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Atherosclerotic cardiovascular disease (ASCVD) continues to be a leading cause of preventable death globally. Polygenic risk scores (PRS) offer a way to detect individuals at higher relative risk of developing ASCVD, but they have not yet been incorporated into routine clinical practice. Pragmatic trials offer a way to evaluate the integration of PRS into cardiovascular disease prevention in primary care, allowing for a more accurate assessment of their effectiveness in everyday clinical practice.
This trial evaluates the effectiveness of preventive statin treatment on reducing the incidence of cardiovascular events and death over 5 years in women (aged 55–80) and men (aged 45–80) with a high coronary artery disease PRS. This is a pragmatic, multicentre, open-label, parallel group, randomised clinical trial with a 1:1 allocation ratio to intervention (n=1350), receiving preventive rosuvastatin 20 mg treatment or control (n=1350), receiving current standard of care. Following the intention-to-treat principle, all randomised participants are analysed according to their allocated group, with the primary outcome defined as time to first major adverse cardiovascular event, comprising ischaemic heart disease, stroke or transient ischaemia, peripheral vascular occlusion and stenosis, revascularisation or cardiovascular death.
This trial has received ethical approval from the Estonian Committee on Bioethics and Human Research (13.06.2024 nr 1.1-12/1531) and the Estonian Ethics Committee for Medicinal Products (19.12.2024 nr RKU-4/92).
by Sophie Lekkerkerker, Karin A. H. Kaasjager, Saskia Haitjema, Cornelia Hulsbergen-Veelken, Karin H. Herbschleb, Marianne C. Verhaar, Meriem Khairoun, Gurbey Ocak
BackgroundAlthough immune checkpoint inhibitors improve survival in patients with malignancies, a substantial number of patients treated with these agents experience immune-related adverse events. It is unknown whether inflammation-related hematological ratios are associated with immune-related adverse events or mortality.
ObjectiveWe aimed to investigate the association between pretreatment inflammation-related hematological ratios and the occurrence of immune-related adverse events and mortality in patients receiving checkpoint inhibitors.
MethodsPatients treated with checkpoint inhibitors within a tertiary hospital in the Netherlands were studied using routine care data between January 2013 and May 2020. Cox regression analysis was performed to assess the association between neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), neutrophil-to-lymphocytes and platelets ratio (NLPR), and systemic immune-inflammation index (SII) and outcomes (immune-related adverse events or mortality).
ResultsAmong 664 patients treated with checkpoint inhibitors, 397 (59.8%) patients developed an immune-related adverse event and 363 (54.7%) patients died during a median follow-up period of 17 months (interquartile range 7–30 months). Hematological ratios were not associated with immune-related adverse events. However, highest tertiles as compared with lowest tertiles of all hematological ratios were independently associated with mortality (NLR: adjusted hazard ratio (HR) 2.23, 95% CI 1.69–2.95; PLR: adjusted HR 1.88, 95% CI 1.43–2.47; NLPR: adjusted 1.59, 95% CI 1.22–2.06; SII: adjusted HR 2.33, 95% CI 1.77–3.08).
ConclusionIn this study, pretreatment inflammation-based hematological ratios were not associated with future immune-related adverse events in patients treated with checkpoint inhibitors. However, elevated hematological ratios were associated with an increased mortality risk.
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