Research framework: For a family, eco-citizenship means among other things adjusting their domestic practices to their desire to act in favor of the environment and the preservation of its resources. ...In the event of a child’s chronic respiratory illness, parents receive medical recommendations designed to protect his or her health. These recommendations relate to the layout and upkeep of the home, and concern some of these practices.Objectives: This article aims to show how the family redefines its practices by articulating its values related to health and the environment.Methodology: This research is based on a qualitative study carried out between 2018 and 2020, involving interviews and observations in the homes of 46 families living in Brittany, France, who have a child with cystic fibrosis or asthma. The purpose of the survey was to ethnographically describe domestic hygiene practices, which may stem from values attached to both health and the environment.Results: This article analyzes the dynamics of change in the family’s ecological domestic practices through the prism of the child’s chronic respiratory illness and its implications. It points out the factors influencing the family’s eco-citizen trajectory in this particular context.Conclusion: The inflection given to this trajectory depends first and foremost on the family’s ways of being and doing, and the cultural and social context that shapes them. It then relies on the specific characteristics of the disease, the context in which it is treated and the way in which the medical authority integrates environmental issues into its health guidelines.Contribution: This article looks at children’s chronic respiratory illness as one of the key factors in the construction of a family’s eco-citizenship and its practical implementation. It questions the medical establishment as to how it takes into account environmental values in a perspective of family’s quality of life.
Cadre de la recherche : L’écocitoyenneté se traduit entre autres pour une famille par l’ajustement de ses pratiques domestiques à sa volonté d’agir en faveur de l’environnement et de la préservation ...de ses ressources. En cas de maladie respiratoire chronique de l’enfant, les parents reçoivent des recommandations médicales visant à protéger sa santé. Relatives à l’aménagement et à l’entretien du logement, elles concernent certaines de ces pratiques.Objectifs : L’objectif de l’article est de montrer comment la famille redéfinit ses pratiques en articulant ses valeurs liées à la santé et à l’environnement.Méthodologie : Cette question est traitée en s’appuyant sur une enquête qualitative menée entre 2018 et 2020 sous forme d’entretiens et d’observations aux domiciles de 46 familles, habitant en Bretagne (France) et hébergeant un enfant atteint de mucoviscidose ou d’asthme. L’objet de l’enquête était la description ethnographique des pratiques d’hygiène domestique, pouvant découler de valeurs attachées à la santé comme à l’environnement.Résultats : L’article analyse les dynamiques d’évolution des pratiques domestiques écologiques de la famille au prisme de la maladie respiratoire chronique de l’enfant et de ses implications. Il pointe les facteurs qui influencent sa trajectoire écocitoyenne dans ce contexte particulier.Conclusion : L’inflexion donnée à cette trajectoire dépend d’abord des manières d’être et de faire de la famille et du contexte culturel et social les façonnant. Elle relève ensuite des caractéristiques propres de la maladie, du contexte de sa prise en charge et de la façon dont l’autorité médicale soignante intègre ou non les questions relatives à l’environnement dans ses préconisations de santé.Contribution : L’article pose la maladie respiratoire chronique de l’enfant comme l’un des facteurs qui importe dans la construction de l’écocitoyenneté de la famille et sa mise en œuvre pratique. Il interroge l’institution médicale quant à sa prise en compte des valeurs environnementales dans une perspective de qualité de vie des familles.
Aims
The aim of this study is to evaluate the usefulness of a personalized discharge checklist (PCL) based on simple baseline characteristics on mortality, readmission for heart failure (HF), and ...quality of care in patients hospitalized for acute HF.
Methods and results
We designed an algorithm to generate PCL, based on 2016 HF European Society of Cardiology Guidelines and the screening of common comorbidities in elderly HF patients. We prospectively included 139 patients hospitalized for HF from May 2018 to October 2018. A PCL was fulfilled for each patient at admission and 24 to 48 hours before the planned discharge. A control cohort of 182 consecutive patients was retrospectively included from May 2017 to October 2017. The primary composite endpoint was mortality or readmission for HF at 6 months. The secondary endpoints were mortality, readmission for HF, and quality of care (evidence‐based medications, management of HF comorbidities, and planned care plan). There was no difference among baseline characteristics between PCL and control cohorts; mean age was 78.1 ± 12.2 vs. 79.0 ± 12.5 years old (P = 0.46) and 61 patients (43.9%) vs. 63 (34.6%) had HF with left ventricular ejection fraction (LVEF) <40% (P = 0.24). During the 6 month follow‐up period, 59 patients (42.4%) reached the primary endpoint in the PCL cohort vs. 92 patients (50.5%) in the control cohort hazard ratio (HR): 0.79, 95% confidence interval (CI) (0.57–1.09), P = 0.15. Subgroup analysis including only patients with either altered (<40%) or mid‐range or preserved (≥40%) LVEF showed no significant difference among groups. There was a non‐significant trend toward a reduction in HF readmission rate in the PCL group 38 patients (27.3%) vs. 64 patients (35.2%), HR: 0.73, 95%CI (0.49–1.09), P = 0.13. There was no difference regarding survival or the use of evidence‐based medications. A higher proportion of patients were screened and treated for iron and vitamin D deficiencies (53.2% vs. 35.7%, P < 0.01 and 73.4% vs. 29.7%, P < 0.01, respectively), as well as malnutrition supplemented in the PCL group. There was a higher referral to HF follow‐up programme in the PCL group but not to telemedicine or cardiac rehabilitation programs.
Conclusions
In this preliminary study, the use of a PCL did not improve outcomes at 6 months in patients hospitalized for acute HF. There was a non‐significant trend towards a reduction in HF readmission rate in the PCL group. In addition, the management of HF comorbidities was significantly improved by PCL with a better referral to follow‐up programme. A multicentre study is warranted to assess the usefulness of a simple costless personalized checklist in a large HF patients' population.
Patients with acute coronary syndrome (ACS) and concomitant noncoronary atherosclerosis have a high risk of major adverse cardiovascular events (MACEs) and death. The impact of lipid lowering by ...proprotein convertase subtilisin-kexin type 9 inhibition in such patients is undetermined.
This pre-specified analysis from ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) determined whether polyvascular disease influenced risks of MACEs and death and their modification by alirocumab in patients with recent ACS and dyslipidemia despite intensive statin therapy.
Patients were randomized to alirocumab or placebo 1 to 12 months after ACS. The primary MACEs endpoint was the composite of coronary heart disease death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, or unstable angina requiring hospitalization. All-cause death was a secondary endpoint.
Median follow-up was 2.8 years. Of 18,924 patients, 17,370 had monovascular (coronary) disease, 1,405 had polyvascular disease in 2 beds (coronary and peripheral artery or cerebrovascular), and 149 had polyvascular disease in 3 beds (coronary, peripheral artery, cerebrovascular). With placebo, the incidence of MACEs by respective vascular categories was 10.0%, 22.2%, and 39.7%. With alirocumab, the corresponding absolute risk reduction was 1.4% (95% confidence interval CI: 0.6% to 2.3%), 1.9% (95% CI: -2.4% to 6.2%), and 13.0% (95% CI: -2.0% to 28.0%). With placebo, the incidence of death by respective vascular categories was 3.5%, 10.0%, and 21.8%; the absolute risk reduction with alirocumab was 0.4% (95% CI: -0.1% to 1.0%), 1.3% (95% CI: -1.8% to 4.3%), and 16.2% (95% CI: 5.5% to 26.8%).
In patients with recent ACS and dyslipidemia despite intensive statin therapy, polyvascular disease is associated with high risks of MACEs and death. The large absolute reductions in those risks with alirocumab are a potential benefit for these patients. (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab ODYSSEY OUTCOMES: NCT01663402).
The ODYSSEY OUTCOMES (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab) trial compared alirocumab with placebo, added to high-intensity or ...maximum-tolerated statin treatment, after acute coronary syndrome (ACS) in 18,924 patients. Alirocumab reduced the first occurrence of the primary composite endpoint and was associated with fewer all-cause deaths.
This pre-specified analysis determined the extent to which alirocumab reduced total (first and subsequent) nonfatal cardiovascular events and all-cause deaths in ODYSSEY OUTCOMES.
Hazard functions for total nonfatal cardiovascular events (myocardial infarction, stroke, ischemia-driven coronary revascularization, and hospitalization for unstable angina or heart failure) and death were jointly estimated, linked by a shared frailty accounting for patient risk heterogeneity and correlated within-patient nonfatal events. An association parameter also quantified the strength of the linkage between risk of nonfatal events and death. The model provides accurate relative estimates of nonfatal event risk if nonfatal events are associated with increased risk for death.
With 3,064 first and 5,425 total events, 190 fewer first and 385 fewer total nonfatal cardiovascular events or deaths were observed with alirocumab compared with placebo. Alirocumab reduced total nonfatal cardiovascular events (hazard ratio: 0.87; 95% confidence interval: 0.82 to 0.93) and death (hazard ratio: 0.83; 95% confidence interval: 0.71 to 0.97) in the presence of a strong association between nonfatal and fatal event risk.
In patients with ACS, the total number of nonfatal cardiovascular events and deaths prevented with alirocumab was twice the number of first events prevented. Consequently, total event reduction is a more comprehensive metric to capture the totality of alirocumab clinical efficacy after ACS.
Heterozygous familial hypercholesterolemia (HeFH) is a genetic disorder characterized by elevated levels of low-density lipoprotein cholesterol (LDL-C).
This phase 2 dose-finding study (NCT02890992) ...evaluated the efficacy, safety, and dose selection of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor alirocumab in pediatric HeFH patients.
HeFH patients (n = 42) who were aged 8–17 years, had body weight (BW) ≥25 kg, and had LDL-C ≥130 mg/dL despite optimal statin/other lipid-modifying therapies were enrolled in 4 cohorts according to BW: cohort #1: 30 mg (<50 kg) or 50 mg (≥50 kg) every 2 weeks (Q2W), #2: 40 mg (<50 kg) or 75 mg (≥50 kg) Q2W, #3: 75 mg (<50 kg) or 150 mg (≥50 kg) every 4 weeks (Q4W), #4: 150 mg (<50 kg) or 300 mg (≥50 kg) Q4W. Primary endpoint was LDL-C % change from baseline to week 8.
Mean age was 12.4 years and 95% of patients were on a statin. Baseline LDL-C levels were 160.0–188.9 mg/dL and free PCSK9 was 186.4–201.7 ng/mL across the cohorts. At week 8, the higher dose cohorts (2 and 4) demonstrated the greatest reductions in LDL-C (–46% and –45%, respectively). Free PCSK9 levels were lowest at week 8 in cohorts 2 and 4 (42.2 ng/mL and 8.6 ng/mL, respectively). Adverse events were reported in 50–90% of patients across the cohorts, and 2 patients discontinued due to adverse events.
In pediatric HeFH patients, LDL-C reductions were greatest in the higher dose cohorts. Alirocumab was generally well tolerated at all doses.
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•Heterozygous familial hypercholesterolemia is underdiagnosed in children, placing them at risk of cardiovascular events.•Target low-density lipoprotein cholesterol levels are often not reached despite optimal lipid-modifying therapies.•We assessed the effects, safety, and doses of alirocumab in pediatric patients with heterozygous familial hypercholesterolemia.•Reductions in low-density lipoprotein cholesterol were observed across all assessed doses.•Overall, treatment with alirocumab was generally well tolerated.
The proprotein convertase subtilisin/kexin type 9 inhibitor alirocumab has produced significant reductions in LDL-C at a dose of 300 mg q4w administered as 2 separate 150-mg injections via a 1-mL ...autoinjector (AI). A recently developed 2-mL device (SYDNEY) permits the administration of a single 300mg dose of alirocumab.
We assessed the usability and product technical complaints (PTCs) reported by patients using the 2-mL SYDNEY device in unsupervised settings, adverse events, and effects on LDL-C, in a multicenter, randomized, open-label, 16-week study conducted in the United States. For their first dose, 69 patients with hypercholesterolemia despite receiving statin with or without other lipid-lowering therapy randomly received supervised, self-administered alirocumab 300 mg via 1 × 300 mg injection with the SYDNEY device (n = 35) or 2 × 150-mg injections with the currently approved AI (n = 34). All continuing patients subsequently received unsupervised, self-administered alirocumab 300 mg q4w using the SYDNEY device at weeks 4, 8, and 12. The primary end point was the proportion of SYDNEY device–associated PTCs related to the use of the unsupervised injections.
Baseline characteristics between the study arms varied only in a higher percentage of males being randomized to the study arm using the SYDNEY device (74.3%) compared with the AI arm (44.1%). A single PTC was reported during the unsupervised injections (0.5%; 1 of 196 injections; 95% CI, 0.0%–3.2%). This event was classified as patient related as opposed to device related. No PTCs occurred during supervised injections. Mean LDL-C reductions from baseline at week 4 were 66.2% with SYDNEY and 51.2% with the AI; after adjustment for sex differences between groups, mean LDL-C reductions were 63.5% and 53.9%, respectively. LDL-C reductions persisted for 16 weeks. The most common adverse event was upper respiratory tract infection (3 with SYDNEY and 0 with the AI during weeks 0–4).
The SYDNEY device allowed for a single 2-mL injection of alirocumab 300 mg, providing substantial LDL-C reductions with no new product technical issues or no new safety concerns compared with the currently marketed 1-mL AI device. In conclusion, the 2-mL SYDNEY device provides patients with the possibility of injecting the 300-mg alirocumab dose as a single injection. ClinicalTrials.gov identifier: NCT03415178.
Abstract Aims Demonstrate superiority of insulin glargine (± glulisine) strategy versus premixed insulin strategy for percentage of patients reaching HbA1c < 7% (< 53 mmol/mol) at study end without ...any documented symptomatic hypoglycemia (bloof glucose BG ≤ 3.1 mmol/L) in type 2 diabetes (T2DM) patients failing oral agents. Methods This 24-week, open-label, multinational trial randomized patients to glargine OD or premix OD or BID, continuing metformin ± insulin secretagogue (IS). Second premix injection could be added any time; glulisine could be added with main meal in glargine OD patients with HbA1c ≥ 7% and fasting blood glucose (FBG) < 7 mmol/L at week 12. IS was stopped with any second injection. Insulin titration targeted FBG ≤ 5.6 mmol/L. Results Modified intent-to-treat population comprised 923 patients (glargine, 462; premix, 461). Baseline characteristics were similar (mean T2DM duration: 9 years; HbA1c: 8.7% (72 mmol/mol); FBG: 10.4 mmol/L). Primary endpoint was achieved by 33.2% of glargine (± glulisine) and 31.4% of premix patients. Superiority was not demonstrated, but non-inferiority was (pre-specified margin: 25% of premix rate). More patients using premix achieved target (52.6% vs. 43.2%, p = 0.005); symptomatic hypoglycemia was less with glargine (1.17 vs. 2.93 events/patient–year). Conclusions Glargine (± glulisine) and premix strategies resulted in similar percentages of well-controlled patients without hypoglycemia, with more patients achieving target HbA1c with premix whereas overall symptomatic hypoglycemia was less with glargine.
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