Publications by authors named "Maciej Banach"

681 Publications

Harnessing polyphenol power by targeting eNOS for vascular diseases.

Crit Rev Food Sci Nutr 2021 Sep 23:1-26. Epub 2021 Sep 23.

Applied Biotechnology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.

Vascular diseases arise due to vascular endothelium dysfunction in response to several pro-inflammatory stimuli and invading pathogens. Thickening of the vessel wall, formation of atherosclerotic plaques consisting of proliferating smooth muscle cells, macrophages and lymphocytes are the major consequences of impaired endothelium resulting in atherosclerosis, hypercholesterolemia, hypertension, type 2 diabetes mellitus, chronic renal failure and many others. Decreased nitric oxide (NO) bioavailability was found to be associated with anomalous endothelial function because of either its reduced production level by endothelial NO synthase (eNOS) which synthesize this potent endogenous vasodilator from L-arginine or its enhanced breakdown due to severe oxidative stress and eNOS uncoupling. Polyphenols are a group of bioactive compounds having more than 7000 chemical entities present in different cereals, fruits and vegetables. These natural compounds possess many OH groups which are largely responsible for their strong antioxidative, anti-inflammatory antithrombotic and anti-hypersensitive properties. Several flavonoid-derived polyphenols like flavones, isoflavones, flavanones, flavonols and anthocyanidins and non-flavonoid polyphenols like tannins, curcumins and resveratrol have attracted scientific interest for their beneficial effects in preventing endothelial dysfunction. This article will focus on in vitro as well as in vivo and clinical studies evidences of the polyphenols with eNOS modulating activity against vascular disease condition while their molecular mechanism will also be discussed.
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http://dx.doi.org/10.1080/10408398.2021.1971153DOI Listing
September 2021

Statins as anti-pyroptotic agents.

Arch Med Sci 2021 9;17(5):1414-1417. Epub 2021 Aug 9.

Applied Biomedical Research Centre, Mashhad University of Medical Sciences, Mashhad, Iran.

Introduction: Pyroptosis is a regulated form of cell death, which is often a consequence of the activation of inflammatory caspases.

Methods: Appropriate inflammatory responses and the induction of pyroptosis enhance the clearance of pathogens and increase innate immunity.

Results: However, excessive pyroptosis contributes to a hyperinflammatory response and aggravates tissue damage, thereby causing inflammatory diseases. There have been recent reports on the modulation of pyroptosis by statins, which may explain part of the pleiotropic actions of these drugs in inflammatory diseases and cancer.

Conclusions: Herein, the extant evidence for the potential value of statins in targeting pyroptosis in various diseases is reviewed.
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http://dx.doi.org/10.5114/aoms/141155DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8425236PMC
August 2021

PCSK9 immunization using nanoliposomes: preventive efficacy against hypercholesterolemia and atherosclerosis.

Arch Med Sci 2021 18;17(5):1365-1377. Epub 2021 Mar 18.

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Introduction: The aim of the study was to study a nanoliposomal anti-PCSK9 vaccine as a novel approach for cholesterol lowering via PCSK9 inhibition.

Material And Methods: An immunogenic peptide construct termed immunogenic fused PCSK9-tetanus (IFPT) was displayed on the surface of liposome nanoparticles (L-IFPT) and mixed into alum adjuvant (L-IFPTA+). The manufactured vaccine formulations IFPT, L-IFPT, L-IFPTA+, IFPTA+, and free nanoliposomes were subcutaneously injected four times with bi-weekly intervals in C57BL/6 mice on a severe atherogenic protocol.

Results: Among the formulations, L-IFPTA+ vaccine was found to elicit the highest IgG response against PCSK9 peptide. The induced PCSK9 antibodies inhibited PCSK9-LDLR interaction through binding to PCSK9 in vaccinated mice. Liver low-density lipoprotein receptor (LDLR) protein was increased in vaccinated mice. L-IFPTA+, L-IFPT and IFPTA+ vaccines reduced total cholesterol by up to -38.13 ±3.8% ( = 0.006), -23 ±4.1% ( = 0.027) and -19.12 ±3% ( = 0.038), and low-density lipoprotein cholesterol (LDL-C) by up to -57 ±7.7% ( = 0.0003), -41.67 ±4.2% ( = 0.03) and -36.11 ±5% ( = 0.02) in hypercholesterolemic mice, respectively, versus control mice after 8 weeks. Long-term assessment indicated that the vaccine formulations could stimulate a long-lasting humoral immune response against PCSK9 peptide, which was associated with a marked reduction of total cholesterol in L-IFPTA+, L-IFPT and IFPTA+ vaccine groups by up to -82.5 ±7.3% ( = 0.002), -70.54 ±6.2% ( = 0.013) and -72.02 ±8.7% ( = 0.004), respectively, and LDL-C by up to -88.14 ±5.6% ( = 0.002), -55.92 ±8.3% ( = 0.003) and 54.81 ±9.3% ( = 0.003), respectively, versus the pre-vaccination time point adjusted to the control group. Anti-inflammatory Th2 cells and IL-4 cytokine were considerably increased in splenocytes of vaccinated mice.

Conclusions: L-IFPTA+ vaccine can induce long-lasting, functional and safe PCSK9-specific antibodies in hypercholesterolemic C57BL/6 mice, providing a long-term protective impact on dyslipidemia and atherosclerosis.
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http://dx.doi.org/10.5114/aoms/133885DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8425258PMC
March 2021

A comprehensive review on the lipid and pleiotropic effects of pitavastatin.

Prog Lipid Res 2021 Sep 9:101127. Epub 2021 Sep 9.

Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland; Cardiovascular Research Centre, University of Zielona Gora, Zielona-Gora, Poland. Electronic address:

The 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors, or statins, are administered as first line therapy for hypercholesterolemia, both in primary and secondary prevention. There is a growing body of evidence showing that beyond their lipid-lowering effect, statins have a number of additional beneficial properties. Pitavastatin is a unique lipophilic statin with a strong effect on lowering plasma total cholesterol and triacylglycerol. It has been reported to have pleiotropic effects such as decreasing inflammation and oxidative stress, regulating angiogenesis and osteogenesis, improving endothelial function and arterial stiffness, and reducing tumor progression. Based on the available studies considering the risk of statin-associated muscle symptoms it seems to be also the safest statin. The unique lipid and non-lipid effects of pitavastatin make this molecule a particularly interesting option for the management of different human diseases. In this review, we first summarized the lipid effects of pitavastatin and then strive to unravel the diverse pleiotropic effects of this molecule.
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http://dx.doi.org/10.1016/j.plipres.2021.101127DOI Listing
September 2021

Impact of PCSK9 Immunization on Glycemic Indices in Diabetic Rats.

J Diabetes Res 2021 30;2021:4757170. Epub 2021 Aug 30.

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Methods: To prepare the anti-PCSK9 vaccine, a peptide construct called Immunogenic Fused PCSK9-Tetanus (IFPT) was linked to the surface of nanoliposome carriers. Healthy rats received four subcutaneous injections of the vaccine at biweekly intervals. Two weeks after the last vaccination, anti-PCSK9 antibody titers, PCSK9 targeting, and inhibition of PCSK9-low-density lipoprotein receptor (LDLR) interaction were evaluated. After verification of antibody generation, the immunized rats were intraperitoneally treated with a single dose (45 mg/kg) of streptozotocin (STZ) to induce diabetes mellitus. The levels of fasting blood glucose (FBG) were measured, and the oral glucose tolerance test (OGTT) as well as the insulin tolerance test (ITT) were carried out to assess glycemic status. At the end of the study, the total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglyceride, and high-density lipoprotein cholesterol concentrations were assayed. Histopathology examination of the liver and pancreas was also performed using the hematoxylin-eosin staining method.

Results: The prepared nanoliposomal vaccine could strongly induce anti-PCSK9 antibodies in the vaccinated rats. Within one week following the STZ injection, the FBG level was lower in the vaccinated group vs. diabetic control group (49% (-171.7 ± 35 mg/dL, < 0.001)). In the OGTT, the injected rats showed improved glucose tolerance as reflected by the reduction of blood glucose levels over 180 min, compared with the diabetic controls. Moreover, the ITT demonstrated that, after the insulin injection, blood glucose concentration declined by 49.3% in the vaccinated group vs. diabetic control group. Expectedly, the vaccinated rats exhibited lower (-26.65%, = 0.03) plasma LDL-C levels compared with the diabetic controls. Histopathology examination of pancreas tissue demonstrated that the pancreatic islets of the vaccinated rats had a slight decline in the population of -cells and few -cells. Normal liver histology was also observed in the vaccinated rats.

Conclusion: PCSK9 inhibition through the liposomal IFPT vaccine can improve the glucose and insulin tolerance impairments as well as the lipid profile in diabetes.
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http://dx.doi.org/10.1155/2021/4757170DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423580PMC
August 2021

Assessment of ECG during hybrid comprehensive telerehabilitation in heart failure patients-Subanalysis of the Telerehabilitation in Heart Failure Patients (TELEREH-HF) randomized clinical trial.

Ann Noninvasive Electrocardiol 2021 Sep 9:e12887. Epub 2021 Sep 9.

Telecardiology Center, National Institute of Cardiology, Warsaw, Poland.

Background: Exercise training in heart failure (HF) patients should be monitored to ensure patients' safety. Electrocardiographic (ECG) telemonitoring was used to assess the safety of hybrid comprehensive telerehabilitation (HCTR).

Objective: Analysis of ECG recorded during HCTR in HF patients.

Methods: The TELEREH-HF multicenter, randomized, controlled trial enrolled 850 HF patients with New York Heart Association class I-III and left ventricular ejection fraction of ≤40%. This subanalysis focuses on 386 patients (aged 62 ± 11 years, LVEF 31 ± 7%) randomized to HCTR. HCTR was telemonitored with a device allowing to record 16-s fragments of ECG and to transmit the data via mobile phone network to the monitoring center. ResultsIn 386 patients, 16,622 HCTR sessions were recorded and 66,488 ECGs fragments were evaluated. Sinus rhythm was present in 320 (83%) and permanent atrial fibrillation (AF) in 66 (17%) patients, respectively. The most common arrhythmias were ventricular and atrial premature beats, recorded in 76.4% and 27.7% of the patients, respectively. Non-sustained ventricular tachycardia (21 episodes in 8 patients) and paroxysmal AF episodes (6 in 4 patients) were rare. None of the analyzed demographic and clinical characteristics was predictive for onset of the new arrhythmias on exercise.

Conclusion: Telerehabilitation in HF patients was safe without the evidence for symptomatic arrhythmias requiring discontinuation of telerehabilitation. Only one mildly symptomatic paroxysmal AF episode led to the short-term suspension of the training program. The most common arrhythmias were atrial and ventricular premature beats. These arrhythmias did not result in any changes in rehabilitation and therapy regimens.
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http://dx.doi.org/10.1111/anec.12887DOI Listing
September 2021

Lipid-lowering therapy use in primary and secondary care in Central and Eastern Europe: DA VINCI observational study.

Atherosclerosis 2021 Aug 25;334:66-75. Epub 2021 Aug 25.

Imperial Centre for Cardiovascular Disease Prevention and Imperial Clinical Trials Unit, Imperial College London, Stadium House, 68 Wood Lane, London, W12 7RH, UK.

Background And Aims: Central and Eastern Europe (CEE) is a largely understudied region, despite having the highest cardiovascular disease mortality in Europe. This analysis aimed to assess the proportion of patients in CEE who achieved their LDL-C goals based on individual cardiovascular risk recommended by the 2016 and 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) guidelines.

Methods: The DA VINCI study was a cross-sectional observational study of primary and secondary prevention patients receiving lipid-lowering therapy across Europe between June 2017 and November 2018.

Results: In total, 2154 patients were enrolled from the Czech Republic (n = 509), Hungary (n = 319), Poland (n = 460), Romania (n = 259), Slovakia (n = 123) and Ukraine (n = 484). At LDL-C measurement, most patients were on either moderate- or high-intensity statin monotherapy (53% and 32%, respectively). Despite this, only 44% of patients achieved risk-based LDL-C goals recommended by the 2016 ESC/EAS guidelines, ranging from 21% in Ukraine to 50% in Hungary and Romania. Only 24% of patients overall achieved the risk-based LDL-C goals recommended by the 2019 ESC/EAS guidelines, ranging from 11% in Ukraine to 32% in Poland.

Conclusions: Among patients receiving lipid-lowering therapy, more than half did not achieve their 2016 LDL-C goals. In one of the first comparative analyses evaluating 2019 risk-based goal attainment among countries in CEE, three-quarters of patients did not meet their 2019 LDL-C goals, highlighting a significant gap between guidelines and clinical practice for lipid management in CEE.
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http://dx.doi.org/10.1016/j.atherosclerosis.2021.08.035DOI Listing
August 2021

RNA Silencing in the Management of Dyslipidemias.

Curr Atheroscler Rep 2021 Sep 1;23(11):69. Epub 2021 Sep 1.

School of Pharmacy and Biomolecular Sciences, Liverpool John Moores University, Byrom Street, Liverpool, L3 3AF, UK.

Purpose Of Review: Remarkable reductions in cardiovascular morbidity and mortality have been achieved in recent decades through the widespread use of 'small-molecule' hypolipidaemic drugs such as statins and ezetimibe. An alternative approach is to perturb the production of proteins through ribonucleic acid (RNA) silencing, leading to long-lasting knock-down of specific biological molecules. This review describes the scientific basis of RNA silencing, and critically evaluates the evidence relating to inclisiran, a small interfering RNA against proprotein convertase subtilisin kexin 9 (PCSK9).

Recent Findings: Pooled analysis of three recent ORION trials has demonstrated that twice-yearly administration of inclisiran reduces LDL-C by 50% in a range of patient groups, with only mild adverse effects. Inclisiran provides safe, effective and long-lasting reductions in PCSK9 and LDL-C. The results of the phase-3 ORION-4 outcomes study are eagerly awaited. Further promising RNA silencing technologies have the potential to improve the management of dyslipidaemia.
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http://dx.doi.org/10.1007/s11883-021-00968-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8410691PMC
September 2021

Genetically Higher Level of Mannose Has No Impact on Cardiometabolic Risk Factors: Insight from Mendelian Randomization.

Nutrients 2021 Jul 27;13(8). Epub 2021 Jul 27.

Department of Preventive Cardiology and Lipidology, Chair of Nephrology and Hypertension, Medical University of Lodz, 93-338 Lodz, Poland.

There is a handful of controversial data from observational studies on the serum levels of mannose and risks of coronary artery disease (CAD) and other cardiometabolic risk factors. We applied Mendelian Randomization (MR) analysis to obtain estimates of the causal effect of serum mannose on the risk of CAD and on cardiometabolic risk factors. : Two-sample MR was implemented by using summary-level data from the largest genome-wide association studies (GWAS) conducted on serum mannose and CAD and cardiometabolic risk factors. The inverse variance weighted method (IVW) was used to estimate the effects, and a sensitivity analysis including the weighted median (WM)-based method, MR-Egger, MR-Pleiotropy RESidual Sum and Outlier (PRESSO) were applied. Radial MR Methods was applied to remove outliers subject to pleiotropic bias. We further conducted a leave-one-out analysis. : Mannose had no significant effect on CAD (IVW: odds ratio: 0.96 (95% Confidence Interval (95%CI): 0.71-1.30)), total cholesterol (TC) (IVW: 95%CI: 0.60-1.08), low density lipoprotein (LDL) (IVW: 95%CI = 0.68-1.15), high density lipoprotein (HDL) (IVW: 95%CI = 0.85-1.20), triglycerides (TG) (IVW: 95%CI = 0.38-1.08), waist circumference (WC) (IVW: 95%CI = 0.94-1.37), body mass index (BMI) (IVW: 95%CI = 0.93-1.29) and fasting blood glucose (FBG) (IVW: 95%CI = 0.92-1.33), with no heterogeneity for CAD, HDL, WC and BMI (all > 0.092), while a significant heterogeneity was observed for TC (IVW: Q = 44.503), LDL (IVW: Q = 33.450), TG (IVW: Q = 159.645) and FBG (IVW: Q = 0. 32.132). An analysis of MR-PRESSO and radial plots did not highlight any outliers. The results of the leave-one-out method demonstrated that the links were not driven by a single instrument. We did not find any effect of mannose on adiposity, glucose, TC, LDL, TG and CAD.
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http://dx.doi.org/10.3390/nu13082563DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8398879PMC
July 2021

Factors and Prognostic Significance of Impaired Exercise Tolerance in Women over 40 with Arterial Hypertension.

J Pers Med 2021 Jul 30;11(8). Epub 2021 Jul 30.

Heart Failure Unit, Department of Cardiology and Congenital Diseases of Adults, Polish Mother's Memorial Hospital Research Institute (PMMHRI), 93-338 Lodz, Poland.

The aim of this study was to identify factors influencing maximal oxygen uptake (VO) and early identification of the profile of hypertensive women in the perimenopausal period at risk of heart failure. This study included 185 female patients. Regression analyses determined predictors of the lowest VO (quartile 1: VO < 17 mL/kg/min). Females with the lowest oxygen consumption had a significantly higher level of high sensitive cardiac Troponin T (hs-cTnT) ( = 0.001), higher values of the left atrial (LA) volume, late diastolic mitral annulus velocity (A'), E/E' ( = 0.0003, = 0.02, = 0.04; respectively), higher BMI and fat content (kg and %) ( < 0.0001), higher fat free mass (FFM) (kg) ( < 0.0001), total body water content (TBW) ( = 0.0002) as well as extracellular body water content (ECW) ( < 0.0001) and intracellular body water content (ICW) ( = 0.005), ECW/TBW × 100% ( < 0.0001) and metabolic age ( < 0.0001) and lower E' ( = 0.001) compared to controls. In a multiple logistic regression model independently associated with VO were: ECW/TBW × 100% (OR 4.45, 95% CI: 1.77-11.21; = 0.002), BMI (OR 7.11, 95% CI: 2.01-25.11; = 0.002) and hs-cTnT level (OR 2.69, 95% CI: 1.23-5.91; = 0.013). High-sensitivity cardiac troponin may serve as an early biomarker of heart failure in hypertensive women. Hydration status should be considered in overall hypertensive women care. There is an importance of body mass compartments analysis in the early identification of hypertensive females at risk of heart failure. Optimization and personalization of body structure may be a preventive method for this disease. ClinicalTrials.gov Identifier: NCT04802369.
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http://dx.doi.org/10.3390/jpm11080759DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8401822PMC
July 2021

Dyslipidemia Management in Patients with Coronary Artery Disease. Data from the POLASPIRE Survey.

J Clin Med 2021 Aug 20;10(16). Epub 2021 Aug 20.

Department of Clinical Epidemiology and Population Studies, Institute of Public Health, Jagiellonian University Medical College, 31-066 Kraków, Poland.

Lipid-lowering in patients with coronary artery disease (CAD) is related to a lower risk of cardiovascular events. We evaluated factors related to the management of hypercholesterolemia in patients with established CAD. Patients were interviewed 6-18 months after hospitalization for an acute coronary syndrome (ACS) or a myocardial revascularization procedure. Statins were prescribed at discharge to 94.4% of patients, while 68.1% of the patients hospitalized for an ACS were prescribed a high-dose statin. Hospitalization in a teaching hospital, percutaneous coronary intervention, cholesterol measurement during hospitalization and the male sex were related to prescription of statins at discharge. The intensity of lipid-lowering therapy in the post-discharge period increased in 17.3%, decreased in 11.7%, and did not change in 71.0% of the patients. The prescription of a lipid-lowering drug (LLD) at discharge (odds ratio 5.88 [95% confidence intervals 3.05-11.34]) and a consultation with a cardiologist (2.48 [1.51-4.08]) were related to the use of LLDs, while age (1.32 [1.10-1.59] per 10 years), loneliness (0.42 [0.19-0.94]), professional activity (1.56 [1.13-2.16]), and diabetes (1.66 [1.27-2.16]) were related to achieving an LDL cholesterol goal 6-18 months after discharge. In conclusion, health-system-related factors are associated with the LLD utilization, whereas mainly patient-related factors are related to the control of hypercholesterolemia following hospitalization for CAD.
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http://dx.doi.org/10.3390/jcm10163711DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8396933PMC
August 2021

Risk-factors associated with extremely high cardiovascular risk of mid- and long-term mortality following myocardial infarction: Analysis of the Hyperlipidaemia Therapy in tERtiary Cardiological cEnTer (TERCET) registry.

Atherosclerosis 2021 Sep 13;333:16-23. Epub 2021 Aug 13.

Department of Preventive Cardiology and Lipidology, Medical University of Lodz (MUL), Lodz, Poland; Polish Mother's Memorial Hospital Research Institute (PMMHRI), Lodz, Poland; Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland. Electronic address:

Background And Aims: Risk-factor identification and risk stratification are prerequisites to the effective primary and secondary prevention of cardiovascular disease (CVD). Patients at the highest risk benefit the most from the intensive risk-factor reduction. However, the high-risk patients' group is heterogeneous, and it is increasingly recognised that there is an 'extreme-risk' category of patients who may require particularly close attention and intensive therapeutic approach. The aim of this study was to identify subgroups of patients at the highest risk of death following myocardial infarction (MI) that might be considered as those at extremely high CVD risk.

Methods: We used data from 19,582 participants of the Hyperlipidaemia Therapy in tERtiary Cardiological cEnTer (TERCET) Registry (NCT03065543) of patients with ischaemic heart disease in Poland from 2006 to present. Characteristics of 13,052 patients with chronic coronary syndromes (CCS) were compared with those of 4295 patients with myocardial infarction (STEMI and NSTEMI). Multivariable logistic regression with stepwise backward elimination was used to identify risk factors associated with mortality in the 12-36 months following the index hospitalisation.

Results: The mortality rates were significantly higher in patients after MI than in patients with CCS. In the multivariable analysis, the risk factors most strongly associated with 12-month mortality in patients after MI were left ventricular ejection fraction (LVEF) lower than 35% (hazard ratio [HR] 3.83, 95% confidence interval [CI] 3.14-4.67), age >75 years (HR 1.91, 95%CI 1.55-2.35), multivessel coronary artery disease (HR 1.61, 95%CI 1.30-1.99), atrial fibrillation (HR 1.53, 95%CI 1.21-1.94) diabetes mellitus (HR 1.35, 95%CI 1.11-1.64) and increased LDL-C (HR per 1 mmol/l 1.09, 95%CI 1.01-1.19) or creatinine levels (HR per 10 μmol/L 1.04, 95% CI 1.04-1.05). The risk factors that influenced mortality after 24-36 months were consistent with those after 12 months, with additional low haemoglobin (20-25% risk increase per 1 mmol reduction) and chronic obstructive pulmonary disease (65% risk increase after 36 months).

Conclusions: In our large, single-center real-world analysis, we identified the patients with the highest risk of death who could probably benefit the most from the most intensive therapy, and hence should be considered to be an 'extreme risk' population.
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http://dx.doi.org/10.1016/j.atherosclerosis.2021.08.024DOI Listing
September 2021

Negatively-charged liposome nanoparticles can prevent dyslipidemia and atherosclerosis progression in the rabbit model.

Curr Vasc Pharmacol 2021 Aug 20. Epub 2021 Aug 20.

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad. Iran.

Background And Aim: Negatively charged nanoliposomes have a strong attraction towards plasma lipoprotein particles and can thereby regulate lipid metabolism. Here, the impact of such nanoliposomes on dyslipidaemia and progression of atherosclerosis was investigated in a rabbit model.

Methods: Two sets of negatively-charged nanoliposome formulations including [hydrogenated soy phosphatidylcholine (HSPC)/1,2-distearoyl-sn-glycero-3- phosphoglycerol (DSPG)] and [1,2-Dimyristoyl-sn-glycero-3-phosphorylcholine (DMPC)/1,2-Dimyristoyl-sn-glycero-3-phosphorylcholine (DMPG)/Cholesterol] were evaluated. Rabbits fed a high-cholesterol diet were randomly divided into 3 groups (n=5/group) intravenously administrated with HSPC/DSPG formulation (DSPG group; 100 mmol/kg), DMPC/DMPG formulation (DMPG group; 100 mmol/kg), or the normal saline (control group; 0.9% NaCl) over a 4-week period. The atherosclerotic lesions of the aortic arch wall were studied using haematoxylin and eosin staining.

Results: Both DSPG and DMPG nanoliposome formulations showed a nano-sized range in diameter with a negatively-charged surface and a polydispersity index of <0.1. After 4 weeks administration, the nanoliposome formulations decreased triglycerides (-62±3% [DSPG group] and -58±2% [DMPG group]), total cholesterol (-58±9% [DSPG group] and -37±5% [DMPG group]), and low-density lipoprotein cholesterol (-64±6% [DSPG group] and -53±10% [DMPG group]) levels, and increased high-density lipoprotein cholesterol (+67±28% [DSPG group] and +35±19% [DMPG group]) levels compared with the controls. The nanoliposomes showed a significant decrease in the severity of atherosclerotic lesions: mean values of the intima to media ratio in DMPG (0.96±0.1 fold) and DSPG (0.54±0.02 fold) groups were found to be significantly lower than that in the control (1.2±0.2 fold) group (p<0.05).

Conclusion: Anionic nanoliposomes containing [HSPC/DSPG] and [DMPC/DMPG] correct dyslipidaemia and inhibit the progression of atherosclerosis.
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http://dx.doi.org/10.2174/1570161119666210820115150DOI Listing
August 2021

Efficacy and safety of colchicine in patients with coronary artery disease: A systematic review and meta-analysis of randomized controlled trials.

Br J Clin Pharmacol 2021 Aug 18. Epub 2021 Aug 18.

Department of Preventive Cardiology and Lipidology, Medical University of Lodz, Poland.

Aims: Inflammation plays a central role in the pathogenesis and clinical manifestations of atherosclerosis. Randomized controlled trials have investigated the potential benefit of colchicine in reducing cardiovascular (CV) events in patients with coronary artery disease (CAD) but produced conflicting results. The aim of this meta-analysis was to evaluate the efficacy and safety of colchicine in patients with CAD.

Methods: We systematically searched selected electronic databases from inception until 10 December 2020. Primary clinical endpoints were: major adverse cardiac events; all-cause mortality; CV mortality; recurrent myocardial infarction; stroke; hospitalization; and adverse medication effects. Secondary endpoints were short-term effect of colchicine on inflammatory markers.

Results: Twelve randomized controlled trials with a total of 13 073 patients with CAD (colchicine n = 6351 and placebo n = 6722) were included in the meta-analysis. At mean follow-up of 22.5 months, the colchicine group had lower risk of major adverse cardiac events (6.20 vs. 8.87%; P < .001), recurrent myocardial infarction (3.41 vs. 4.41%; P = .005), stroke (0.40 vs. 0.90%; P = .002) and hospitalization due to CV events (0.90 vs. 2.87%; P = .02) compared to the control group. The 2 patient groups had similar risk for all-cause mortality (2.08 vs. 1.88%; P = .82) and CV mortality (0.71 vs. 1.01%; P = .38). Colchicine significantly reduced high-sensitivity C-reactive protein (-4.25, P = .001) compared to controls but did not significantly affect interleukin (IL)-β1 and IL-18 levels.

Conclusion: Colchicine reduced CV events and inflammatory markers, high-sensitivity C-reactive protein and IL-6, in patients with coronary disease compared to controls. Its impact on cardiovascular and all-cause mortality requires further investigation.
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http://dx.doi.org/10.1111/bcp.15041DOI Listing
August 2021

Pre-Clinical Evaluation of the Nanoliposomal antiPCSK9 Vaccine in Healthy Non-Human Primates.

Vaccines (Basel) 2021 Jul 6;9(7). Epub 2021 Jul 6.

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad 9177948564, Iran.

Background: Our previous studies showed the safe preventive and therapeutic effects of immunization using the nanoliposomal antiPCSK9 vaccine called "Liposomal Immunogenic Fused PCSK9-Tetanus plus Alum adjuvant" (L-IFPTA), in mouse models of atherosclerosis. Here we aimed to ascertain the immunogenicity and safety of the L-IFPTA vaccine in a pre-clinical study in healthy non-human primates.

Methods: Five male rhesus macaque monkeys were subcutaneously immunized with the L-IFPTA vaccine, four times with bi-weekly intervals. To evaluate immunogenicity, the plasma antiPCSK9 antibody in immunized monkeys was detected and quantified using the ELISA method. The functionality of the induced antiPCSK9 antibodies was determined by the PCSK9/LDLR in vitro binding assay kit. The safety of the vaccine was tested using the evaluation of several major circulating indicators including plasma lipid alterations, inflammatory biomarkers and organ injury biomarkers.

Results: The resultant data indicated that the L-IFPTA vaccine significantly and highly induced the generation of functional and safe antiPCSK9 antibodies in immunized monkeys. Plasma levels of specific biomarkers indicating organ performance including creatinine, urea, uric acid, bilirubin, ALP, AS, ALT and TSH were not significantly altered. After immunization in healthy monkeys, non-prespecified endpoints (plasma levels of TC, LDL-C, VLDL-C and TG) were non-significantly reduced by 11.6 ± 36%; 16 ± 28%; 22 ± 53% and 24 ± 51%, respectively, while HDL-C was slightly increased by 2 ± 64%. There were also no significant changes in plasma levels of pro- and anti-inflammatory biomarkers.

Conclusion: The L-IFPTA vaccine could efficiently stimulate the host humoral immune response to produce active antibodies that inhibit plasma PCSK9 while not provoking systemic inflammation and not adversely affecting organ performance.
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http://dx.doi.org/10.3390/vaccines9070749DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8309966PMC
July 2021

Nutraceuticals in the Management of Dyslipidemia: Which, When, and for Whom? Could Nutraceuticals Help Low-Risk Individuals with Non-optimal Lipid Levels?

Curr Atheroscler Rep 2021 Aug 4;23(10):57. Epub 2021 Aug 4.

Italian Society of Nutraceuticals (SINut), Bologna, Italy.

Purpose Of Review: The aim of this review is to summarize the available clinical efficacy and safety data related to the most studied and used lipid-lowering nutraceuticals.

Recent Findings: A growing number of meta-analyses of randomized clinical trials supports the effectiveness and tolerability of some lipid-lowering nutraceuticals such as red yeast rice, plant sterols and stanols, soluble fibers, berberine, artichoke extracts, bergamot polyphenol fraction, garlic, green tea, and spiruline. No significant safety concern has been raised for the use of such products. Association of more lipid-lowering nutraceuticals and of some nutraceuticals with lipid-lowering drugs has been tested as well. Current evidence suggests that some clinically tested lipid-lowering nutraceuticals could be safely used to improve plasma lipid levels in subjects affected by mild-to-moderate dyslipidaemia with low cardiovascular risk.
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http://dx.doi.org/10.1007/s11883-021-00955-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8332568PMC
August 2021

On the present and future role of Lp-PLA in atherosclerosis-related cardiovascular risk prediction and management.

Arch Med Sci 2021 20;17(4):954-964. Epub 2020 Aug 20.

Department of Hypertension, Medical University of Lodz, Poland.

Circulating concentration and activity of secretory phospholipase A (sPLA) and lipoprotein-associated phospholipase A (Lp-PLA) have been proven as biomarkers of increased risk of atherosclerosis-related cardiovascular disease (ASCVD). Lp-PLA might be part of the atherosclerotic process and may contribute to plaque destabilisation through inflammatory activity within atherosclerotic lesions. However, all attempts to translate the inhibition of phospholipase into clinically beneficial ASCVD risk reduction, including in randomised studies, by either non-specific inhibition of sPLA (by varespladib) or specific Lp-PLA inhibition by darapladib, unexpectedly failed. This gives us a strong imperative to continue research aimed at a better understanding of how Lp-PLA and sPLA regulate vascular inflammation and atherosclerotic plaque development. From the clinical viewpoint there is a need to establish and validate the existing and emerging novel anti-inflammatory therapeutic strategies to fight against ASCVD development, by using potentially better animal models and differently designed clinical trials in humans.
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http://dx.doi.org/10.5114/aoms.2020.98195DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314407PMC
August 2020

Postmarketing nutrivigilance safety profile: a line of dietary food supplements containing red yeast rice for dyslipidemia.

Arch Med Sci 2021 4;17(4):856-863. Epub 2021 Mar 4.

IRCCS Azienda Ospedaliero-Universitaria Di Bologna, Bologna, Italy.

Introduction: In the absence of a European standardized postmarketing food supplement surveillance system (nutrivigilance), some member states and companies have developed their own approaches to monitoring potential adverse reactions to secure a high level of product safety. This paper describes the use of a nutrivigilance system in monitoring the incidence of spontaneously reported suspected adverse reactions associated with food supplements containing red yeast rice (RYR).

Material And Methods: We report the data from a widely used product marketed under the trademark Armolipid/Armolipid Plus. Postmarketing information was collected in a voluntary nutrivigilance system established by the manufacturing company (Meda Pharma SpA, a Viatris Company, Monza, Italy). From 1 October 2004 to 31 December 2019, this system captured cases of suspected adverse reactions spontaneously reported by consumers, healthcare professionals, health authorities, regardless of causality.

Results: The total number of case reports received mentioning the RYR food supplement product line was 542, in which 855 adverse events (AEs) were reported. The total reporting rate of AEs was estimated to be 0.037% of 2,287,449 exposed consumers. Of the 542 cases, 21 (0.0009% of exposed consumers) included suspected serious adverse events (SAEs). After careful investigation, 6 cases (0.0003% of consumers exposed) and 6 AEs were assessed by the manufacturer as serious and potentially related to exposure to the above-mentioned RYR-based nutraceutical.

Conclusions: This nutrivigilance-derived data analysis clearly demonstrates a low prevalence of suspected adverse events associated with the red yeast rice product line. Consumer safety of food supplements could be generally improved by raising awareness of the importance of following the indications and warnings detailed in a food supplement's labeling.
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http://dx.doi.org/10.5114/aoms/133716DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8314417PMC
March 2021

Protective Effects of Curcumin on Endothelium: An Updated Review.

Adv Exp Med Biol 2021 ;1291:103-119

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Endothelial dysfunction is the common early stage of most cardiovascular afflictions. The endothelium is considered the main mediator of vascular homeostasis via its vasodilator, anti-inflammatory and anticoagulant properties. Among the different endothelial-derived mediators, nitric oxide is produced by nitric oxide synthase and has a critical role in regulating endothelial function. Physiological and pathological processes such as aging and diabetes mellitus are associated with disturbances of endothelial function which, at least at the earliest stage, can be reversed by lifestyle and pharmacological intervention to reduce the risk of incident cardiovascular diseases. Among dietary strategies, curcumin is a cheap and safe nutraceutical polyphenol with proven antioxidant and anti-inflammatory properties. Given the important role of such processes in the development of endothelium dysfunction, a role for curcumin in the prevention or treatment of this condition has been hypothesized. This review summarizes the available literature on the beneficial role of curcumin on vascular endothelial function.
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http://dx.doi.org/10.1007/978-3-030-56153-6_6DOI Listing
August 2021

Predicting the environmental suitability for onchocerciasis in Africa as an aid to elimination planning.

PLoS Negl Trop Dis 2021 Jul 28;15(7):e0008824. Epub 2021 Jul 28.

Department of Health Policy Planning and Management, University of Health and Allied Sciences, Ho, Ghana.

Recent evidence suggests that, in some foci, elimination of onchocerciasis from Africa may be feasible with mass drug administration (MDA) of ivermectin. To achieve continental elimination of transmission, mapping surveys will need to be conducted across all implementation units (IUs) for which endemicity status is currently unknown. Using boosted regression tree models with optimised hyperparameter selection, we estimated environmental suitability for onchocerciasis at the 5 × 5-km resolution across Africa. In order to classify IUs that include locations that are environmentally suitable, we used receiver operating characteristic (ROC) analysis to identify an optimal threshold for suitability concordant with locations where onchocerciasis has been previously detected. This threshold value was then used to classify IUs (more suitable or less suitable) based on the location within the IU with the largest mean prediction. Mean estimates of environmental suitability suggest large areas across West and Central Africa, as well as focal areas of East Africa, are suitable for onchocerciasis transmission, consistent with the presence of current control and elimination of transmission efforts. The ROC analysis identified a mean environmental suitability index of 0·71 as a threshold to classify based on the location with the largest mean prediction within the IU. Of the IUs considered for mapping surveys, 50·2% exceed this threshold for suitability in at least one 5 × 5-km location. The formidable scale of data collection required to map onchocerciasis endemicity across the African continent presents an opportunity to use spatial data to identify areas likely to be suitable for onchocerciasis transmission. National onchocerciasis elimination programmes may wish to consider prioritising these IUs for mapping surveys as human resources, laboratory capacity, and programmatic schedules may constrain survey implementation, and possibly delaying MDA initiation in areas that would ultimately qualify.
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http://dx.doi.org/10.1371/journal.pntd.0008824DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8318275PMC
July 2021

Statin therapy in chronic viral hepatitis: a systematic review and meta-analysis of nine studies with 195,602 participants.

Ann Med 2021 12;53(1):1227-1242

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Background: Conflicting data suggest that statins could cause chronic liver disease in certain group of patients, while improving prognosis in those with chronic viral hepatitis (CVH).

Purpose: To quantify the potential protective role of statins on some main liver-related health outcomes in clinical studies on CVH patients. The search strategy was explored by a medical librarian using bibliographic databases, from January 2015 to April 2020. The results showed no significant difference in the risk of mortality between statin users and non-users in the overall analysis. However, the risk of mortality significantly reduced by 39% in statin users who were followed for more than three years. Moreover, the risk of HCC, fibrosis, and cirrhosis in those on statins decreased by 53%, 45% and 41%, respectively. Although ALT and AST reduced slightly following statin therapy, this reduction was not statistically significant.

Limitations: A significant heterogeneity among studies was observed, resulting from differences in clinical characteristics between statin users and non-users, study designs, population samples, diseases stage, comorbidities, and confounding covariates.

Conclusion: Not only long-term treatment with statins seems to be safe in patients affected by hepatitis, but also it significantly improves their prognosis.
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http://dx.doi.org/10.1080/07853890.2021.1956686DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8317925PMC
December 2021

Cardiac manifestations of COVID-19.

Rev Cardiovasc Med 2021 06;22(2):365-371

Department of Preventive Cardiology and Lipidology, Chair of Nephrology and Hypertension, Medical University of Lodz, Rzgowska 281/289, 93-338 Lodz, Poland.

COVID-19 is a novel viral infection caused by severe acute respiratory syndrome (SARS) beta-coronavirus. Epidemiological status changes dynamically as the pandemy is far from ending. Several complications of presented virus may be similar to those observed in other viral infections. Despite lacking data, the heart involvement may be comparable to cardiac complications observed previously in those with SARS as well as Middle East Respiratory Syndrome (MERS). In COVID-19 we observe elevated levels of cardiac biomarkers, such as natriuretic peptides, troponins, myoglobin, C-reactive protein (CRP), interleukin-2 (IL-2), interleukin-6 (IL-6) and ferritin, which is likely the result of myocardial injury. The possible mechanisms of cardiovascular injury include direct toxicity through the viral invasion of cardiac myocytes, ACE-2 receptor-mediated CV (cardiac and endothelial) injury, microvascular dysfunction and thrombosis and cytokine release syndrome (mainly IL-6 mediated). Cardiac manifestations of COVID-19 are focal or global myocardial inflammation, necrosis, ventricular dysfunction, heart failure and arrhythmia.
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http://dx.doi.org/10.31083/j.rcm2202043DOI Listing
June 2021

The Effects of Glucagon-Like Peptide-1 Receptor Agonists and Dipeptydilpeptidase-4 Inhibitors on Blood Pressure and Cardiovascular Complications in Diabetes.

J Diabetes Res 2021 30;2021:6518221. Epub 2021 Jun 30.

Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Glucagon-like peptide-1 receptor (GLP-1R) agonists are a class of newly introduced antidiabetic medications that potentially lower blood glucose by several molecular pathways. DPP-4 inhibitors are the other type of novel antidiabetic medications which act by preventing GLP-1 inactivation and thereby increasing the activity levels of GLP-1, leading to more glucose-induced insulin release from islet -cells and suppression of glucagon release. Most patients with diabetes have concurrent hypertension and cardiovascular disorder. If antihyperglycemic agents can attenuate the risk of hypertension and cardiovascular disease, they will amplify their overall beneficial effects. There is conflicting evidence on the cardiovascular benefits of GLP-1R induction in laboratory studies and clinical trials. In this study, we have reviewed the main molecular mechanisms by which GLP-1R induction may modulate the cardiovascular function and the results of cardiovascular outcome clinical trials.
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http://dx.doi.org/10.1155/2021/6518221DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263148PMC
June 2021

May Measurement Month 2019: an analysis of blood pressure screening results from Poland.

Eur Heart J Suppl 2021 May 20;23(Suppl B):B124-B127. Epub 2021 May 20.

Department of Family Medicine and Public Health, Faculty of Medicine, University of Opole, Oleska 48, 45-052 Opole, Poland.

May Measurement Month 2019 is the third edition of a global initiative organized by the International Society of Hypertension aimed at raising awareness of hypertension and the need for blood pressure (BP) screening. We present data analysis from Poland. To evaluate the potential of opportunistic BP measurements as a tool for cardiovascular disease prevention programmes. To collect new country data for further annual comparisons. An opportunistic cross-sectional survey of volunteers aged ≥18 was carried out in 201 sites in May 2019. BP was measured in 7072 subjects (mean age: 54 ± 15 years; 62.3% females). After multiple imputation, the age- and sex-standardized systolic BP (SBP) and diastolic BP (DBP) was 125.4/78.5 mmHg in the whole group, 133.3/82.8 mmHg in individuals on antihypertensive medication and 123.3/77.7 mmHg in those not taking antihypertensive drugs. The proportion of subjects with high BP (≥140/90 mmHg) were 41.8% in subjects taking antihypertensive drugs, and 19.6% in those not taking any antihypertensive drugs. Overall, hypertension was present in 55.4% of participants (3917 out of 7072), of whom 83.0% were aware of their diagnosis. 80.4% of hypertensives were taking antihypertensive medication. 46.7% of all hypertensives had BP controlled to target (<140/90 mmHg). Higher BP correlated with body mass index and age but not tobacco smoking. SBP but not DBP was higher in diabetic participants. These data provide evidence on the current epidemiology of hypertension and may serve as a source of information to introduce primary and secondary prevention programmes to reduce cardiovascular risk in Poland.
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http://dx.doi.org/10.1093/eurheartj/suab045DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8263086PMC
May 2021

Impact of nutraceuticals on markers of systemic inflammation: Potential relevance to cardiovascular diseases - A position paper from the International Lipid Expert Panel (ILEP).

Prog Cardiovasc Dis 2021 Jul-Aug;67:40-52. Epub 2021 Jun 27.

Department of Hypertension, Medical University of Lodz (MUL), Lodz, Poland; Cardiovascular Research Centre, University of Zielona Gora, Zielona Gora, Poland. Electronic address:

Inflammation is a marker of arterial disease stemming from cholesterol-dependent to -independent molecular mechanisms. In recent years, the role of inflammation in atherogenesis has been underpinned by pharmacological approaches targeting systemic inflammation that have led to a significant reduction in cardiovascular disease (CVD) risk. Although the use of nutraceuticals to prevent CVD has largely focused on lipid-lowering (e.g, red-yeast rice and omega-3 fatty acids), there is growing interest and need, especially now in the time of coronavirus pandemic, in the use of nutraceuticals to reduce inflammatory markers, and potentially the inflammatory CVD burden, however, there is still not enough evidence to confirm this. Indeed, diet is an important lifestyle determinant of health and can influence both systemic and vascular inflammation, to varying extents, according to the individual nutraceutical constituents. Thus, the aim of this Position Paper is to provide the first attempt at recommendations on the use of nutraceuticals with effective anti-inflammatory properties.
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http://dx.doi.org/10.1016/j.pcad.2021.06.010DOI Listing
August 2021

Association of statin use in older people primary prevention group with risk of cardiovascular events and mortality: a systematic review and meta-analysis of observational studies.

BMC Med 2021 06 22;19(1):139. Epub 2021 Jun 22.

Head Department of Hypertension, WAM University Hospital in Lodz, Medical University of Lodz (MUL), Lodz, Poland.

Background: Current evidence from randomized controlled trials on statins for primary prevention of cardiovascular disease (CVD) in older people, especially those aged > 75 years, is still lacking. We conducted a systematic review and meta-analysis of observational studies to extend the current evidence about the association of statin use in older people primary prevention group with risk of CVD and mortality.

Methods: PubMed, Scopus, and Embase were searched from inception until March 18, 2021. We included observational studies (cohort or nested case-control) that compared statin use vs non-use for primary prevention of CVD in older people aged ≥ 65 years; provided that each of them reported the risk estimate on at least one of the following primary outcomes: all cause-mortality, CVD death, myocardial infarction (MI), and stroke. Risk estimates of each relevant outcome were pooled as a hazard ratio (HR) with a 95% confidence interval (CI) using the random-effects meta-analysis model. The quality of the evidence was rated using the GRADE approach.

Results: Ten observational studies (9 cohorts and one case-control study; n = 815,667) fulfilled our criteria. The overall combined estimate suggested that statin therapy was associated with a significantly lower risk of all-cause mortality (HR: 0.86 [95% CI 0.79 to 0.93]), CVD death (HR: 0.80 [95% CI 0.78 to 0.81]), and stroke (HR: 0.85 [95% CI 0.76 to 0.94]) and a non-significant association with risk of MI (HR 0.74 [95% CI 0.53 to 1.02]). The beneficial association of statins with the risk of all-cause mortality remained significant even at higher ages (> 75 years old; HR 0.88 [95% CI 0.81 to 0.96]) and in both men (HR: 0.75 [95% CI: 0.74 to 0.76]) and women (HR 0.85 [95% CI 0.72 to 0.99]). However, this association with the risk of all-cause mortality remained significant only in those with diabetes mellitus (DM) (HR 0.82 [95% CI 0.68 to 0.98]) but not in those without DM. The level of evidence of all the primary outcomes was rated as "very low."

Conclusions: Statin therapy in older people (aged ≥ 65 years) without CVD was associated with a 14%, 20%, and 15% lower risk of all-cause mortality, CVD death, and stroke, respectively. The beneficial association with the risk of all-cause mortality remained significant even at higher ages (> 75 years old), in both men and women, and in individuals with DM, but not in those without DM. These observational findings support the need for trials to test the benefits of statins in those above 75 years of age.
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http://dx.doi.org/10.1186/s12916-021-02009-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8218529PMC
June 2021

PCSK9 vaccine: so near, yet so far!

Eur Heart J 2021 Jun 21. Epub 2021 Jun 21.

Department of Hypertension, WAM University Hospital in Lodz, Medical University of Lodz, Lodz, Poland.

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http://dx.doi.org/10.1093/eurheartj/ehab299DOI Listing
June 2021

Nocebo/drucebo effect in statin-intolerant patients: an attempt at recommendations.

Eur Heart J 2021 Jun 21. Epub 2021 Jun 21.

Department of Hypertension, Chair of Nephrology and Hypertension, Medical University of Lodz, Rzgowska 281/289, 93-338 Lodz, Poland.

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http://dx.doi.org/10.1093/eurheartj/ehab358DOI Listing
June 2021

Cost-effectiveness of telerehabilitation in patients with heart failure in Poland: an analysis based on the results of Telerehabilitation in the Heart Failure Patients (TELEREH-HF) randomized clinical trial.

Kardiol Pol 2021 ;79(5):510-516

HealthQuest, Warszawa, Poland.

Background: Telerehabilitation in the Heart Failure Patients (TELEREH-HF) study showed a statistically significant improvement in the tertiary outcomes i.e. the New York Heart Association (NYHA) class after a 9-week follow-up, consistent with telerehabilitation-related benefits to quality of life (QoL) measured with the 36-item Short Form questionnaire (SF-36).

Aims: The study analyzed the cost-effectiveness of hybrid telerehabilitation compared to standard care in heart failure patients in the Polish setting using findings from the TELEREH-HF trial.

Methods: Cost-utility analysis was conducted from the perspective of a public payer (the Polish National Health Fund). The quality-adjusted life-year (QALY) measure was based on QoL, as survival benefit was not confirmed in the TELEREH-HF. Utility values were estimated based on NYHA improvement and a systematic review of NYHA-specific utility values. Alternatively, SF-36 results were translated into utility values. Telerehabilitation costs covered 8 weeks, 5 days/week, at a daily cost of 74 Polish zloty (PLN). Standard care costs resulted from extra in-patient and out-patient rehabilitation costs incurred for selected patients. A lifetime horizon was adopted, with an estimated average survival time of 3.9 years based on 2 years TELEREH-HF follow-up and subsequent literature-derived prognosis.

Results: Base case analysis yielded a 0.044 and 0.027 gain in QALY for the NYHA and SF-36-based approaches, corresponding to a cost per QALY of 58.7 and 96 thousand PLN, respectively. Sensitivity analysis confirmed that the cost per QALY value was likely below the official cost-effectiveness threshold in Poland.

Conclusions: The use of telerehabilitation was found cost-effective in Poland, i.e., the clinical benefits justify the additional costs.
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http://dx.doi.org/10.33963/KP.15885DOI Listing
June 2021

Quercetin and metabolic syndrome: A review.

Phytother Res 2021 Jun 8. Epub 2021 Jun 8.

Department of Pharmacodynamics and Toxicology, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

Metabolic syndrome (MetS) is a complex of diseases that lead to mortality due to the development of cardiovascular problems. Quercetin, as an important flavonoid, has various properties such as decreasing blood pressure, anti-hyperlipidemia, anti-hyperglycemia, anti-oxidant, antiviral, anticancer, anti-inflammatory, anti-microbial, neuroprotective, and cardio-protective effects. In this review article, we collected original articles from different sources such as Google Scholar, Medline, Scopus, and Pubmed, which is related to the effect of quercetin on the improvement of the signs of MetS, including elevated glucose level, hyperlipidemia, obesity, and blood pressure. According to these data, quercetin may also have a role in the management of metabolic disorders via different mechanisms such as increasing adiponectin, decreasing leptin, anti-oxidant activity, reduction of insulin resistance, the elevation of insulin level, and blocking of calcium channel. We have attempted to make some recommendations on the quercetin application in patients. However, it needs to do further clinical trials and more investigations to show the real clinical value of quercetin on metabolic syndrome.
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http://dx.doi.org/10.1002/ptr.7144DOI Listing
June 2021
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