title: Aterofisiol(®) in carotid plaque evolution.
abstract: BACKGROUND
  In patients with carotid stenosis, the risk of plaque rupture is related to the composition of the atherosclerotic plaque rather than to its magnitude. In this regard, we evaluated the effects of a supplement, Aterofisiol,(®) containing omega-3 (EPA [eicosapen acid] DHA [docosahexaenoic acid]), vitamin K2, vitamin B6, vitamin B12, oligomeric proanthocyanidins (OPC) and resveratrol on the composition of atherosclerotic plaque and on neurological symptoms in patients with carotid stenosis undergoing carotid endarterectomy.
  
  
  METHODS
  The study was randomized, prospective, and double-blinded. Eligible patients were of both sexes, with carotid stenosis >70% who underwent endarterectomy. Enrolled patients were randomly allocated to receive either one tablet of acetylsalicylic acid 100 mg (Cardioaspirin(®)) + one tablet of Aterofisiol every 24 hours or one tablet of Cardioaspirin + one tablet of placebo every 24 hours. Each treatment was started 30 days before the surgery and was stopped 5 days before the surgery. The plaques were removed "en bloc" using standard surgical technique.
  
  
  RESULTS
  During the study period, 214 patients (135 men and 79 women) were enrolled for intent-to-treat and randomized in two groups: Group A: 107 patients (68 men and 39 women) were treated with Cardioaspirin + Aterofisiol. Group B: 107 patients (67 men and 40 women) were treated with Cardioaspirin + placebo. At the end of the study, 202 patients participated fully (103 patients in Group A and 99 patients in Group B), making up the protocol evaluation population (94.4%). The mean lipid content of removed plaques was significantly lower (P<0.05) in Group A. We recorded a significantly lower incidence of neurological symptoms in Group A in comparison with Group B (P<0.05).
  
  
  CONCLUSIONS
  In the study, Aterofisiol showed to be effective in reducing the amounts of cholesterol and lipids in the plaques and in reducing adverse neurological events in the study group with respect to controls.
authors.affiliation: Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Catanzaro, Italy ; Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Amato
authors.affiliation: Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Catanzaro, Italy ; Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy.
authors.forename: Rita
authors.initials: R
authors.lastname: Compagna
authors.affiliation: Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Amato
authors.affiliation: Department of Health Sciences, University of Catanzaro, Catanzaro, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Gallelli
authors.affiliation: Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Catanzaro, Italy ; Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: de Franciscis
authors.affiliation: Interuniversity Center of Phlebolymphology (CIFL), International Research and Educational Program in Clinical and Experimental Biotechnology, University Magna Graecia of Catanzaro, Catanzaro, Italy ; Department of Clinical Medicine and Surgery, University Federico II of Naples, Naples, Italy ; Department of Health Sciences, University of Catanzaro, Catanzaro, Italy ; Department of Medical and Surgical Sciences, University Magna Graecia of Catanzaro, Catanzaro, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Serra
mesh_terms: D000328:Adult; D000368:Aged; D001241:Aspirin / Q000008:administration & dosage; D016893:Carotid Stenosis / Q000473:pathology / Q000601:surgery*; D019587:Dietary Supplements; D004311:Double-Blind Method; D016894:Endarterectomy, Carotid / Q000379:methods*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D058226:Plaque, Atherosclerotic / Q000188:drug therapy* / Q000473:pathology; D044945:Proanthocyanidins / Q000008:administration & dosage / Q000627:therapeutic use; D011446:Prospective Studies; D000077185:Resveratrol; D013267:Stilbenes / Q000008:administration & dosage / Q000627:therapeutic use; D014815:Vitamins / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D015525:Fatty Acids, Omega-3; D044945:Proanthocyanidins; D013267:Stilbenes; D014815:Vitamins; D000077185:Resveratrol; D001241:Aspirin
keywords: Aterofisiol®; carotid plaque; carotid stenosis; cholesterol; endarterectomy; neurological symptoms