The risk/benefit ratio of using statins for primary prevention of cardiovascular (CV) events in elderly people has not been established. The main objectives of the present study are to assess the ...cost-effectiveness of statin cessation and to examine the non-inferiority of statin cessation in terms of mortality in patients aged 75 years and over, treated with statins for primary prevention of CV events.
The "Statins in the elderly" (SITE) study is an ongoing 3-year follow-up, open-label comparative multi-centre, randomized clinical trial that is being conducted in two parallel groups in outpatient primary care offices. Participants meeting the following criteria are included: people aged 75 years and older being treated with statins as primary prevention for CV events, who provide informed consent. After randomization, patients in the statin-cessation strategy are instructed to withdraw their treatment. In the comparison strategy, patients continue their statin treatment at the usual dosage. The cost-effectiveness of the statin-cessation strategy compared to continuing statins will be estimated through the incremental cost per quality-adjusted life years (QALYs) gained at 36 months, from the perspective of the French healthcare system. Overall mortality will be the primary clinical endpoint. We assumed that the mortality rate at 3 years will be 15%. The sample size was computed to achieve 90% power in showing the non-inferiority of statin cessation, assuming a non-inferiority margin of 5% of the between-group difference in overall mortality. In total, the SITE study will include 2430 individuals.
There is some debate on the value of statins in people over 75 years old, especially for primary prevention of CV events, due to a lack of evidence of their efficacy in this population, potential compliance-related events, drug-drug interactions and side effects that could impair quality of life. Data from clinical trials guide the initiation of medication therapy for primary or secondary prevention of CV disease but do not define the timing, safety, or risks of discontinuing the agents. The SITE study is one of the first to examine whether treatment cessation is a cost-effective and a safe strategy in people of 75 years and over, formerly treated with statins.
ClinicalTrials.gov: NCT02547883. Registered on 11 September 2015.
Background
With the growing rate of childhood cancer cure and the risks of sequelae, long‐term follow‐up (FU) of survivors is a central issue. Several models have been proven far from satisfactory. ...Shared care FU is the result of collaboration between general practitioners (GPs) and cancer centers. We sought to demonstrate the feasibility of setting up a shared care program based on the patient‐centered education of GPs and to evaluate the impact of this model in an intervention study.
Methods
We compared the FU care achievement in two childhood cancer survivor cohorts in the same pediatric oncology center, (i) control group (n = 134) and (ii) intervention study cohort (n = 137), after setting up the program.
Results
The rate of survivors answering the survey and the rate of patients involved in FU by their GPs were higher in intervention study cohort than in baseline one (132/137 vs. 72/134 and 110/132 vs. 13/72; P ≤ 0.0001). The lack of any FU was definitely lower (10/132 vs. 18/72; P = 0.001) in the intervention study cohort.
Conclusion
In this shared care program, survivors overcame distrust in their GP's knowledge and entered the FU program after their GPs had been involved in patient‐centered education. Personalized and incentive‐based guidance was very useful in helping survivors to adhere to FU. Support of a dedicated long‐term FU team was very useful. A nationwide organization, consideration of special needs in subgroups of survivors and sustained funding are needed to adjust the program in the very long term.
Statins in primary prevention before 75 years old reduce cardiovascular events from 20 to 30% and mortality from 10% with acceptable side effects. We investigated whether these results persisted for ...patients aged 75 and older taking statin.
Methodic review of large randomized clinical trials and meta-analyzes that included patients 75 years and older treated with statins in primary prevention.
Since the 1990s, a score of randomized controlled trials studying statins versus placebo in primary prevention were published and studied in meta-analyses. Exclusion criteria, including persons older than 70 years, are often restrictive. The impact on all-cause mortality in the four main studies and meta-analyses in over 75 years has not been demonstrated. On the other hand, a recent meta-analyses of observational studies including subjects between 70 and 89 years treated with statins found that low total cholesterol was associated with a moderate decrease in cardiovascular mortality, with no decrease in all-cause mortality. Moreover, in a common context of comorbidities in this age group, statins may be responsible for many adverse effects, drug interactions and impaired quality of life.
Given the lack of formal evidence of effectiveness in terms of all-cause mortality and a high level of adverse effects, the benefit/risk of primary prevention with statins is not established in the elderly. The economic weight of statin prescriptions and their possible impact on quality of life justify an economic analysis of discontinuing statin therapy for people 75 years and older.
Contexte : Le portfolio est utilisé dans la formation et la validation du diplôme d’études spécialisées de médecine générale à l’Université de Bordeaux depuis 2004. L’appropriation de cet outil ...restait difficile pour les étudiants, ce qui a conduit le Département de médecine générale (DMG) à proposer une aide individuelle à l’écriture du premier script du portfolio en 2010. Objectif : Analyser l’usage de l’aide individuelle à l’écriture du premier script auprès des étudiants de première année de troisième cycle et des enseignants impliqués dans le dispositif. Méthode : enquête déclarative par questionnaires à l’attention des étudiants et des enseignants en 2012. Résultats : Le taux de réponse a été de 70 % chez les étudiants et de 44 % chez les enseignants. Soixante-douze pour cent des étudiants étaient intéressés par cette aide et 86 % d’entre eux avaient envoyé leur premier script à un enseignant désigné. Le temps de rétroaction avec les enseignants a été jugé insuffisant par 74 % des étudiants et 81 % souhaiteraient une aide complémentaire. Plus de 65 % trouvaient un intérêt à l’aide apportée mais 31 % se sentaient encore en difficulté au décours. Chez les enseignants, 88 % estimaient que l’aide était partiellement suffisante et que 12 % des étudiants étaient motivés. Conclusion : Le dispositif était perçu comme une bonne initiative mais l’adhésion restait dépendante du lien tissé entre l’étudiant et l’enseignant. Des modifications ont été apportées au dispositif. Le DMG a notamment mis en place un e-portfolio qui fera l’objet de prochaines études.
Background: The portfolio used at the University of Bordeaux since 2004 has a double purpose: the learning and the assessment of the postgraduate general medicine degree. Postgraduate students found it hard to suit the portfolio to their needs, which is why the teachers of the general practice department set up individual mentoring to help students draft the first script. Goal: To analyze the individual mentoring process among first-year postgraduate students and teachers involved in the project. Method: Declarative survey questionnaires filled in by the involved students and teachers. Results: The response rate for students was 70% and for teachers 44%. Some 72% of students were interested in the mentoring and 86% returned their first script to their appointed teacher. Some 74% of students felt that the time spent with teachers was inadequate and 81% would have liked further assistance. Over 65% found the assistance helpful, but 31% still felt uncomfortable with script writing after the mentoring. Some 88% of teachers felt that the one-time mentoring had been partly satisfactory and that 12% of students were motivated. Conclusion: The process was considered helpful but adherence depended on teacher-student relationship. The department has made some changes in the process and set up the ePortfolio, which will be the subject of future studies.
Les statines prescrites en prévention primaire avant 75ans permettent de réduire les évènements cardiovasculaires de 20 à 30 % et la mortalité de 10 % au prix d’effets indésirables acceptables. Nous ...avons cherché à savoir si ces résultats persistaient après 75ans.
Revue de la littérature des grands essais randomisés statines versus placebo et des méta-analyses ayant inclus des patients de 75ans et plus traités par statines en prévention primaire.
Depuis les années 1990, une vingtaine d’essais contrôlés randomisés étudiant les statines versus placebo en prévention primaire ont été publiés et étudiés dans des méta-analyses. Les critères d’exclusions, en particulier l’âge supérieur à 70ans, sont le plus souvent restrictifs. L’impact sur la mortalité toutes causes dans les quatre principales études et les méta-analyses chez les plus de 75ans n’est pas démontré. D’un autre côté, une récente méta-analyse d’études observationnelles incluant des sujets entre 70 et 89ans traités par statines a retrouvé qu’un cholestérol total bas était associé à une baisse modérée de la mortalité cardiovasculaire, sans diminution de la mortalité toutes causes. De plus, dans un contexte fréquent de polymédication dans cette tranche d’âge, les statines peuvent être responsables de nombreux effets indésirables, d’interactions médicamenteuses et d’une altération de la qualité de vie.
Compte tenu de l’absence de preuve formelle d’efficacité en termes de mortalité toutes causes et d’un niveau élevé d’effets secondaires, le rapport bénéfice/risque d’une prévention primaire par statines n’est pas établi chez les personnes âgées. Le poids économique des prescriptions de statines et leur retentissement possible sur la qualité de vie justifient une analyse médico-économique de l’arrêt de ce traitement chez les personnes de 75 et plus.
Statins in primary prevention before 75 years old reduce cardiovascular events from 20 to 30% and mortality from 10% with acceptable side effects. We investigated whether these results persisted for patients aged 75 and older taking statin.
Methodic review of large randomized clinical trials and meta-analyzes that included patients 75 years and older treated with statins in primary prevention.
Since the 1990s, a score of randomized controlled trials studying statins versus placebo in primary prevention were published and studied in meta-analyses. Exclusion criteria, including persons older than 70 years, are often restrictive. The impact on all-cause mortality in the four main studies and meta-analyses in over 75 years has not been demonstrated. On the other hand, a recent meta-analyses of observational studies including subjects between 70 and 89 years treated with statins found that low total cholesterol was associated with a moderate decrease in cardiovascular mortality, with no decrease in all-cause mortality. Moreover, in a common context of comorbidities in this age group, statins may be responsible for many adverse effects, drug interactions and impaired quality of life.
Given the lack of formal evidence of effectiveness in terms of all-cause mortality and a high level of adverse effects, the benefit/risk of primary prevention with statins is not established in the elderly. The economic weight of statin prescriptions and their possible impact on quality of life justify an economic analysis of discontinuing statin therapy for people 75 years and older.
Patients who have experienced a cardiovascular clinical event such as a myocardial infarction or stroke qualify for intensive risk factor evaluation and management. The aim of this study is to ...explore lifestyle changes as well as the achievement of targets for risk factors in patients with established cardiovascular disease.
Cross-sectional study conducted in primary care practices. The study was carried out in six European countries (Croatia, France, Portugal, Slovenia, Spain and Turkey). Patients with established cardiovascular disease (coronary heart disease and stroke) attended in primary care were selected and assessed from January to June 2016. Patients were recruited and assessed at the practice by research assistants between 6 months and 3 years after the event. Statistical comparisons were done with the unpaired two-sided Student's t-test for continuous variables and Chi-square test for categorical variables.
Nine hundred and seventy-three patients (32.4% females) were assessed. About 14% of them were smokers, 32% were physically inactive, and 30% had nutritionally poor eating behaviours. LDL cholesterol target value below 70 mg/dl was achieved in about 23% of patients, and in general, women were less cardio-protected by drugs than men.
Many patients with established cardiovascular disease who attended in general practice still fail to achieve the lifestyle, risk factor, and therapeutic targets set by European guidelines. These results are relevant to general practitioners because these patients have a high risk of subsequent cardiovascular events, including MI, stroke, and death.
In 2016-2017, a European-wide circulation of genotype IA hepatitis A virus was responsible for hepatitis A outbreaks in men who have sex with men (MSM). This study aimed to describe the outbreak ...investigation in Seine-Maritime department (France) and the control measures implemented accordingly.
Outbreak description used data from mandatory reporting and enhanced surveillance of male cases. Confirmed case was genotype IA isolated, possible cases had no reported genotype information. Targeted control measures included communication on sexual practices at risk of hepatitis A transmission and two vaccination campaigns in April 2017 and January 2018. Characteristics of cases and vaccinees were described. We reported the best communication channel for relaying outbreak information and control measures based on the monitoring of social network activities and feedback from vaccinees.
During the outbreak period (December 2016 to December 2017), a total of 48 confirmed outbreak cases and 30 possible outbreak cases were notified. Among them, 69 were male (88%). Two epidemic waves were observed. Cases encountered their partners through gay-dating apps (54%) and in one specific sauna (62%). In response to the outbreak, two vaccination campaigns were deployed. A total of 156 MSM were vaccinated, of whom 56 in a truck parked beside the sauna. Most of the vaccinees had been informed about the campaign through dating apps (44%). Community-based organizations involved in sexual health promotion and other gay social media were very proactive in sharing information about the outbreak and promoting the vaccination campaign through their social media account and also on site (gay venues). Vaccinees reported the same sexual practices at risk of hepatitis A transmission as cases.
In response to this massive hepatitis A outbreak that affected mostly MSM in Seine-Maritime department, vaccination campaign remained the cornerstone of prevention. Prevention officers from the community-based organization played a key role in vaccination promotion. Gay-dating apps and outdoor sessions of vaccination allowed to effectively reach MSM. Cost-effectiveness studies might analyze the interest of a continuous sexual health promotion including vaccination against hepatitis A in MSM through dating apps and social networks.
•First on-line RPLC x SFCHRMS analyses of microalgae bio-oil samples.•New interface configuration to remove peak distortion in 2D despite large injection volumes.•Highlighting the interest of RPLC x ...SFC for isomeric separation.•Achieving high retention space coverage and peak capacity of 700 in 60 min only.
Bio-oils obtained by thermochemical or biochemical conversion of biomass represent a promising source of energy to complement fossil fuels, in particular for maritime or air transport for which the use of hydrogen or electricity appears complicated. As these bio-oils are very rich in water and heteroatoms, additional treatments are necessary before they can be used as biofuel. In order to improve the efficiency of these treatments, it is important to have a thorough knowledge of the composition of the bio-oil. The characterization of bio-oils is difficult because they are very complex mixtures with thousands of compounds covering a very wide range of molecular weight and polarity. Due to the high degree of orthogonality between the two chromatographic dimensions, the on-line combination of reversed-phase liquid chromatography and supercritical fluid chromatography (on-line RPLC x SFC) can significantly improve the characterization of such complex matrices. The hyphenation was optimized by selecting, in SFC, the stationary phase, the co-solvent, the make-up solvent prior to high resolution mass spectrometry (HRMS) and the injection solvent. Additionally, a new interface configuration is described. Quality descriptors such as the occupation of the separation space, the peak shapes and the signal intensity were considered to determine the optimal conditions. The best results were obtained with bare silica, a co-solvent composed of acetonitrile and methanol (50/50, v/v), a make-up solvent composed of methanol (90%) and water (10%) with formic acid (0.1%), an addition of co-solvent through an additional pump for SFC separation in a 2.1 mm column, and an hydro-organic solvent as injection solvent. The optimized setup was used to analyze two microalgae bio-oils: the full bio-oil coming from hydrothermal liquefaction and Soxhlet extraction of microalgae, and the gasoline cut obtained after distillation of the full bio-oil. Results in on-line RPLC x SFC-qTOF were particularly interesting, with very good peak shapes and high reproducibility. Moreover, the high degree of orthogonality for microalgae bio-oils of RPLC and SFC was highlighted by the very large occupation of the separation space. Isomeric profiles of compound families could be obtained in RPLC x SFC-qTOF and many isomers not separated in SFC alone were separated in RPLC and vice versa, thus showing the complementarity of the two chromatographic techniques.
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