Comparison of low-dose statin versus low-dose statin + Armolipid Plus in high-intensity statin-intolerant patients with a previous coronary event and percutaneous coronary intervention (ADHERENCE Trial)

Marazzi, Giuseppe; Campolongo, Giuseppe; Pelliccia, Francesco; Quattrino, Silvia; Vitale, Cristiana; Cacciotti, Luca; Massaro, Rosalba; Volterrani, Maurizio; Rosano, Giuseppe

doi:10.1016/j.amjcard.2017.06.015

Cited by 36Lipoproteins and Cardiovascular HealthNatural Products and Biological ResearchCholesterol and Lipid Metabolism

Comparison of low-dose statin versus low-dose statin + Armolipid Plus in high-intensity statin-intolerant patients with a previous coronary event and percutaneous coronary intervention (ADHERENCE Trial)

Marazzi, Giuseppe, Campolongo, Giuseppe, Pelliccia, Francesco, Quattrino, Silvia, Vitale, Cristiana, Cacciotti, Luca, Massaro, Rosalba, Volterrani, Maurizio +1 more·2017·The American Journal of Cardiology

DOI 10.1016/j.amjcard.2017.06.015

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Abstract

Low-density lipoprotein cholesterol (LDL-C) reduction is associated with a significant decrease in mortality, and statins represent the most effective drugs to achieve this. However, side effects of statins are very common and may lead to treatment discontinuation. Nutraceuticals are a combination of natural components that have shown efficacy in lowering LDL-C concentration when used alone or in association with other agents in patients who are intolerant to high-dose statins. Our aim was to compare the efficacy and tolerability of low-dose statin (LDS) therapy versus combined therapy of LDS plus a nutraceutical combination containing red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin (Armolipid Plus) in high-risk patients. We performed a randomized (1:1), prospective, parallel group, single-blind trial in which participants had coronary artery disease (n = 100), had undergone percutaneous coronary intervention in the preceding 12 months, were high-dose statin intolerant, and did not achieve ≥50% reduction in LDL-C with LDS treatment alone. After 3 months, patients in the LDS + Armolipid Plus (n = 50) group presented with a significantly greater reduction of LDL-C and total cholesterol (p <0.0001), and 70% of patients in this group achieved the therapeutic target (LDL-C <70 mg/dl), whereas patients in the LDS group did not. Six patients (3 from each group) dropped out due to myalgia. In conclusion, in patients with coronary artery disease and high-dose statin intolerance, the combination of LDS and nutraceuticals represents a valuable therapeutic option.

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In the ADHERENCE trial, after 3 months the LDS plus Armolipid Plus group had significant LDL-C and TC reductions and 70% reached LDL-C <70 mg/dl, while the LDS group did not.
“After 3 months, patients in the LDS þ Armolipid Plus (n ¼ 50) group had a substantial reduction in LDL-C (À26.8%;p < 0.0001) and TC (À17.5;p < 0.0001), and 70% of patients in this group reached the treatment target (LDL-C <70 mg/dl), whereas patients in the LDS group did not (145).”
From The Role of Nutraceuticals in Statin Intolerant Patients (2018) · cites this paper as [145]
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 [145]

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Usefulness of Low-Dose Statin Plus Ezetimibe and/or Nutraceuticals in Patients With Coronary Artery Disease Intolerant to High-Dose Statin Treatment
Marazzi, G., Campolongo, G., Pelliccia, F., Calabrò, P., Cacciotti, L., Vitale, C., Massaro, R., Volterrani, M., & Rosano, G. M. C. (2018) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2018.09.041 · Cited by 19 · see citing works
Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease
Marazzi, G., Pelliccia, F., Campolongo, G., Quattrino, S., Cacciotti, L., Volterrani, M., Gaudio, C., & Rosano, G. (2015) · The American Journal of Cardiology · doi:10.1016/j.amjcard.2015.09.023 · Cited by 48 · see citing works
Abstract 8523: Randomized Trial of Nutraceuticals in Statin-Intolerant Patients Treated with Percutaneous Coronary Intervention
Pelliccia, F., Marazzi, G., Pasceri, V., Arrivi, A., Tanzilli, G., Mangieri, E., Rosano, G., Mercuro, G. G., & Gaudio, C. (2011) · Circulation · doi:10.1161/circ.124.suppl_21.a8523
Statin dose reduction with complementary diet therapy: A pilot study of personalized medicine
Scolaro, B., Nogueira, M. S., de Paiva, A. G., Bertolami, A., Barroso, L. P., Vaisar, T., Heffron, S. P., Fisher, E. A. A., & de Castro, I. A. (2018) · Molecular Metabolism · doi:10.1016/j.molmet.2018.02.005 · Cited by 20 · see citing works

Authors: Marazzi, G., Campolongo, G., Pelliccia, F., Quattrino, S., Vitale, C., Cacciotti, L., Massaro, R., Volterrani, M., & Rosano, G.
Affiliations: Istituti di Ricovero e Cura a Carattere Scientifico (IT)
Sapienza University of Rome (IT)
Corresponding author: Marazzi, Giuseppe
ORCID: Marazzi, Giuseppe
Pelliccia, Francesco
Vitale, Cristiana
Cacciotti, Luca
Massaro, Rosalba
Volterrani, Maurizio
Rosano, Giuseppe
Venue: The American Journal of Cardiology
Publisher: Elsevier BV
Published: 2017-09
Volume: 120
Issue: 6
Pages: 893-897
ISSN: 0002-9149 (ISSN-L)
DOI: 10.1016/j.amjcard.2017.06.015
OpenAlex: W2726914836
Cited by: 36
References: 30
Citations by year: 2026: 1 · 2025: 1 · 2024: 4 · 2023: 7 · 2022: 3 · 2021: 1 · 2020: 2 · 2019: 10 · 2018: 6 · 2017: 1
FWCI: 5.32
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/legal/tdmrep-license (tdm)
Locations: The American Journal of Cardiology (publishedVersion)
PubMed (publishedVersion)
IRIS Research product catalog (Sapienza University of Rome) (submittedVersion)
Funders: Ministero dell’Istruzione, dell’Università e della Ricerca
European Regional Development Fund
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: low-dose statins, statin intolerance, high-intensity statin therapy, LDL cholesterol lowering, nutraceuticals, red yeast rice, policosanol, berberine, folic acid, coenzyme Q10, astaxanthin, coronary artery disease, percutaneous coronary intervention, LDL-C goal attainment, statin adverse effects, myalgia
MeSH terms: Aged, Biological Products, Cholesterol, Coronary Artery Disease, Dose-Response Relationship, Drug, Drug Combinations, Drug Therapy, Combination, Drug Tolerance, Female, Follow-Up Studies, Humans, Male, Prospective Studies, Single-Blind Method, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Dietary Supplements, Percutaneous Coronary Intervention

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Comparison of low-dose statin versus low-dose statin + Armolipid Plus in high-intensity statin-intolerant patients with a previous coronary event and percutaneous coronary intervention (ADHERENCE Trial)

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