Lifestyle versus ezetimibe plus lifestyle in patients with biopsy-proven non-alcoholic steatohepatitis (LISTEN): A double-blind randomised placebo-controlled trial.

BACKGROUND AND AIMS: The LISTEN trial (ClinicalTrial.gov accession: NCT01950884) is a phase IV 52 weeks double blind parallel randomized controlled trial that evaluated the effect of ezetimibe plus lifestyle and dietary intervention (eze) vs. lifestyle and dietary intervention alone (placebo) on progression and complications of non-alcoholic steatohepatitis (NASH) evaluated by liver histology. METHODS AND RESULTS: Forty patients with NASH ascertained by histology were randomly allocated on the two study groups and subjected to a follow-up of 52 weeks, when they underwent a second liver biopsy. Main composite end point (EP) was based on the histological improvement in the severity of NASH. Thirty patients completed the study, Eze treatment was not able to improve the primary EP in comparison with placebo, with and odds ratio of 1.029 (0.18-6.38), p = 0.974. Treatment emergent adverse events registered during the study were not more prevalent in the treatment arm. CONCLUSIONS: ezetimibe administered on top of lifestyle and dietary modification failed to improve the histology of NASH in comparison with lifestyle and dietary modification alone. TRIAL ACCESSION NUMBER: ClinicalTrial.gov: NCT01950884.

Clinical Utility of Midregional Proadrenomedullin in Patients with COVID-19.

OBJECTIVE: The aim of the study was to assess the role of midregional proadrenomedullin (MR-proADM) in patients with COVID-19. METHODS: We included 110 patients hospitalized for COVID-19. Biochemical biomarkers, including MR-proADM, were measured at admission. The association of plasma MR-proADM levels with COVID-19 severity, defined as a requirement for mechanical ventilation or in-hospital mortality, was evaluated. RESULTS: Patients showed increased levels of MR-proADM. In addition, MR-proADM was higher in patients who died during hospitalization than in patients who survived (median, 2.59 nmol/L; interquartile range, 2.3-2.95 vs median, 0.82 nmol/L; interquartile range, 0.57-1.03; P <.0001). Receiver operating characteristic curve analysis showed good accuracy of MR-proADM for predicting mortality. A MR-proADM value of 1.73 nmol/L was established as the best cutoff value, with 90% sensitivity and 95% specificity (P <.0001). CONCLUSION: We found that MR-proADM could represent a prognostic biomarker of COVID-19.

Use of Saliva in Alternative to Serum Sampling to Monitor Biomarkers Modifications in Professional Soccer Players.

We aimed to investigate the correlation between serum and salivary concentrations of steroid hormones and IgA, and the variation in concentrations of these biomarkers, across a soccer competitive season in a sample of players playing for an Italian major League team. Thirty-five elite male soccer players were recruited and assessed for salivary hormones (cortisol, testosterone, T/C‰ and DHEA-S) and IgA at three different time-points: (t1) after the pre-season period and 16 official matches played; (t2) after a winter break and three official matches played; (t3) 2 days after the final match of the championship and 19 matches played. Players were also tested for blood biomarkers (ser-C, ser-T, ser-T/C‰, ser-IgA, ACTH) at two detection times (t1 and t3). Blood samples were collected immediately after saliva sampling. The Spearman's rank correlation was used to explore the correlation between blood and salivary concentrations of cortisol, free testosterone and IgA in the different time points. One-way ANOVA and permutation test were performed to explore changes by time of hormones and IgA concentrations over the competitive season. We documented a positive correlation between serum and saliva concentrations for Cortisol at t1 (+58.2%; p-value = 0.002) and t3 (+54.2%; p-value = 0.018) and for Testosterone at t1 (+42.0%; p-value = 0.033). Moreover, a positive variation was documented across the season (D = t3-t1) for Cortisol (D = +6.83; SEM = ±2.70; Var% = +37.6; p-value = 0.032), Testosterone (D = +0.33; SEM = ±0.07; Var% = +27.3; p-value = 0.002) and DHEA-S (D = +44.48; SEM = ±18.54; Var% = +82.0; p-value = 0.042), while a decrease of sal-T/C ratio and no variation in salivary IgA concentrations were reported. In conclusion, our findings support for experimental use of saliva samples to monitor steroid hormones modifications in professional soccer players across a competitive season.

Heart-type fatty acid binding protein is a sensitive biomarker for early AMI detection in troponin negative patients: a pilot study.

BACKGROUND: Early detecting AMI in individuals presenting to the ED with chest pain continues to be a challenge. cTn is the gold standard for AMI diagnosis but early presenters (<1 hours from symptom onset) maybe cTn negative on admission. We analysed the diagnostic value of h-FABP and hs-TnI in patients presenting to ED with chest pain and no cTnI elevations. METHODS: 28 AMI and 28 no-AMI individuals both presented to ED within one hour from pain onset were included. Blood donors were analysed for h-FABP cut-off identification. Among AMI patients, 55% were positive for h-FABP and 34.6% were positive for hs-TnI (p = .015), thus 21% were positive only for h-FABP. The diagnostic accuracy was assessed by ROC curve. h-FABP showed a higher sensitivity but lower specificity than hs-TnI. CONCLUSIONS: In our study, the frequency of h-FABP positivity among AMI patients was higher than that of hs-TnI, which would have missed six of them; however, hs-TnI AUC was superior to that of h-FABP. These preliminary findings might confirm that h-FABP may be a good candidate for AMI rule-in/rule-out within the ED context.