ORIGINAL ARTICLE   

Minerva Cardioangiologica 2020 February;68(1):15-21

DOI: 10.23736/S0026-4725.19.05051-5

Copyright © 2019 EDIZIONI MINERVA MEDICA

language: English

Delayed progression of atherosclerosis and cardiovascular events in asymptomatic patients with atherosclerotic plaques: 3-year prevention with the supplementation with Pycnogenol®+Centellicum®

Gianni BELCARO ^{1, 2, 3} ✉, Maria R. CESARONE ^{1, 2, 3}, Claudia SCIPIONE ^{1, 2}, Valeria SCIPIONE ^{1, 2}, Mark DUGALL ^{1, 2}, Hu SHU ^{1, 2}, Paula PETERZAN ^{1, 2}, Marcello CORSI ^{1, 2}, Roberta LUZZI ^{1, 2}, Morio HOSOI ^{1, 2}, Beatrice FERAGALLI ³, Roberto COTELLESE ³

¹ Irvine3 Labs & San Valentino Vascular Screening Project, Chieti-Pescara University, Chieti, Italy; ² International Agency for Pharma-Standard Supplements (IA-PSS), Pescara, Italy; ³ DSMO-Biotec, Chieti-Pescara University, Chieti, Italy

BACKGROUND: The aim of this study was the evaluation of the progression of atherosclerosis and the occurrence of cardiovascular events in asymptomatic patients with atherosclerotic plaques (Class IV and V) and arterial wall atherosclerotic lesions and intima-media thickening (IMT).
METHODS: Progression of atherosclerotic lesions, oxidative stress and IMT were measured in a 3-year concept, pilot registry study. All subjects were followed with standard management (SM) - including diet and exercise - to control cardiovascular risk factors.The target measurements were: the rate of progression of the atherosclerotic lesions (the passage of subjects from one atherosclerotic class to the next class); the occurrence of “hard” cardiovascular events (i.e. myocardial infarction or strokes; angina was not considered a “hard” event). The study included 3 groups: 1) SM): 2) subjects using cardioaspirin (100 mg/day) and SM; 3) subjects following SM, taking cardioaspirin and supplemented with Pycnogenol® (150 mg/day)+Centellicum® (450 mg/day).
RESULTS: The groups were comparable for age and baseline evaluations. 54 subjects completed the 3 year study with standard management only, 74 with aspirin and 56 with aspirin and Pycnogenol®+Centellicum®. The BMI of all subjects was <26. No side effects and no tolerability problems were observed with the supplements. Progression was defined by the passage of the atherosclerotic lesions from one class to the next more advanced class. Progression in the supplement group was observed in 5.3% of the subjects in comparison with a progression >20% in the other groups (P<0.05). In comparison with the SM group and the cardioaspirin group the rate of ‘hard’ cardiovascular events, requiring hospital admissions were <4% with the combined supplement in comparison with a value >12% in the other two groups (22.22% event rate in the SM group). The reduction produced by the aspirin only was significantly lower (P<0.05) in comparison with supplemented patients. Antiplatelet management appears to reduce a significant number of events (P<0.05) without a real effect on progression of atherosclerotic lesions. The additional parameters of carotid IMT and oxidative stress were also lower (P<0.05) with the supplements.
CONCLUSIONS: In conclusion, this study indicates that the combined supplementation with Pycnogenol®+Centelicum® appears to control both the progression of atherosclerosis and the occurrence of cardiovascular events in this 3 year study. Larger studies, in a wider population with more complex and less standardized conditions may be needed.

KEY WORDS: Atherosclerosis; Plaque, atherosclerotic; Pycnogenols; Centella asiatica extract; Aspirin