Pazzucconi Dott. Franco
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Exploiting routine laboratory test to identify primary severe hypertriglyceridaemic patients in a large Italian hospital.
Eur J Prev Cardiol2024 Feb;():. doi: zwae056.
Pavanello Chiara, Pazzucconi Franco, Parolini Marina, Turri Marta, Mombelli Giuliana Germana, Castiglione Sofia, Alberti Antonia, De Maria Renata, Calabresi Laura
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Systematic Lab Knowledge Integration for Management of Lipid Excess in High-Risk Patients: Rationale and Design of the SKIM LEAN Project.
Front Big Data2018 ;1():4. doi: 4.
Pavanello Chiara, Parolini Marina, Alberti Antonia, Carenini Michele, Maino Paolo, Mombelli Giuliana, Pazzucconi Franco, Origgi Gianni, Orsi Federica, Trivella Maria Giovanna, Calabresi Laura, De Maria Renata
Abstract
SKIM LEAN aims at exploiting Electronic Health Records (EHRs) to integrate knowledge derived from routine laboratory tests with background analysis of clinical databases, for the identification and early referral to specialist care, where appropriate, of patients with hypercholesterolemia, who may be inadequately controlled according to their cardiovascular (CV) risk level. SKIM LEAN addresses gaps in care that may occur through the lack of coordination between primary and specialist care, incomplete adherence to clinical guidelines, or poor patient's compliance to the physician's prescriptions because of comorbidities or drug side effects. Key project objectives include: (1) improved health professionals' competence and patient empowerment through a two-tiered educational website for general practitioners (GPs) and patients, and (2) implementation of a hospital-community shared care pathway to increase the proportion of patients at high/very-high CV risk (Familial Hypercholesterolemia, previous CV events) who achieve target LDL cholesterol (LDL-C) levels. Thanks to a close collaboration between clinical and information technology partners, SKIM LEAN will fully exploit the value of big data deriving from EHRs, and filter such knowledge using clinically-derived algorithms to risk-stratify patients. Alerts for GPs will be generated with interpreted test results. GPs will be able to refer patients with uncontrolled LDL-C within the shared pathway to the lipid or secondary prevention outpatient clinics of NIG hospital. Metrics to verify the project achievements include web-site visits, the number of alerts generated, numbers of patients referred by GPs, the proportion of secondary prevention patients who achieve LDL-C 50% decrease from baseline.
Copyright © 2018 Pavanello, Parolini, Alberti, Carenini, Maino, Mombelli, Pazzucconi, Origgi, Orsi, Trivella, Calabresi and De Maria.
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Indicators of Cardiovascular Risk in Metabolic Syndrome: Long Term Follow-up in Italian Patients.
Curr Vasc Pharmacol2017 ;15(3):248-256. doi: 10.2174/1570161115666170126124149.
Mombelli Giuliana, Pavanello Chiara, Castelnuovo Samuela, Bosisio Raffaella, Simonelli Sara, Pazzucconi Franco, Sirtori Cesare Riccardo
Abstract
BACKGROUND:
Cardiovascular risk (CV) factors associated with the metabolic syndrome (MetS) may vary in different populations. In some, hypertension may be the major determinant, in others are low high-density lipoprotein cholesterol (HDL-C), high triglycerides, or another component.
SUBJECTS AND METHODS:
Subjects included in this analysis were identified in 2006, among those attending the Lipid Clinic of the Niguarda Hospital, and followed up through to 2013. Patient characteristics (including the occurrence of CV events) were obtained from electronic medical records. MetS was diagnosed according to the American Heart Association/National Heart, Lung and Blood Institute (AHA/NHLBI) guidelines. The carotid intima media thickness (cIMT) was also followed in these patients over the years.
RESULTS:
After 7 years a total of 858 subjects had a complete follow-up; 271 of those had MetS. Patients developing a CV event showed elevated baseline cIMT (e.g. cIMTmax ? 2.4 mm in males and ? 2.2 mm in females); moreover the cIMT in MetS patients was higher at baseline and the rise over 7 years was larger compared with patients without MetS. By examining each body variable for MetS we found that a waist to height ratio (WHtR) ? 0.5 was present in nearly all subjects with a CV event.
CONCLUSION:
The follow-up data of a series of Italian patients with and without MetS, clearly indicates that the former have a raised cIMT and their arterial IMT progression is greater and the presence of a larger WHtR is apparently linked to a higher incidence of CV events.
Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.
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Gender-related lipid and/or lipoprotein responses to statins in subjects in primary and secondary prevention.
J Clin Lipidol2015 ;9(2):226-33. doi: 10.1016/j.jacl.2014.12.003.
Mombelli Giuliana, Bosisio Raffaella, Calabresi Laura, Magni Paolo, Pavanello Chiara, Pazzucconi Franco, Sirtori Cesare R
Abstract
BACKGROUND:
Cardiovascular risk in men rises around the fourth decade of life, whereas women appear to be protected by sex hormones until menopause. This, in turn, tends to negatively affect the lipid profile. Since the 1980s, the incidence of cardiovascular diseases has been reported to progressively decline in men, but it has persisted almost unchanged in women. Major clinical trials on statins have been mostly conducted in men and have fostered the introduction of these agents into clinical practice worldwide. However, only few reports have examined a possible differential activity of statins in the 2 genders, providing in some cases opposite findings.
OBJECTIVE:
To evaluate gender-related differences in statin responses.
METHODS:
Variations of lipid profile after 1-year of treatment with different statins in 337 dyslipidemic patients (171 men and 166 women).
RESULTS:
In this series of patients, a significantly attenuated reduction of total cholesterol and low-density lipoprotein cholesterol in women vs men on drug treatment was noted after adjustment for dose and statin power (low-density lipoprotein cholesterol: -28.5 ± 11.8% in men vs -22.7 ± 11.8% in women; P
CONCLUSIONS:
The present study indicates that statin treatment has a reduced effectiveness in improving the plasma lipid profile in dyslipidemic women vs men. Whether such gender-related differences may have an impact on clinical outcomes remains to be elucidated.
Copyright © 2015 National Lipid Association. Published by Elsevier Inc. All rights reserved.
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Nutraceutical approach to moderate cardiometabolic risk: results of a randomized, double-blind and crossover study with Armolipid Plus.
J Clin Lipidol2014 ;8(1):61-8. doi: 10.1016/j.jacl.2013.11.003.
Ruscica Massimiliano, Gomaraschi Monica, Mombelli Giuliana, Macchi Chiara, Bosisio Raffaella, Pazzucconi Franco, Pavanello Chiara, Calabresi Laura, Arnoldi Anna, Sirtori Cesare R, Magni Paolo
Abstract
BACKGROUND:
Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs, although a relevant role is now emerging for specific functional foods and nutraceuticals.
OBJECTIVES:
The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment.
SUBJECTS:
Thirty patients with moderate dyslipidemia and metabolic syndrome (according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults) were included in an 8-week randomized, double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract, berberine, policosanol, astaxanthin, coenzyme Q10, and folic acid (Armolipid Plus). Subsequently, they were subjected to another 8-week treatment with pravastatin 10 mg/d. This dosage was selected on the basis of its expected -20% efficacy in reducing low-density lipoprotein-cholesterol.
RESULTS:
Treatment with Armolipid Plus led to a significant reduction of total cholesterol (-12.8%) and low-density lipoprotein-cholesterol (-21.1%), similar to pravastatin (-16% and -22.6%, respectively), and an increase of high-density lipoprotein-cholesterol (4.8%). Armolipid Plus improved the leptin-to-adiponectin ratio, whereas adiponectin levels were unchanged.
CONCLUSIONS:
These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment. Hence, it may be a safe and useful option, especially in conditions of moderate cardiovascular risk, in which a pharmacologic intervention may not be appropriate.
Copyright © 2014 National Lipid Association. Published by Elsevier Inc. All rights reserved.
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Hypocholesterolaemic effects of lupin protein and pea protein/fibre combinations in moderately hypercholesterolaemic individuals.
Br J Nutr2012 Apr;107(8):1176-83. doi: 10.1017/S0007114511004120.
Sirtori Cesare R, Triolo Michela, Bosisio Raffaella, Bondioli Alighiero, Calabresi Laura, De Vergori Viviana, Gomaraschi Monica, Mombelli Giuliana, Pazzucconi Franco, Zacherl Christian, Arnoldi Anna
Abstract
The present study was aimed to evaluate the effect of plant proteins (lupin protein or pea protein) and their combinations with soluble fibres (oat fibre or apple pectin) on plasma total and LDL-cholesterol levels. A randomised, double-blind, parallel group design was followed: after a 4-week run-in period, participants were randomised into seven treatment groups, each consisting of twenty-five participants. Each group consumed two bars containing specific protein/fibre combinations: the reference group consumed casein+cellulose; the second and third groups consumed bars containing lupin or pea proteins+cellulose; the fourth and fifth groups consumed bars containing casein and oat fibre or apple pectin; the sixth group and seventh group received bars containing combinations of pea protein and oat fibre or apple pectin, respectively. Bars containing lupin protein+cellulose ( - 116 mg/l, - 4·2%), casein+apple pectin ( - 152 mg/l, - 5·3%), pea protein+oat fibre ( - 135 mg/l, - 4·7%) or pea protein+apple pectin ( - 168 mg/l, - 6·4%) resulted in significant reductions of total cholesterol levels (P
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Paradoxical decrease in high-density lipoprotein cholesterol with fenofibrate: a quite rare phenomenon indeed.
Cardiovasc Ther2010 Jun;28(3):153-60. doi: 10.1111/j.1755-5922.2009.00121.x.
Mombelli Giuliana, Pazzucconi Franco, Bondioli Alighiero, Zanaboni AnnaMaria, Gaito Sabrina, Calabresi Laura, Sirtori Cesare R
Abstract
Some recent clinical reports have suggested that paradoxical decreases in high-density lipoprotein cholesterol (HDL-C) levels after fenofibrate treatment may be quite common. These appear to occur mainly in patients with combined fibrate/statin therapy and possibly in those with low baseline HDL-C. Reports on HDL-C reductions after fenofibrate are possibly supported by the disappointing results in terms of HDL-C responses from the recent FIELD study. A survey on 581 patients treated for 1 year or longer was carried out in our Clinical Center. This indicated that paradoxical HDL-C reductions are a relatively uncommon phenomenon. Not more than 15.3% of the present series showed an HDL-C reduction, mostly of a modest degree. Further, reductions of HDL-C appear to occur mainly in individuals with significant HDL-C elevations (>50 mg/dL), almost never in patients with low HDL-C. Otherwise, there seems to be no impact of a previous diagnosis of diabetes or hypertension on the HDL-C changes. From a very recent pharmacogenomic study on the apo A1/C3/A4/A5 gene cluster, genetic influences appear only to reduce the positive impact of fenofibrate on HDL-C, but do not indicate any risk of occurrence of HDL-C reductions. Also based on our very long experience with this drug, it appears that fenofibrate raises HDL-C levels in the vast majority of treated patients, with a particularly dramatic effect in individuals with low HDL-C and hypertriglyceridemia.
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Serum from hypercholesterolemic patients treated with atorvastatin or simvastatin inhibits cultured human smooth muscle cell proliferation.
Pharmacol Res2007 Dec;56(6):503-8.
Arnaboldi Lorenzo, Guzzetta Massimiliano, Pazzucconi Franco, Radaelli Giovanni, Paoletti Rodolfo, Sirtori Cesare R, Corsini Alberto
Abstract
We evaluated the pharmacological activity of whole-blood serum from atorvastatin- vs. simvastatin- (both 40 mg/day) treated hypercholesterolemic patients (n=10) on cultured smooth muscle cell (SMC) proliferation and cholesterol biosynthesis, as related to lipid-lowering effect. Patients received either single or 2-weeks repeated doses of both simvastatin and atorvastatin, following a randomised, double-blind, cross-over design. Blood samples were collected before drug administration and at the scheduled intervals after administration, and the obtained serum was separated by centrifugation, sterilized and frozen until assayed. Cultured SMC were supplemented with medium plus 15% of separate serum sampled from the patients, and grown for 72 h. Proliferation was assayed by a Coulter Counter, while cholesterol biosynthesis was measured by the incorporation of 14C-acetate into cholesterol, under the same experimental conditions. Atorvastatin was more active vs. simvastatin in reducing total- (-28.3% vs. -20.7%; p=0.045) and LDL-cholesterol (-39.8% vs. -30.1%; p=0.011) after a 2-weeks regimen. Serum from atorvastatin-treated patients inhibited SMC proliferation vs.t=0 after both single (AUC -21.6%) and repeated (AUC -26.9%) doses, while serum from simvastatin-treated patients inhibited SMC proliferation only after repeated doses (AUC -24.5%). Interestingly, in the same experimental conditions, the serum concentrations of both statins (and of their active metabolites) were constantly below the detection limits, as shown from the lack of inhibition of cholesterol biosynthesis. The absence of any significant association between the lipid-lowering effects and the inhibition of SMC proliferation, together with no detectable active statin in the serum, suggests that these effects are elicited through independent mechanisms.
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Pharmacokinetic interactions between omeprazole/pantoprazole and clarithromycin in health volunteers.
Pharmacol Res2004 May;49(5):493-9.
Calabresi Laura, Pazzucconi Franco, Ferrara Stefano, Di Paolo Antonello, Tacca Mario Del, Sirtori Cesare
Abstract
The association omeprazole/clarithromycin is of current wide use in the treatment of Helicobacter pylori associated gastroduodenal ulcer. This combination may result in increased levels of omeprazole with potential interactions with commonly associated drugs. Kinetic/metabolic changes occurring after omeprazole/clarithromycin were compared to those occurring after pantoprazole/clarithromycin in healthy volunteers. Eight healthy volunteers, all males, age 25-34 years, all EM for CYP2C19, participated in a randomized, double blind crossover study in two periods of 7 days, separated by a 14-day washout. In each treatment period, subjects took either omeprazole 20mg b.i.d. together with clarithromycin 500 mg b.i.d., or pantoprazole 40 mg b.i.d. with the same dose of the antibiotic. The pharmacokinetic parameters of omeprazole and pantoprazole were compared to those after intake of both agents alone. Kinetics of unchanged clarithromycin was evaluated at the end of the two periods. The mean value of the area under the plasma concentration versus time curve (AUC) of unchanged omeprazole increased almost two-fold after concomitant administration of clarithromycin; the average 5-OH-omeprazole AUC was instead significantly reduced by 42%. Omeprazole clearance and volume of distribution were reduced significantly by 75 and 56%, respectively, after administration of the drug with clarithromicyn. No significant changes of the kinetic of pantoprazole and metabolites were observed. Kinetics of clarithromycin did not differ after the two associated treatments. The administration of clarithromycin with two different proton pump inhibitors indicates that the antibiotic can markedly increase omeprazole, not pantoprazole, levels. This observation may result in a better therapeutic response to omeprazole, but it may also potentially affect either the metabolism of CYP3A4 substrates or interfere with the absorption of drugs requiring an intact gastric digestion system.
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Enantioselective liquid chromatographic-electrospray mass spectrometric assay of beta-adrenergic blockers: application to a pharmacokinetic study of sotalol in human plasma.
J Chromatogr B Analyt Technol Biomed Life Sci2003 Oct;796(1):45-54.
Badaloni Elena, D'Acquarica Ilaria, Gasparrini Francesco, Lalli Silvana, Misiti Domenico, Pazzucconi Franco, Sirtori Cesare R
Abstract
An enantioselective high performance liquid chromatographic-electrospray ionization mass spectrometric (HPLC-ESI-MS) method for the direct determination of several beta-adrenergic blockers was developed and validated. The method is based on the direct separation of the enantiomers of drugs on a laboratory-made chiral stationary phase (CSP) containing covalently bonded teicoplanin (TE) as chiral selector. Detection of the effluent was performed by electrospray ionization mass spectrometry, run in the selected-ion recording (SIR) mode. The method was applied to the pharmacokinetic monitoring of sotalol (STL) in the plasma of five young healthy volunteers, dosed with racemic drug. The limits of quantitation (LOQ) reached 4 ng/ml for both sotalol enantiomers. Such a method, fully validated, offers a novel, fast and very efficient tool for the direct determination of sotalol enantiomers in human plasma, and can be generally applied to the beta-adrenergic blockers stereoselective pharmacokinetics.
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Soy milk with a high glycitein content does not reduce low-density lipoprotein cholesterolemia in type II hypercholesterolemic patients.
Ann Nutr Metab2002 ;46(2):88-92.
Sirtori Cesare R, Bosisio Raffaella, Pazzucconi Franco, Bondioli Alighiero, Gatti E, Lovati Maria Rosa, Murphy Patricia
Abstract
In order to evaluate acceptability and effectiveness of a partial addition of soy protein to the daily diet in well-established type II hypercholesterolemic individuals, a double-blind study was carried out with a soy milk providing 25 g/day of protein versus an identically formulated cow's milk. Twenty patients with type II hypercholesterolemia, 4 males and 16 females, age range 38-76 years, all with cholesterol levels >7 mmol/l and low-density lipoprotein cholesterol
Copyright 2002 S. Karger AG, Basel
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