European journal of clinical investigation
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In biomedicine, randomized controlled trials are regarded as the gold standard of evidence owing to their ability to minimize confounding factors that may influence results. Randomized trials that are properly designed serve as a basis for drug regulation and national guideline development. Despite the many advantages of the study design, there are several misconceptions regarding randomized trials, particularly in oncology. ⋯ Furthermore, developing regulatory and strategic frameworks has the potential to enhance the randomized trial landscape. Such initiatives will focus on relevant clinical issues that persist in oncology, reducing duplicative and unethical trials and maximizing value-based healthcare. Here, we address several misconceptions regarding randomized controlled trials and provide potential solutions to enhance their methodology and implementation.
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Eur. J. Clin. Invest. · Nov 2022
ReviewNovel Insights into the Pathogenic Impact of Diabetes on the Gastrointestinal Tract.
Type 2 and type 1 diabetes are common endocrine disorders with a progressively increasing incidence worldwide. These chronic, systemic diseases have multiorgan implications, and the whole gastrointestinal (GI) tract represents a frequent target in terms of symptom appearance and interdependent pathophysiological mechanisms. Metabolic alterations linked with diabetic complications, neuropathy and disrupted hormone homeostasis can lead to upper and/or lower GI symptoms in up to 75% of diabetic patients, with multifactorial involvement of the oesophagus, stomach, upper and lower intestine, and of the gallbladder. ⋯ Finally, diabetes has been linked with increased cancer risk at different levels of the GI tract. The presence of GI symptoms and a comprehensive assessment of GI function should be carefully considered in the management of diabetic patients to avoid further complications and to ameliorate the quality of life. Additionally, the presence of gastrointestinal dysfunction should be adequately managed to improve metabolic homeostasis, the efficacy of antidiabetic treatments and secondary prevention strategies.
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Eur. J. Clin. Invest. · Nov 2022
Observational StudyCHA2 DS2 -VASc and R2 CHA2 DS2 -VASc scores predict mortality in high cardiovascular risk population.
The CHA2 DS2 -VASc score, widely used to estimate cardioembolic risk in patients with atrial fibrillation (AF), appears to be useful also in predicting vascular adverse events and death in different sets of patients without AF. The R2 CHA2 DS2 -VASc score, which includes renal impairment, allows a better prediction of death and thromboembolism in patients without AF. The aims of our study were to assess, in a large sample of patients at high cardiovascular (CV) risk, (i) the correlation between CHA2 DS2 -VASc and R2 CHA2 DS2 -VASc with all-cause mortality, and (ii) to compare the performances of CHA2 DS2 -VASc and R2 CHA2 DS2 -VASc in predicting all-cause mortality. ⋯ The CHA₂DS₂-VASc and R2 CHA2 DS2 -VASc scores are useful predictors of all-cause mortality in subjects at high CV risk, with the R2 CHA2 DS2 -VASc score being the best performer.
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Eur. J. Clin. Invest. · Nov 2022
Review Meta AnalysisVolanesorsen to treat severe hypertriglyceridaemia: A pooled analysis of randomized controlled trials.
Patients with severe hypertriglyceridaemia (sHTG) are often refractory to lipid-lowering therapy. Apolipoprotein (Apo) CIII inhibition could be promising to treat subjects with sHTG. The antisense oligonucleotide against APOC3 mRNA volanesorsen was recently introduced to treat sHTG. We performed a systematic review and meta-analysis of RCTs on the efficacy and safety of volanesorsen as compared to placebo treatment in patients with severe HTG. ⋯ In patients with severe HTG, volanesorsen is associated with a significant reduction in TG, VLDL-C, Apo-B48 and non-HDL-C and increment of HDL-C as compared to placebo. Documented efficacy is accompanied by an acceptable safety profile.
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Eur. J. Clin. Invest. · Nov 2022
Meta AnalysisIn-hospital incidence of and risk factors for influenza associated respiratory failure.
Respiratory failure (RF) is the most important complication of influenza virus infection. Its definition and incidence are heterogeneous in the literature. ⋯ Respiratory failure is frequent in hospitalized influenza patients, especially in patients with pneumonia and since the 2009 pandemic, although its definition and reporting widely vary in the literature. This complicates its characterization and comparison between cohorts and with other respiratory viruses.