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.

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) / Campolongo, G; Pelliccia, F; Quattrino, S; Vitale, C; Cacciotti, L; Massaro, R; Volterrani, M; Rosano, G; G., Marazzi; Giuseppe, Marazzi. - In: THE AMERICAN JOURNAL OF CARDIOLOGY. - ISSN 0002-9149. - STAMPA. - 120:6(2017), pp. 893-897. [10.1016/j.amjcard.2017.06.015]

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)

Campolongo G;Pelliccia F
Investigation
;
Quattrino S;Rosano G;
2017

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.
2017
aged; biological products; cholesterol; coronary artery disease; dose-response relationship, drug; drug combinations; drug therapy, combination; female; follow-up studies; humans; hydroxymethylglutaryl-coa reductase inhibitors; male; prospective studies; single-blind method; treatment outcome; dietary supplements; drug tolerance; percutaneous coronary intervention; cardiology and cardiovascular medicine
01 Pubblicazione su rivista::01l Trial clinico
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) / Campolongo, G; Pelliccia, F; Quattrino, S; Vitale, C; Cacciotti, L; Massaro, R; Volterrani, M; Rosano, G; G., Marazzi; Giuseppe, Marazzi. - In: THE AMERICAN JOURNAL OF CARDIOLOGY. - ISSN 0002-9149. - STAMPA. - 120:6(2017), pp. 893-897. [10.1016/j.amjcard.2017.06.015]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1012236
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