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Procopio G.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Verzoni E.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Bracarda S.,Ospedale San Donato | Ricci S.,O.M. Santa Chiara | And 6 more authors.
British Journal of Cancer | Year: 2011

Background: Preclinical investigations support combining sorafenib with IL-2 in the treatment of metastatic renal cell carcinoma (mRCC). Methods: In this open-label, phase II study, 128 patients with mRCC were randomised to receive oral sorafenib, 400 mg twice daily, plus subcutaneous IL-2, 4.5 million international units (MIU) five times per week for 6 in every 8 weeks, or sorafenib alone. After enrolment of the first 40 patients, IL-2 dose was reduced to improve the tolerability. Results: After a median follow-up of 27 months, median progression-free survival (PFS) was 33 weeks with sorafenib plus IL-2, and 30 weeks with sorafenib alone (P=0.109). For patients receiving the initial higher dose of IL-2, median PFS was 43 weeks vs 31 weeks for those receiving the lower dose. The most common adverse events were asthenia, hand-foot syndrome, hypertension, and diarrhoea. Grade 3-4 adverse events were reported for 38 and 25% of patients receiving combination and single-agent treatment, respectively. Conclusion: The combination of sorafenib and IL-2 did not demonstrate improved efficacy vs sorafenib alone. Improvements in PFS appeared greater in patients receiving higher-dose IL-2. © 2011 Cancer Research UK All rights reserved.


Tavazzi L.,GVM Hospitals of Care and Research | Senni M.,Papa Giovanni XXIII Hospital | Metra M.,University of Brescia | Gorini M.,Research Center | And 6 more authors.
Circulation: Heart Failure | Year: 2013

Background.Clinical observational studies on heart failure (HF) deal mostly with hospitalized patients, few with chronic outpatients, all with no or limited longitudinal observation. Methods and Results.This is a multicenter, nationwide, prospective observational trial on a population of 5610 patients, 1855 hospitalized for acute HF (AHF) and 3755 outpatients with chronic HF (CHF), followed up for 1 year. The cumulative total mortality rate at 1 year was 24% in AHF (19.2% in 797 patients with de novo HF and 27.7% in 1058 with worsening HF) and 5.9% in CHF. Cardiovascular deaths accounted for 73.1% and 65.3% and HF deaths for 42.4% and 40.5% of total deaths in AHF and CHF patients, respectively. One-year hospitalization rates were 30.7% in AHF and 22.7% in CHF patients. Among the independent predictors of 1-year all-cause death, age, low systolic blood pressure, anemia, and renal dysfunction were identified in both acute and chronic patients. A few additional variables were significant only in AHF (signs of cerebral hypoperfusion, low serum sodium, chronic obstructive pulmonary disease, and acute pulmonary edema), whereas others were observed only in CHF patients (lower body mass index, higher heart rate, New York Heart Association class, large QRS, and severe mitral regurgitation). Conclusions.In this contemporary data set, patients with CHF had a relatively low mortality rate compared with those with AHF. Rates of adverse outcomes in patients admitted for AHF remain very high either in-hospital or after discharge. Most deaths were cardiovascular in origin and .40% of deaths were directly related to HF. © 2013 American Heart Association, Inc.


Oliva F.,Niguarda Hospital | Oliva F.,Outcome Coordinating Center | Mortara A.,Policlinico di Monza | Cacciatore G.,San Giovanni Addolorata Hospital | And 7 more authors.
European Journal of Heart Failure | Year: 2012

Aims Registries and surveys improve knowledge of the 'real world'. This paper Aims to describe baseline clinical profiles, management strategies, and the in-hospital outcome of patients admitted to hospital for an acute heart failure (AHF) episode.Methods and resultsIN-HF Outcome is a nationwide, prospective, multicentre, observational study conducted in 61 Cardiology Centres in Italy. Up to December 2009, 5610 patients had been enrolled, 1855 (33) with AHF and 3755 (67) with chronic heart failure (CHF). Baseline and in-hospital outcome data of AHF patients are presented. Mean age was 72 ± 12 years, and 39.8 were female. Hospital admission was due to new-onset heart failure (HF) in 43 of cases. Co-morbid conditions were observed more frequently in the worsening HF group, while those with de novo HF showed a higher heart rate, blood pressure, and more preserved left ventricular ejection fraction (LVEF). Electrical devices were previously implanted in 13.3 of the entire group. Inotropes were administered in 19.4 of the patients. The median duration of hospital stay was 10 days (interquartile range 7-15). All-cause in-hospital death was 6.4, similar in worsening and de novo HF. Older age, hypotension, cardiogenic shock, pulmonary oedema, symptoms of hypoperfusion, hyponatraemia, and elevated creatinine were independent predictors of all-cause death.ConclusionOur registry confirms that in-hospital mortality in AHF is still high, with a long length of stay. Pharmacological treatment seems to be practically unchanged in the last decades, and the adherence to HF guidelines concerning implantable cardioverter defibrillators/cardiac resynchronization therapy is still very low. Some AHF phenotypes are characterized by worst prognosis and need specific research projects. © 2012 The Author.


Rosato V.,Instituto Of Ricerche Farmacologiche Mario Negri | Bosetti C.,Instituto Of Ricerche Farmacologiche Mario Negri | Talamini R.,Centro Of Riferimento Oncologico | Levi F.,University of Lausanne | And 6 more authors.
Annals of Oncology | Year: 2011

Background: Only a few small studies investigated the association between postmenopausal breast cancer and metabolic syndrome (MetS) as a single entity. Materials and methods: We analyzed the data of two Italian and Swiss case-control studies conducted between 1983 and 2007, including 3869 postmenopausal women with incident breast cancer and 4082 postmenopausal controls admitted to the same hospitals as cases for acute conditions. MetS was defined as the presence of at least three components among diabetes, drug-treated hypertension, drug-treated hyperlipidemia, and obesity. Results: The odds ratios (ORs) of postmenopausal breast cancer were 1.33 [95% confidence interval (CI) 1.09-1.62] for diabetes, 1.19 (95% CI 1.07-1.33) for hypertension, 1.08 (95% CI 0.95-1.22) for hyperlipidemia, 1.26 (95% CI 1.11-1.44) for body mass index ≥30 kg/m 2, and 1.22 (95% CI 1.09-1.36) for waist circumference ≥88 cm. The risk of postmenopausal breast cancer was significantly increased for women with MetS (OR = 1.75, 95% CI 1.37-2.22, for three or more MetS components, P for trend for increasing number of components < 0.0001) and the risk was higher at older age (OR = 3.04, 95% CI 1.75-5.29, at age ≥70 years for three or more MetS components). Conclusions: This study supports a direct association between MetS and postmenopausal breast cancer risk. © The Author 2011. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.


Rondanelli M.,University of Pavia | Giacosa A.,Policlinico di Monza | Opizzi A.,University of Pavia | Pelucchi C.,Mario Negri Institute for Pharmacological Research | And 6 more authors.
Journal of the American College of Nutrition | Year: 2010

Objective: In elderly individuals, depression is one of the most frequently missed diagnoses with negative effects on quality of life. The authors investigated whether a supplement containing long-chain omega-3 polyunsaturated fatty acids (n-3 LCPUFA) improves depressive symptoms and health-related quality of life (HRQoL) in depressed elderly patients. Design: Eight-week, randomized, double-blind, placebo-controlled trial. Setting: Nursing home in Pavia, Italy. Participants: Forty-six depressed women, aged 66-95 years. Intervention: Twenty-two depressed women were included in the intervention group (n-3 group, which received 2.5 g/d of n-3 LCPUFA, with 1.67 g of eicosapentaenoic acid [EPA] and 0.83 g of docosahesaenoic acid [DHA]), and 24 patients were included in the placebo group. The primary endpoint was the improvement of depressive symptoms, as evaluated by the Geriatric Depression Scale (GDS). Secondary endpoints were the evaluation of HRQoL, by using the Short-Form 36-Item Health Survey (SF-36), and modifications of erythrocyte membrane phospholipids fatty acid profile. All variables were assessed before and after the treatment period of 8 weeks. Results: The mean GDS at 8 weeks was significantly lower compared with the n-3 group. The SF-36 physical and mental components were significantly increased in the intervention group. Compliance was good, as confirmed by erythrocyte membrane phospholipid FA concentrations, with a significant increase of EPA and DHA in the intervention group. Conclusion: Supplementation with n-3 LCPUFA is efficacious in the amelioration of depressive symptoms and quality of life in the treatment of depressed elderly female patients.


Rondanelli M.,University of Pavia | Giacosa A.,Policlinico di Monza | Orsini F.,University of Pavia | Opizzi A.,University of Pavia | Villani S.,University of Pavia
Phytotherapy Research | Year: 2011

The management of overweight may include the use of dietary supplements targeted to favour the increase of the satiation associated with a decrease in blood glucose and lipid levels. The aim of this study was to evaluate the efficacy of a dietary supplementation with an extract from Phaseolus vulgaris and Cynara scolymus, on satiation, the glucose and lipid pattern. A randomized, double-blind, placebo-controlled clinical trial was performed in 39 overweight subjects (20 supplemented group, 19 placebo group) for 2months. The modification of satiation, by Haber's scale, was the primary end-point, and the variation of the glucose and lipid pattern, of the anthropometric parameters and of the psychodynamic tests score were the secondary end-points. At the end of treatment, the net change of the Haber's mean score increased significantly in the intervention group. The net change of the glycaemia and of the dietary restriction score of the three factor eating questionnaire (TFEQ), were reduced significantly only in the intervention group. Moreover, in the supplemented group, the homeostasis model assessment, the body mass index and the susceptibility-to-hunger score of the TFEQ, decreased significantly after intervention; these parameters did not change in the controls. This treatment appears potentially useful in the management of overweight and dysglycaemia. Copyright © 2011 John Wiley & Sons, Ltd.


Meroni R.,University of Milan Bicocca | Cerri C.G.,University of Milan Bicocca | Lanzarini C.,Policlinico di Monza | Gessaga V.,University of Milan Bicocca | And 2 more authors.
Clinical Journal of Sport Medicine | Year: 2010

OBJECTIVES: To compare a passive and an active stretching technique to determine which one would produce and maintain the greatest gain in hamstring flexibility. To determine whether a passive or an active stretching technique results in a greater increase in hamstring flexibility and to compare whether the gains are maintained. DESIGN: Randomized controlled trial. SETTING: Institutional. PARTICIPANTS: Sixty-five volunteer healthy subjects completed the enrollment questionnaire, 33 completed the required 75% of the treatment after 6 weeks, and 22 were assessed 4 weeks after the training interruption. INTERVENTION: A 6-week stretching program with subjects divided into 2 groups with group 1 performing active stretching exercises and group 2 performing passive stretching exercises. MAIN OUTCOME MEASURES: Range of motion (ROM) was measured after 3 and 6 weeks of training and again 4 weeks after the cessation of training and compared with the initial measurement. RESULTS: After 3 weeks of training, the mean gain in group 1 (active stretching) on performing the active knee extension range of motion (AKER) test was 5.7°, whereas the mean gain in group 2 (passive stretching) was 3° (P =.015). After 6 weeks of training, the mean gain in group 1 was 8.7°, whereas the mean gain in group 2 was 5.3° (P =.006). Twenty-two subjects were reassessed 4 weeks after the cessation of the training with the maintained gain of ROM in group 1 being 6.3°, whereas the maintained gain in group 2 was 0.1° (P =.003). CONCLUSIONS: Active stretching produced the greater gain in the AKER test, and the gain was almost completely maintained 4 weeks after the end of the training, which was not seen with the passive stretching group. Active stretching was more time efficient compared with the static stretching and needed a lower compliance to produce effects on flexibility. © 2010 by Lippincott Williams & Wilkins.


Giacosa A.,Policlinico di Monza | Rondanelli M.,University of Pavia
Journal of Clinical Gastroenterology | Year: 2010

The metabolic syndrome (MS) is a clustering of hyperglycemia/insulin resistance, dyslipidemia, overweight and hypertension. MS identifies patients who are at high risk of developing atherosclerotic cardiovascular disease (CVD) and type 2 diabetes (T2D). Based on current data dietary fibre intake from whole foods or supplements may lower blood pressure, may improve serum lipid levels,may reduce indicators of inflammations,may lower serum glucose levels and favour body weight loss. US Food and Drug Adminstration in 2006 authorized a health claim that psyllium husk, beta glucan in oats and beta glucan in barley can reduce the risk of heart disease. Solubility in water, viscosity, fermentability, and the kind and amounts of protein and tocotrienols have been explored as possible basis for this effect. In particular, many experimental and clinical studies suggest that psyllium does lower serum and liver cholesterol concentrations and may increase HDL-cholesterol levels- Moreover,water soluble fibres, such as psyllium, moderate post prandial glucose and insulin concentrations in non-insulin dependent diabetic patients, if taken with meals and favour the reduction of body weight and hypertension. Therefore, the favourable effect of various fibres and particularly of psyllium, on body weight reduction and satiety, on cholesterol and tryglycerides levels, on fasting glycaemia and on blood pressure suggests a potential role of these fibres in the treatment of MS. Copyright © 2010 by Lippincott Williams & Wilkins.


Pisani P.,Ncc Citta Of Alessandria Hospital | Sandrelli L.,Ncc Citta Of Alessandria Hospital | Fabbrocini M.,Ncc Citta Of Alessandria Hospital | Tesler U.F.,Policlinico di Monza | Medici D.,Ncc Citta Of Alessandria Hospital
Texas Heart Institute Journal | Year: 2014

Percutaneous closure of the left atrial appendage (LAA) is a new approach to the prevention of cardioembolic events in patients with atrial fibrillation. We implanted an LAA occlusion device (Amplatzer™ Cardiac Plug) in a 70-year-old woman via a transseptal approach. Upon her discharge from the hospital, a transthoracic echocardiogram showed stable anchoring of the device; 6 months after implantation, a routine transthoracic echocardiogram revealed migration of the occluder into the left ventricular outflow tract, in the absence of symptoms. We surgically removed the device from the mitral subvalvular apparatus and closed the LAA with sutures. This case shows that percutaneous LAA occlusion can result in serious adverse events, including device migration in the absence of signs or symptoms; therefore, careful follow-up monitoring is mandatory. © 2014 by the Texas Heart® Institute, Houston.


Scalise F.,Policlinico di Monza | Novelli E.,Biostatistics Unit | Auguadro C.,Policlinico di Monza | Casali V.,Policlinico di Monza | And 2 more authors.
Journal of Invasive Cardiology | Year: 2015

Introduction. Carbon dioxide (CO2) has been validated as a contrast agent in a large series of studies. A particular advantage of CO2 over iodinated contrast medium (ICM) is the absence of nephrotoxicity and allergic reactions. One of the limitations of CO2 angiography is the difficulty of CO2 manual injection due to its compressibility. The manual gas injection does not permit optimal control of the gas output. Development of an automated CO2 injector has overcome these problems. Aim. This study compares the feasibility, safety, and diagnostic accuracy of automated CO2 digital subtraction angiography (DSA) in comparison with ICM-DSA in the evaluation of critical limb ischemic (CLI) patients. Methods. We performed DSA with both CO2 and ICM on 40 consecutive CLI patients and directly compared the two techniques. Sixteen females and 24 males participated in the study (mean age, 71.7 years). We assessed the diagnostic accuracy of CO2 in identifying arterial stenosis in the lower limb, with ICM-DSA used as the gold standard. Results. The overall diagnostic accuracy of CO2-DSA was 96.9% (sensitivity, 99.0%; specificity, 96.1%; positive predictive value, 91.1%; negative predictive value, 99.6%). Tolerable minor symptoms occurred in 3 patients. No allergic reactions or significant decline in renal function were observed in patients receiving the CO2 injection. Conclusion. Carbon dioxide DSA is a valuable and safe alternative to traditional ICM-DSA for evaluating CLI patients. This modality should be considered as the standard choice for CLI patients undergoing angiographic evaluation who are known to have renal insufficiency or contrast allergy.

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