Background: The number of homeless families has increased considerably since the 1990s in France. We aimed to estimate the homeless children vaccination coverage (VC) for diphtheria, tetanus, polio, measles–mumps–rubella and hepatitis B and identify factors associated with insufficient VC according to birthplace. Methods: A cross-sectional survey was conducted among homeless shelter families in the greater Paris area. A nurse conducted face-to-face interviews and collected vaccination records. We analyzed factors associated with insufficient VC, stratified by birthplace and vaccine, using robust Poisson regression. Results: The study included 214 children born in France and 236 born outside France. VC in French-born homeless children was high (>90% at 24 months for most vaccinations) and similar to levels observed in the general population, whereas VC in those born outside France was low (<50% at 24 months for all vaccines). Factors significantly associated with insufficient VC among children born outside France were age, parents with French-language difficulties, and changing residence at least twice in the previous year. Children in contact with the healthcare system at least once in the previous year had significantly higher VC, irrespective of vaccine and birthplace. Conclusion: Special attention should be paid to homeless children born outside France, with recent European and French recommendations confirming the need for catch-up vaccination in children with undocumented VC.
TPS395 Background: Epidemiological studies showed an association between GnRH agonists and a long-term increased risk of CVD, early after treatment initiation and with a higher risk seen in pts with pre-existing CVD. Retrospective pooled safety analyses of 6 randomized trials showed that significantly fewer pts treated with the GnRH receptor antagonists, degarelix, had a CV event or death compared with pts receiving a GnRH receptor agonist. In those studies showing an increased CV risk, Androgen-Deprivation Therapy (ADT) was primarily with GnRH receptor agonists. The mechanistic differences between GnRH antagonists and agonists, including testosterone surge and time to suppression at initiation, effect on follicle-stimulating hormone and on GnRH receptors e.g. T-lymphocytes in atherosclerotic plaque, raises the possibility of different CV risk profiles. The PRONOUNCE trial is the first to prospectively assess whether a GnRH agonist/antagonist can worsen pre-existing CVD; assess the impact of GnRH agonist/antagonist on CV risk biomarkers; and effects of hormonal therapy on immune system. Methods: PRONOUNCE is a multi-center, randomized, controlled trial of 900 men with pc and concomitant CVD, assessing adjudicated MACEs, i.e. myocardial infarction (fatal, non-fatal), stroke (fatal, non-fatal), or death in pts randomized 1:1 to either degarelix or leuprolide according to label recommendations for up to one year. Eligibility include pre-defined CVD, metastatic or locally advanced pc; high-risk disease with plan for definitive radiation therapy (RT); recurrence after local therapy with PSA doubling time <12 months; or salvage RT with neoadjuvant/adjuvant ADT for at least 12 months. Serum samples are collected for the analysis of various CV, inflammatory, and immune biomarkers. The primary endpoint will be based on Kaplan-Meier estimator of survival function and stratified for age group and region. Interim analysis is scheduled when 50% of MACE events have occurred allowing the DSMB to recommend for sample size correction. Clinical trial information: NCT02663908.
Background/Introduction
Lower extremity peripheral arterial disease (PAD) is a severe form of atherosclerotic cardiovascular (CV) disease. The classical symptom is intermittent claudication (IC), associated with limited walking ability and poor health-related quality of life (QoL). Type 2 diabetes (T2D) is one of the leading causes of PAD; ∼30% of patients with PAD have T2D. While anti-atherosclerotic drugs and lifestyle changes are recommended, there are no effective drugs to specifically improve functional outcomes in PAD and T2D. Semaglutide is a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved as an adjunct to diet and exercise for glycaemic control in patients with T2D. In the T2D SUSTAIN clinical trial programme, once-weekly (OW) subcutaneous semaglutide 0.5 and 1.0 mg was superior for glycaemic control and weight loss vs placebo and a range of approved antidiabetic drugs. In SUSTAIN 6, a dedicated CV outcomes trial, OW semaglutide resulted in a 26% reduction in three-point major adverse CV events (MACE) compared with placebo in patients with T2D at high CV risk, leading to its approval for MACE risk reduction in those with T2D and CV disease in the USA. Evidence suggests this may be partly attributable to the anti-inflammatory and anti-atherosclerotic effects of semaglutide, which may also apply to PAD.
Purpose
The STRIDE trial will demonstrate the effect of OW semaglutide 1.0 mg vs placebo on walking ability in patients with T2D and PAD with IC.
Methods
STRIDE is a 52-week, randomised, double-blind, placebo-controlled, phase 3b trial. Trial design and eligibility criteria are shown in the Figure; ∼800 patients will be randomised 1:1 to OW semaglutide 1.0 mg or placebo, both added to standard of care. The primary endpoint is change in maximum walking distance on a constant load treadmill test from baseline to week 52. Secondary confirmatory endpoints include changes in pain-free walking distance and PAD-specific, health-related patient-reported outcomes (Vascular QoL Questionnaire-6) from baseline to week 52.
Results
The trial started in October 2020 and is currently recruiting, with ∼120 sites in ∼20 countries across Asia, Europe, and North America.
Conclusion
STRIDE is the first and only dedicated PAD outcomes trial with a GLP-1RA and thus presents a unique trial design. While major adverse limb events typically occur in the later stages of PAD, STRIDE instead measures the effect of OW semaglutide on functional outcomes such as walking ability and QoL, which affect everyday living in patients with PAD and IC. STRIDE data will provide important clinical insights regarding the role of OW semaglutide in patients with T2D and PAD.
FUNDunding Acknowledgement
Type of funding sources: Private company. Main funding source(s): Novo Nordisk A/S
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