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Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients

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Abstract

Introduction

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.

Conclusion

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.

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Authors and Affiliations

  1. Department of Medical Sciences, IRCCS San Raffaele, Rome, Italy

    Giuseppe Marazzi, Maurizio Volterrani, Giuseppe Caminiti, Barbara Sposato, Rosalba Massaro & Giuseppe Rosano

  2. Cardiac Unit Vannini Hospital, Rome, Italy

    Luca Cacciotti

  3. Cardiac Unit San Filippo Neri, Rome, Italy

    Francesco Pelliccia

  4. Cardiac Unit Fatebenefratelli Isola Tiberina, Rome, Italy

    Luigi Iaia

  5. Department of Clinical Medicine, Cardiovascular Science, University of Naples Federico II, Naples, Italy

    Fabrizia Grieco

Authors
  1. Giuseppe Marazzi
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  2. Luca Cacciotti
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  3. Francesco Pelliccia
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  4. Luigi Iaia
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  5. Maurizio Volterrani
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  6. Giuseppe Caminiti
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  7. Barbara Sposato
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  8. Rosalba Massaro
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  9. Fabrizia Grieco
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  10. Giuseppe Rosano
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Correspondence to Giuseppe Marazzi.

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Marazzi, G., Cacciotti, L., Pelliccia, F. et al. Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients. Adv Therapy 28, 1105–1113 (2011). https://doi.org/10.1007/s12325-011-0082-5

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  • DOI: https://doi.org/10.1007/s12325-011-0082-5

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