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1.
Nutrients ; 14(14)2022 Jul 08.
Article in English | MEDLINE | ID: mdl-35889769

ABSTRACT

BACKGROUND: Nutraceutical combinations (NCs) against hypercholesterolemia are increasing in the marketplace. However, the availability of NCs without monacolin K is scarce even though the statin-intolerant population needs it. METHODS: This study is a parallel-group, randomized, placebo-controlled, double-blind trial. We evaluated the effects of the NC containing phytosterols, bergamot, olive fruits, and vitamin K2 on lipid profile and inflammatory biomarkers in 118 subjects (mean age ± SD, 57.9 ± 8.8 years; 49 men and 69 women) with hypercholesterolemia (mean total cholesterol ± SD, 227.4 ± 20.8 mg/dL) without clinical history of cardiovascular diseases. At baseline and 6 and 12 weeks of treatment, we evaluated lipid profile (total, LDL and HDL cholesterol, and triglycerides), safety (liver, kidney, and muscle parameters), and inflammatory biomarkers such as hs-CRP, leukocytes, interleukin-32, and interleukin-38 and inflammatory-microRNAs (miRs) miR-21, miR-126, and miR-146a. RESULTS: Compared to the placebo, at 6 and 12 weeks, NC did not significantly reduce total cholesterol (p = 0.083), LDL cholesterol (p = 0.150), and triglycerides (p = 0.822). No changes were found in hs-CRP (p = 0.179), interleukin-32 (p = 0.587), interleukin-38 (p = 0.930), miR-21 (p = 0.275), miR-126 (p = 0.718), miR-146a (p = 0.206), myoglobin (p = 0.164), and creatine kinase (p = 0.376). Among the two reported, only one adverse event was probably related to the nutraceutical treatment. CONCLUSIONS: The evaluated nutraceutical combination did not change serum lipid profile and inflammatory parameters, at least not with the daily dose applied in the present study.


Subject(s)
Dietary Supplements , Hypercholesterolemia , Adult , Aged , Biomarkers , C-Reactive Protein , Cholesterol, LDL , Double-Blind Method , Female , Humans , Hypercholesterolemia/drug therapy , Lipids , Lovastatin , Male , MicroRNAs , Middle Aged , Triglycerides
2.
Trials ; 21(1): 616, 2020 Jul 06.
Article in English | MEDLINE | ID: mdl-32631422

ABSTRACT

BACKGROUND: Elevated cholesterol levels and systemic inflammation are considered relevant risk factors for cardiovascular disease (CVD) development and progression. Increasing evidence suggests that cholesterol-lowering and inflammation-lowering nutraceuticals are useful in the management of moderate hypercholesterolemia. Here, we describe the study protocol of a clinical trial aimed to evaluate the cholesterol and inflammatory lowering effect of an innovative dietary supplement (BruMeChol™, Mivell S.r.l., Italy), composed of a mixture of extracts of bergamot and olive fruits in association with vitamin K2 in subjects with mild hypercholesterolemia. METHODS: The study was planned as a randomized, double-blind, placebo-controlled, parallel group clinical trial for 12 weeks at the Cardiology Unit of the IRCCS INRCA of Ancona, Italy. A total of 125 subjects (age ≥ 40 years) with mild hypercholesterolemia (total serum cholesterol levels ≥ 200 and ≤ 250 mg/dl) will be recruited. Intervention arm participants will take one capsule of dietary supplement two times a day, 15 min before the main meal. Control arm participants will receive one capsule of placebo in the same way. The dietary supplement capsule contains the following ingredients: phytosterols, flavonoid-rich extract of bergamot fruit (Citrus bergamia), flavonoid-rich extract of olive fruit (Olea europaea), and vitamin K2. Participants will undergo a medical evaluation and chemical-clinical examinations, which include lipid profile, glycemia, biomarkers of renal, liver and cardiac/muscular functions, interleukins (IL 6, IL-32, IL-37, and IL-38), and innovative mediators of inflammation such as inflamma-miRs (miR-21 and miR-146a), at baseline, and after 6 and 12 weeks of treatment. The decrease in total cholesterol levels and inflammatory biomarkers will be the primary and secondary endpoints of the study. DISCUSSION: This protocol study, planned to verify the effects of BruMeChol™ dietary supplementation in subjects with mild hypercholesterolemia, could also contribute to new study designs for next large-scale multicenter clinical trials. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12619000170123 . Retrospectively registered on 5 February 2019.


Subject(s)
Dietary Supplements , Hypercholesterolemia/drug therapy , Biomarkers/blood , Cardiovascular Diseases/prevention & control , Double-Blind Method , Drug Combinations , Humans , Hypercholesterolemia/blood , Italy , Lipids/blood , Randomized Controlled Trials as Topic , Risk Factors
3.
Drugs Aging ; 35(7): 649-656, 2018 07.
Article in English | MEDLINE | ID: mdl-29936693

ABSTRACT

OBJECTIVE: The clinical efficacy of clopidogrel in secondary prevention of vascular events is hampered by marked inter-patient variability in drug response, which partially depends on genetic make-up. The aim of this pilot prospective study was to evaluate 12-month cardiovascular outcomes in elderly patients with acute coronary syndrome (ACS) receiving dual antiplatelet therapy (aspirin and clopidogrel) according to the clustering of CYP2C19 and ABCB1 genetic variants. METHODS: Participants were 100 consecutive ACS patients who were genotyped for CYP2C19 (G681A and C-806T) and ABCB1 (C3435T) polymorphisms, which affect clopidogrel metabolism and bioavailability, using PCR-restriction fragment length polymorphism. They were then grouped as poor, extensive and ultra-rapid metabolisers based on the combination of CYP2C19 loss-of-function (CYP2C19*2) and gain-of-function (CYP2C19*17) alleles and ABCB1 alleles. The predictive value of each phenotype for acute vascular events was estimated based on 12-month cardiovascular outcomes. RESULTS: The poor metabolisers were at an increased risk of thrombotic events (OR 1.26; 95% CI 1.099-1.45; χ2 = 5.676; p = 0.027), whereas the ultra-rapid metabolisers had a 1.31-fold increased risk of bleeding events compared with the poor and extensive metabolisers (OR 1.31; 95% CI 1.033-1.67; χ2 = 5.676; p = 0.048). Logistic regression model, including age, sex, BMI and smoking habit, confirmed the differential risk of major events in low and ultra-rapid metabolisers. CONCLUSIONS: Our findings suggest that ACS patients classified as 'poor or ultra-rapid' metabolisers based on CYP2C19 and ABCB1 genotypes should receive alternative antiplatelet therapies to clopidogrel.


Subject(s)
Acute Coronary Syndrome/drug therapy , Cytochrome P-450 CYP2C19/genetics , Platelet Aggregation Inhibitors/administration & dosage , ATP Binding Cassette Transporter, Subfamily B/genetics , Aged , Aged, 80 and over , Alleles , Aspirin/adverse effects , Aspirin/therapeutic use , Clopidogrel/administration & dosage , Clopidogrel/adverse effects , Female , Genotype , Hemorrhage/chemically induced , Humans , Male , Phenotype , Pilot Projects , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/therapeutic use , Polymorphism, Genetic , Prospective Studies , Risk , Thrombosis/epidemiology
4.
Haematologica ; 92(3): 366-73, 2007 Mar.
Article in English | MEDLINE | ID: mdl-17339186

ABSTRACT

BACKGROUND AND OBJECTIVES: Since the impairment of platelet function may cause excess peri-operative bleeding, pre-operative discontinuation of aspirin and heparin bridging are common for cardiac surgery. We evaluated the impact of pre-operative administration of enoxaparin and unfractionated heparin (UFH) on coagulation parameters and peri-operative bleeding in patients undergoing elective coronary artery bypass grafting (CABG) surgery after discontinuation of aspirin. DESIGN AND METHODS: Forty-three patients with three-vessel coronary artery disease undergoing elective CABG surgery discontinued aspirin and were randomized to receive either UFH 180 UI/Kg x 2/day s.c. or enoxaparin 100 UI/Kg x 2/day s.c. until 12 h before surgery (median pre-operative treatment 8 days, range 6-12 days). Surgery was performed as usual with UFH. Neither UFH nor any low molecular weight heparin was given in the immediate post-operative period. The effects of UFH and enoxaparin were monitored by the activated partial thromboplastin time (aPTT) and the Enox-test (sensitive to factor Xa inhibition) using a Rapidpoint Coagulation Analyzer. aPTT and factor Xa activity were also measured by standard methods. Peri-operative bleeding and the nadirs of hemoglobin concentration, hematocrit and platelet count were monitored post-operatively. RESULTS: Patients in the two groups were similar for number of bypasses, on-pump time, total surgery time, and time from the last heparin administration. Coagulation parameters increased significantly and similarly at 30 min and 6 h with both treatments, but returned within the normal range at 12 h. Hemoglobin, hematocrit and platelet counts significantly decreased to the same extent after CABG and re-normalized at the same time. Transfusional requirements of blood and plasma units were similar in the two groups. INTERPRETATION AND CONCLUSIONS: From the kinetics of coagulation parameters and the evaluation of bleeding, enoxaparin is a safe alternative to UFH as a bridging therapy to CABG after discontinuation of aspirin.


Subject(s)
Anticoagulants/adverse effects , Blood Loss, Surgical/statistics & numerical data , Coronary Artery Bypass , Enoxaparin/adverse effects , Heparin/adverse effects , Preanesthetic Medication/adverse effects , Preoperative Care/adverse effects , Adult , Aged , Anticoagulants/administration & dosage , Anticoagulants/therapeutic use , Blood Coagulation Tests , Blood Loss, Surgical/prevention & control , Coronary Disease/surgery , Elective Surgical Procedures , Enoxaparin/administration & dosage , Enoxaparin/therapeutic use , Factor Xa/analysis , Female , Hemoglobins/analysis , Heparin/administration & dosage , Heparin/therapeutic use , Humans , Male , Middle Aged , Partial Thromboplastin Time , Platelet Count , Postoperative Complications/prevention & control , Postoperative Hemorrhage/chemically induced , Sample Size , Thrombosis/prevention & control
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