Proinflammatory cytokines in acute myocardial infarction with and without cardiogenic shock

Background: Inflammatory response is an important feature of acute coronary syndromes and myocardial infarction (MI). The prognostic value of proinflammatory cytokines in patients with acute MI complicated by cardiogenic shock is unknown. Methods and results: In 41 patients admitted with acute MI (age 60 ± 11 years, six females, 19 Killip class IV) serial plasma concentration of tumor necrosis factor alpha (TNF-α), interleukin 6 (IL-6) and interleukin 1 receptor antagonist (IL-1Ra) were measured. Seven patients with cardiogenic shock (CS) developed a systemic inflammatory response syndrome (SIRS). Patients with CS—particularly those who developed SIRS—showed significantly higher cytokine levels than patients with uncomplicated MI. In patients with CS and SIRS peak levels of IL-1Ra were 223,973 pg/ml, IL-6 252.8 pg/ml and TNF-α 7.0 pg/ml. In CS without SIRS IL-1Ra levels were 19,988 pg/ml, IL-6 109.3 pg/ml and TNF-α 3.8 pg/ml. In uncomplicated MI peak IL-1Ra levels were 1,088 pg/ml, IL-6 34.1 pg/ml and TNF-α 2.6 pg/ml. Conclusions: The inflammation-associated cytokines TNF-α, IL-6 and IL-1Ra are significantly elevated in patients with MI complicated by CS when compared to patients with uncomplicated MI. Among shock-patients IL-1Ra levels are promising diagnostic markers for early identification of patients developing SIRS, heralding a poor outcom

Effect of antimicrobial stewardship on antimicrobial prescriptions for selected diseases of dogs in Switzerland.

BACKGROUND Antimicrobial stewardship programs (ASPs) are important tools to foster prudent antimicrobial use. OBJECTIVE To evaluate antimicrobial prescriptions by Swiss veterinarians before and after introduction of the online ASP AntibioticScout.ch in December 2016. ANIMALS Dogs presented to 2 university hospitals and 14 private practices in 2016 or 2018 for acute diarrhea (AD; n = 779), urinary tract infection (UTI; n = 505), respiratory tract infection (RTI; n = 580), or wound infection (WI; n = 341). METHODS Retrospective study. Prescriptions of antimicrobials in 2016 and 2018 were compared and their appropriateness assessed by a justification score. RESULTS The proportion of dogs prescribed antimicrobials decreased significantly between 2016 and 2018 (74% vs 59%; P < .001). The proportion of prescriptions in complete agreement with guidelines increased significantly (48% vs 60%; P < .001) and those in complete disagreement significantly decreased (38% vs 24%; P < .001) during this time. Antimicrobial prescriptions for dogs with AD were significantly correlated with the presence of hemorrhagic diarrhea in both years, but a significantly lower proportion of dogs with hemorrhagic diarrhea were unnecessarily prescribed antimicrobials in 2018 (65% vs 36%; P < .001). In private practices, in 2018 a bacterial etiology of UTI was confirmed in 16% of dogs. Prescriptions for fluoroquinolones significantly decreased (29% vs 14%; P = .002). Prescriptions for antimicrobials decreased significantly in private practices for RTI (54% vs 31%; P < .001). CONCLUSION Antimicrobials were used more prudently for the examined indications in 2018 compared to 2016. The study highlights the continued need for ASPs in veterinary medicine

Risks and benefits of optimised medical and revascularisation therapy in elderly patients with angina - on-treatment analysis of the TIME trial

Aim To assess treatment effects of optimised medical therapy and PCI or CABG surgery on one-year outcome in patients ⩾75 years old with chronic angina. Methods and Results On-treatment analysis of the TIME data: all re-vascularised patients (REVASC \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $n=174$ \end{document}: 112 randomised to revascularisation and 62 to drugs with late revascularisation) were compared to all patients on continued drug therapy (MED \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $n=127$ \end{document}: 86 randomised to drugs and 41 to revascularisation only). Baseline characteristics of both groups were similar (age 80±4 years). Risk of death at one year (adjusted hazard ratio (HR)=1.31; 95%-CI: 0.58-2.99; \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $P=0.52$ \end{document}) and of death/infarction (adjusted hazard ratio=1.77; 95%-CI 0.91-3.41; \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $P=0.09$ \end{document}) were comparable between REVASC and MED patients. Furthermore, the risk of death within 30 days was even slightly lower among REVASC patients (unadjusted hazard ratio=0.73; 95%-CI: 0.21-2.53; \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $P=0.98)$ \end{document}. Overall, REVASC patients had greater improvements in symptoms and well-being than MED patients \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $(P{<}0.01)$ \end{document}. Surgical patients had similar mortality rates as angioplasty patients, but they also had greater symptomatic improvements \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} $(P{<}0.01)$ \end{document}. Conclusion Treated medically, elderly patients with chronic angina have a similarly high 30-day and one-year mortality as patients of the same age being re-vascularised; however, they can expect lower improvements in symptoms and well bein

Annual post-market environmental monitoring (PMEM) report on the cultivation of genetically modified maize MON 810 in 2014 from Monsanto Europe S.A.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) assessed the annual post-market environmental monitoring (PMEM) report for the 2014 growing season of maize MON 810 provided by Monsanto Europe S.A. The GMO Panel concludes that the insect resistance monitoring data do not indicate a decrease in susceptibility of field Iberian populations of corn borers to the Cry1Ab protein over the 2014 season. However, as the methodology for insect resistance monitoring remained unchanged compared to previous PMEM reports, the GMO Panel reiterates its previous recommendations for improvement of the insect resistance management plan. The GMO Panel considers that the farmer alert system to report complaints regarding product performance could complement the information obtained from the laboratory bioassays, but encourages the consent holder to provide more information in order to be in a position to appraise its usefulness. The data on general surveillance activities do not indicate any unanticipated adverse effects on human and animal health or the environment arising from the cultivation of maize MON 810 cultivation in 2014. The GMO Panel reiterates its previous recommendations to improve the methodology for the analysis of farmer questionnaires and conduct of the literature review in future annual PMEM reports on maize MON 810. The GMO Panel urges the consent holder to consider how to make best use of the information recorded in national registers to optimise sampling for farmer questionnaires, and requests to continue reviewing and discussing relevant scientific publications on possible adverse effects of maize MON 810 on rove beetles. Also, the GMO Panel encourages relevant parties to continue developing a methodological framework to use existing networks in the broader context of environmental monitorin

Risk assessment of new sequencing data on GM maize event MIR604

In 2009 and 2010, the EFSA GMO Panel concluded the assessment of genetically modified (GM) maizes MIR604, MIR604 × GA21, MIR604 × Bt11 and MIR604 × GA21 × Bt11. These maizes were found to be as safe as their conventional counterparts and other appropriate comparators with respect to potential effects on human and animal health and the environment. On 23 July 2015, the European Commission (EC) received from Syngenta new nucleic acid sequencing data on maize event MIR604 and updated bioinformatic analyses using the new sequencing data. EC tasked EFSA to analyse these data and to indicate whether the previous conclusions of the EFSA GMO Panel on the above-listed GM maizes remain valid. The EFSA GMO Panel used the appropriate principles described in its guidelines for the risk assessment of GM plants to analyse the received data. The new sequencing data indicated a single base pair difference compared to the sequencing data originally provided, located in a non-coding region of the insert. which had already been present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence did not give rise to safety issues. Therefore, the GMO Panel concludes that the original risk assessment of event MIR604 as a single and as a part of stacked events remains valid

Scientific Opinion on application EFSA‐GMO‐BE‐2013‐117 for authorisation of genetically modified maize MON 87427 × MON 89034 × NK603 and subcombinations independently of their origin, for food and feed uses, import and processing submitted under Regulation (EC) No 1829/2003 by Monsanto Company

Scientific opinionRequestor: Competent Authority of BelgiumQuestion number: EFSA-Q-2013-00765In this opinion, the EFSA Panel on Genetically Modified Organisms (GMO Panel) assessed the three-event stack maize MON 87427 9 MON 89034 9 NK603 and its three subcombinations, independently of their origin. The GMO Panel has previously assessed the three single events combined to produce this three-event stack maize and did not identify safety concerns. No new data on the single events, leading to modification of the original conclusions on their safety, were identified. Based on the molecular, agronomic, phenotypic and compositional characteristics, the combination of the single maize events and of the newly expressed proteins in the three-event stack maize did not give rise to issues regarding food and feed safety or nutrition. In the case of accidental release of viable grains of maize MON 87427 9 MON 89034 9 NK603 into the environment, the three-event stack maize would not raise environmental safety concerns. The GMO Panel concludes that the threeevent stack maize is as safe and as nutritious as the non-GM comparator and the tested non-GM reference varieties in the context of its scope. The GMO Panel considered that its previous conclusions on the two-event stack maize MON 89034 9 NK603 remain valid. For the two maize subcombinations for which no experimental data were provided the GMO Panel assessed the likelihood of interactions among the single events, and concluded that their combination would not raise safety concerns. These two subcombinations are therefore expected to be as safe as the single events, the previously assessed maize MON 89034 9 NK603 and maize MON 87427 9 MON 89034 9 NK603. Since the post-market environmental monitoring plan for the three-event stack maize does not include any provisions for the two subcombinations not previously assessed, the GMO Panel recommended the applicant to revise the plan accordingly

Technical Note on the quality of DNA sequencing for the molecular characterisation of genetically modified plants

As part of the risk assessment (RA) requirements for genetically modified (GM) plants, according to Regulation (EU) No 503/2013 and the EFSA guidance on the RA of food and feed from GM plants (EFSA GMO Panel, 2011), applicants need to perform a molecular characterisation of the DNA sequences inserted in the GM plant genome. The European Commission has mandated EFSA to develop a technical note to the applicants on, and checking of, the quality of the methodology, analysis and reporting covering complete sequencing of the insert and flanking regions, insertion site analysis of the GM event, and generational stability and integrity. This Technical Note puts together requirements and recommendations for when DNA sequencing is part of the molecular characterisation of GM plants, in particular for the characterisation of the inserted genetic material at each insertion site and flanking regions, the determination of the copy number of all detectable inserts, and the analysis of the genetic stability of the inserts, when addressed by Sanger sequencing or NGS. This document reflects the current knowledge in scientific‐technical methods for generating and verifying, in a standardised manner, DNA sequencing data in the context of RA of GM plants. From 1 October 2018, this Technical Note will replace the JRC guideline of 2016 (updated April 2017) related to the verification and quality assessment of the sequencing of the insert(s) and flanking regions. It does not take into consideration the verification and validation of the detection method which remains under the remit of the JRC

Assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA‐GMO‐NL‐2014‐121)

Soybean MON87751 was developed through Agrobacterium tumefaciens-mediated transformation to provide protection certain specific lepidopteran pests by the expression of the Cry1A.105 and Cry2Ab2 proteins derived from Bacillus thuringiensis. The molecular characterisation data and bioinformatic analyses did not identify issues requiring assessment for food and feed safety. None of the compositional, agronomic and phenotypic differences identified between soybean MON87751 and the conventional counterpart required further assessment. The GMO Paneldid not identify safety concerns regarding the toxicity and allergenicity of the Cry1A.105 and Cry2Ab2 proteins as expressed in soybean MON87751, and found no evidence that the genetic modification might significantly change the overall allergenicity of soybean MON87751. The nutritional impact of soybean MON87751-derived food and feed is expected to be the same as those derived from the conventional counterpart and non-GM commercial reference varieties. The GMO Panelconcludes that soybean MON87751, as described in this application, is nutritionally equivalent to and as safe as the conventional counterpart and the non-GM soybean reference varieties tested, and no post-market monitoring of food and feed is considered necessary. In the case of accidental release of viable soybean MON87751 seeds into the environment, soybean MON87751 would not raise environmental safety concerns. The post-market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean MON87751. In conclusion, soybean MON87751, as described in this application, is as safe as its conventional counterpart and the tested non-GM soybean reference varieties with respect to potential effects on human and animal health and the environment

Guidance for the risk assessment of the presence at low level of genetically modified plant material in imported food and feed under Regulation (EC) No 1829/2003

This document provides guidance for the risk assessment under Regulation (EC) No1829/2003 of the unintended, adventitious or technically unavoidable presence in food and feed of low level of genetically modified plant material intended for markets other than in the European Union. In this context, the presence at low level is defined to be maximum 0.9% of genetically modified plant material per ingredient. This guidance is intended to assist applicants by indicating which scientific requirements of AnnexII of Regulation (EU) No503/2013 are considered necessary for the risk assessment of the presence at low levels of genetically modified plant material in food and feed. (C) 2017 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority