The enhanced national pharmacovigilance system implemented for COVID-19 vaccines in France: A 2-year experience report.

In March 2020, World Health Organization recognized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emergence as a public health emergency of international concern. One of the major preventative measures developed against coronavirus disease 2019 (COVID-19) was vaccines. To monitor their use and safety of vaccines from the first utilization in humans during clinical development phases to implementation for the general population, an enhanced national pharmacovigilance system was enabled by the French National Agency for Medicines and Health Products Safety in collaboration with the 30 Regional Pharmacovigilance Centres.

Six-year follow-up of phase II study exploring chemo-free treatment association with idelalisib and obinutuzumab in symptomatic relapsed/ refractory patients with Waldenström's macroglobulinemia.

We present the 6-year update of a phase 2 study evaluating the combination of obinutuzumab and idelalisib in relapse/refractory Waldenstrom macroglobulinemia. The results of the REMODEL trial demonstrated interesting efficacy in a high-risk genotype profile population. The primary endpoint was achieved with a median PFS of 25.

Fibroblast-derived extracellular vesicles contain SFRP1 and mediate pulmonary fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a lethal chronic lung disease characterized by aberrant intercellular communication, extracellular matrix deposition, and destruction of functional lung tissue. While extracellular vesicles (EVs) accumulate in the IPF lung, their cargo and biological effects remain unclear. We interrogated the proteome of EV and non-EV fractions during pulmonary fibrosis and characterized their contribution to fibrosis.

Teatime: epigallocatechin gallate targets fibroblast-epithelial cell crosstalk to combat lung fibrosis.

Epigallocatechin gallate (EGCG) is a polyphenol plant metabolite abundant in tea that has demonstrated antifibrotic properties in the lung. In this issue of the JCI, Cohen, Brumwell, and colleagues interrogated the mechanistic action of EGCG by investigating lung biopsies of patients with mild interstitial lung disease (ILD) who had undergone EGCG treatment. EGCG targeted the WNT inhibitor SFRP2, which was enriched in fibrotic fibroblasts and acted as a TGF-β target, with paracrine effects leading to pathologic basal metaplasia of alveolar epithelial type 2 cells.

Protein arginine methyltransferase 2 controls inflammatory signaling in acute myeloid leukemia.

Arginine methylation is catalyzed by protein arginine methyltransferases (PRMTs) and is involved in various cellular processes, including cancer development. PRMT2 expression is increased in several cancer types although its role in acute myeloid leukemia (AML) remains unknown. Here, we investigate the role of PRMT2 in a cohort of patients with AML, PRMT2 knockout AML cell lines as well as a Prmt2 knockout mouse model.

Profiles of patients referred to specialized palliative care from the cardiology department at a university hospital: an 11-year longitudinal retrospective study.

Background: Although the majority of patients with cardiovascular diseases (CVD) have a significant symptom burden and progressive course towards the end of life, only a small proportion of patients currently receive palliative care. The current referral practices to palliative care from the cardiology department need to be scrutinized. The current study aimed to examine: 1) the clinical profile; 2) time between referral to palliative care and death; and 3) place of death for CVD patients who were referred to palliative care from a cardiology department.

Home treatment versus early discharge for the outpatient management of acute pulmonary embolism: A non-interventional, post-hoc cohort analysis.

Introduction: We prospectively investigated whether home treatment of pulmonary embolism (PE), is as effective and safe as the recommended early discharge management in terms of outcomes at 3 months.

Methods: We performed a post hoc analysis of prospectively and consecutively recorded data in acute PE patients from a tertiary care facility between January 2012 and November 2021. Home treatment was defined as discharge to home directly from the emergency department (ED) after <24 h stay.

Extended Anticoagulation After Pulmonary Embolism: A Multicenter Observational Cohort Analysis.

Background Pulmonary embolism (PE) has a long-term risk of adverse events, which can be prevented by extended anticoagulation. We compared clinical characteristics and outcomes between patients treated with 2-year extended anticoagulation and those who were not, in a population who had completed an initial phase of 3 to 6 months of anticoagulant therapy after acute PE. Methods and Results Observational cohort analysis of patients with PE who survived an initial phase of 3 to 6 months anticoagulation.

Extracellular Lipids in the Lung and Their Role in Pulmonary Fibrosis.

Lipids are major actors and regulators of physiological processes within the lung. Initial research has described their critical role in tissue homeostasis and in orchestrating cellular communication to allow respiration. Over the past decades, a growing body of research has also emphasized how lipids and their metabolism may be altered, contributing to the development and progression of chronic lung diseases such as pulmonary fibrosis.

An Original Risk Score to Predict Early Major Bleeding in Acute Pulmonary Embolism: The Syncope, Anemia, Renal Dysfunction (PE-SARD) Bleeding Score.

Background: Improved prediction of the risk of early major bleeding in pulmonary embolism (PE) is needed to optimize acute management.

Research Question: Does a simple scoring system predict early major bleeding in acute PE patients, identifying patients with either high or low probability of early major bleeding?

Study Design And Methods: From a multicenter prospective registry including 2,754 patients, we performed post hoc multivariable logistic regression analysis to build a risk score to predict early (up to hospital discharge) major bleeding events. We validated the endpoint model internally, using bootstrapping in the derivation dataset by sampling with replacement for 500 iterations.

Lipid-lowering therapy and low-density lipoprotein cholesterol goal achievement in patients with acute coronary syndromes: The ACS patient pathway project.

Background And Aims: Post-acute coronary syndrome (ACS) patients are at very high risk for recurrent events and mortality, despite the availability of effective pharmacological approaches. Aim of this survey was to evaluate the compliance to ESC/EAS guidelines during the management of ACS patients and the effectiveness of secondary prevention in seven European countries.

Methods: By means of an online questionnaire, data on 2775 ACS patients (either acute case or follow-up patients) were collected, including data on lipid profile, medications, follow-up visit planning, screening for familial hypercholesterolemia.

Renal dysfunction improves risk stratification and may call for a change in the management of intermediate- and high-risk acute pulmonary embolism: results from a multicenter cohort study with external validation.

Background: Renal dysfunction influences outcomes after pulmonary embolism (PE). We aimed to determine the incremental value of adding renal dysfunction, defined by estimated glomerular filtration rate (eGFR), on top of the European Society of Cardiology (ESC) prognostic model, for the prediction of 30-day mortality in acute PE patients, which in turn could lead to the optimization of acute PE management.

Methods: We performed a multicenter, non-interventional retrospective post hoc analysis based on a prospectively collected cohort including consecutive confirmed acute PE stratified per ESC guidelines.

The burden of cholesterol accumulation through the lifespan: why pharmacological intervention should start earlier to go further?

Among the cardiovascular risk factors, cholesterol-rich atherogenic lipoproteins play a central role in the pathogenesis of atherosclerosis. In middle-aged adults, the size of the total atherosclerotic plaque burden is influenced by both the concentration of circulating atherogenic lipoproteins and the total duration of exposure to these lipoproteins. This review describes the evidence supporting a causal link between lifelong elevations in atherogenic lipoproteins and future risk of atherosclerosis; evidence strengthened by recent epidemiological, genetic, and clinical data.

Diagnostic Accuracy of Four Commercial Triplex Immunochromatographic Tests for Rapid Detection of Rotavirus, Adenovirus, and Norovirus in Human Stool Samples.

Noroviruses (NoV), rotaviruses (RVA), and adenoviruses (AdV) are the main viral agents responsible for acute gastroenteritis (AGE) in humans. We aimed to determine the diagnostic accuracy of four commercial immunochromatographic tests (ICTs) intended for the rapid and simultaneous detection of these three pathogens. Diagnostic accuracy of bioNexia Noro/Rota-Adeno (bioMérieux), Immunoquick NoRotAdeno (Biosynex), Rota+Adeno+Noro combo card (CerTest Biotec), and Rida Quick Rota/Adeno/Noro Combi (R-Biopharm) ICTs was assessed retrospectively using a collection of 160 stool specimens (including 43 RVA-, 47 AdV-, and 42 NoV-positive samples) from French patients with AGE and using molecular methods as the reference standard.

Pathogenesis of fibrosis in interstitial lung disease.

Purpose Of Review: Pulmonary fibrosis is a chronic and progressive lung disease involving unclear pathological mechanisms. The present review presents and discusses the major and recent advances in our knowledge of the pathogenesis of lung fibrosis.

Recent Findings: The past months have deepened our understanding on the cellular actors of fibrosis with a better characterization of the abnormal lung epithelial cells observed during lung fibrosis.

Enteral versus parenteral nutrition in the conservative treatment of upper gastrointestinal fistula after surgery: a multicenter, randomized, parallel-group, open-label, phase III study (NUTRILEAK study).

Background: Postoperative upper gastrointestinal fistula (PUGIF) is a devastating complication, leading to high mortality (reaching up to 80%), increased length of hospital stay, reduced health-related quality of life and increased health costs. Nutritional support is a key component of therapy in such cases, which is related to the high prevalence of malnutrition. In the prophylactic setting, enteral nutrition (EN) is associated with a shorter hospital stay, a lower incidence of severe infectious complications, lower severity of complications and decreased cost compared to total parenteral nutrition (TPN) following major upper gastrointestinal (GI) surgery.

Bilateral vocal cord paralysis after endoscopic placement of fully covered self-expandable metal stent for palliative treatment of malignant proximal esophageal obstruction: two case reports.

Background: Oesophageal stents have several well-known respiratory complications, including aspiration pneumonia, fistula and airway compression. However, bilateral vocal cord paralysis has rarely been described.

Methods: We describe two patients who presented with refractory dysphagia due to malignant proximal oesophageal strictures.

Outcomes of Patients With Advanced NSCLC From the Intergroupe Francophone de Cancérologie Thoracique Biomarkers France Study by Mutation Subtypes.

Introduction: mutations are detected in 20% to 30% of NSCLC. However, mutation subtypes may differently influence the outcome of patients with advanced NSCLC.

Methods: In the Biomarkers France study, 4894 mutations (26.

Association of body mass index and cardiotoxicity related to anthracyclines and trastuzumab in early breast cancer: French CANTO cohort study.

Background: In patients treated with cardiotoxic chemotherapies, the presence of cardiovascular risk factors and previous cardiac disease have been strongly correlated to the onset of cardiotoxicity. The influence of overweight and obesity as risk factors in the development of treatment-related cardiotoxicity in breast cancer (BC) was recently suggested. However, due to meta-analysis design, it was not possible to take into account associated cardiac risk factors or other classic risk factors for anthracycline (antineoplastic antibiotic) and trastuzumab (monoclonal antibody) cardiotoxicity.