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

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.

• Authors: Giuseppe Marazzi, Luca Cacciotti, Francesco Pelliccia, Luigi Iaia, Maurizio Volterrani, Giuseppe Caminiti, Barbara Sposato, Rosalba Massaro, Fabrizia Grieco, Giuseppe Rosano
• Journal: Advances in therapy (Adv Ther) Vol. 28 Issue 12 Pg. 1105-13 (Dec 2011) ISSN: 1865-8652 [Electronic] United States
• PMID: 22113535 (Publication Type: Journal Article, Randomized Controlled Trial)

Chemical References

• Anticholesteremic Agents
• Biological Products
• Blood Glucose
• Fatty Alcohols
• Lipoproteins, LDL
• Xanthophylls
• red yeast rice
• Berberine
• Ubiquinone
• policosanol
• astaxanthine
• Folic Acid
• Cholesterol
• coenzyme Q10

Topics

• Aged
• Aged, 80 and over
• Anticholesteremic Agents (administration & dosage, adverse effects, therapeutic use)
• Berberine (pharmacology, therapeutic use)
• Biological Products (pharmacology, therapeutic use)
• Blood Glucose (drug effects)
• Cholesterol (blood)
• Dietary Supplements
• Fatty Alcohols (pharmacology, therapeutic use)
• Female
• Folic Acid (therapeutic use)
• Humans
• Hypercholesterolemia (drug therapy)
• Lipoproteins, LDL (blood)
• Male
• Medication Adherence
• Prospective Studies
• Single-Blind Method
• Ubiquinone (analogs & derivatives, therapeutic use)
• Xanthophylls (therapeutic use)