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Adverse Effects of Low-Dose Methotrexate: A Randomized Trial.
Solomon, DH, Glynn, RJ, Karlson, EW, Lu, F, Corrigan, C, Colls, J, Xu, C, MacFadyen, J, Barbhaiya, M, Berliner, N, et al
Annals of internal medicine. 2020;(6):369-380
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Abstract
BACKGROUND Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred. OBJECTIVE To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo. DESIGN Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333). SETTING North America. PARTICIPANTS Adults with known cardiovascular disease and diabetes or metabolic syndrome. INTERVENTION Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week. MEASUREMENTS Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication. RESULTS After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]). LIMITATION The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period. CONCLUSION Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased. PRIMARY FUNDING SOURCE National Institutes of Health.
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Effects of a 3-Week In-Hospital Body Weight Reduction Program on Cardiovascular Risk Factors, Muscle Performance, and Fatigue: A Retrospective Study in a Population of Obese Adults with or without Metabolic Syndrome.
Rigamonti, AE, Cicolini, S, Caroli, D, De Col, A, Scacchi, M, Cella, SG, Sartorio, A
Nutrients. 2020;(5)
Abstract
BACKGROUND In clinical practice, there is the diffuse conviction that obese subjects with metabolic syndrome may be more difficult to treat. OBJECTIVES AND METHODS The aim of the present study was that to investigate the effectiveness of a 3-week in-hospital body weight reduction program (BWRP) in a large population of obese subjects with and without metabolic syndrome (n = 1922; 222 men and 1700 women, age range 18-83 yr). Outcomes such as body mass index (BMI), total (TOT) and HDL cholesterol, systolic and diastolic blood pressures (SBP and DBP, respectively), coronary heart disease (CHD) score, fatigue severity score (FSS), and stair climbing test (SCT) time were evaluated before and after the intervention (Δ). A sex-, BMI-, and age-related stratification of the obese population with or without metabolic syndrome was applied. RESULTS When compared to obese subjects without metabolic syndrome, at the basal conditions, obese subjects had a poorer cardiometabolic profile, as demonstrated by higher triglycerides, TOT-cholesterol, DBP, SBP, and CHD score, and a more compromised muscle performance (evaluated by SCT), associated with more perception of fatigue (measured by FSS). Nevertheless, obese subjects with metabolic syndrome obtained more benefits from BWRP than those without metabolic syndrome for some outcomes (i.e., ΔTOT-cholesterol, ΔSBP, and ΔCHD score). Despite these differences, the BWRP-induced weight loss was similar between the two groups (i.e., ΔBMI) as well as the gain of muscle performance (i.e., ΔSCT) and the reduction of fatigue (i.e., ΔFSS). Interestingly, the potentially deleterious fall in HDL-cholesterol levels after BWRP was less evident in obese subjects with metabolic syndrome than those without metabolic syndrome. When pooling all data, the ΔCHD score was associated with age, sex, and metabolic syndrome. The remaining outcomes, such as ΔBMI, ΔFSS, and ΔSCT time, were associated with sex and age but not with metabolic syndrome. Finally, ΔBMI was positively correlated with ΔCHD score, ΔFSS, and ΔSCT time in both obese subjects without metabolic syndrome and obese subjects with metabolic syndrome. CONCLUSIONS When comparing obese subjects undergoing a BWRP, metabolic syndrome is not a negative predictive factor affecting the effectiveness of this intervention in terms of weight loss, muscle performance, and psychological well-being.
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Supervised exercise training and increased physical activity to reduce cardiovascular disease risk in women with polycystic ovary syndrome: study protocol for a randomized controlled feasibility trial.
Woodward, A, Broom, D, Dalton, C, Metwally, M, Klonizakis, M
Trials. 2020;(1):101
Abstract
BACKGROUND Polycystic ovary syndrome (PCOS) affects up to 20% of women and is characterised by higher amounts of visceral fat, obesity, insulin resistance, dyslipidemia and reproductive and cardiometabolic complications. Increased oxidised low-density lipoprotein (LDL) concentrations have been associated with an increased risk of cardiovascular disease (CVD)-related events. Oxidised LDL is rarely used as a marker for CVD risk in PCOS-related studies despite its widely accepted role in atherogenesis and the increased risk factors associated with PCOS. Additionally, prolonged periods of sedentary behaviour can negatively affect metabolic health. No studies have specifically examined the effects of reducing sedentary behaviour on CVD risk in PCOS with a lifestyle physical activity intervention. The aim of the current study is to measure the feasibility of a randomised controlled trial (RCT) examining the effects of supervised exercise and reducing sedentary behaviour in women with PCOS on CVD risk. METHODS/DESIGN A feasibility, exploratory RCT will be conducted. Fifty-one pre-menopausal females will be randomly allocated between an exercise group (EG), a lifestyle physical activity group (LPAG) and a control group. Participants in the EG will undertake a 12-week supervised aerobic exercise programme. The LPAG will aim to increase daily physical activity and reduce sedentary behaviour for 12 weeks. The control group will not take part in any intervention. Primary outcomes are feasibility and acceptability of the intervention and procedures. Secondary outcomes are oxidised LDL, aerobic fitness, blood lipid profile, fasting glucose and insulin, testosterone and inflammatory markers. DISCUSSION PCOS is associated with various increased risk factors for CVD, including hypertension, dyslipidemia, abdominal obesity, insulin resistance, and inflammation. Whether oxidised LDL has a role in this increased risk is not yet known. The present study aims to measure the feasibility of implementing structured exercise training and/or increased lifestyle physical activity in women with PCOS, so that a subsequent adequately powered RCT can be designed. The results from the study will be used to refine the interventions and determine the acceptability of the study design. A limitation is that some self-monitoring in the lifestyle physical activity group may not be reliable or replicable, for example inputting information about time spent cleaning/gardening. TRIAL REGISTRATION ClinicalTrials.gov, NCT03678714. Registered 20 September 2018.
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Effectiveness of Mobile Health Interventions Promoting Physical Activity and Lifestyle Interventions to Reduce Cardiovascular Risk Among Individuals With Metabolic Syndrome: Systematic Review and Meta-Analysis.
Sequi-Dominguez, I, Alvarez-Bueno, C, Martinez-Vizcaino, V, Fernandez-Rodriguez, R, Del Saz Lara, A, Cavero-Redondo, I
Journal of medical Internet research. 2020;(8):e17790
Abstract
BACKGROUND Physical activity and lifestyle interventions, such as a healthy diet, have been proven to be effective approaches to manage metabolic syndrome. However, these interventions require great commitment from patients and clinicians owing to their economic costs, time consumption, and lack of immediate results. OBJECTIVE The aim of this systematic review and meta-analysis was to analyze the effect of mobile-based health interventions for reducing cardiometabolic risk through the promotion of physical activity and healthy lifestyle behaviors. METHODS PubMed, Scopus, Web of Science, Cochrane Central Register of Controlled Trials, and SPORTdiscus databases were searched for experimental studies evaluating cardiometabolic risk indicators among individuals with metabolic syndrome who were included in technology-assisted physical activity and lifestyle interventions. Effect sizes, pooled mean changes, and their respective 95% CIs were calculated using the DerSimonian and Laird method. Outcomes included the following clinical and biochemical parameters: body composition (waist circumference [WC] and BMI), blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), glucose tolerance (fasting plasma glucose [FPG] and glycated hemoglobin A1c [HbA1c]), and lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol [HDL-C], and triglycerides). RESULTS A total of nine studies were included in the meta-analysis. Owing to the scarcity of studies, only pooled mean pre-post changes in the intervention groups were estimated. Significant mean changes were observed for BMI (-1.70 kg/m2, 95% CI -3.20 to -0.20; effect size: -0.46; P=.03), WC (-5.77 cm, 95% CI -9.76 to -1.77; effect size: -0.54; P=.005), SBP (-7.33 mmHg, 95% CI -13.25 to -1.42; effect size: -0.43; P=.02), DBP (-3.90 mmHg, 95% CI -7.70 to -0.11; effect size: -0.44; P=.04), FPG (-3.65 mg/dL, 95% CI -4.79 to -2.51; effect size: -0.39; P<.001), and HDL-C (4.19 mg/dL, 95% CI 2.43-5.95; effect size: 0.23; P<.001). CONCLUSIONS Overall, mobile-based health interventions aimed at promoting physical activity and healthy lifestyle changes had a strong positive effect on cardiometabolic risk indicators among individuals with metabolic syndrome. Nevertheless, further research is required to compare this approach with usual care in order to support the incorporation of these technologies in health systems. TRIAL REGISTRATION PROSPERO CRD42019125461; https://tinyurl.com/y3t4wog4.
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Effects of Bilberry Supplementation on Metabolic and Cardiovascular Disease Risk.
Chan, SW, Tomlinson, B
Molecules (Basel, Switzerland). 2020;(7)
Abstract
Metabolic syndrome is a cluster of interrelated conditions that is associated with an increased risk of cardiovascular disease (CVD) and type 2 diabetes mellitus (T2DM). Oxidative stress may impair normal physiological functions, leading to various illnesses. T2DM is considered to be associated with increased oxidative stress, inflammation, and dyslipidemia, which may play a significant role in the development of cardiovascular complications, cancer and vision loss through cataracts and retinopathy. While conventional therapies are a cornerstone for the management of the major risk factors of metabolic syndrome, increasing antioxidant defense by increasing intake of antioxidant-rich foods may improve long term prospects in CVD, obesity and T2DM. Bilberry (Vaccinium myrtillus L.) is one of the richest natural sources of anthocyanins which give berries their red/purple/blue coloration. Anthocyanins are powerful antioxidants and are reported to play an important role in the prevention of metabolic disease and CVD as well as cancer and other conditions. This review focuses on the potential effects of bilberry supplementation on metabolic and cardiovascular risk factors. Although there is evidence to support the use of bilberry supplementation as part of a healthy diet, the potential benefits from the use of bilberry supplementation in patients with T2DM or CVD needs to be clarified in large clinical trials.
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Sleep duration and cardiovascular risk factors in children and adolescents: A systematic review.
Sun, J, Wang, M, Yang, L, Zhao, M, Bovet, P, Xi, B
Sleep medicine reviews. 2020;:101338
Abstract
An association between short sleep duration and cardiovascular risk factors and outcomes is well demonstrated in adults. However, findings on the association in children and adolescents have been inconsistent. In this review, we searched PubMed, Embase and ISI Web of Science for eligible publications until March 16, 2020. We identified 37 reviews/meta-analyses on the association between sleep duration and cardiovascular risk factors and 15 studies on the association between sleep duration and metabolic syndrome (MetS) in children and adolescents. We found strong evidence on the association between short sleep duration and increased adiposity markers and high blood pressure, some evidence on the association between short sleep duration and insulin resistance, but inconsistent findings on the association between sleep duration and blood lipids, inflammation and MetS. Although more studies are needed to further assess the association between sleep duration and selected cardiovascular risk factors, our findings support interventions to improve sleep duration and quality as a potential means to promote cardiovascular health in children and adolescents.
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Cardiovascular risk factors in people deprived of their liberty: an integrative review.
Silva, GPD, Morais, SCRV, Frazão, CMFQ, Lopes, CT, Mangueira, SO, Linhares, FMP
Revista gaucha de enfermagem. 2020;:e20190357
Abstract
OBJECTIVE To investigate the scientific evidence on the most frequent risk factors for cardiovascular disease in persons deprived of their liberty. METHODS An integrative literature review carried out in the CINAHL, Medline/Pubmed, Scopus, LILACS, CUIDEN, Web of Science and Virtual Health Library portal databases using the following keywords: cardiovascular diseases, risk factors, prisons, prisoners. RESULTS The final sample consisted of 17 primary articles published in English and Spanish. Overweight and obesity were the most cited cardiovascular risk factors besides diabetes, hypertension, smoking, dyslipidemia, consumption of alcohol and other drugs, physical inactivity, metabolic syndrome, anxiety, depression and unhealthy heart diet. CONCLUSIONS The most frequent risk factors for cardiovascular disease in persons deprived of their liberty were those classified as modifiable. In the prison setting, these factors are enhanced due to an environment with little modification of these opportunities.
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Adherence to a priori dietary indexes and baseline prevalence of cardiovascular risk factors in the PREDIMED-Plus randomised trial.
Alvarez-Alvarez, I, Toledo, E, Lecea, O, Salas-Salvadó, J, Corella, D, Buil-Cosiales, P, Zomeño, MD, Vioque, J, Martinez, JA, Konieczna, J, et al
European journal of nutrition. 2020;(3):1219-1232
Abstract
PURPOSE Cardiovascular disease remains the global leading cause of death. We evaluated at baseline the association between the adherence to eight a priori high-quality dietary scores and the prevalence of individual and clustered cardiovascular risk factors (CVRF) in the PREDIMED-Plus cohort. METHODS All PREDIMED-Plus participants (6874 men and women aged 55-75 years, with overweight/obesity and metabolic syndrome) were assessed. The prevalence of 4 CVRF (hypertension, obesity, diabetes, and dyslipidaemia), using standard diagnoses criteria, were considered as outcomes. The adherence to eight a priori-defined dietary indexes was calculated. Multivariable models were fitted to estimate differences in mean values of factors and prevalence ratios for individual and clustered CVRF. RESULTS Highest conformity to any dietary pattern did not show inverse associations with hypertension. The modified Mediterranean Diet Score (PR = 0.95; 95% CI 0.90-0.99), Mediterranean Diet Adherence Score (MEDAS) (PR = 0.94; 95% CI 0.89-0.98), the pro-vegetarian dietary pattern (PR = 0.95; 95% CI 0.90-0.99) and the Alternate Healthy Eating Index 2010 (PR = 0.92; 95% CI 0.87-0.96) were inversely associated with prevalence of obesity. We identified significant inverse trend among participants who better adhered to the MEDAS and the Prime Diet Quality Score (PDQS) in the mean number of CVRF across categories of adherence. Better adherence to several high-quality dietary indexes was associated with better blood lipid profiles and anthropometric measures. CONCLUSIONS Highest adherence to dietary quality indexes, especially Mediterranean-style and PDQS scores, showed marginal associations with lower prevalence of individual and clustered CVRF among elderly adults with metabolic syndrome at high risk of cardiovascular disease.
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Metabolically Healthy Obesity: Criteria, Epidemiology, Controversies, and Consequences.
Tsatsoulis, A, Paschou, SA
Current obesity reports. 2020;(2):109-120
Abstract
PURPOSE OF REVIEW To present a comprehensive overview regarding criteria, epidemiology, and controversies that have arisen in the literature about the existence and the natural course of the metabolic healthy phenotype. RECENT FINDINGS The concept of metabolically healthy obesity (MHO) implies that a subgroup of obese individuals may be free of the cardio-metabolic risk factors that commonly accompany obese subjects with adipose tissue dysfunction and insulin resistance, known as having metabolic syndrome or the metabolically unhealthy obesity (MUO) phenotype. Individuals with MHO appear to have a better adipose tissue function, and are more insulin sensitive, emphasizing the central role of adipose tissue function in metabolic health. The reported prevalence of MHO varies widely, and this is likely due the lack of universally accepted criteria for the definition of metabolic health and obesity. Also, the natural course and the prognostic value of MHO is hotly debated but it appears that it likely evolves towards MUO, carrying an increased risk for cardiovascular disease and mortality over time. Understanding the pathophysiology and the determinants of metabolic health in obesity will allow a better definition of the MHO phenotype. Furthermore, stratification of obese subjects, based on metabolic health status, will be useful to identify high-risk individuals or subgroups and to optimize prevention and treatment strategies to compact cardio-metabolic diseases.
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The effects of Prickly Pear fruit and cladode (Opuntia spp.) consumption on blood lipids: A systematic review.
Gouws, C, Mortazavi, R, Mellor, D, McKune, A, Naumovski, N
Complementary therapies in medicine. 2020;:102384
Abstract
BACKGROUND The current dietary recommendations for cardiovascular disease (CVD) risk reduction include increased fruit and vegetable consumption. The Opuntia spp., Prickly Pear (PP) fruit is rich in dietary fiber and may have lipid-lowering effects but it is often confused with the PP stem/leaf (Cladode (CLD)), or not identified. The efficacy of the PP fruit and CLD in reducing CVD risk is a growing area of research. METHODS This systematic review (PROSPERO CRD42018110643), examined the effects of consuming the Opuntia spp. components (PP or CLD) on CVD risk factors, specifically total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C) and triglycerides (TG). The review, performed from February through September 2019, used resources available through Food Science and Technology Abstracts (EBSCO), Medline, Scopus, CINAHL, Web of Science and Cochrane databases. RESULTS AND DISCUSSION Eleven articles met the inclusion criteria, which characterised Opuntia spp. products as either PP (n = 6), CLD (n = 4) or commercial products' (n=1). Effects were investigated in healthy and obese populations as well as those with metabolic illnesses, specifically type 2 diabetes and metabolic syndrome. PP consumption was associated with significant reductions in TC (p < 0.05) in all but one included study, whereas in the remaining studies (n=6), LDL-C levels decreased (p < 0.05). Separately, the effect of CLD consumption on lipids was small with one study reporting a significant increase in plasma HDL-C in a subgroup of participants (>45 years of age) following consumption of a patented CLD powder product. It is plausible, that differences in overall effect may be due to compositional distinctions between CLD and PP, such as fiber composition. Care must be taken in future studies to accurately report the identity of the selected components of Opuntia spp.