Atherosclerosis Clinical Trial
Official title:
Preventive Arterial Wall Phenotype in Subjects at Moderate Cardiovascular Risk Induced by Very Low-dose Fluvastatin/Valsartan Combination: a Pilot Study
The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function, arterial stiffness, vascular inflammation, oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk.
The largest population that suffers from cardiovascular events are subjects at moderate
cardiovascular risk. However, no effective and safe preventive treatment is available for
this population. This study aimed to investigate whether their arterial wall phenotype could
be turned to a preventive direction by low-dose fluvastatin/valsartan combination
(low-flu/val).
Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised
into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo).
At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta
stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive
hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell
adhesion molecule 1, total antioxidant status and expression of several protective genes
(SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.
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