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Castel Guelfo di Bologna, Italy

Larrey D.,Servise dHepato Gastro Enterologie et Transplantation | Lohse A.W.,Universitatsklinikum Hamburg Eppendorf | De Ledinghen V.,Hepato gastroenterologie | Trepo C.,Service dHepato Gastroenterologie | And 22 more authors.
Journal of Hepatology | Year: 2012

Background & Aims: BI 207127 is a potent non-nucleoside hepatitis C virus (HCV) NS5B polymerase inhibitor in vitro. Methods: In this double-blind, placebo-controlled study, 57 HCV genotype (GT)-1 patients (n = 27 treatment-naïve [TN]; n = 30 treatment-experienced [TE]) with compensated liver disease were randomised for 28-day treatment with 400, 600, or 800 mg BI 207127 three times daily (TID) or placebo (only TN) in combination with peginterferon alfa 2a and ribavirin (PegIFN/RBV). Plasma HCV RNA was measured by Roche COBAS TaqMan assay. Results: HCV RNA decreased in a dose-dependent manner with little difference between 600 mg (TN 5.6 log10, TE 4.2 log 10) and 800 mg (TN 5.4 log10, TE 4.5 log10). Rapid virological response (RVR; HCV RNA <15 IU/ml) at day 28 occurred in 11/19 TN and 4/30 TE patients treated with BI 207127. GT-1b patients had stronger reductions in HCV RNA than GT-1a (RVR: TN 64% vs. 43%; TE 33% vs. 5%). There were no breakthroughs (HCV RNA rebound >1 log10 from nadir) in the TN groups, whereas 3/30 TE patients experienced breakthrough due to P495-mutations. Gastrointestinal adverse events (AEs) and rash were the major AEs and most frequent at higher doses. One and four patients discontinued due to AEs in the 600 and 800 mg groups, respectively. Overall, tolerability was good and better at 600 mg than 800 mg. Conclusions: BI 207127 in combination with PegIFN/RBV demonstrated strong antiviral activity with a favourable safety and tolerability profile. The best benefit/risk ratio was observed at 600 mg. © 2012 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Gridelli C.,Oncologia Medica | Morabito A.,Unita Sperimentazioni Cliniche | Gebbia V.,University of Palermo | Mencoboni M.,Oncologia | And 16 more authors.
Lung Cancer | Year: 2010

Background: Two parallel randomized phase 2 trials were performed to choose the optimal way of combining cetuximab with gemcitabine in the first-line treatment of elderly (CALC1-E) and adult PS2 (CALC1-PS2) patients with advanced NSCLC. Methods: Stage IV or IIIB NSCLC patients, aged ≥70 years with PS 0-2 for CALC1-E or aged <70 with PS2 for CALC1-PS2, not selected for EGFR expression, were eligible. Patients were randomized to concomitant (gemcitabine, for a maximum of 6 cycles, plus cetuximab until progression) or sequential (gemcitabine, for a maximum of 6 cycles, followed by cetuximab) strategy. A selection design, with 1-year survival rate as the primary endpoint, was applied, requiring 58 elderly and 42 PS2 patients. Results: All planned patients were randomized. In sequential arms, 34.5% and 60.0% patients were not able to receive cetuximab after gemcitabine in CALC1-E and CALC1-PS2, respectively. Survival rates (95% CI) at 1-year for concomitant and sequential arms were 41.4% (23.5-61.1) and 31.0% (15.3-50.8) in CALC1-E and 27.3% (10.7-50.2) and 35.0% (15.4-59.2) in CALC1-PS2. In both studies, survival curves crossed at about 10 months and the worse arm until that time became the better one at 1-year. Toxicity was similar across treatment groups. In concomitant arm of CALC1-E (but not of CALC1-PS2), survival was longer for patients who developed skin toxicity within the first two cycles of treatment. Conclusion: In both groups of patients, sequential strategy cannot be proposed for future trials because of low compliance. Inconsistency of survival outcomes makes also concomitant treatment not a candidate for further testing in unselected elderly and PS2 NSCLC patients. © 2009 Elsevier Ireland Ltd. All rights reserved.

Colao A.,University of Naples Federico II | Muscogiuri G.,University of Naples Federico II | Rubino M.,University of Naples Federico II | Vuolo L.,University of Naples Federico II | And 7 more authors.
Endocrine | Year: 2015

Purpose: The aim of this study is to investigate in a population of adolescents living in Regione Campania, undergoing sun exposure at least 9 months per year the prevalence of severe deficiency (<20 ng/ml) or insufficiency (21–29 ng/ml) of 25-Hydroxyvitamin D (25(OH)D) levels and its relationship with individual body weight, use of smoking, and exercise performance. Methods: From October 2012 to October 2013, 373 healthy subjects (153 girls, 223 boys 11–20 years) without chronic diseases were consecutively enrolled in a campaign to prevent metabolic, cardiovascular, and oncological diseases. 25(OH)D assay, BMI, and lifestyle habitudes (smoking and exercise indoor or outdoor) were assessed. Results: In this population, median 25(OH) level was 25.0 ng/ml (95 %CI 23.8–25.2) without any difference between girls (25.0 (95 %CI 23.1–25.7)) and boys (24.3 (95 %CI 23.8–25.2)). Severe deficiency was found in 6 girls (0.02 %), while insufficiency was found in 296 patients (110 girls, 79.3 %). Normal levels were found in 71 patients (37 girls, 19 %). Vitamin D levels were significantly correlated with BMI (r = −0.429, p < 0.0001), smoking (r = −0.241; p < 0.0001), and exercise performance (r = 0.791; p < 0.0001). At the multistep regression analysis, Vitamin D levels were best predicted by exercise performance (t = 19.6, p < 0.0001), less smoking addiction (t = −4.97, p < 0.001), and lower BMI (t = −4.69, p < 0.0001). Conclusions: The current study demonstrates that Vitamin D levels are commonly unsatisfactory in adolescents. Lower levels were found in overweight or obese adolescent, smokers and with low or absence of physical activity outdoors. © 2014, Springer Science+Business Media New York.

Miscione M.T.,Istituto Ortopedico Rizzoli | Bruno F.,University of Bologna | Ripamonti C.,Medicina Generale | Nervuti G.,Direzione Sanitaria | And 5 more authors.
The Scientific World Journal | Year: 2013

Objective. To determine the contributions of body mass, adiposity, and muscularity to physical function and muscle strength in adult patients with Bethlem myopathy (BM) and Ullrich congenital muscular dystrophy (UCMD). Materials and Methods. Evaluation involved one UCMD and 7 BM patients. Body composition was determined by body mass index (BMI) and dual-energy-X-ray- absorptiometry (DXA), muscle strength by dynamometry, physical function by the distance walked in 6 minutes (6MWD), forced vital capacity (FVC) by a spirometer. Results. Six participants were of normal weight and 2 overweight based on BMI; all were sarcopenic based on appendicular fat free mass index (AFFMI); and 7 were sarcopenic obese based on AFFMI and % fat mass. Average muscle strength was reduced below 50% of normal. The 6MWD was in BM patients 30% less than normal. FVC was reduced in 4 of the BM patients. Muscle strength had a good correlation with the physical function variables. Correlation between muscle strength and BMI was poor; it was very high with AFFMI. AFFMI was the best single explicator of muscle strength and physical function. Conclusion. Muscle mass determined by DXA explains most of the variability of the measures of muscle strength and physical function in patients with BM and UCMD. © 2013 Maria Teresa Miscione et al.

Pallucca F.,Medicina Generale
Rivista Italiana della Medicina di Laboratorio | Year: 2010

The metabolic syndrome (MS) is a cluster of conditions that includes abdominal obesity, increased blood glucose, hypertension, abnormal HDL cholesterol and triglycerides levels. In the US about 47 million adults (25%) have MS. In Italy, about 7 million adults are affected by the disease. MS is linked to insulin resistance; in this condition, cells do not respond normally to insulin that becomes less effective at lowering blood sugars. General Practitioners (GP) provide preventive care and health education to patients at risk of cardiovascular disease and diabetes, through educational strategies. These strategies include patient-centered counselling; a four-step triage to select the population at risk; application of the Disease Management Program (DMP) with Care Manager (CM) in order to support GPs and specialists work. Leonardo Project shows that is possible to apply a Disease Care Management Program in patients with major factors determinate MS.

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