European journal of clinical investigation
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Eur. J. Clin. Invest. · Sep 2022
ReviewInformed Consent and Biological Agents in Rheumatology and Internal Medicine.
The need for highly effective therapies in rheumatologic diseases has led to the widespread and growing use of a heterogeneous class of molecules called biological agents. The increasing experience with biological agents has raised concerns about safety and efficacy issues that need to be discussed in the informed consent acquisition process. ⋯ The reported association between biological agents and serious infections or malignancies, including reactivation of latent tuberculosis, needs specific disclosure in informed consent acquisition, together with information about the possible efficacy in clinical contexts often characterized by resistance to previous treatments. Ethical and clinical issues bound to the need for experimenting with new agents with potentially serious adverse effects deserve specific attention. Studies aimed at evaluating mental capacity to consent in subjects receiving biological agents are required.
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Eur. J. Clin. Invest. · Sep 2022
Letter Multicenter StudyUse of rivaroxaban attenuates renal function impairment in patients with atrial fibrillation: insight of the EMIR study.
In atrial fibrillation (AF) patients on vitamin K antagonists, a progressive deterioration of renal function is common but there is limited evidence with long-term use of rivaroxaban. Herein, we investigated the change in renal function in AF patients after 2 years of rivaroxaban treatment. ⋯ 1433 patients (638, 44.5% women, mean age of 74.2 ± 9.7 years) were included. Creatinine clearance (CrCl) was available at baseline and at 2 years in 1085 patients. At inclusion, 33.2% of patients had impaired renal function (CrCl <60 ml/min). At 2 years, we were not able to find changes in the proportion of patients with impaired renal function, which increased to 34.6% (p = 0.290). However, the baseline mean CrCl was 76.0 ± 30.5 ml/min and slightly improved at 2 years (77.0 ± 31.8 ml/min; p = 0.014). Overall, the proportion of patients with CrCl <60 ml/min at baseline that had CrCl ≥60 ml/min at 2 years was significantly higher compared to that of patients with CrCl ≥60 ml/min at baseline and CrCl <60 ml/min after (22.2% vs. 13.1%; p < 0.001) CONCLUSIONS: In AF patients on long-term rivaroxaban therapy, a decrease in renal function was not observed. We even observed a slight improvement in the patients with renal impairment. These results reinforce the idea that rivaroxaban may be a safe option even in patients with renal impairment.
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Eur. J. Clin. Invest. · Sep 2022
Observational StudyThe Discrepancy between biomarkers of lung injury and 1-year mortality in COVID-19.
COVID-19 global pandemic started in late 2019 with the first wave. In this cross-sectional and observational study, we evaluated the associations between the biomarkers, COVID-19 pneumonia severity and 1-year mortality. ⋯ LDH is a sensitive and specific biomarker to determine patients with severe lung injury in COVID-19. d-dimer is the only biomarker that predicts 1-year mortality. Neither LDH nor CT-SS is associated with 1-year mortality.
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Eur. J. Clin. Invest. · Sep 2022
Continuous metabolic syndrome severity score and the risk of CVD and all-cause mortality.
The dualistic diagnostic criteria for metabolic syndrome overlooked the severity of metabolic syndrome, and the relationships between the severity of metabolic syndrome and adverse health conditions are poorly characterized. We therefore aimed to investigate the associations of metabolic syndrome severity with incident cardiovascular disease (CVD)/all-cause mortality. ⋯ This study suggests significant dose-response relationships between MetS score and the risk of CVD/mortality. Subjects without metabolic syndrome but with a relatively high MetS score should raise their awareness and pay more attention to the possible increased risk of CVD events.
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Eur. J. Clin. Invest. · Sep 2022
Lifestyle changes and kidney function: A ten year follow-up study in patients with manifest cardiovascular disease.
Patients with cardiovascular disease (CVD) are at higher risk of kidney function decline. The current study aimed to examine the association of lifestyle changes with kidney function decline in patients with manifest CVD. ⋯ In patients with CVD, continuing smoking, recent smoking cessation and an increase in obesity markers were related to a steeper kidney function decline. Although no definite conclusions from this study can be drawn, the results support the importance of encouraging weight loss and smoking cessation in high-risk patients as a means of slowing down kidney function decline.