515 research outputs found

    Efficacy and safety of alirocumab in insulin-treated patients with type 1 or type 2 diabetes and high cardiovascular risk:Rationale and design of the ODYSSEY DM-INSULIN trial

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    Aims: The coadministration of alirocumab, a PCSK9 inhibitor for treatment of hypercholesterolaemia, and insulin in diabetes mellitus (DM) requires further study. Described here is the rationale behind a phase-IIIb study designed to characterize the efficacy and safety of alirocumab in insulin-treated patients with type 1 (T1) or type 2 (T2) DM with hypercholesterolaemia and high cardiovascular (CV) risk. Methods: ODYSSEY DM-INSULIN (NCT02585778) is a randomized, double-blind, placebo-controlled, multicentre study that planned to enrol around 400 T2 and up to 100 T1 insulin-treated DM patients. Participants had low-density lipoprotein cholesterol (LDL-C) levels at screening. ≥. 70. mg/dL (1.81. mmol/L) with stable maximum tolerated statin therapy or were statin-intolerant, and taking (or not) other lipid-lowering therapy; they also had established CV disease or at least one additional CV risk factor. Eligible patients were randomized 2:1 to 24. weeks of alirocumab 75. mg every 2. weeks (Q2W) or a placebo. Alirocumab-treated patients with LDL-C. ≥. 70. mg/dL at week 8 underwent a blinded dose increase to 150. mg Q2W at week 12. Primary endpoints were the difference between treatment arms in percentage change of calculated LDL-C from baseline to week 24, and alirocumab safety. Results: This is an ongoing clinical trial, with 76 T1 and 441 T2 DM patients enrolled; results are expected in mid-2017. Conclusion: The ODYSSEY DM-INSULIN study will provide information on the efficacy and safety of alirocumab in insulin-treated individuals with T1 or T2 DM who are at high CV risk and have hypercholesterolaemia not adequately controlled by the maximum tolerated statin therapy

    Review of the Commission Decision 2010/477/EU concerning MSFD criteria for assessing Good Environmental Status, Descriptor 7

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    This report represents the result of the scientific and technical review of Commission Decision 2010/477/EU in relation to Descriptor 7. The review has been carried out by the EC JRC together with experts nominated by EU Member States, and has considered contributions from the GES Working Group in accordance with the roadmap set out in the MSFD implementation strategy (agreed on at the 11th CIS MSCG meeting). The report is one of a series of reports (review manuals) including Descriptor 1, 2, 5, 7, 8, 9, 10 that conclude phase 1 of the review process and, as agreed within the MSFD Common Implementation Strategy, are the basis for review phase 2, towards an eventual revision of the Commission Decision 2010/477/EU. The report presents the state of the technical discussions as of 30 April 2015 (document version 7.0: ComDecRev_D7_V7.0_FINAL.docx), as some discussions are ongoing, it does not contain agreed conclusions on all issues. The document does not represent an official, formal position of any of the Member States and the views expressed in the document are not to be taken as representing the views of the European Commission.JRC.H.1-Water Resource

    Identifying the anti-inflammatory response to lipid lowering therapy: a position paper from the working group on atherosclerosis and vascular biology of the European Society of Cardiology

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    Dysregulated lipid metabolism induces an inflammatory and immune response leading to atherosclerosis. Conversely, inflammation may alter lipid metabolism. Recent treatment strategies in secondary prevention of atherosclerosis support beneficial effects of both anti-inflammatory and lipid-lowering therapies beyond current targets. There is a controversy about the possibility that anti-inflammatory effects of lipid-lowering therapy may be either independent or not of a decrease in low-density lipoprotein cholesterol. In this Position Paper, we critically interpret and integrate the results obtained in both experimental and clinical studies on anti-inflammatory actions of lipid-lowering therapy and the mechanisms involved. We highlight that: (i) besides decreasing cholesterol through different mechanisms, most lipid-lowering therapies share anti-inflammatory and immunomodulatory properties, and the anti-inflammatory response to lipid-lowering may be relevant to predict the effect of treatment, (ii) using surrogates for both lipid metabolism and inflammation as biomarkers or vascular inflammation imaging in future studies may contribute to a better understanding of the relative importance of different mechanisms of action, and (iii) comparative studies of further lipid lowering, anti-inflammation and a combination of both are crucial to identify effects that are specific or shared for each treatment strategy

    No association between fear of hypoglycemia and blood glucose variability in type 1 diabetes: The cross-sectional VARDIA study

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    AIMS: In type 1 diabetes (T1D), treatment efficacy is limited by the unpredictability of blood glucose results and glycemic variability (GV). Fear of Hypoglycemia (FOH) remains a major brake for insulin treatment optimization. We aimed to assess the association of GV with FOH in participants with T1D in an observational cross-sectional study performed in 9 French Diabetes Centres (NCT02790060). METHODS: Participants were T1D for ≥5 years, aged 18-75 years, on stable insulin therapy for ≥3 months. The coefficient of variation (CV) of blood glucose and mean amplitude of glycemic excursions (MAGE) were used to assess GV from 7-point self-monitoring of blood glucose (SMBG). FOH was assessed using the validated French version of the Hypoglycemia Fear Survey-II (HFS-II) questionnaire. RESULTS: Among a total of 570 recruited participants, 298 were suitable for analysis: 46% women, 58% on continuous subcutaneous insulin infusion [CSII], mean age 49 ± 16 years, HbA1c 7.5 ± 0.9%, HFS-II score 67 ± 18 and 12% with recent history of severe hypoglycemia during the previous 6 months, mean CV 39.8 ± 9.7% and MAGE 119 ± 42 mg/dL. CV and MAGE did not significantly correlate with HFS-II score (R = -0.05;P = 0.457 and R = 0.08;P = 0.170). Participants with severe hypoglycemia in the previous 6 months had higher HFS scores. Participants with higher HFS scores presented more hypoglycemias during follow-up. CONCLUSIONS: FOH as determined using the HFS-II questionnaire was not associated with 7-point SMBG variability in participants with T1D, but was associated with a positive history of severe hypoglycemia. Higher FOH was associated with higher frequency of hypoglycemia during follow-up

    Telemonitoring Devices and Systems: Current Status and Future Trends

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    In the future, the number of elderly and chronically ill will be quite large. Additionally, pathologies will in many cases be in comorbidity. Alongside this reality, the health care resources will be insufficient for the population, thus the current research for solutions that can be fully implemented in the future. There are available several telemonitoring devices and systems for chronic diseases. Massive use of these devices will be essential to address the current and future lack of health system resources. Research on telemonitoring devices and systems for chronic diseases was con-ducted in academic and scientific databases. The technical specifications were collected in the manufacturers’ web page. The gathered data was analysed and compared in order to propose scenarios for the future trend of technical specifi-cations required in telemonitoring devices/system is performed. Telemonitoring for chronic diseases can bring great benefits to patient and health systems. Widening this practice will be a reality in the near future. This procedure will be fostered by the promotion and regulation of interoperability between de-vices/systems, as well as of front-end programs providing the link between health support systems. Interoperability issues are the main flaw of tedevicesring devices/systems on the market today.info:eu-repo/semantics/publishedVersio

    Telemonitoring Devices and Systems: Current Status and Future Trends

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    In the future, the number of elderly and chronically ill will be quite large. Additionally, pathologies will in many cases be in comorbidity. Along with this reality, the health care resources will be insufficient for the population, thus the current research for technological solutions needs to be implemented in the future. There are available several telemonitoring devices and systems for chronic diseases. Massive use of these devices will be essential to address the current and future lack of health system resources. Research on telemonitoring devices and systems for chronic diseases was conducted in academic and scientific databases. The technical specifications were collected from the manufacturers’ web page. The collected data was analysed and compared in order to propose scenarios for the future trend of technical specifications required in telemonitoring devices/system. Telemonitoring for chronic diseases can bring great benefits to patient and health systems. Widening this practice will be a reality in the near future. This procedure will be fostered by the promotion and regulation of interoperability between devices/systems, as well as of front-end programs providing the link between health support systems. Interoperability issues are the main flaws of telemonitoring devices/systems on the market today.info:eu-repo/semantics/publishedVersio
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