Challenges in the Implementation of EU Risk Minimisation Measures for Medicinal Products in Clinical Practice Guidelines: Mixed Methods Multi-Case Study.

Introduction: Risk minimisation measures (RMMs) aim to ensure safe use of medicines, but their implementation in clinical practice is complicated by the diversity of stakeholders whose clinical decision making they seek to inform. Clinical practice guidelines (CPGs) are considered integral in clinical decision making.

Objectives: To determine the extent to which RMMs are included in the relevant CPGs and to describe factors that determine RMM inclusion.

Serum metabolomic profiling of incident type 2 diabetes mellitus in the Multi-Ethnic Study of Atherosclerosis and Rotterdam Study.

Objective: This study aimed to investigate serum metabolomic biomarkers associated with incident type 2 diabetes mellitus (T2DM) and evaluate their performance in improving T2DM risk prediction.

Methods: Untargeted proton nuclear magnetic resonance (1H NMR) spectroscopy-based metabolomics analyses were conducted in the Multi-Ethnic Study of Atherosclerosis (MESA; n=3460; discovery cohort) and Rotterdam Study (RS; n=1556; replication cohort). Multivariable cause-specific hazards models were used to analyze the associations between 23,571 serum metabolomic spectral variables and incident T2DM.

Subclassification of obesity for precision prediction of cardiometabolic diseases.

Obesity and cardiometabolic disease often, but not always, coincide. Distinguishing subpopulations within which cardiometabolic risk diverges from the risk expected for a given body mass index (BMI) may facilitate precision prevention of cardiometabolic diseases. Accordingly, we performed unsupervised clustering in four European population-based cohorts (N ≈ 173,000).

Exploring Biomarkers in Nonalcoholic Fatty Liver Disease Among Individuals With Type 2 Diabetes Mellitus.

Integrating biomarkers into a comprehensive strategy is crucial for precise patient management, especially considering the significant healthcare costs associated with diseases. Current studies emphasize the urgent need for a paradigm shift in conceptualizing nonalcoholic fatty liver disease (NAFLD), now renamed metabolic dysfunction-associated steatotic liver disease (MASLD). Biomarkers are emerging as indispensable tools for accurate diagnosis, risk stratification, and monitoring disease progression.

Metabolic syndrome, radiographic osteoarthritis progression and chronic pain of the knee among men and women from the general population: The Rotterdam study.

Objective: Although a relationship between osteoarthritis and components of metabolic syndrome (MetS) has been suggested, most of the results have been cross-sectional. We, therefore, aimed to investigate the sex-specific longitudinal association of (components of) MetS with progression of radiographic osteoarthritis and chronic pain in the knee joints in a large prospective cohort.

Method: In the large population-based Rotterdam study of up to 6,138 individuals, median follow-up time 5.

Statin therapy and cardiovascular protection in type 2 diabetes: The role of baseline LDL-Cholesterol levels. A systematic review and meta-analysis of observational studies.

Aim: The guidelines recommend statins to prevent cardiovascular events in patients with type 2 diabetes (T2D) however, the importance of baseline LDL-Cholesterol (LDL-C) levels remains controversial. This study aimed to determine the association of statin use in T2D patients with major adverse cardiovascular events (MACE) and all-cause mortality and whether this association differs by baseline LDL-C levels.

Data Synthesis: Medline, Embase, and Web of Science were systematically searched from inception until January 2022.

The effects of aerobic and resistant exercises on the lipid profile in healthy women: a systematic review and meta-analysis.

Exercise can have a wide range of health benefits, including improving blood lipid profiles. For women to achieve optimal cardiovascular health, it is vital to determine the effect of exercise on their health and whether different exercise intensities can affect their blood lipid profile. A systematic review and meta-analysis were conducted to examine the effects of exercise on improving the lipid profile of healthy women.

The NOS1AP gene rs10494366 common genetic variant does not modify the risk of sudden cardiac death in users of digoxin.

Aims: Common genetic variations in the nitric oxide synthase-1 adaptor protein (NOS1AP) gene are associated with QT-interval prolongation. In a previous study, we observed an association between the rs10494366 variant of this gene and an increased QT-interval shortening in digoxin users. As QT-interval shortening is a risk factor for sudden cardiac death (SCD), in this study, we investigated whether the association between digoxin use and risk of SCD differs in participants with different NOS1AP rs10494366 genotypes.

Respiratory syncytial virus vaccination during pregnancy for improving infant outcomes.

Background: Respiratory syncytial virus (RSV) is a major cause of lower respiratory tract infections (LRTIs) in infants. Maternal RSV vaccination is a preventive strategy of great interest, as it could have a substantial impact on infant RSV disease burden. In recent years, the clinical development of maternal RSV vaccines has advanced rapidly.

Machine learning-based models to predict the conversion of normal blood pressure to hypertension within 5-year follow-up.

Background: Factors contributing to the development of hypertension exhibit significant variations across countries and regions. Our objective was to predict individuals at risk of developing hypertension within a 5-year period in a rural Middle Eastern area.

Methods: This longitudinal study utilized data from the Fasa Adults Cohort Study (FACS).

Machine-learning algorithms in screening for type 2 diabetes mellitus: Data from Fasa Adults Cohort Study.

Introduction: The application of machine learning (ML) is increasingly growing in biomedical sciences. This study aimed to evaluate factors associated with type 2 diabetes mellitus (T2DM) and compare the performance of ML methods in identifying individuals with the disease in an Iranian setting.

Methods: Using the baseline data from Fasa Adult Cohort Study (FACS) and in a sex-stratified manner, we studied factors associated with T2DM by applying seven different ML methods including Logistic Regression (LR), Support Vector Machine (SVM), Random Forest (RF), K-Nearest Neighbours (KNN), Gradient Boosting Machine (GBM), Extreme Gradient Boosting (XGB) and Bagging classifier (BAG).

Are maternal vaccines effective and safe for mothers and infants? A systematic review and meta-analysis of randomised controlled trials.

Introduction: Maternal vaccination is a promising strategy to reduce the burden of vaccine-preventable diseases for mothers and infants. We aimed to provide an up-to-date overview of the efficacy and safety of all available maternal vaccines.

Methods: We searched PubMed, Embase, CENTRAL and ClinicalTrials.

Statin Use and Coronary Artery Calcification: a Systematic Review and Meta-analysis of Observational Studies and Randomized Controlled Trials.

Purpose Of Review: This review aimed to determine the association between statin use and coronary artery calcification (CAC), as detected by computed tomography in the general population, in previously published observational studies (OSs) and randomized controlled trials (RCTs).

Recent Findings: A systematic search until February 2022 identified 41 relevant studies, comprising 29 OSs and 12 RCTs. We employed six meta-analysis models, stratifying studies based on design and effect metrics.

Gene-environment interactions and the effect on obesity risk in low and middle-income countries: a scoping review.

Background: Obesity represents a major and preventable global health challenge as a complex disease and a modifiable risk factor for developing other non-communicable diseases. In recent years, obesity prevalence has risen more rapidly in low- and middle-income countries (LMICs) compared to high-income countries (HICs). Obesity traits are shown to be modulated by an interplay of genetic and environmental factors such as unhealthy diet and physical inactivity in studies from HICs focused on populations of European descent; however, genetic heterogeneity and environmental differences prevent the generalisation of study results to LMICs.

Bi-Directional Interactions between Glucose-Lowering Medications and Gut Microbiome in Patients with Type 2 Diabetes Mellitus: A Systematic Review.

: Although common drugs for treating type 2 diabetes (T2D) are widely used, their therapeutic effects vary greatly. The interaction between the gut microbiome and glucose-lowering drugs is one of the main contributors to the variability in T2D progression and response to therapy. On the one hand, glucose-lowering drugs can alter gut microbiome components.

Exploring Metabolomic Patterns in Type 2 Diabetes Mellitus and Response to Glucose-Lowering Medications-Review.

The spectrum of information related to precision medicine in diabetes generally includes clinical data, genetics, and omics-based biomarkers that can guide personalized decisions on diabetes care. Given the remarkable progress in patient risk characterization, there is particular interest in using molecular biomarkers to guide diabetes management. Metabolomics is an emerging molecular approach that helps better understand the etiology and promises the identification of novel biomarkers for complex diseases.

The healthy beverage index is not associated with insulin resistance, prediabetes and type 2 diabetes risk in the Rotterdam Study.

Purpose: Whether beverage quality affects changes in glycaemic traits and type 2 diabetes (T2D) risk is unknown. We examined associations of a previously developed Healthy Beverage Index (HBI) with insulin resistance, and risk of prediabetes and T2D.

Methods: We included 6769 participants (59% female, 62.

COVID-19 Vaccine Safety Monitoring Studies in Low- and Middle-Income Countries (LMICs)-A Systematic Review of Study Designs and Methods.

Background: Post-marketing vaccine safety surveillance aims to monitor and quantify adverse events following immunization in a population, but little is known about their implementation in low- and middle-income countries (LMICs). We aimed to synthesize methodological approaches used to assess adverse events following COVID-19 vaccination in LMICs.

Methods: For this systematic review, we searched articles published from 1 December 2019 to 18 February 2022 in main databases, including MEDLINE and Embase.

: outbreak fungal pathogen in COVID-19 pandemic: a systematic review and meta-analysis.

Background And Objectives: is the first fungal pathogen considered a global health threat. Because, is associated with multidrug resistance and associated diseases such as diabetes, sepsis, lung and kidney disease. This study investigated the prevalence and mortality of infection during Covid-19 pandemic.

Safety of COVID-19 Vaccines Among the Paediatric Population: Analysis of the European Surveillance Systems and Pivotal Clinical Trials.

Background And Objectives: The European Medicine Agency extended the use of Comirnaty, Spikevax, and Nuvaxovid in paediatrics; thus, these vaccines require additional real-world safety evidence. Herein, we aimed to monitor the safety of COVID-19 vaccines through Covid-19 Vaccine Monitor (CVM) and EudraVigilance surveillance systems and the published pivotal clinical trials.

Methods: In a prospective cohort of vaccinees aged between 5 and 17 years, we measured the frequency of commonly reported (local/systemic solicited) and serious adverse drug events (ADRs) following the first and second doses of COVID-19 vaccines in Europe using data from the CVM cohort until April 2022.