Assessment of cardiovascular risk of new drugs for the treatment of diabetes mellitus: risk assessment vs. risk aversion.
; ; et al
in European heart journal. Cardiovascular pharmacotherapy (2016), 2(3), 200-205
The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this ... [more ▼]
The Food and Drug Administration issued guidance for evaluating the cardiovascular risk of new diabetes mellitus drugs in 2008. Accumulating evidence from several completed trials conducted within this framework raises questions as to whether requiring safety outcome studies for all new diabetes mellitus therapies remains justified. Given the burden of cardiovascular disease in patients with diabetes, the focus should shift towards cardiovascular outcome studies designed to evaluate efficacy (i.e. to determine the efficacy of a drug over placebo or standard care) rather than demonstrating that risk is not increased by a pre-specified safety margin. All stakeholders are responsible for ensuring that new drug approvals occur under conditions of appropriate safety and effectiveness. It is also a shared responsibility to avoid unnecessary hurdles that may compromise access to useful drugs and threaten the sustainability of health systems. It is critical to renew this debate so that stakeholders can collectively determine the optimal approach for developing new drugs to treat type 2 diabetes mellitus. [less ▲]Detailed reference viewed: 5 (0 ULg)
Adherence to physical activity recommendations and its associated factors: an interregional population-based study
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in Journal of Public Health Research (2015), 4(1),
Background. Though the influence of physical activity in preventing cardiovascular diseases is well documented, only a few comparative studies have determined the degree of adherence to physical activity ... [more ▼]
Background. Though the influence of physical activity in preventing cardiovascular diseases is well documented, only a few comparative studies have determined the degree of adherence to physical activity recommendations among populations and identified the demographic, socioeconomic, behavioural and health-related factors associated with good compliance. Design and methods. Cross-sectional interregional NESCaV survey of 3133 subjects compared three populations, Luxembourg, Lorraine (France) and Wallonia (Belgium), by using the International Physical Activity Questionnaire. Age and gender prevalence rates of physical activity were standardized to the European population. Results. The likelihood to meet the recommendations was higher in Luxembourg, after adjustment for age, gender, education, employment, weight status, morbidity score, health perception and level of importance attributed to the practice of physical activity (P<0.0001). The odds for meeting the recommendations were significantly higher among those with secondary than tertiary education. Compared to good self-health perception, subjects with poor or fair self-perceived health were less likely to meet the recommendations; this also applied to those attributing little or enough importance to physical activity compared with great importance. Conclusions. Region, education, self-perceived health and perception of importance of physical activity were emerged as independent determinants of meeting the recommendations. Awareness of the positive health effects of physical activity might thus be crucial for motivating the people to become more active. Further research is needed to explore potential region-specific factors which might explain the difference in population behaviours with respect to physical activity. [less ▲]Detailed reference viewed: 14 (4 ULg)
2015 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: The Task Force for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death of the European Society of Cardiology (ESC)Endorsed by: Association for European Paediatric and Congenital Cardiology (AEPC).
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in European heart journal (2015), 36(41), 2793-867Detailed reference viewed: 27 (0 ULg)
ON THE RELATIONSHIP BETWEEN DIETARY PATTERNS AND CARDIOVASCULAR RISK FACTORS IN THE GREATER REGION POPULATION
Sauvageot, Nicolas ; ; et al
Conference (2013, October 25)
Abstract Background: The prevalence of chronic pathologies such as cardio-vascular diseases is increasing, in part due to dietary habits. Some dietary patterns may influence health more than individual ... [more ▼]
Abstract Background: The prevalence of chronic pathologies such as cardio-vascular diseases is increasing, in part due to dietary habits. Some dietary patterns may influence health more than individual foods, nutrients or food groups. The objective of this research was to identify dietary patterns associated with common cardiovascular risk factors (CVRF) in a sample of adult individuals living in the Greater Region. Methods: Data were taken from the cross-sectional NESCAV (Nutrition, Environment and Cardiovascular Health) study, aiming to describe the cardiovascular health of the Greater Region’s population (1). Dietary intake was assessed using a 132-item food frequency questionnaire (FFQ), from which 44 food groups were formed. Food group consumptions were adjusted for energy intake using the residuals method of Willet and Stampfer (2). Participants under a special diet to manage their CVRF were excluded. Likewise, those who had a history of cardiovascular disease or with confirmed diabetes, hypertension, and/or dyslipidemia were also discarded as they may have changed their diet. Thus, a total of 1691 individuals were included in the study (865 from Luxembourg, 527 from Wallonia and 299 from Lorraine). We applied the reduced rank regression method to identify specific dietary patterns strongly associated with common CVRF (3). The CVRF-specific dietary patterns were constructed by choosing intake data as predictors and CVRF as outcomes. Nine CVRF (BMI, waist to hip ratio, total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, blood glucose, diastolic and systolic blood pressure) were used in the statistical analysis. Associations between dietary patterns and CVRF were adjusted according to gender, age, smoking status and level of physical activity. Results: Two main dietary patterns were identified. A pattern characterized by high intakes of alcohol, potatoes and high-fat food such as pastries, fried foods, offal, processed and smoked meat, margarine, but low intakes of cereals, soups, soft drink and olive oil, was significantly associated with an increase of all CVRF. On the other hand, a healthy pattern characterized by high consumption of brown bread, nuts, soups, vegetables, smoked and canned fish, olive oil and oil rich in omega 6 and 3, high-fat dairy products, butter and margarine, but a low consumption of fried foods, rice/pasta, meat, ready meal, soft drink and beer, was associated with a decrease of all CVRF except LDL. Conclusions: Our results suggest that dietary patterns of the Greater Region population are related to CVRF. Diet rich in alcohol and high-fat food is associated with a higher cardiovascular risk whereas a healthy diet is associated with a lower cardiovascular risk. These results emphasize the need for cross-border preventive nutritional strategies. [less ▲]Detailed reference viewed: 39 (5 ULg)
2013 ESH/ESC Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Hypertension (ESH) and of the European Society of Cardiology (ESC).
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in European Heart Journal (2013)Detailed reference viewed: 146 (7 ULg)
Rapport d'activités final - « Nutrition, Environnement, et Santé Cardio-Vasculaire (NESCaV)»
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Report (2012)Detailed reference viewed: 4 (0 ULg)
ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.
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in European journal of heart failure (2012), 14(8), 803-69Detailed reference viewed: 55 (0 ULg)
ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC.
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in European Heart Journal (2012), 33(14), 1787-847Detailed reference viewed: 127 (4 ULg)
Nutrition, environment and cardiovascular health (NESCAV): protocol of an inter-regional cross-sectional study.
; Guillaume, Michèle ; et al
in BMC Public Health (2010), 10(1), 698
BACKGROUND: Despite the remarkable technological progress in health care and treatment, cardiovascular disease remains the leading cause of premature death, prolonged hospitalization and disability in ... [more ▼]
BACKGROUND: Despite the remarkable technological progress in health care and treatment, cardiovascular disease remains the leading cause of premature death, prolonged hospitalization and disability in most European countries. In the population of the Greater Region (Grand-Duchy of Luxembourg, Wallonia in Belgium, and Lorraine in France), the prevalence of cardiovascular risk factors and disease is among the highest in Europe, warranting the need for a better understanding of factors contributing to this pattern. In this context, the cross-border "Nutrition, Environment and Cardiovascular Health-NESCAV" project is initiated by an inter-regional multi-disciplinary consortium and supported by the INTERREG IV A program "Greater Region", 2007-2013, to fight synergically and harmoniously against this major public health problem. METHODS/DESIGN: The objectives of the three-year planned project are to assess, in a representative sample of 3000 randomly selected individuals living at the Greater Region, 1) the cardiovascular health and risk profile, 2) the association between the dietary habits and the cardiovascular risk, 3) the association of occupational and environmental pollution markers with the cardiovascular risk, 4) the knowledge, awareness and level of control of cardiovascular risk factors, 5) the potential gaps in the current primary prevention, and finally, to address evidence-based recommendations enabling the development of inter-regional guidance to help policy-makers and health care workers for the prevention of cardiovascular disease. DISCUSSION: The findings will provide tools that may enable the Greater Region's decision-makers and health professionals to implement targeted and cost-effective prevention strategies. [less ▲]Detailed reference viewed: 56 (22 ULg)
Rosuvastatin and cardiovascular events in patients undergoing hemodialysis
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in New England Journal of Medicine [=NEJM] (2009), 360
Background Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved ... [more ▼]
Background Statins reduce the incidence of cardiovascular events in patients at high cardiovascular risk. However, a benefit of statins in such patients who are undergoing hemodialysis has not been proved. Methods We conducted an international, multicenter, randomized, double-blind, prospective trial involving 2776 patients, 50 to 80 years of age, who were undergoing maintenance hemodialysis. We randomly assigned patients to receive rosuvastatin, 10 mg daily, or placebo. The combined primary end point was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. Secondary end points included death from all causes and individual cardiac and vascular events. Results After 3 months, the mean reduction in low-density lipoprotein (LDL) cholesterol levels was 43% in patients receiving rosuvastatin, from a mean baseline level of 100 mg per deciliter (2.6 mmol per liter). During a median follow-up period of 3.8 years, 396 patients in the rosuvastatin group and 408 patients in the placebo group reached the primary end point (9.2 and 9.5 events per 100 patient-years, respectively; hazard ratio for the combined end point in the rosuvastatin group vs. the placebo group, 0.96; 95% confidence interval [CI], 0.84 to 1.11; P = 0.59). Rosuvastatin had no effect on individual components of the primary end point. There was also no significant effect on all-cause mortality (13.5 vs. 14.0 events per 100 patient-years; hazard ratio, 0.96; 95% CI, 0.86 to 1.07; P = 0.51). Conclusions In patients undergoing hemodialysis, the initiation of treatment with rosuvastatin lowered the LDL cholesterol level but had no significant effect on the composite primary end point of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke. (ClinicalTrials.gov number, NCT00240331.) [less ▲]Detailed reference viewed: 19 (4 ULg)