Laboratorio di Studio, Diagnosi, Terapia delle Dislipidemie e Prevenzione della Aterosclerosi

Laboratorio di Studio, Diagnosi, Terapia delle Dislipidemie e Prevenzione della Aterosclerosi
Responsabile: Dott.ssa Claudia Stefanutti

Principali linee di ricerca

  • Ruolo dei mediatori dell’infiammazione, segnatamente le citochine e i markers di danno endoteliale nello sviluppo della lesione aterosclerotica ed in risposta a strumenti terapeutici di tipo farmacologico e non farmacologico.
  • Dislipidemie geneticamente determinate e dislipidemie nel diabete mellito e nelle nefropatie ed in gruppi speciali di popolazione: bambini e donne in età fertile ed in climaterio.
  • Clinical Trials di fase II e III su farmaci modulatori dei lipidi e delle lipoproteine plasmatiche nel contrasto alla aterosclerosi e alle sue complicanze d’organo.
  • Sperimentazione, messa a punto e validazione di prototipi di separatori cellulari e di  altre tecniche terapeutiche extracorporee innovative nell’ambito delle malattie metaboliche ed immunologiche. Studi multicentrici nazionali ed internazionali sulla aferesi terapeutica selettiva.


Collaborazioni scientifiche internazionali

  • Multidisciplinary International Group for Hemapheresis TherapY  and MEtabolic DIsturbances Contrast – Italy  / Acronimo: MIGHTY  MEDIC – I(former Italian Multicenter Study for LDL-apheresis Working Group) Coordinator: Claudia Stefanutti
  • University of Pennsylvania, School of Medicine, Institute for Translational Medicine and Therapeutics, USA (Marina Cuchel)
  • Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden Anstalt öffentlichen Rechts des Freistaates Sachsen, Medizinische Klinik und Poliklinik II, Germany (Ulrich Julius)
  • Griffith University, School of Medicine, Queensland, Australia (Ian Hamilton-Craig)
  • Clinic for Dialysis and Apheresis, Rostock, Germany (Wolfgang Ramlow)

    Advisor delle seguenti Aziende:
  • Aegerion, Pharmaceuticals, Inc., USA
  • Regeneron Pharmaceuticals, Inc., USA
  • Genzyme – Sanofi Corporate, Inc. USA
  • Fresenius Medical Care GermanyAG & Co. KGaA. Germany
  • Kaneka Pharma Europe NV, Brussels, Belgium
     

Progetti di ricerca finanziati (anni 2010-2013)

Responsabile scientifico: Claudia Stefanutti
2010 Clinical trial: “A phase III, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of lomitapide (AEGR-733) plus current maximal tolerated therapy (MTT) in subjects with severe refractory heterozygous familial hypercholesterolemia”. Aegerion, Pharmaceuticals, Inc., USA          
2010-2011 "Cytokines profile in serum of homozygous familial hypercholesterolaemia is changed by LDL-apheresis".  Kaneka Pharma Europe NV, Bruxelles, Belgium
2011 "Apheresis-inducible cytokines pattern change in severe, genetic dyslipidemias". Fresenius Medical Care, Bad Homburg, German
2011 Clinical trial: "Modifying orphan disease evaluation (MODE) study: a multicenter, open-label study of  the effects of CER-001 on plaque volume in subjects with Homozygous Familial Hypercholesterolemia HoFH)”. Cerenis™  Therapeutics, S.A., USA.
2012 Clinical trial: ”A 52-week open-label extension and safety study of Pitavastatin in high-risk hyperlipidaemia in childhood”. Kowa Research Europe Ltd
2012 Clinical trial: “A phase III, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety and efficacy of two different regimens of Mipomersen in patients with familial hypercholesterolemia and inadequately controlled low-density lipoprotein cholesterol”. Genzyme-Sanofi Corporation.
2012 Clinical trial R727-CL-1110: "A randomized, double-blind study of the efficacy and safety of REGN727 added-on to Atorvastatin versus Ezetimibe added-on to Atorvastatin versus Atorvastatin dose increase versus switch to Rosuvastatin in patients who are not controlled on Atorvastatin". Regeneron, Pharmaceuticals, Inc.USA
2012 Clinical Trial R727-CL-1118: "A randomized, double-blind study of the efficacy and safety of REGN727 added-on to Rosuvastatin versus Ezetimibe added-on to Rosuvastatin versus Rosuvastatin dose increase in patients who are not controlled on Rosuvastatin".  Regeneron Pharmaceuticals, Inc.USA


Pubblicazioni più rilevanti (anni 2010-1012)

Stefanutti C, Gozzer M, Pisciotta L, D'Eufemia P, Bosco G, Morozzi C, Papadia F, Shafii M, Di Giacomo S, Bertolini S. A three month-old infant with severe hyperchylomicronemia: Molecular diagnosis and extracorporeal treatment. Atheroscler Suppl. 2013 Jan;14(1):73-6.

Stefanutti C, Julius U. Lipoprotein apheresis: State of the art and novelties. Atheroscler Suppl. 2013 Jan;14(1):19-27.

Cuchel M, Meagher EA, du Toit Theron H, Blom DJ, Marais AD, Hegele RA, Averna MR, Sirtori CR, Shah PK, Gaudet D, Stefanutti C, Vigna GB, Du Plessis AM, Propert KJ, Sasiela WJ, Bloedon LT, Rader DJ; Phase 3 HoFH Lomitapide Study investigators. Efficacy and safety of a microsomal triglyceride transfer protein inhibitor in patients with homozygous familial hypercholesterolaemia: a single-arm, open-label, phase 3 study. Lancet. 2013 Jan 5;381(9860):40-6. Epub 2012 Nov 2. 

Stefanutti C, Morozzi C, Di Giacomo S. New clinical perspectives of hypolipidemic drug therapy in severe hypercholesterolemia. Curr Med Chem. 2012;19(28):4861-8.

Stefanutti C, Mazza F. Multiple lipid-lowering treatment in pediatric patients with hyperlipidemia. Med Chem. 2012 Nov;8(6):1171-81.

Stefanutti C, Morozzi C, Petta A. Lipid and low-density-lipoprotein apheresis. Effects on plasma inflammatory profile and on cytokine pattern in patients with severe dyslipidemia. Cytokine. 2011 Dec;56(3):842-9. Epub 2011 Sep 14. Review.

Stefanutti C, Vivenzio A, Ferraro PM, Morozzi C, Belotherkovsky D. Apheresis-inducible cytokine pattern change in severe, genetic dyslipidemias. Cytokine. 2011 Dec;56(3):835-41.  Epub 2011 Sep 14.

Stefanutti C, Vivenzio A, Di Giacomo S, Ferraro PM. Cytokines profile in serum of homozygous familial hypercholesterolemia is changed by LDL-apheresis. Cytokine. 2011 Aug;55(2):245-50.  Epub 2011 May 10.

Stefanutti C. The 2009 2nd Italian Consensus Conference on LDL-apheresis. Nutr Metab Cardiovasc Dis. 2010 Dec;20(10):761-2. Epub 2010 Aug 13.

Stefanutti C; Italian Multicenter Study on Low-density Lipoprotein Apheresis Working Group. Italian Multicenter Study on Low-Density Lipoprotein Apheresis: retrospective analysis (2007). Ther Apher Dial. 2010 Feb;14(1):79-86.