Effect of sitagliptin on cardiovascular outcomes in type 2 diabetes

BACKGROUND: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease. METHODS: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients. To determine whether sitagliptin was noninferior to placebo, we used a relative risk of 1.3 as the marginal upper boundary. The primary cardiovascular outcome was a composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina. RESULTS: During a median follow-up of 3.0 years, there was a small difference in glycated hemoglobin levels (least-squares mean difference for sitagliptin vs. placebo, -0.29 percentage points; 95% confidence interval [CI], -0.32 to -0.27). Overall, the primary outcome occurred in 839 patients in the sitagliptin group (11.4%; 4.06 per 100 person-years) and 851 patients in the placebo group (11.6%; 4.17 per 100 person-years). Sitagliptin was noninferior to placebo for the primary composite cardiovascular outcome (hazard ratio, 0.98; 95% CI, 0.88 to 1.09; P<0.001). Rates of hospitalization for heart failure did not differ between the two groups (hazard ratio, 1.00; 95% CI, 0.83 to 1.20; P = 0.98). There were no significant between-group differences in rates of acute pancreatitis (P = 0.07) or pancreatic cancer (P = 0.32). CONCLUSIONS: Among patients with type 2 diabetes and established cardiovascular disease, adding sitagliptin to usual care did not appear to increase the risk of major adverse cardiovascular events, hospitalization for heart failure, or other adverse events

Effects of Once-Weekly Exenatide on Cardiovascular Outcomes in Type 2 Diabetes.

Abstract BACKGROUND: The cardiovascular effects of adding once-weekly treatment with exenatide to usual care in patients with type 2 diabetes are unknown. METHODS: We randomly assigned patients with type 2 diabetes, with or without previous cardiovascular disease, to receive subcutaneous injections of extended-release exenatide at a dose of 2 mg or matching placebo once weekly. The primary composite outcome was the first occurrence of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. The coprimary hypotheses were that exenatide, administered once weekly, would be noninferior to placebo with respect to safety and superior to placebo with respect to efficacy. RESULTS: In all, 14,752 patients (of whom 10,782 [73.1%] had previous cardiovascular disease) were followed for a median of 3.2 years (interquartile range, 2.2 to 4.4). A primary composite outcome event occurred in 839 of 7356 patients (11.4%; 3.7 events per 100 person-years) in the exenatide group and in 905 of 7396 patients (12.2%; 4.0 events per 100 person-years) in the placebo group (hazard ratio, 0.91; 95% confidence interval [CI], 0.83 to 1.00), with the intention-to-treat analysis indicating that exenatide, administered once weekly, was noninferior to placebo with respect to safety (P<0.001 for noninferiority) but was not superior to placebo with respect to efficacy (P=0.06 for superiority). The rates of death from cardiovascular causes, fatal or nonfatal myocardial infarction, fatal or nonfatal stroke, hospitalization for heart failure, and hospitalization for acute coronary syndrome, and the incidence of acute pancreatitis, pancreatic cancer, medullary thyroid carcinoma, and serious adverse events did not differ significantly between the two groups. CONCLUSIONS: Among patients with type 2 diabetes with or without previous cardiovascular disease, the incidence of major adverse cardiovascular events did not differ significantly between patients who received exenatide and those who received placebo. (Funded by Amylin Pharmaceuticals; EXSCEL ClinicalTrials.gov number, NCT01144338 .)

Absorpcja pary wodnej tkanin frotowych z przędz lnianych i konopnych w okrywie pętelkowej

A textile material’s ability to pass water vapour greatly affects the comfort of the wearer. Terry fabrics are characterised by their high absorption ability acquired by an increased absorbing surface of the pile structure. In this study we set out to elucidate the effects of textile structure and finishing technology on the vapour absorption of material. This paper presents an experimental investigation of the water vapour absorption of linen/cotton and hemp/cotton terry woven fabrics with respect to pile height and finishing procedures. The terry textiles used in the experimental work were made with a pile height of 6, 9, and 12 mm. The research demonstrated that the character of the water vapour absorption of terry woven fabrics depends on the fabric structure and finishing applied. It was found that various finishing operations such as washing in water, washing with detergent and softening as well as washing with detergent, softening, and tumbling processes had an influence on the water vapour absorption of terry fabrics. The uniformity of dispersions was proved for the variants investigated. High informativity of the experiment was found by analysing the data of water vapour absorption of tumbled linen/cotton terry fabric with a 12 mm pile height. The polynomial regression showed a match with experimental data with a regression of R2 = 0.7687. From this empiric model, the effect of the tumbling period can be understood.Zdolność materiałów włókienniczych do przepuszczania pary wodnej w znacznym stopniu wpływa na komfort noszenia. Tkaniny frotowe charakteryzują się wysoką zdolnością pochłaniania dzięki zwiększonej powierzchni absorbującej. W pracy przedstawiono wpływ struktury tkanin i obróbki wykańczającej na wchłanianie pary wodnej przez materiał tkaniny. Badania absorpcji pary wodnej przeprowadzono na tkaninach frotowych lnianobawełnianych i konopno-bawełnianych uwzględniając wysokość pętelki okrywy (6, 9 i 12 mm) i procedury wykańczania. Badania wykazały, że na absorpcję pary wodnej tkanin frotowych miały wpływ różne procesy wykańczania, takie jak: kąpiel w wodzie, kąpiel z detergentem i zmiękczaczem oraz kąpiel z detergentem i zmiękczaczem z zastosowaniem procesu bębnowania. Wykazano jednorodność dyspersji dla badanych wariantów. Regresja wielomianowa wykazała zgodność wyników eksperymentalnych ze współczynnikiem regresji R2 = 0,7687

Badanie odporności tkanin wykonanych z ramii i lnu na wyciąganie okrywy

The paper presents an investigation of the resistance to pile loop extraction of terry fabrics in relation to the pile height, impacts/finishing, and weft density. Terry fabrics analysed in the experimental work were made from linen/cotton or ramie/cotton yarns. The pile height of the fabrics was 6 and 12 mm, and the weft density varied from 80 to 200 dm-1. The samples were affected by impacts or finishing operations. Grey fabrics were also investigated. Analysing a 10 mm pulling distance, the highest resistance to pile loop extraction of grey terry fabrics (1064.2 mN) was determined for linen/cotton fabric with a 6 mm loop pile. It was found that an increase in the weft density of ramie/cotton terry fabrics from 80 to 160 dm-1 led to an increase in the resistance to pile loop extraction for all pulling distances investigated but with a different intensity: for a 5 mm pulling distance the difference was 3.2 times, and for a 25 mm pulling distance it was in 2.1 times. The decrease in the resistance to pile loop extraction of 18.6 - 38.0% of industrially finished and tumbled linen/cotton fabrics compared with grey ones was determined at a 10 mm pulling distance. The changes in the resistance to pile loop extraction in relation to the tumbling period were not statistically significant.Badano odporność na wyciąganie pętli okrywy tkanin frotowych w zależności od długości okrywy, sposobu wykańczania i gęstości wątku. Tkaniny frotowe zastosowane w eksperymencie wykonano z mieszanek len/bawełna oraz ramia/bawełna. Badano tkaniny o wysokości okrywy 6 i 12 mm oraz gęstości wątku od 80 - 200 dm-1. Próbki badano surowe oraz poddano działaniu rożnych procesów wykańczających

The effectiveness of a community-based, type 2 diabetes prevention programme on healthrelated quality of life. The DE-PLAN study

Background and aims The DE-PLAN was a European multicenter study, with the primary objective of testing whether a community-based lifestyle modification programme could serve as a means of primary prevention for type 2 diabetes (T2D) in high-risk individuals (based on the FINDRISC questionnaire). The aim of this study was to examine the impact of a 1-year community- based lifestyle intervention on health-related quality of life (HRQOL) in individuals from four participating European centers (Athens, Barcelona, Krakow, Kaunas), through a posthoc analysis. Materials and methods Each center was allowed to implement different intervention strategies specifically tailored to the needs of their corresponding population sample. Before and after the intervention, participants underwent clinical evaluation, anthropometric measurements, an oral glucose tolerance test and lipid profile measurements. Health-related quality of life was assessed using the validated HRQOL-15D questionnaire. A difference of ±0.015 in the 15D questionnaire score was set as the threshold of clinically meaningful change. Results Data from 786 participants (67% females, mean age 59.7±9.4 years, BMI 31.5±4.5 kg/m2) with complete data regarding the HRQOL were analyzed (Athens: 104, Barcelona: 434, Krakow: 175, Kaunas: 70). After 1 year, a significant overall improvement in HRQOL was shown, as depicted by a change of 15D score from baseline value (0.88±0.9) to post-intervention (0.90±0.87, P&lt;0.001), achieving the threshold of clinically meaningful change. A significant weight reduction was also observed (-0.8±4.0 kg, P&lt;0.001). In multivariate analysis, improvement in HRQOL was independently associated with lower 15D score at baseline (P&lt;0.001) and self-reported increase in overall exercise time (P&lt;0.001) as assessed through specifically designed trial questionnaires. Conclusion A community-based lifestyle intervention programme aiming at T2D prevention, applied on a heterogeneous population and with varied methods, was shown to improve overall healthrelated quality of life to a clinically meaningful degree. © 2019 Karamanakos et al. © 2019 by the authors. Licensee MDPI, Basel, Switzerland

Take Action to Prevent Diabetes – The IMAGE Toolkit for the Prevention of Type 2 Diabetes in Europe

When we ask people what they value most, health is usually top of the list. While effective care is available for many chronic diseases, the fact remains that for the patient, the tax payer and the whole of society: prevention is better than cure. Diabetes and its complications are a serious threat to the survival and well-being of an increasing number of people. It is predicted that one in ten Europeans aged 20-79 will have developed diabetes by 2030. Once a disease of old age, diabetes is now common among adults of all ages and is beginning to affect adolescents and even children. Diabetes accounts for up to 18 % of total healthcare expenditure in Europe. The good news is that diabetes is preventable. Compelling evidence shows that the onset of diabetes can be prevented or delayed greatly in individuals at high risk (people with impaired glucose regulation). Clinical research has shown a reduction in risk of developing diabetes of over 50 % following relatively modest changes in lifestyle that include adopting a healthy diet, increasing physical activity, and maintaining a healthy body weight. These results have since been reproduced in real-world prevention programmes. Even a delay of a few years in the progression to diabetes is expected to reduce diabetes-related complications, such as heart, kidney and eye disease and, consequently, to reduce the cost to society. A comprehensive approach to diabetes prevention should combine population based primary prevention with programmes targeted at those who are at high risk. This approach should take account of the local circumstances and diversity within modern society (e.g. social inequalities). The challenge goes beyond the healthcare system. We need to encourage collaboration across many different sectors: education providers, non-governmental organisations, the food industry, the media, urban planners and politicians all have a very important role to play. Small changes in lifestyle will bring big changes in health. Through joint efforts, more people will be reached. The time to act is now

Quality Indicators for the Prevention of Type 2 Diabetes in Europe – IMAGE

Pajunen P, Landgraf R, Muylle F, et al. Quality Indicators for the Prevention of Type 2 Diabetes in Europe – IMAGE. Hormone and Metabolic Research. 2010;42(S 01):S56-S63

A European Evidence-Based Guideline for the Prevention of Type 2 Diabetes

BACKGROUND: The prevalence and socioeconomic burden of type 2 diabetes (T2DM) and associated co-morbidities are rising worldwide. AIMS: This guideline provides evidence-based recommendations for preventing T2DM. METHODS: A European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria. RESULTS: Obesity and sedentary lifestyle are the main modifiable risk factors. Age and ethnicity are non-modifiable risk factors. Case-finding should follow a step-wise procedure using risk questionnaires and oral glucose tolerance testing. Persons with impaired glucose tolerance and/or fasting glucose are at high-risk and should be prioritized for intensive intervention. Interventions supporting lifestyle changes delay the onset of T2DM in high-risk adults (number-needed-to-treat: 6.4 over 1.8-4.6 years). These should be supported by inter-sectoral strategies that create health promoting environments. Sustained body weight reduction by >or= 5 % lowers risk. Currently metformin, acarbose and orlistat can be considered as second-line prevention options. The population approach should use organized measures to raise awareness and change lifestyle with specific approaches for adolescents, minorities and disadvantaged people. Interventions promoting lifestyle changes are more effective if they target both diet and physical activity, mobilize social support, involve the planned use of established behaviour change techniques, and provide frequent contacts. Cost-effectiveness analysis should take a societal perspective. CONCLUSIONS: Prevention using lifestyle modifications in high-risk individuals is cost-effective and should be embedded in evaluated models of care. Effective prevention plans are predicated upon sustained government initiatives comprising advocacy, community support, fiscal and legislative changes, private sector engagement and continuous media communication

A European evidence-based guideline for the prevention of type 2 diabetes

Background: The prevalence and socioeconomic burden of type 2 diabetes (T2DM) and associated co-morbidities are rising worldwide. Aims: This guideline provides evidence-based recommendations for preventing T2DM. Methods: A European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria. Results: Obesity and sedentary lifestyle are the main modifiable risk factors. Age and ethnicity are non-modifiable risk factors. Case-finding should follow a step-wise procedure using risk questionnaires and oral glucose tolerance testing. Persons with impaired glucose tolerance and/or fasting glucose are at high-risk and should be prioritized for intensive intervention. Interventions supporting lifestyle changes delay the onset of T2DM in high-risk adults (number-needed-to-treat: 6.4 over 1.84.6 years). These should be supported by inter-sectoral strategies that create health promoting environments. Sustained body weight reduction by 5% lowers risk. Currently metformin, acarbose and orlistat can be considered as second-line prevention options. The population approach should use organized measures to raise awareness and change lifestyle with specific approaches for adolescents, minorities and disadvantaged people. Interventions promoting lifestyle changes are more effective if they target both diet and physical activity, mobilize social support, involve the planned use of established behaviour change techniques, and provide frequent contacts. Cost-effectiveness analysis should take a societal perspective. Conclusions: Prevention using lifestyle modifications in high-risk individuals is cost-effective and should be embedded in evaluated models of care. Effective prevention plans are predicated upon sustained government initiatives comprising advocacy, community support, fiscal and legislative changes, private sector engagement and continuous media communication. © Georg Thieme Verlag KG Stuttgart - New York