A nutraceutical approach (Armolipid Plus) to reduce total and LDL cholesterol in individuals with mild to moderate dyslipidemia: Review of the clinical evidence
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Compelling evidence supports the effectiveness of the reduction of total and LDL cholesterol (TC and LDL-C) in primarily preventing cardiovascular events, within the framework of life-long prevention programs mainly consisting in lifestyle changes. Pharmacological treatment should be introduced when lifestyle changes, including use of nutraceuticals, have failed. ESC/EAS guidelines list a number of nutraceutical compounds and functional foods which have been individually studied in randomized, controlled clinical trials (RCTs). To date only a proprietary formulation of three naturally occurring substances with putative complementary lipid-lowering properties − red yeast rice, policosanol and berberine – combined with folic acid, astaxanthin, and coenzyme Q10 (Armolipid Plus®) has been extensively investigated in several RCTs, 7 of which were placebo-controlled, 2 were ezetimibe comparators and 4 were “real life” studies comparing diet and Armolipid Plus to diet alone. The trials included mostly patients with mild to moderate dyslipidemia, treated for 6–48 weeks. The trials also included special populations and patients in whom statins were contraindicated or who could not tolerate them. Armolipid Plus has proved to be able to achieve significant reductions in TC (11–21%) and in LDL-C (15–31%) levels, which is equivalent to expectations from low dose statins. In patients intolerant to statins, who do not achieve their therapeutic target with ezetimibe, Armolipid Plus can achieve a further 10% improvement in TC and LDL-C. The safety and tolerability of Armolipid Plus were excellent, thought likely due to the intentional combination of low doses of its active ingredients: low enough not to be associated with untoward effects, but high enough to exert therapeutic effects in combination with other complementary substances. Consequently, in the event of intolerance to statins, Armolipid Plus offers an effective alternative, which is devoid of the safety risks associated with synthetic pharmacological therapy. In conclusion Armolipid Plus, in addition to dietary measures, could be a rational choice for individuals with mild to moderate hyperlipidemia and for all dyslipidemic patients in whom statins are not indicated or who cannot tolerate them.
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Armolipid Plus improves vascular stiffness, an independent predictor of cardiovascular events.
“Moreover, Armolipid Plus offers the additional benefit of improving vascular stiffness, which is an independent predictor of CV events (146).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [146]
In statin-intolerant patients with mild to moderate hyperlipidemia not at target on ezetimibe, Armolipid Plus can further lower TC and LDL-C by at least 10%.
“In patients, with mild to moderate hyperlipidemia who are intolerant to statins and who do not achieve their therapeutic target with ezetimibe, Armolipid Plus can promote a further at least 10% reduction in TC and LDL-C.”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [146]
Armolipid Plus lowers TC by 11-21% and LDL-C by 15-31%, equivalent to low-dose statin changes.
“Armolipid Plus induces reductions in TC (11% to 21%; p ¼ 0.001) and LDL-C (15% to 31%; p ¼ 0.001) levels, which is equivalent to changes associated with LDS.”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [146]
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- Authors
- Barrios, V., Escobar, C., Cicero, A. F. G., Burke, D., Fasching, P., Banach, M., & Bruckert, E.
- Affiliations
- Hospital Universitario Ramón y Cajal (ES)
- Hospital Universitario La Paz (ES)
- University of Bologna (IT)
- Wilhelminen Hospital (AT)
- Medical University of Lodz (PL)
- Corresponding author
- Barrios, Vivencio
- Venue
- Atherosclerosis Supplements
- Publisher
- Elsevier BV
- Published
- 2017-02
- Volume
- 24
- Pages
- 1-15
- ISSN
- 1567-5688 (ISSN-L)
- OpenAlex
- W2561047698
- Cited by
- 96
- References
- 71
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 5 · 2023: 6 · 2022: 10 · 2021: 16 · 2020: 13 · 2019: 13 · 2018: 21 · 2017: 8
- FWCI
- 15.51
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Atherosclerosis Supplements (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- HAL (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- Lenus, The Irish Health Repository (Dr Steevens Hospital Library) (submittedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Natural Products and Biological Research
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Keywords
- nutraceuticals, dyslipidemia, hyperlipidemia, LDL cholesterol, total cholesterol, red yeast rice, policosanol, berberine, folic acid, astaxanthin, coenzyme Q10, statin intolerance, ezetimibe, lipid-lowering therapy, cardiovascular disease prevention, functional foods
- MeSH terms
- Anticholesteremic Agents, Antioxidants, Cholesterol, Drug Combinations, Humans, Cholesterol, LDL, Risk Factors, Biomarkers, Down-Regulation, Randomized Controlled Trials as Topic, Treatment Outcome, Diet, Fat-Restricted, Dietary Supplements, Risk Reduction Behavior, Dyslipidemias
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