods: We enrolled 88 patients consecutively observed for a new BC diagnosis at 80 years or older. The aim was to investigate progression-free (PFS) and overall survival (OS), with a long follow-up period, along with clinico-pathological characteristics of the population. Results: At the end of the 5-year follow-up, the estimated OS and PFS probabilities were 82.9% (95% CI: 71.3–95.3%) and 64.0% (95% CI: 51.7–79.2%), respectively. After 8.5 years from the BC diagnosis, 48.9% died. The cause of death was BC in 32.6% of patients, different from BC in 13.9%, and unknown in the remaining. Surgery was performed in 69.3% of the cases and was associated with improved 12-month PFS (p < 0.001). Adjuvant systemic therapy and radiotherapy were omitted in 32% and 93% of eligible patients, respectively. A higher rate of metastatic disease at the diagnosis was observed in comparison with data described in younger people, as well as a significantly high rate of drop-out (27.3%). Conclusions: Ultra-old patients have a not negligible life expectancy; therefore, the oncologic treatment should be optimal and should adequately fight BC, always considering the quality of life of these frail patients. Future research should focus on developing personalized treatment protocols that incorporate comprehensive geriatric assessments and quality-of-life metrics. Additionally, larger, multicentric studies are needed to validate our findings and explore the role of emerging therapies in this age group. [ABSTRACT FROM AUTHOR]

The recent passage of European Union (EU) Regulation 2017/745 on medical devices (MDs) has improved the classification of MDs and revised their approval process and the post-marketing evaluation of their safety and effectiveness, promoting transparency and post-marketing oversight in Europe. This new regulation can better ensure patient safety and provide new opportunities for therapeutic innovation. In addition, the new regulations include and define MDs made of substances or of combinations of substances (substance-based MDs: SBMDs). The impressive growth of the MD, including SBMDs, that have been marketed over the recent years has likely been a relevant factor fueling this change. MD regulation requires a major effort from both industry and regulatory bodies to comply with its provisions. Manufacturers should produce sufficient clinical evidence that an MD, under normal conditions of use, provides adequate performance and that the foreseeable risks and frequency of adverse events (AEs) have an acceptable minimum rate, taking into account the benefits provided. We describe how we implemented the post-marketing surveillance (PMS) system of SBMDs to properly deal with post-market monitoring and confirmation of safety and performance, including AEs and the benefit–risk evaluation, as required by the 2017/745 Regulation. The two pillars of this novel system are: 1) passive vigilance, i.e., spontaneous reporting and 2) active post-marketing clinical follow-up (PMCF) activities, which systematically gather, record, and analyze real-world data (RWD) on performance, quality, function, use, tolerability, and safety of an MD, collected through a dedicated, structured web platform. Active PMCF is achieved through a process of generation, validation, and administration of digital questionnaires to all stakeholders, i.e., patients, physicians, both general practitioners and specialists, and pharmacists. The technology, potential use, advantages, and limitations of this large source of RWD are also discussed. [ABSTRACT FROM AUTHOR]

Diarrhea continues to be a global health problem as acute diarrhea carries the risk of dehydration, while both acute and chronic diarrhea can significantly affect patients' quality of life and reduce productivity. The innovative medical device Actitan, which consists of a complex of natural molecules, could be an effective option for the treatment of diarrhea from various causes. The aim of this post-market cross-sectional study was to evaluate the perceived efficacy, safety and usage pattern of the two formulations for adults (Actitan-P) and children (Actitan-F) among patients/child caregivers, physicians and pharmacists. Participants completed online questionnaires with closed multiple-choice questions that were rated on a verbal 5-point Likert scale. These surveys were conducted via the online platform Real World Data, which provides digital questionnaires for patients, doctors and pharmacists. Two separate surveys were conducted for the two formulations, with a total of 2630 participants (1488 participants for Actitan-P and 1142 participants for Actitan-F). Overall, the results indicate a high level of efficacy and safety of the product. In the case of Actitan-F, more than 96% of caregivers rated safety as good or excellent, and over 92% rated efficacy as good or excellent. Actitan-P also received positive feedback: nearly 86% of patients reported good/excellent efficacy, and more than 93% rated safety as good or excellent. These positive evaluations were confirmed by physicians and pharmacists, who also did not report adverse effects. In summary, this study confirms the role of Actitan as a safe and effective option for the treatment of diarrhea of different causes and in different patient groups, including young children. [ABSTRACT FROM AUTHOR]