title: Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients.
abstract: BACKGROUND
  Statins are at the forefront of strategies to manage dyslipidemia, although they are not always well tolerated. At 6-7 months after the drug was supplied, discontinuation rates averaged 30%. Alternate agents to statins have been studied. Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations. However, there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients. The purpose of this study was to examine the efficacy, safety, and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins.
  
  
  METHODS
  This study was performed as a randomized, prospective, parallel group, single-blind study. Patients were included in the study if they had high total cholesterolemia, high low-density lipoprotein cholesterol (LDL-C), >75 years of age, statin-intolerant, and were refusing other pharmaceutical treatments for hypercholesterolemia. At the baseline visit, eligible patients were randomized to either nutraceutical-combined pill (containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2.0 mg, and astaxanthin 0.5 mg) or placebo, and the first dose was dispensed. The efficacy, safety, and tolerability of the proposed treatment were fully assessed after 3, 6, and 12 months of treatment.
  
  
  RESULTS
  Out of 106 consecutive patients screened, 80 eligible patients were randomized to receive either nutraceutical-combined pill (40 patients) or placebo (40 patients). No patients were lost and no deaths occurred during the follow-up. There was a statistically significant reduction in total cholesterolemia (-20%), LDL-C (-31%), and insulin resistance (-10%) with nutraceutical treatment. No significant changes were detected for plasma high-density lipoprotein cholesterol (HDL-C). Furthermore, no statistical differences were found between baseline and end-study safety parameters. Medication compliance and tolerability were high.
  
  
  CONCLUSIONS
  In this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant. Combined nutraceuticals is also safe and well tolerated in these patients.
authors: Department of Medical Sciences, IRCCS San Raffaele, Rome, Italy. giuseppe.marazzi@sanraffaele.it
authors: Giuseppe
authors: G
authors: Marazzi
authors: Luca
authors: L
authors: Cacciotti
authors: Francesco
authors: F
authors: Pelliccia
authors: Luigi
authors: L
authors: Iaia
authors: Maurizio
authors: M
authors: Volterrani
authors: Giuseppe
authors: G
authors: Caminiti
authors: Barbara
authors: B
authors: Sposato
authors: Rosalba
authors: R
authors: Massaro
authors: Fabrizia
authors: F
authors: Grieco
authors: Giuseppe
authors: G
authors: Rosano
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000924:Anticholesteremic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001599:Berberine / Q000494:pharmacology / Q000627:therapeutic use; D001688:Biological Products / Q000494:pharmacology / Q000627:therapeutic use; D001786:Blood Glucose / Q000187:drug effects; D002784:Cholesterol / Q000097:blood; D019587:Dietary Supplements; D005233:Fatty Alcohols / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D005492:Folic Acid / Q000627:therapeutic use; D006801:Humans; D006937:Hypercholesterolemia / Q000188:drug therapy*; D008077:Lipoproteins, LDL / Q000097:blood; D008297:Male; D055118:Medication Adherence; D011446:Prospective Studies; D016037:Single-Blind Method; D014451:Ubiquinone / Q000031:analogs & derivatives / Q000627:therapeutic use; D024341:Xanthophylls / Q000627:therapeutic use
chemical_list: D000924:Anticholesteremic Agents; D001688:Biological Products; D001786:Blood Glucose; D005233:Fatty Alcohols; D008077:Lipoproteins, LDL; D024341:Xanthophylls; C117343:red yeast rice; D001599:Berberine; D014451:Ubiquinone; C080710:policosanol; C005948:astaxanthine; D005492:Folic Acid; D002784:Cholesterol; C024989:coenzyme Q10