Awareness of major cardiovascular risk factors and its relationship with markers of vascular aging: Data from the Brisighella Heart Study.

BACKGROUND AND AIM: General population awareness about cardiovascular risk factors is usually low. The aim of the present study was to evaluate the vascular aging of subjects aware and not aware to be hypertensive, hypercholesterolemic, hypertriglyceridemic or diabetics in a general population sample. METHODS AND RESULTS: We interviewed 1652 subjects without atherosclerotic cardiovascular diseases (M: 46.6%, F: 53.4%) about their awareness of hypertension, hypercholesterolemia, hypertriglyceridemia or type 2 diabetes. Then we compared the augmentation index and pulse wave velocity of subjects aware and not aware of the investigated cardiovascular risk factors. 1049 participants declared not to be hypertensive, while 32 were not sure. Among them, respectively, 23.5% and 50% were hypertensive. Subjects not aware of their hypertension had significantly higher aortic blood pressure than aware ones (p < 0.001). 841 participants declared not to be hypercholesterolemic, while 60 were not sure. Among them, respectively, 18.1% and 40% were hypercholesterolemic. Subjects not aware of their hypercholesterolemia had significantly higher augmentation index than the aware ones (p < 0.05). 1226 participants declared not to be hypertriglyceridemic, while 200 were not sure. Among them, respectively, 19.2% and 44% were hypertriglyceridemic. Subjects not aware of their hypertriglyceridemia had significantly higher TG levels aware ones (p < 0.05), although this seemed to not related to increased arterial stiffness. 1472 participants declared not to be diabetic, while 20 were not sure. Among them, respectively, 2.0% and 25.0% were diabetics. Subjects not aware of their diabetes had significantly higher augmentation index than the aware ones (p < 0.05). CONCLUSIONS: In conclusion, the lack of awareness of hypertension and hypercholesterolemia is relatively frequent in the general population and is associated to significantly higher arterial stiffness.

Middle-Term Dietary Supplementation with Red Yeast Rice Plus Coenzyme Q10 Improves Lipid Pattern, Endothelial Reactivity and Arterial Stiffness in Moderately Hypercholesterolemic Subjects.

AIM: The aim of our study was to investigate whether treatment with red yeast rice added with Coenzyme Q10 is associated with changes in endothelial function and arterial stiffness. METHODS: This double blind, placebo-controlled, randomized clinical trial was carried out on 40 non-smoker moderately hypercholesterolemic subjects (ClinicalTrial.gov ID NCT02492464). After 4 weeks of diet and physical activity, patients were allocated to treatment with placebo or with an active product containing 10 mg monacolins and 30 mg Coenzyme Q10, to be assumed for 6 months. Endothelial reactivity and arterial stiffness have been measured through the validated Vicorder® device. RESULTS: During monacolin treatment, patients experienced a more favorable percentage change in low density lipoprotein (LDL)-cholesterol (after monacolin treatment: -26.3%; after placebo treatment: +3.4%, p < 0.05). Endothelial reactivity (pulse volume displacement after monacolin treatment: +6.0%; after placebo treatment: -0.3%, p < 0.05), and arterial stiffness (pulse wave velocity (PWV) after monacolin treatment: -4.7%; after placebo: +1.1%, p < 0.05) also significantly improved only after monacolin treatment. CONCLUSION: The long-term assumption of the tested dietary supplement is associated with an improvement in LDL-cholesterolemia, endothelial reactivity and PWV in moderately hypercholesterolemic subjects.

Short-term effects of a combined nutraceutical of insulin-sensitivity, lipid level and indexes of liver steatosis: a double-blind, randomized, cross-over clinical trial.

BACKGROUND: Overweight subjects easily develop alterations of the glucose and lipid metabolism and are exposed to an increased cardiometabolic risk. This condition is potentially reversible through the improvement of dietary and behavioural habits. However, a well-assembled nutraceutical would be a useful tool to better improve the metabolic parameters associated to overweight and insulin resistance. METHODS: To evaluate the effect of a combined nutraceutical containing berberine, chlorogenic acid and tocotrienols, we performed a double blind, cross-over designed trial versus placebo, in 40 overweight subjects with mixed hyperlipidaemia. After the first 8 weeks of treatment (or placebo), patients were asked to observe a 2-week washout period, and they were then assigned to the alternative treatment for a further period of 8 weeks. Clinical and laboratory data associated to hyperlipidaemia and insulin resistance have been obtained at the baseline, at the end of the first treatment period, after the washout, and again after the second treatment period. RESULTS: Both groups experienced a significant improvement of anthropometric and biochemical parameters versus baseline. However, total cholesterol, LDL cholesterol, triglycerides, non-HDL cholesterol, fasting insulin, HOMA-IR, GOT and Lipid Accumulation Product decreased more significantly in the nutraceutical group versus placebo. CONCLUSIONS: This combination seems to improve a large number of metabolic and liver parameters on the short-term in overweight subjects. Further studies are needed to confirm these observations on the middle- and long-term.

Serum LDL cholesterol levels and new onset of arterial hypertension: an 8-year follow-up.

BACKGROUND: Serum cholesterol has been demonstrated to correlate with blood pressure values; therefore, abnormal levels of serum cholesterol might contribute to the development of hypertension. The aim of this study was to assess the new onset of hypertension over a period of 8 years in a pharmacologically untreated population sample in normo- and hypercholesterolemic individuals. DESIGN: 1864 Caucasian subjects with baseline blood pressure values <140/90 mmHg were subdivided into two different groups, according to LDL cholesterol changes observed over a period of 8 years. Group 1 included subjects whose LDL cholesterol levels remained or decreased within the normal range, while Group 2 included those whose LDL cholesterol levels were persistently increased above the normal range. The 8-year incidence of new-onset hypertension was 7·1% in Group 1 and 13·8% in Group 2 (P = 0·02), after adjustment for the main confounding risk factors. The difference between Groups 1 and 2 was confirmed in men (8·2 vs. 13·1%, P = 0·04) and women (6·1. vs. 14·5%, P = 006), as well as in subjects younger than 65 years (5·7 vs. 10·9%; P = 0·011), but not in older ones. CONCLUSIONS: Baseline serum LDL cholesterol levels are related to the rate of new-onset hypertension in patients with normal or marginally elevated blood pressure values.

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on the Effect of a Dietary Supplement Containing Dry Artichoke and Bergamot Extracts on Metabolic and Vascular Risk Factors in Individuals with Suboptimal Cholesterol Levels.

The aim of this study was to assess whether dietary supplementation with a nutraceutical blend comprising extracts of bergamot and artichoke-both standardized in their characteristic polyphenolic fractions-could positively affect serum lipid concentration and insulin sensitivity, high-sensitivity C-reactive protein (hs-CRP), and indexes of non-alcoholic fatty liver disease (NAFLD) in 90 healthy individuals with suboptimal cholesterol levels. Participants were randomly allocated to treatment with a pill of either active treatment or placebo. After 6 weeks, the active-treated group experienced significant improvements in levels of triglycerides (TG), apolipoprotein B-100 (Apo B-100), and apolipoprotein AI (Apo AI) versus baseline. Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high density lipoprotein cholesterol (Non-HDL-C), and hs-CRP also significantly decreased in the active-treated group compared to both baseline and placebo. At the 12-week follow-up, individuals allocated to the combined nutraceutical experienced a significant improvement in TC, LDL-C, Non-HDL-C, TG, Apo B-100, Apo AI, glucose, alanine transaminase (ALT), gamma-glutamyl transferase (gGT), hs-CRP, several indexes of NAFLD, and brachial pulse volume (PV) in comparison with baseline. Improvements in TC, LDL-C, Non-HDL-C, TG, fatty liver index (FLI), hs-CRP, and endothelial reactivity were also detected compared to placebo (p < 0.05 for all). Overall, these findings support the use of the tested dietary supplement containing dry extracts of bergamot and artichoke as a safe and effective approach for the prevention and management of a broad spectrum of cardiometabolic disorders.

Self-Reported Coffee Consumption and Central and Peripheral Blood Pressure in the Cohort of the Brisighella Heart Study.

Even though coffee consumption has been clearly related to a number of benefits to the cardiovascular system, its effect on blood pressure (BP) has not been fully elucidated. In this sub-analysis of the Brisighella Heart Study (BHS), we compared central and peripheral BP values in a sub-cohort of 720 men (47.9%) and 783 women (52.1%) reporting the drinking of different amounts of coffee each day, for whom a full set of clinical, laboratory and hemodynamic parameters was available. According to our observations, moderate coffee drinking was associated to either higher levels of systolic BP (SBP) compared to those with heavy coffee consumption or lower SBP than that in the non-coffee drinking group (p-value for trend <0.05). In particular, people who drank 2 cups of coffee per day and people who drank >3 cups per day had lower SBP than non-coffee drinkers by 5.2 ± 1.6 mmHg (p = 0.010) and 9.7 ± 3.2 mmHg, respectively (p = 0.007). Similar trends were also observed for peripheral pulse pressure (PP), aortic BP and aortic PP. In the age-adjusted multiple linear regression model, negative predictors of SBP, PP, aortic BP and aortic PP were the estimated glomerular filtration rate (eGFR), female sex and coffee consumption. Positive predictors included body mass index (BMI) and low-density lipoprotein cholesterol (LDL-C). Then, our findings show that regular coffee drinking is associated with lower SBP, PP, aortic BP and aortic PP, but with similar arterial stiffness.

Effect of dietary supplementation with a new nutraceutical formulation on cardiometabolic risk factors: a double-blind, placebo-controlled, randomized clinical study.

Introduction: The scientific community and consumers are increasingly interested in the potential cholesterol-lowering effect of various nutraceuticals and their combinations. The aim of our study was to test the short-term effect of a new lipid-lowering nutraceutical formulation in mildly hypercholesterolemic patients. Material and methods: We consecutively enrolled 80 mildly hypercholesterolemic patients with low-density lipoprotein-cholesterol (LDL-C) between 130 and 190 mg/dl with a low-estimated cardiovascular disease risk. After a 8 week-stabilization diet, the enrolled subjects were randomized to take 1 pill/evening of Zeta Colest (including: 400 mg of Berberis aristata dry extract with 340 mg of berberine, 98 mg of red yeast rice extract with 2.9 mg of total monacolins, 87.5 mg of milk thistle dry extract with 70 mg of silymarin, 50 mg of guggul dry extract with 1.3 mg of guggulsterones) or placebo for 8 weeks. Patients were followed up for metabolic and haemodynamic parameters. Results: After 8 week-supplementation with the tested combined nutraceuticals, we observed a significant reduction in total cholesterol (-15.2 ±1.4%), LDL-C (-18.1 ±1.9%), non-high-density lipoprotein cholesterol (-17.7 ±1.8%), apoB (-16.9 ±1.9%) and high-sensitivity C-reactive protein (-3.7 ±0.7%), versus both baseline (p < 0.05) and the control group (p < 0.05). No other metabolic or liver parameters significantly changed during the observation period. Endothelial reactivity also mildly but significantly improved by 2.96 ±0.23% with the tested product. Conclusions: In the short term, the tested combined nutraceutical improved lipid metabolism, systemic inflammation and vascular function in mildly hypercholesterolemic overweight subjects.

Estimating the Prevalence and Characteristics of Patients Potentially Eligible for Lipoprotein(a)-Lowering Therapies in a Real-World Setting.

High lipoprotein(a) (Lp(a)) plasma levels are significantly associated with an increased risk of developing atherosclerotic cardiovascular diseases (ASCVD). The aim of this analysis was to estimate the prevalence and characteristics of patients potentially eligible for Lp(a)-lowering therapies in a real-world setting (i.e., patients with ASCVD and Lp(a) levels > 70 mg/dL). For this reason, we pooled data from a large cohort of Italian outpatients (N = 5961; men: 2879, women: 3982) with dyslipidemia. A binary logistic regression analysis was used to determine the significant predictors of ASCVD in the cohort, which were age (Odds Ratio (OR): 1.158, 95% Confidence Interval (CI): 1.114 to 1.203, p < 0.001), low-density lipoprotein cholesterol at entry (OR: 1.989, 95% CI: 1.080 to 1.198, p = 0.020) and Lp(a) (OR: 1.090, 95% CI: 1.074 to 1.107, p < 0.001). In our cohort, almost half of patients with ASCVD (44.7%) may be eligible to be treated with Lp(a)-lowering agents. Interestingly, patients who do not meet the treatment criteria despite high Lp(a) (50-70 mg/dL), respectively, account for 4.7% and 7.3% of those in primary and secondary ASCVD prevention. In conclusion, in our large cohort of outpatients with dyslipidemia, the prevalence of individuals with ASCVD and very high Lp(a) plasma levels is quite high, even with a conservative estimation.

Compliance between Food and Feed Safety: Eight-Year Survey (2013-2021) of Aflatoxin M1 in Raw Milk and Aflatoxin B1 in Feed in Northern Italy.

Aflatoxins (AFs) are fungal metabolites that are found in feed and food. When ruminants eat feed contaminated with aflatoxin B1 (AFB1), it is metabolised and aflatoxin M1 (AFM1) is excreted in the milk. Aflatoxins can result in hepatotoxic, carcinogenic, and immunosuppressive effects. The European Union thus set a low threshold limit (50 ng/L) for presence of AFM1 in milk. This was in view of its possible presence also in dairy products and that quantification of these toxins is mandatory for milk suppliers. In the present study, a total of 95,882 samples of whole raw milk, collected in northern Italy between 2013 and 2021, were evaluated for presence of AFM1 using an ELISA (enzyme-linked immunosorbent assay) method. The study also evaluated the relationship between feed materials collected from the same farms in the same area during the same period (2013-2021) and milk contamination. Only 667 milk samples out of 95,882 samples analysed (0.7%) showed AFM1 values higher than the EU threshold limit of 50 ng/L. A total of 390 samples (0.4%) showed values between 40 and 50 ng/L, thus requiring corrective action despite not surpassing the regulatory threshold. Combining feed contamination and milk contamination data, some feedingstuffs seem to be more effective in defying potential carryover of AFs from feed to milk. Combining the results, it can be concluded that a robust monitoring system that covers both feed, with a special focus on high risk/sentinel matrices, and milk is essential to guarantee high quality and safety standards of dairy products.

The Effect of Dietary Supplementation with Plant Sterols on Total and LDL-Cholesterol in Plasma Is Affected by Adherence to Mediterranean Diet: Insights from the DESCO Randomized Clinical Study.

Plant sterols are well-known natural lipid-lowering agents. The DESCO (Diet and plant sterols in the control of cholesterolemia) study was a single-center, randomized, double-blind, placebo-controlled, two-way crossover clinical trial designed to investigate the effect of a once-a-day ready-to-drink dietary supplement containing 2.5 g of phytosterols on the lipid profile, also in relation to the quality of the diet, in a cohort of 50 Italian individuals with polygenic hypercholesterolemia and low global cardiovascular risk. Eligible individuals were enrolled in a run-in period of 2 weeks. Then, participants who qualified for continuation in the study were randomly allocated (1:1) to a 3-week treatment with either phytosterols or placebo. After a 2-week washout period, enrolled individuals were crossed over to receive the alternative treatment. Dietary supplementation with phytosterols was associated with significant improvement in plasma levels of total cholesterol (TC; -11.8 ± 4.0 mg/dL, p = 0.016), low-density lipoprotein cholesterol (LDL-C; -7.8 ± 7.7 mg/dL, p = 0.021), and apolipoprotein B-100 (Apo B-100, -3.7 ± 4.1 mg/dL, p = 0.048) compared to baseline. The changes in TC and LDL-C were also significant compared to placebo, and greater adherence to the Mediterranean diet was significantly associated with greater reductions in LDL-C. Dietary supplementation with phytosterols was well tolerated and adherence to treatment was high. According to the findings of DESCO, the once-a-day ready-to-drink dietary supplement we tested is able to quickly and significantly decrease plasma levels of TC, LDL-C, and Apo B-100, with a greater effect in individuals more adhering to the Mediterranean dietary pattern.

Three arms, double-blind, non-inferiority, randomized clinical study testing the lipid-lowering effect of a novel dietary supplement containing red yeast rice and artichoke extracts compared to Armolipid Plus® and placebo.

Introduction: There is growing interest in head-to-head comparison between different lipid-lowering nutraceuticals. The aim of our study was to test the lipid-lowering effect of dietary supplementation with low-dose monacolins from red yeast rice (2.8 mg per daily dose) combined with berberine (Armolipid Plus®) or highly standardized artichoke extract versus placebo. Material and methods: 60 overall healthy adult volunteers with polygenic hypercholesterolemia (baseline low-density lipoprotein cholesterol (LDL-C) = 160.2 ±9.2 mg/dl) were enrolled in a 3-arm, double-blind, non-inferiority, randomized, parallel-group clinical trial. After 4-week diet standardization, enrolled individuals were randomized to be treated for 8 weeks with red yeast rice and highly standardized artichoke extracts (ATC group), Armolipid Plus®, or placebo. Results: At the enrolment visit, LDL-C values were similar in the compared groups. After 8 weeks, all actively treated subjects experienced significant improvements in baseline total cholesterol (TC), LDL-C and apolipoprotein B (Apo-B) (all p < 0.01) (ATC group: TC = -18.9%, LDL-C = -26.7% (placebo-corrected: -12.4%), Apo-B = -19.6%; Armolipid Plus®: TC = -18.4%, LDL-C = -25.8% (placebo-corrected: -12.1%), Apo-B = -23.2%; placebo: TC = -6.2%, LDL-C = -8%, Apo-B = -8.4%). Participants in the ATC group attained significantly lower body mass index (BMI) values (-2.1%), while individuals treated with Armolipid Plus® showed improvements in baseline high-density lipoprotein cholesterol (HDL-C) (+8.7%) and triglyceride (TG) (+17.5%) levels. Finally, baseline hepatic steatosis index (HSI) values significantly decreased in both actively treated groups (by -2.4% and -2.4% in ATC and in Armolipid Plus®, respectively). Conclusions: Patients with polygenic hypercholesterolemia experienced a significant improvement in several cardiovascular risk factors in both ATC and Armolipid Plus® groups.

Metabolic and vascular effect of a new standardized bergamot phytocomplex: a three-arm, placebocontrolled, double-blind clinical trial.

Introduction: In addition to healthy lifestyle and balanced diet, nutraceutical supplementation may be useful to maintain overall metabolic wellness. The aim of the present study was to assess the metabolic and vascular effects of a new, highly standardized bergamot phytocomplex supplement in healthy volunteers with the features of metabolic syndrome. Material and methods: We carried out a double-blind, randomized, placebo-controlled, three-arm, parallel-group clinical trial in 90 adult subjects (30 per group) treated for 12 weeks with two different dosages of a highly standardized bergamot phytocomplex (Endoberg by AKHYNEX and Kalita by Giellepi) or placebo. Lipid plasma levels, glycemia, plasma hs-CRP, HOMA-IR, body fat, endothelial reactivity and fatty liver index were assessed at baseline, after 6 weeks and at the end of treatment in all subjects. Results: At the end of treatment, both tested bergamot extract doses were able to significantly improve atherogenic dyslipidemia and insulin sensitivity (p < 0.05) compared to placebo. In the high-dose treated group, total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG) improved versus placebo (p < 0.05) just after 6 weeks of treatment. After 12 weeks of treatment, TC decreased by 13.2 ±2.1%, LDL-C by 17.7 ±3.2%, non-HDL-C by 17.5 ±3.1%, TG by 16.6 ±3.3%, TG/HDL-C by 22.5 ±4.4%, homeostasis insulin resistance index (HOMA-IR) by 12.2 ±2.1%, γ-glutamyl transferase (GGT) by 22.2 ±4.6%, and high-sensitivity C-reactive protein (hs-CRP) by 17.9 ±3.4% versus baseline (p < 0.05) and vs. placebo (p < 0.05). Percentage body fat and endothelial reactivity improved versus baseline, but not versus placebo, in the high-dose treatment only (p < 0.05). Conclusions: The tested bergamot phytocomplex was able to significantly improve glucose and lipid metabolism, as well as inflammation, and might represent a novel multi-target approach to control metabolic syndrome.

Nutraceuticals as Modulators of Immune Function: A Review of Potential Therapeutic Effects.

Dietary supplementation with nutraceuticals can promote optimal immune system activation, modulating different pathways that enhance immune defenses. Therefore, the immunity-boosting effects of nutraceuticals encompass not only immunomodulatory but also antioxidant, antitumor, antiviral, antibacterial, and antifungal properties, with therapeutic effects against diverse pathological conditions. However, the complexity of the pathways that regulate the immune system, numerous mechanisms of action, and heterogeneity of the immunodeficiencies, and subjects treated make their application in the clinical field difficult. Some nutraceuticals appear to safely improve immune system function, particularly by preventing viral and bacterial infections in specific groups, such as children, the elderly, and athletes, as well as in frail patients, such as those affected by autoimmune diseases, chronic diseases, or cancer. Several nutraceuticals, such as vitamins, mineral salts, polyunsaturated omega-3 fatty acids, many types of phytocompounds, and probiotic strains, have the most consolidated evidence in humans. In most cases, further large and long-term randomized clinical trials are needed to confirm the available preliminary positive data.

Evaluation of the effect of a dietary supplementation with a red yeast rice and fish oil-containing nutraceutical on lipid pattern, high sensitivity C-reactive protein, and endothelial function in moderately hypercholesterolaemic subjects: a double-blind, placebo-controlled, randomized clinical trial.

Introduction: Red yeast rice and omega-3 polyunsaturated fatty acids (PUFAs) are dietary supplements with well-known lipid-lowering, anti-inflammatory, and vascular health improving effects. However, they have rarely been tested in combination. The aim of our study was to test the short-term effect of a combined nutraceutical including red yeast rice and PUFAs on plasma lipids, jigh-sensitive C-reactive protein (hsCRP), and endothelial function in healthy subjects. Material and methods: We carried out a double-blind, randomized, placebo-controlled clinical trial with parallel groups testing the effect of 8 weeks of supplementation with softgels containing red yeast rice (2.8 mg monacolins) and PUFAs (588 mg of fish oil, standardized in PUFAs: 350 EPA, 45 mg DHA) versus placebo. A full lipid panel, hsCRP, and endothelial reactivity were measured at the baseline and after 8 weeks of treatment. Results: The tested combined nutraceutical was very well tolerated, and after 8 weeks of supplementation it was associated with a 17.3 ±3.4% reduction of lipid-density lipoprotein-cholesterol (LDL-C), a 12.1 ±2.2% reduction of total cholesterol (TC), a 22.3 ±4.3% reduction of apoB, and a -14.9 ±1.8% reduction of hsCRP, as well as a significant improvement of pulse volume change by 5.0 ±0.9%. Conclusions: The tested combined dietary supplement containing red yeast rice and PUFAs was very well tolerated and significantly improved LDL-C, TC, apoB, hsCRP and endothelial function in healthy subjects with suboptimal LDL-cholesterolaemia.

An Eight-Year Survey on Aflatoxin B1 Indicates High Feed Safety in Animal Feed and Forages in Northern Italy.

Aflatoxins (AFs) remain the main concern for the agricultural and dairy industries due to their effects on the performances and quality of livestock production. Aflatoxins are always unavoidable and should be monitored. The objective of this paper is to bring to light a significant volume of data on AF contamination in several animal feed ingredients in Northern Italy. The Regional Breeders Association of Lombardy has been conducting a survey program to monitor mycotoxin contamination in animal feeds, and in this paper, we present data relating to AFB1 contamination. In most cases (95%), the concentrations were low enough to ensure compliance with the European Union's (EU's) maximum admitted levels for animal feed ingredients. However, the data show a high variability in AF contamination between different matrices and, within the same matrix, a high variability year over year. High levels of AFs were detected in maize and cotton, especially in the central part of the second decade of this century, i.e., 2015-2018, which has shown a higher risk of AF contamination in feed materials in Northern Italy. Variability due to climate change and the international commodity market affect future prospects to predict the presence of AFs. Supplier monitoring and control and reduced buying of contaminated raw materials, as well as performing analyses of each batch, help reduce AF spread.

Management of High-Risk Hypercholesterolemic Patients and PCSK9 Inhibitors Reimbursement Policies: Data from a Cohort of Italian Hypercholesterolemic Outpatients.

Proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors are effective and safe lipid-lowering treatments (LLT). The primary endpoint of the study was to assess the prevalence of patients eligible for treatment with PCSK9 inhibitors in a real-life clinical setting in Italy before and after the recent enlargement of reimbursement criteria. For this study, we consecutively considered the clinical record forms of 6231 outpatients consecutively admitted at the Lipid Clinic of the University Hospital of Bologna (Italy). Patients were stratified according to whether they were allowed or not allowed to access to treatment with PCSK9 inhibitors based on national prescription criteria and reimbursement rules issued by the Italian Medicines Agency (AIFA). According to the indications of the European Medicines Agency (EMA), 986 patients were candidates to treatment with PCSK9 inhibitors. However, following the prescription criteria issued by AIFA, only 180 patients were allowed to access to PCSK9 inhibitors before reimbursement criteria enlargement while 322 (+14.4%) with the current ones. Based on our observations, low-cost tailored therapeutic interventions for individual patients can significantly reduce the number of patients potentially needing treatment with PCSK9 inhibitors among those who are not allowed to access to the treatment. The application of enlarged reimbursement criteria for PCSK9 inhibitors could mildly improve possibility to adequately manage high-risk hypercholesterolemic subjects in the setting of an outpatient lipid clinic.

COVID-19-Related Quarantine Effect on Dietary Habits in a Northern Italian Rural Population: Data from the Brisighella Heart Study.

North of Italy was severely hit by the COVID-19 (Coronavirus disease 19) pandemic. This induced the government to adopt severely restrictive measures to reduce the contagion risk, forcing most of the population to stop working and from leisure activities, and to remain at home for several weeks. Our study aimed to evaluate the effect of COVID-related quarantine on smoking and dietary habits of a well-characterized northern Italian rural population. For this purpose, while lockdown restrictions were in place (February-April 2020), 359 subjects from the Brisighella Heart Study cohort underwent a phone interview about their lifestyle habit changes during COVID-19-related quarantine. Quarantine did not significantly modify smoking habit nor body mass index. Subjects significantly increased daily carbohydrates consumption, all fresh vegetables, healthy vegetable oils, milk and yogurt, alcoholic drinks, sugars and sweets, and coffee. The weekly consumption of low-fat meat, cured meat other than ham, cheeses, eggs, nuts and mixed seed oils significantly increased, while the weekly intake of fish, mussels, and legumes significantly decreased during lockdown. The Dietary Quality Index was reduced from 42.4 ± 4.1 to 37.8 ± 4.7 (p < 0.03). In accordance with our findings, COVID-19-related quarantine might worsen the quality of diet, also leading to an increased intake of almost all food categories.

Psychosocial factors and metabolic parameters: is there any association in elderly people? The Massa Lombarda Project.

OBJECTIVE: Several studies claim that psychophysical stress and depression contribute significantly to cardiovascular disease (CVD) development. The aim of our research is to discover and analyse a possible relationship between two psychosocial disorders (depression and perceived mental stress) and traditional cardiovascular risk markers. METHODS: We selected 106 subjects (58 males and 48 females), mean age 79.5 +/- 3.8-years old, from the Massa Lombarda Project, an epidemiological study, including 7000 north Italian adult subjects. We carried out anamnesis, clinical and blood tests. Then, we administered the Perceived Stress Questionnaire (PSQ range score 0-1) and the Self-Rating Depression Scale (SRDS range score 50-70 Z), as validated instruments for depression and stress evaluation, which focus on the individual's subjective perception and emotional response. Statistical descriptive and inferential analyses of data collected were performed. RESULTS: The multiple linear regression analysis showed a negative correlation between PSQ index score and uric acid, low-density lipoprotein cholesterol (LDL-c), body mass index (BMI), systolic and diastolic blood pressure values, a positive and statistically significant correlation between PSQ index score and triglycerides (p < 0.05). We found an inverse relationship between Zung SRDS score and LDL-c, uric acid, glucose waist circumference values, this correlation was significant only for uric acid (p < 0.01). Besides, a positive and significant correlation between Zung SRDS and triglycerides (p < 0.05) was observed. CONCLUSION: We suppose that psycho-emotional stress and depression disorder, often diagnosed in elderly people, may influence different metabolic parameters (triglycerides, uric acid and BMI) that are involved in the complex process of metabolic syndrome.

Short-Term Effect of a New Oral Sodium Hyaluronate Formulation on Knee Osteoarthritis: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial.

OBJECTIVE: the aim of this pilot study was to test the short-term effect of oral supplementation with a sodium hyaluronate with a large spectrum of molecular weights (FS-HA®) on the symptoms and functionality of knee osteoarthritis (OA). METHODS: 60 subjects affected by clinical and/or radiological diagnosis of symptomatic knee OA were consecutively enrolled in a randomized, double blind, placebo-controlled, clinical trial. At randomization visit, at day 28 (visit 2), and day 56 (visit 3), the Western Ontario McMaster Universities Osteoarthritis Index (WOMAC), the Lequesne Functional Index (LFI) and the Visual Analogue Scale (VAS) for pain (VAS-p) were administered to the enrolled patients. Then, patients were asked how many times they used rescue medications (non-steroidal antinflammatory drugs - NSAIDs and/or anti-pain drugs) during the previous 4 weeks. Finally, the range of knee joint motion (ROM) was also instrumentally measured. RESULTS: In FS-HA® treated subjects, VAS-p, pain and total WOMAC score, LFI and ROM significantly improved compared to the baseline values (p < 0.05). At 60 days, the VAS-p and the pain WOMAC score were significantly lower after FS-HA® treatment when compared with placebo as well (p < 0.05). The FS-HA® treated subjects significantly reduced the weekly use of NSAIDs and/or antipain drugs when compared to the placebo-treated ones (p < 0.05). CONCLUSION: the oral supplementation with a FS-HA® characterized by a large spectrum of molecular weight was associated with a short-term improvement in symptomatology and functionality of osteoarthritis-affected knees, and associated with a reduction in the use of NSAIDS and anti-pain drugs.