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Offidani M.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Corvatta L.,Ospedale Stelluti Scala | Morabito L.,Instituto Clinico Humanitas | Gentili S.,Azienda Ospedaliero Universitaria Ospedali Riuniti
Expert Opinion on Investigational Drugs | Year: 2015

Introduction: Proteasome inhibition is a mainstay in the treatment of multiple myeloma (MM). Bortezomib, the first proteasome inhibitor (PI) approved for MM therapy, has shown efficacy in relapsed/refractory patients and in the front-line setting. Among second-generation PIs, MLN9708 (ixazomib) is the first oral compound to be evaluated in MM treatment and has shown improvement in pharmacokinetic and pharmacodynamic parameters compared with bortezomib with a similar efficacy in the control of myeloma growth and in the prevention of bone loss.Areas covered: In this review, the authors discuss the rationale for use of PIs. They then summarize the clinical development of ixazomib in MM, from initial Phase I to Phase II studies as a monotherapy and in combination with other chemotherapeutics.Expert opinion: Preliminary data of Phase I/II trials showed that ixazomib had a good safety profile and exerted anti-myeloma activity as a single agent in relapsed/refractory patients. Furthermore, ixazomib also had efficacy in patients who were refractory to bortezomib. Its use in combination with lenalidomide and dexamethasone was shown to be an effective and well-tolerated regimen in up-front treatment leading to minimal residual disease negativity in a significant number of patients. Results of Phase III trials, evaluating ixazomib in induction or maintenance therapy, are awaited. © 2015 © Informa UK, Ltd.

PubMed | University of Trieste and Azienda Ospedaliero Universitaria Ospedali Riuniti
Type: Journal Article | Journal: Microbial drug resistance (Larchmont, N.Y.) | Year: 2016

This study describes the dissemination of a carbapenem-resistant Acinetobacter baumannii (CRAB) strain in a university hospital in Northeast Italy. Characterization of the outbreak strain was combined with a retrospective analysis of all CRAB isolates collected in the same hospital during the 5 years preceding the outbreak, with the aim of elucidating the origin of the epidemic spread. The outbreak strain was shown to belong to the International Clone II and carry the bla

PubMed | International Center for Genetic Engineering and Biotechnology, University of Trieste and Azienda Ospedaliero Universitaria Ospedali Riuniti
Type: Journal Article | Journal: Clinical nutrition (Edinburgh, Scotland) | Year: 2016

Ghrelin is a gastric hormone circulating in acylated (AG) and unacylated (UG) forms, and higher plasma total ghrelin (TG) and UG may be cross-sectionally associated with lower insulin resistance in metabolic syndrome patients. The potential value of ghrelin forms in predicting insulin resistance and its time-related changes in community-based population cohorts remains unknown.We measured TG, AG and calculated UG (TG-AG) in 716 individuals from the North-East-Italy MoMa study (age: 559 years, BMI: 295kg/m(2), M/F:349/367) to test the hypothesis that circulating TG and UG, but not AG are negatively associated with insulin resistance (HOMA). We further hypothesized that baseline TG and UG negatively predict 5-year HOMA changes in a 350-individual subgroup.Baseline TG and UG were associated negatively with HOMA after adjusting for gender and body mass index (BMI). Baseline gender- and BMI-adjusted TG and UG were also negatively associated with HOMA at 5-year follow-up (n=350), and changes in TG and UG were negatively associated with changes in HOMA (P<0.05) after adjustment for anthropometric and metabolic confounders. No statistically significant correlations were observed between AG and baseline or 5-year HOMA.In a North-East Italy community-based population cohort, plasma TG and UG but not AG are negatively associated with HOMA. TG and UG and their changes also independently predict 5-year HOMA changes. TG and UG are therefore novel potential modulators of insulin resistance and may contribute to predict its time-related changes in humans.

PubMed | Instituto Nazionale Per Lo Studio E La Cura Dei Tumori Fondazione G Pascale Irccs, San Gennaro Hospital, University of Naples Federico II, San Giovanni Bosco Hospital and 6 more.
Type: Journal Article | Journal: The oncologist | Year: 2016

Everolimus, an oral mTOR (mammalian target of rapamycin) inhibitor, is currently approved for the treatment of progressive pancreatic neuroendocrine tumors (NETs). Although promising, only scattered data, often from nondedicated studies, are available for extrapancreatic NETs.A systematic review of the published data was performed concerning the use of everolimus in extrapancreatic NET, with the aim of summarizing the current knowledge on its efficacy and tolerability. Moreover, the usefulness of everolimus was evaluated according to the different sites of the primary.The present study included 22 different publications, including 874 patients and 456 extrapancreatic NETs treated with everolimus. Nine different primary sites of extrapancreatic NETs were found. The median progression-free survival ranged from 12.0 to 29.9 months. The median time to progression was not reached in a phase II prospective study, and the interval to progression ranged from 12 to 36 months in 5 clinical cases. Objective responses were observed in 7 prospective studies, 2 retrospective studies, and 2 case reports. Stabilization of the disease was obtained in a high rate of patients, ranging from 67.4% to 100%. The toxicity of everolimus in extrapancreatic NETs is consistent with the known safety profile of the drug. Most adverse events were either grade 1 or 2 and easy manageable with a dose reduction or temporary interruption and only rarely requiring discontinuation.Treatment with everolimus in patients with extrapancreatic NETs appears to be a promising strategy that is safe and well tolerated. The use of this emerging opportunity needs to be validated with clinical trials specifically designed on this topic.The present study reviewed all the available published data concerning the use of everolimus in 456 extrapancreatic neuroendocrine tumors (NETs) and summarized the current knowledge on the efficacy and safety of this drug, not yet approved except for pancreatic NETs. The progression-free survival rates and some objective responses seem promising and support the extension of the use of this drug. The site-by-site analysis seems to suggest that some subtypes of NETs, such as colorectal, could be more sensitive to everolimus than other primary NETs. No severe adverse events were usually reported and discontinuation was rarely required; thus, everolimus should be considered a valid therapeutic option for extrapancreatic NETs.

Pierri M.D.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Capestro F.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Zingaro C.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Torracca L.,Azienda Ospedaliero Universitaria Ospedali Riuniti
European Journal of Cardio-thoracic Surgery | Year: 2010

Objectives: Data of 9 years of surgical activity (on about 10. 000 patients), obtained from the database of our cardiac surgery care centre, were analysed to assess time-related variations in demographics, clinical and surgical characteristics. Methods: Data of patients submitted to major cardiac surgery procedures between 1999 and 2007 were examined using the chi-square test, analysis of variance (ANOVA) test or non-parametric tests, where applicable. The 'linear-by-linear' association test was used to verify the existence of a time-related trend. A value of p< 0.05 was considered significant. Results: In the time interval of 9 years, there was an increment of valve procedures and a decrease in coronary revascularisation surgery. Patients aged 75 years or more at the time of operation increased from 17% in 1999 to 29% in 2005, and the percentage of patients aged 80 or more demonstrated a threefold increase. Operated patients had more co-morbidity (the rate of hypertension rate 43.7% in 1999 and 68.9% in 2007, and obese patients were 13% in 1999 and 17.5% in 2007) and had worse functional and cardiac status (reduced ejection fraction (EF), haemodynamic instability and shock). As a consequence, there was an increased calculated surgical risk. At the same time, there was no significant increment in the observed mortality (3.1% in 1999 vs 3.8% in 2007 for all patients and 1.6% compared with 1.5% in isolated coronary artery bypass graft (CABG) patients). Conclusions: These changes can reflect both a variation in the characteristics of the population and a major evolution in intervention cardiology and also impose more intensive and extensive postoperative treatment and less invasive cardiac surgery practice. © 2010 European Association for Cardio-Thoracic Surgery.

Busilacchi A.,Marche Polytechnic University | Olivieri M.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Ulisse S.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Gesuita R.,Marche Polytechnic University | And 4 more authors.
Knee Surgery, Sports Traumatology, Arthroscopy | Year: 2016

Purpose: To evaluate the sonoelastographic features of Achilles tendon healing after percutaneous treatment using real-time sonoelastography, a new tool able to quantify deformation in biological tissues. Methods: Patients with atraumatic Achilles tendon ruptures, treated with a percutaneous technique, were assessed. Sonoelastographic evaluations were performed at the myotendinous junction, tendon body/lesion site and osteotendinous junction, both for the operated and contralateral side, at 40 days, 6 months and 1 year after surgery. Using standard regions of interest, the “strain index” (SI) was calculated as an indicator of tendon elasticity. Clinical outcomes were assessed by the ATRS questionnaire at 6 months and 1 year post-operatively and correlated with sonoelastographic findings. Sixty healthy tendons from 30 volunteers were used to provide a healthy control range. Results: Twenty-five patients were recruited for this study. The SI in treated tendons showed progressive stiffening over time, especially at myotendinous junction and at the site of the sutured lesion, resulting in significantly higher stiffness than both the contralateral tendon and healthy volunteers. Peak thickness of treated tendons occurred at 6 months, with a tendency to reduce at 1 year, while never achieving a normal physiological state. Greatest remodelling was seen at the lesion site. The contralateral tendon showed significant thickening at the myotendinous and osteotendinous junctions. The SI of the contralateral tendon was found to be stiffer than physiological values found in the control group. ATRS score improved significantly between 6 months and 1 year, being negatively correlated with the SI (p < 0.001). Conclusion: RTSE showed that operatively treated Achilles tendons become progressively stiffer during follow-up, while the ATRS score improved. From a biomechanical point of view, at 1 year after surgery Achilles tendons did not show a “restitutio ad integrum”. Real-time sonoelastography provides more qualitative and quantitative details in the diagnostics and follow-up of Achilles tendon conditions as the post-operative evolution of the repairing tissue. Level of evidence: Diagnostic and therapeutic study, Level III. © 2014, European Society of Sports Traumatology, Knee Surgery, Arthroscopy (ESSKA).

Crescenzi G.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Torracca L.,Azienda Ospedaliero Universitaria | Pierri M.D.,Azienda Ospedaliero Universitaria | Rosica C.,Azienda Ospedaliero Universitaria Ospedali Riuniti | And 2 more authors.
Interactive Cardiovascular and Thoracic Surgery | Year: 2015

OBJECTIVES Acute kidney injury after cardiac surgery (CS-AKI) is strongly associated with in-hospital mortality and morbidity. We aimed to investigate whether 'early' or 'late' initiation of renal replacement therapy (RRT) in patients with CS-AKI is associated with a survival benefit or more favourable outcomes. METHODS All patients who had undergone cardiac surgery at 'Ospedali Riuniti' of Ancona from July 2011 to February 2013 were prospectively enrolled and divided into two treatment groups: the 'early' approach was used during the first 10 months, and the 'late' approach during the next 10 months. 'Early' RRT was started after 6 h of urine output less than 0.5 ml/kg/h, whereas in the 'late' group, therapy started on the basis of persistent (>12 h) oliguria. A total of 1658 patients were enrolled in the trial. The primary outcome was operative mortality, and the secondary outcomes were length of intensive care unit and hospital stay. RESULTS The total number of patients treated with RRT was 59 (3.6%): 46 (5.5%) in the 'early' group and 13 (1.6%) in the 'late' group (P < 0.0001). Although RRT was significantly less utilized in the 'late' group, no significant difference in the primary and secondary outcomes was found, but a trend towards a better outcome in the 'late' group was observed. Furthermore, we found a significant difference in mortality between the two approaches in the subgroups of patients with preoperative renal dysfunction and in patients suffering from CS-AKI with a clear advantage of the late strategy. CONCLUSIONS Our results do not support the use of early RRT in CS-AKI. CLINICAL TRIAL REGISTRATION This trial is registered in the clinicaltrial.gov registry: NCT01961999. © 2015 © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Lapillonne A.,University of Paris Descartes | Lapillonne A.,Baylor College of Medicine | Carnielli V.P.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Embleton N.D.,Newcastle upon Tyne Hospitals NHS Foundation Trust | Mihatsch W.,Pediatric Clinic Harlaching
BMJ Open | Year: 2013

Objective: The level of adherence to guidelines should be explored particularly in preterm infants for whom poor nutrition has major effects on outcomes in later life. The objective was to evaluate compliance to international guidelines for parenteral nutrition (PN) in preterm infants across neonatal intensive care units (NICUs) of four European countries. Design: Clinical practice survey by means of a questionnaire addressing routine PN protocols, awareness and implementation of guidelines. Setting: NICUs in the UK, Italy, Germany and France. Participants: One senior physician per unit; 199 units which represent 74% of the NICUs of the four countries. Primary outcome measure: Adherence of unit protocol to international guidelines. Secondary outcome measure: Factors that influence adherence to guidelines. Results: 80% of the respondents stated that they were aware of some PN clinical practice guidelines. For amino acid infusion (AA), 63% of the respondents aimed to initiate AA on D0, 38% aimed to administer an initial dose ≥1.5 g/kg/day and 91% aimed for a target dose of 3 or 4 g/kg/day, as recommended. For parenteral lipids, 90% of the respondents aimed to initiate parenteral lipids during the first 3 days of life, 39% aimed to use an initial dose ≥1.0 g/kg/day and 76% defined the target dose as 3-4 g/kg/day, as recommended. Significant variations in PN protocols were observed among countries, but the type of hospital or the number of admissions per year had only a marginal impact on the PN protocols. Conclusions: Most respondents indicated that their clinical practice was based on common guidelines. However, the initiation of PN is frequently not compliant with current recommendations, with the main differences being observed during the first days of life. Continuous education focusing on PN practice is needed, and greater efforts are required to disseminate and implement international guidelines.

Calabrese R.,University of Trieste | Beltrame M.,Azienda Ospedaliero Universitaria Ospedali Riuniti | Accardo A.,University of Trieste
Journal of Digital Imaging | Year: 2016

Today, many hospitals have a running enterprise picture archiving and communication system (PACS) and their administrators should have the tools to measure the system activity and, in particular, how much it is used. The information would be valuable for decision-makers to address asset management and the development of policies for its correct utilization and eventually start training initiatives to get the best in resource utilization and operators’ satisfaction. On the economic side, a quantitative method to measure the usage of the workstations would be desirable to better redistribute existing resources and plan the purchase of new ones. The paper exploits in an unconventional way the potential of the IHE Audit Trail and Node Authentication (ATNA) profile: it uses the data generated in order to safeguard the security of patient data and to retrieve information about the workload of each PACS workstation. The method uses the traces recorded, according to the profile, for each access to image data and to calculate how much each station is used. The results, constituted by measures of the frequency of PACS station usage suitably classified and presented according to a convenient format for decision-makers, are encouraging. In the time of the spending review, the careful management of available resources is the top priority for a healthcare organization. Thanks to our work, a common medium such as the ATNA profile appears a very useful resource for purposes other than those for which it was born. This avoids additional investments in management tools and allows optimization of resources at no cost. © 2016 Society for Imaging Informatics in Medicine

PubMed | Pediatric Research Institute Citta della Speranza, University of Udine, Marche Polytechnic University, Azienda Ospedaliero Universitaria Ospedali Riuniti and University of Padua
Type: Journal Article | Journal: Lipids | Year: 2016

Several studies reported the association between total plasma phytosterol concentrations and the parenteral nutrition-associated cholestasis (PNAC). To date, no data are available on phytosterol esterification in animals and in humans during parenteral nutrition (PN). We measured free and esterified sterols (cholesterol, campesterol, stigmasterol, and sitosterol) plasma concentrations during PN in 16 preterm infants (500-1249g of birth weight; Preterm-PN), in 11 term infants (Term-PN) and in 12 adults (Adult-PN). Gas chromatography-mass spectrometry was used for measurements. Plasma concentrations of free cholesterol (Free-CHO), free phytosterols (Free-PHY) and esterified phytosterols (Ester-PHY) were not different among the three PN groups. Esterified cholesterol (Ester-CHO) was statistically lower in Preterm-PN than Adult-PN. Preterm-PN had significantly higher Free-CHO/Ester-CHO and Free-PHY/Ester-PHY ratios than Adult-PN (Free-CHO/Ester-CHO: 1.10.7 vs. 0.60.2; Free-PHY/Ester-PHY: 4.12.6 vs. 1.30.8; *P<0.05). Free-CHO/Ester-CHO and Free-PHY/Ester-PHY ratios of Term-PN (Free-CHO/Ester-CHO: 1.10.4; Free-PHY/Ester-PHY: 2.91.7) were not different from either Preterm-PN or from Adult-PN. Plasma Free-CHO/Ester-CHO and Free-PHY/Ester-PHY were unchanged after 24h on fat-free PN both in Preterm-PN and in Adult-PN. Free-PHY/Ester-PHY did not correlate with phytosterol intake in Preterm-PN. Free-PHY/Ester-PHY of Preterm-PN was positively correlated with the Free-CHO/Ester-CHO and negatively correlated with gestational age and birth weight. In conclusion, PHY were esterified to a lesser extent than CHO in all study groups; the esterification was markedly decreased in Preterm-PN compared to Adult-PN. The clinical consequences of these findings warrant further investigations.

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