Cost effectiveness of lifelong therapy with PCSK9 inhibitors for lowering cardiovascular events in patients with stable coronary artery disease: Insights from the Ludwigshafen Risk and Cardiovascular Health cohort.

Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) reduce cardiovascular events in coronary artery disease (CAD). Their costs exceed that of established oral lipid-lowering agents. Previous cost-effectiveness assessments have been inconsistent. Markov cohort state transitions models for stable CAD patients were calculated using information from 1530 participants of the Ludwigshafen Risk and Cardiovascular Health Study (LURIC) with known causes of deaths. Non-fatal to fatal event rates, drug prices, direct treatment costs, and utility weights were from public sources. At an assumed relative risk reduction of 32.5% and an annual drug price of 8500 Euros, QALYs gained were 1.23 and 1.20, savings were 2390 and 2410 Euros, and ICERs were 112,530 and 108,660 Euros in women and men, respectively. When the annual cost of this medication was set at 1600 Euros, corresponding ICERs were 21,180 and 20,450 Euros. PCSK9i treatment is cost-effective in stable CAD at a threshold of 150,000 Euro and annual costs of 8500 Euros. As the broad use of PCSK9i therapy in CAD would have a disruptive impact on the healthcare budget, treatment should be focused on very high risk patients (≥3 comorbidities, annual risk of 10%); alternatively, and for lower risk, significant cost reductions would be needed.

Quantifying Unmet Need in Statin-Treated Hyperlipidemia Patients and the Potential Benefit of Further LDL-C Reduction Through an EHR-Based Retrospective Cohort Study.

BACKGROUND: Statins are effective in helping prevent cardiovascular disease (CVD). However, studies suggest that only 20%-64% of patients taking statins achieve reasonable low-density lipoprotein cholesterol (LDL-C) thresholds. On-treatment levels of LDL-C remain a key predictor of residual CVD event risk. OBJECTIVES: To (a) determine how many patients on statins achieved the therapeutic threshold of LDL-C < 100 mg per dL (general cohort) and < 70 mg per dL (secondary prevention cohort, or subcohort, with preexisting CVD); (b) estimate the number of potentially avoidable CVD events if the threshold were reached; and (c) forecast potential cost savings. METHODS: A retrospective, longitudinal cohort study using electronic health record data from the Indiana Network for Patient Care (INPC) was conducted. The INPC provides comprehensive information about patients in Indiana across health care organizations and care settings. Patients were aged > 45 years and seen between January 1, 2012, and October 31, 2016 (ensuring study of contemporary practice), were statin-naive for 12 months before the index date of initiating statin therapy, and had an LDL-C value recorded 6-18 months after the index date. Subsequent to descriptive cohort analysis, the theoretical CVD risk reduction achievable by reaching the threshold was calculated using Framingham Risk Score and Cholesterol Treatment Trialists' Collaboration formulas. Estimated potential cost savings used published first-year costs of CVD events, adjusted for inflation and discounted to the present day. RESULTS: Of the 89,267 patients initiating statins, 30,083 (33.7%) did not achieve the LDL-C threshold (subcohort: 58.1%). In both groups, not achieving the threshold was associated with patients who were female, black, and those who had reduced medication adherence. Higher levels of preventive aspirin use and antihypertensive treatment were associated with threshold achievement. In both cohorts, approximately 64% of patients above the threshold were within 30 mg per dL of the respective threshold. Adherence to statin therapy regimen, judged by a medication possession ratio of ≥ 80%, was 57.4% in the general cohort and 56.7% in the subcohort. Of the patients who adhered to therapy, 23.7% of the general cohort and 50.5% of the subcohort had LDL-C levels that did not meet the threshold. 10-year CVD event risk in the at-or-above threshold group was 22.78% (SD = 17.24%) in the general cohort and 29.56% (SD = 18.19%) in the subcohort. By reducing LDL-C to the threshold, a potential relative risk reduction of 14.8% in the general cohort could avoid 1,173 CVD events over 10 years (subcohort: 15.7% and 454 events). Given first-year inpatient and follow-up costs of $37,300 per CVD event, this risk reduction could save about $1,455 per patient treated to reach the threshold (subcohort: $1,902; 2017 U.S. dollars) over a 10-year period. CONCLUSIONS: Across multiple health care systems in Indiana, between 34% (general cohort) and 58% (secondary prevention cohort) of patients treated with statins did not achieve therapeutic LDL-C thresholds. Based on current CVD event risk and cost projections, such patients seem to be at increased risk and may represent an important and potentially preventable burden on health care costs. DISCLOSURES: Funding support for this study was provided by Merck (Kenilworth, NJ). Chase and Boggs are employed by Merck. Simpson is a consultant to Merck and Pfizer. The other authors have nothing to disclose.

Increased triglyceride/high-density lipoprotein cholesterol ratio may be associated with reduction in the low-density lipoprotein particle size: assessment of atherosclerotic cardiovascular disease risk.

Hypertriglyceridemia, which often leads to both low-density lipoprotein (LDL) and high-density lipoprotein (HDL) metabolic disorders, is a strong risk factor for the development of atherosclerotic cardiovascular disease (ASCVD). We hypothesized that the triglyceride (TG)/HDL cholesterol (TG/HDL-C) ratio may be more useful for estimation of the LDL-particle size, as a well-known risk factor for ASCVD, as compared to the serum TG level per se. Polyacrylamide gel electrophoresis was used in this study to estimate the LDL-particle size [relative LDL migration (LDL-Rm value)] in 649 consecutive patients with one additional risk factor for ASCVD. Multivariable regression analysis identified both serum TG (ß = 0.556, p < 0.0001) and the serum TG/HDL-C ratio (ß = 0.607, p < 0.0001) as independent indicators of the LDL-particle size. In terms of evaluation of the accuracy of indicators of LDL-Rm values equal to or greater than 0.40, which are suggestive of the presence of large amounts of small-dense LDL and represent the upper limit (mean + 2 standard deviation) of the normal range in this population, both the serum TG level and serum TG/HDL-C ratio showed high accurate areas under the receiver-operating characteristic curve (0.900 vs. 0.914), but with a negative likelihood ratio of 0.506 vs. 0.039, indicating that the TG/HDL-C ratio model is superior for excluding patients with values below the cutoff value and with LDL-Rm values ≥ 0.40. Furthermore, in 456 patients followed up for at least 1 year, multivariable regression analysis identified increased serum TG/HDL-C ratio as an independent predictor of a decreased LDL-particle size. These results suggest that the serum TG/HDL-C ratio may be more useful for assessing the risk of ASCVD as compared to the serum TG level per se. To reduce the risk of ASCVD, it may be important to focus not only on changes of the serum LDL-C, but also on those of the serum TG/HDL-C ratio.

Hyperlipidemia: Management with Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibitors.

Coronary artery disease is the leading cause of death in United States. Hyperlipidemia is an independent and potentially reversible risk factor for coronary artery disease. The 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitors, collectively known as statins, have been the mainstay of pharmacologic therapy. Their availability, ease of administration, low cost, and strong evidence behind safety and efficacy makes them one of the most widely prescribed lipid-lowering agents. However, some patients may be intolerant to statins, and few others suffer from very high serum levels of cholesterol in which statin therapy alone or in combination with other cholesterol-lowering agents is insufficient in reducing serum lipid levels to achieve desired levels. In 2015, the Food and Drug Administration approved a new family of lipid-lowering agents, collectively known as proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors.PCSK9 inhibitors are biologically active molecules that decrease serum low-density lipoprotein cholesterol compared with statin therapy alone. They serve as an alternative to statins for patients who are intolerant to statin or as supplemental therapy in those patients for whom lower levels in serum low-density lipoprotein cholesterol are not achieved by statins alone. This article discusses PCSK9 inhibitors, their mechanism of action, indications, efficacy, safety, costs and limitations.

Comparison of Low-Density Lipoprotein Cholesterol Assessment by Martin/Hopkins Estimation, Friedewald Estimation, and Preparative Ultracentrifugation: Insights From the FOURIER Trial.

Importance: Recent studies have shown that Friedewald underestimates low-density lipoprotein cholesterol (LDL-C) at lower levels, which could result in undertreatment of high-risk patients. A novel method (Martin/Hopkins) using a patient-specific conversion factor provides more accurate LDL-C levels. However, this method has not been tested in proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor-treated patients. Objective: To investigate accuracy of 2 different methods for estimating LDL-C levels (Martin/Hopkins and Friedewald) compared with gold standard preparative ultracentrifugation (PUC) in patients with low LDL-C levels in the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Patients With Elevated Risk (FOURIER) trial. Design, Setting, and Participants: The FOURIER trial was a randomized clinical trial of evolocumab vs placebo added to statin therapy in 27 564 patients with stable atherosclerotic cardiovascular disease. The patients' LDL-C levels were assessed at baseline, 4 weeks, 12 weeks, 24 weeks, and every 24 weeks thereafter, and measured directly by PUC when the level was less than 40 mg/dL per the Friedewald method (calculated as non-HDL-C level - triglycerides/5). In the Martin/Hopkins method, patient-specific ratios of triglycerides to very low-density lipoprotein cholesterol (VLDL-C) ratios were determined and used to estimate VLDL-C, which was subtracted from the non-HDL-C level to obtain the LDL-C level. Main Outcomes and Measures: Low-density lipoprotein cholesterol calculated by the Friedewald and Martin/Hopkins methods, with PUC as the reference method. Results: For this analysis, the mean (SD) age was 62.7 (9.0) years; 2885 of the 12 742 patients were women (22.6%). A total of 56 624 observations from 12 742 patients had Friedewald, Martin/Hopkins, and PUC LDL-C measurements. The median difference from PUC LDL-C levels for Martin/Hopkins LDL-C levels was -2 mg/dL (interquartile range [IQR], -4 to 1 mg/dL) and for Friedewald LDL-C levels was -4 mg/dL (IQR, -8 to -1 mg/dL; P < .001). Overall, 22.9% of Martin/Hopkins LDL-C values were more than 5 mg/dL different than PUC values, and 2.6% were more than 10 mg/dL different than PUC levels. These were significantly less than respective proportions with Friedewald estimation (40.1% and 13.3%; P < .001), mainly because of underestimation by the Friedewald method. The correlation with PUC LDL-C was significantly higher for Martin/Hopkins vs Friedewald (ρ, 0.918 [95% CI 0.916-0.919] vs ρ, 0.867 [0.865-0.869], P < .001). Conclusions and Relevance: In patients achieving low LDL-C with PCSK9 inhibition, the Martin/Hopkins method for LDL-C estimation more closely approximates gold standard PUC than Friedewald estimation does. The Martin/Hopkins method may prevent undertreatment because of LDL-C underestimation by the Friedewald method. Trial Registration: ClinicalTrials.gov Identifier: NCT01764633.

Association of Patient Perceptions of Cardiovascular Risk and Beliefs on Statin Drugs With Racial Differences in Statin Use: Insights From the Patient and Provider Assessment of Lipid Management Registry.

Importance: African American individuals face higher atherosclerotic cardiovascular disease risk than white individuals; reasons for these differences, including potential differences in patient beliefs regarding preventive care, remain unknown. Objective: To evaluate differences in statin use between white and African American patients and identify the potential causes for any observed differences. Design, Setting, and Participants: Using the 2015 Patient and Provider Assessment of Lipid Management (PALM) Registry data, we compared statin use and dosing between African American and white outpatient adults who were potentially eligible for primary or secondary prevention statins. A total of 138 US community health care practices contributed to the data. Data analysis was conducted from March 2017 to May 2018. Main Outcomes and Measures: Primary outcomes were use and dosing of statin therapy according to the 2013 American College of Cardiology/American Heart Association guideline by African American or white race. Secondary outcomes included lipid levels and patient-reported beliefs. Poisson regression was used to evaluate the association between race and statin undertreatment, a category combining people who were not taking a statin or those taking a dose intensity lower than recommended. Results: A total of 5689 patients (806 [14.2%] African American) in the PALM registry were eligible for statin therapy. African American individuals were less likely than white individuals to be treated with a statin (570/807 [70.6%] vs 3654/4883 [74.8%]; P = .02). Among those treated, African American patients were less likely than white patients to receive a statin at guideline-recommended intensity (269 [33.3%] vs 2145 [43.9%], respectively; P < .001; relative risk, 1.07 [95% CI, 1.00-1.15]; P = .05, after adjustment for demographic and clinical factors). The median (interquartile range) low-density lipoprotein cholesterol levels of patients receiving treatment were higher among African American than white individuals (97.0 [76.0-121.0] mg/dL vs 85.0 [68.0-105.0] mg/dL; P < .001). African American individuals were less likely than white individuals to believe statins were safe (292 [36.2%] vs 2800 [57.3%]; P < .001) or effective (564 [70.0%] vs 3635 [74.4%]; P = .008) and were less likely to trust their clinician (663 [82.3%] vs 4579 [93.8%]; P < .001). Group differences in statin undertreatment were not significant after adjusting for demographic, clinical, and clinician factors, socioeconomic status, and patient beliefs (final adjusted relative risk, 1.03 [95% CI 0.96-1.11]; P = .35). Conclusions and Relevance: African American individuals were less likely to receive guideline-recommended statin therapy. Demographic, clinical, socioeconomic, belief-related, and clinician differences contributed to observed differences and represent potential targets for intervention.

Monitoring of Recommended Metabolic Laboratory Parameters Among Medicaid Recipients on Second-Generation Antipsychotics in Federally Qualified Health Centers.

BACKGROUND: In 2004, a consensus statement outlining recommended metabolic monitoring for patients prescribed second-generation antipsychotics (SGAs) was published. More than a decade later, suboptimal adherence rates to these recommendations continue to be reported, which could lead to long-term and costly complications. OBJECTIVES: To define the prevalence of appropriately monitored Medicaid patients receiving care at federally qualified health centers (FQHCs) prescribed SGAs. METHODS: This was a retrospective study examining electronic health record and Medicaid claims data to assess the rates of glucose and lipid monitoring for patients prescribed SGAs from January 2014 to August 2016 in a FQHC. Prescription and laboratory claims for patients receiving care at 4 FQHCs were reviewed. Descriptive statistics were used to evaluate the primary outcome. RESULTS: A total of 235 patients were included in the analysis. Patients initiated on SGA therapy (n = 92) had baseline glucose and lipid monitoring rates of 50% and 23%, respectively. The 3-month monitoring rates were 37% for glucose and 26% for lipids, whereas annual rates were 71% and 40%, respectively. Patients continuing SGA therapy (n = 143) had annual glucose and lipid monitoring rates of 67% and 44%. CONCLUSIONS: Medicaid patients at FQHCs initially prescribed SGAs have low baseline and 3-month metabolic monitoring, whereas annual monitoring was comparable to previously published studies. Adults receiving chronic care at a FQHC were more likely to receive glucose monitoring. Those with type 2 diabetes mellitus and/or hyperlipidemia were more likely to receive glucose and lipid monitoring.

Experimentally designed lyophilized dry emulsion tablets for enhancing the antihyperlipidemic activity of atorvastatin calcium: Preparation, in-vitro evaluation and in-vivo assessment.

This article presents the development of lyophilized orally disintegrating tablets prepared with the dry emulsion technique to enhance the in-vitro dissolution and in-vivo performance of the poorly bioavailable drug atorvastatin calcium (ATV). Tablets were fabricated by freeze-drying o/w emulsions of ATV. The Emulsions were prepared using a matrix former solution (alginate or gelatin, 2 or 4%) containing a sugar alcohol (mannitol) and a collapse protectant (glycine) as the water phase and Labrafac® as the oil phase in the presence of surfactant (synperonic® PE/P 84 or synperonic® F108) under proper homogenization. The influence of formulation parameters on friability of the prepared tablets, disintegration time and in-vitro dissolution of the drug from these tablets were investigated. Results showed the significant influence of the matrix former and emulsifier type on the disintegration time. In-vitro dissolution study revealed the enhanced dissolution rate of ATV from the lyophilized dry emulsion tablets (LDET) compared to the plain drug. DSC and XRD studies of the optimized ATV-loaded LDET proved the presence of the drug in the amorphous form. SEM images showed the intact, porous and non-collapsible structure of the prepared LDET with complete loss of ATV crystallinity. Administration of ATV-loaded LDET to high fat diet-induced hyperlipidemic rats demonstrated a significant decrease (p<0.05) in the serum and tissue levels of the tested parameters compared to the market product used. The obtained results suggest a promising, easy-to-manufacture and effective dosage form for the treatment of hyperlipidemia.

Safety assessment of niacin in the US Food and Drug Administration's mini-sentinel system.

PURPOSE: The Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events (HPS2-THRIVE) trial found higher incidence rates of adverse reactions, including bleeding, in patients receiving the combination of extended-release niacin and laropiprant versus placebo. It is not known whether these adverse events are attributable to laropiprant, not approved in the USA, or to extended-release niacin. We compared rates of major gastrointestinal bleeding and intracranial hemorrhage among initiators of extended-release niacin and initiators of fenofibrate. METHODS: We used Mini-Sentinel (now Sentinel) to conduct an observational, new user cohort analysis. We included data from 5 Data Partners covering the period from January 1, 2007 to August 31, 2013. Individuals who initiated extended-release niacin were propensity score-matched to individuals who initiated fenofibrate. Within the matched cohorts, we used Cox proportional hazards models to compare rates of hospitalization for major gastrointestinal bleeding events and intracranial hemorrhage assessed using validated claims-based algorithms. RESULTS: A total of 234 242 eligible extended-release niacin initiators were identified, of whom 210 389 (90%) were 1:1 propensity score-matched to eligible fenofibrate initiators. In propensity score-matched analyses, no differences were observed between exposure groups in rates of major gastrointestinal bleeding (hazard ratio [HR], 0.98; 95% confidence interval [CI], 0.82 to 1.18) or intracranial hemorrhage (HR, 1.21; 95% CI, 0.66 to 2.22). Results were similar in pre-specified sensitivity and subgroup analyses. CONCLUSIONS: We did not observe evidence for an association between extended-release niacin versus fenofibrate and rates of major gastrointestinal bleeding or intracranial hemorrhage.

Avaliação de Compostos Bioativos, Composição Físico-Química e Atividade Antioxidante In Vitro da Farinha de Berinjela / Assessment of Bioactive Compounds, Physicochemical Composition, and In Vitro Antioxidant Activity of Eggplant Flour

Fundamento: A berinjela (Solanum melongena) é um fruto de consumo mundial. Seu processamento em forma de farinha é uma maneira de evitar perdas e aproveitar suas características nutricionais. Objetivos: Este estudo avaliou a composição físico-química (umidade, proteínas, lipídeos, fibra bruta, carboidratos, minerais, niacina, saponinas, acidez titulável, fibra alimentar e fenóis totais) da farinha de berinjela preparada a partir do fruto inteiro desidratado em estufa. Métodos: Avaliou-se a atividade antioxidante in vitro usando os seguintes ensaios: radical 2,2-difenil-1-picrilhidrazila (DPPH); poder antioxidante de redução do ferro (FRAP); e análise de polifenóis com Cromatografia Líquida de Alta Eficiência (CLAE - ácido clorogênico, ácido cafeico, ácido ferúlico e rutina). Resultados: Verificou-se a presença de: 23,09% de carboidratos; 13,34% de proteínas; 1,85% de lipídeos; 39,19% de fibras totais; 1.540 mg/100 g de compostos fenólicos solúveis totais; 840 mg/100 g de saponinas; minerais (potássio, magnésio, cobre, ferro, zinco, manganês); e niacina. Observou-se atividade antioxidante in vitro para DPPH (455,6 mg de ácido ascórbico/100 g) e FRAP (486,8 mg de ácido ascórbico/100 g). A CLAE determinou a presença de ácido ascórbico, tirosina e ácidos fenólicos (ácido clorogênico, ácido cafeico e ácido ferúlico). Conclusão: A farinha de berinjela tem alto teor de fibra além de bom teor de compostos fenólicos e saponinas com importante capacidade antioxidante observada através de ensaios in vitro. A farinha de berinjela é uma boa opção para ser adicionada à dieta da população, devido aos seus potenciais benefícios à saúde

Background: The eggplant (Solanum melongena) is a fruit of world consumption. Its processing in the form of flour is a way to avoid losses and to take advantage of its nutritional characteristics. Objective: This study assessed the physicochemical composition (moisture, proteins, lipids, crude fiber, carbohydrates, minerals, niacin, saponins, titratable acidity, dietary fiber, and total phenols) of eggplant flour prepared from the whole fruit dehydrated in an oven. Methods: In vitro antioxidant activity was assessed using the following methods: 2.2-diphenyl-1-picrylhydrazyl radical (DPPH); Ferric Reducing/ Antioxidant Power (FRAP); and analysis of polyphenols using HPLC (chlorogenic acid, caffeic acid, ferulic acid, and rutin). Results: It was possible to observe: 23.09% carbohydrates; 13.34% proteins; 1.85% lipids; 39.19% total fibers; 1,540 mg/100 g total soluble phenolic compounds; 840 mg/100 g saponins; minerals (potassium, magnesium, copper, iron, zinc, manganese); and niacin. In vitro antioxidant activity was observed through DPPH (455.6 mg ascorbic acid/100 g) and FRAP (486.8 mg ascorbic acid/100 g). The HPLC method determined the presence of ascorbic acid, tyrosine, and phenolic acids (chlorogenic acid, caffeic acid, and ferulic acid). Conclusion: The eggplant flour had great fiber content in addition to good content of phenolic compounds and saponins with important antioxidant capacity observed through in vitro assays. As a result, eggplant flour is a good addition to the diet of the population, since it can bring potential health benefits

Fermented green tea extract exhibits hypolipidaemic effects through the inhibition of pancreatic lipase and promotion of energy expenditure.

Hyperlipidaemia is a major cause of atherosclerosis and related CVD and can be prevented with natural substances. Previously, we reported that a novel Bacillus-fermented green tea (FGT) exerts anti-obesity and hypolipidaemic effects. This study further investigated the hypotriglyceridaemic and anti-obesogenic effects of FGT and its underlying mechanisms. FGT effectively inhibited pancreatic lipase activity in vitro (IC50, 0·48 mg/ml) and ameliorated postprandial lipaemia in rats (26 % reduction with 500 mg/kg FGT). In hypertriglyceridaemic hamsters, FGT administration significantly reduced plasma TAG levels. In mice, FGT administration (500 mg/kg) for 2 weeks augmented energy expenditure by 22 % through the induction of plasma serotonin, a neurotransmitter that modulates energy expenditure and mRNA expressions of lipid metabolism genes in peripheral tissues. Analysis of the gut microbiota showed that FGT reduced the proportion of the phylum Firmicutes in hamsters, which could further contribute to its anti-obesity effects. Collectively, these data demonstrate that FGT decreases plasma TAG levels via multiple mechanisms including inhibition of pancreatic lipase, augmentation of energy expenditure, induction of serotonin secretion and alteration of gut microbiota. These results suggest that FGT may be a useful natural agent for preventing hypertriglyceridaemia and obesity.

Assessment of bioactive metabolites and hypolipidemic effect of polyphenolic-rich red cabbage extract.

CONTEXT: Cardiovascular disease is the leading cause of death worldwide and the consumption of red cabbage (Brassica oleracea var. capitata f. rubra DC. - Brassicaceae) has been linked with the reduction risk of chronic diseases. OBJECTIVE: The present study assesses the bioactive metabolites and hypolipidemic effect of red cabbage on rats. MATERIALS AND METHODS: The content of total phenols, flavonoids, anthocyanins, carotenoids, ascorbic acid and antioxidant capacity were assessed, while individual phenolic acids and flavonoids were detected using reverse phase-high performance liquid chromatography (HPLC) analysis. Acute hypolipidemic activity of aqueous extract of red cabbage (RC - 125, 250 and 500 mg/kg) was investigated using a Triton WR-1339 (400 mg/kg) induced hyperlipidemic Wistar rats compared to fenofibrate (65 mg/kg). RESULTS: The HPLC analysis of extracts revealed eight phenolic acids, gallic, protocatechuic, p-hydroxybenzoic, m-coumaric, syringic, caffeic, cinnamic, dicaffeoylquinic and three flavonoids, epicatechin, epigallocatechin, gallocatechin. Furthermore, the aqueous extract showed higher amounts of total phenolics (116.00 mg/g), flavonoids (161.32 µg/g) and, antioxidant activity (87.19%) than the hydromethanolic (89.33 mg/g, 123.34 µg/g and 75.07%), respectively. The RC significantly (p < 0.001) ameliorated the levels of cholesterol, triglycerides and lipoproteins alterations in hyperlipidemic rats without toxicity. DISCUSSION AND CONCLUSION: Herein, the RC presented the higher amounts of phenolics and flavonoids comparing with the hydromethanolic extract. Additionally, the RC showed as the majority compounds, dicaffeoylquinic and cinnamic acids, and the flavonoids epicatechin and gallocatechin. Furthermore, the RC demonstrated a beneficial effect against hypercholesterolemia and hypertriglyceridemia, demonstrating its potential therapeutic effect on these risk factors of cardiovascular diseases.

Platelet Reactivity in Patients With Stroke and Hyperlipidemia, GPIbα Assessment.

The aim of this study was to assess platelet reactivity in patients after ischemic stroke and to investigate the influence of hyperlipidemia (HL) on platelet activity markers. A total of 41 patients after ischemic stroke were divided into the following 2 groups: patients with HL and patients with normolipidemia. Expression of CD42b on resting, thrombin-activated blood platelets, and fibrinogen level was assessed. The CD42b-positive platelets were analyzed using the flow cytometer, anti-CD61, and anti-CD42b monoclonal antibodies. The results confirmed increased platelet reactivity to thrombin in all patients after ischemic stroke manifested by significantly lower CD42b expression and percentage of CD42b(+) platelets after activation by thrombin. The influence of HL on the expression of CD42b on resting and thrombin-activated platelets was not found. However, increased level of fibrinogen but no influence of HL on fibrinogen concentration was observed in patients after ischemic stroke. Increased susceptibility to platelet agonists was found in patients after ischemic stroke in the convalescent phase.

Randomized trial of a health IT tool to support between-visit-based laboratory monitoring for chronic disease medication prescriptions.

BACKGROUND: Lack of timely medication intensification and inadequate medication safety monitoring are two prevalent and potentially modifiable barriers to effective and safe chronic care. Innovative applications of health information technology tools may help support chronic disease management. OBJECTIVE: To examine the clinical impact of a novel health IT tool designed to facilitate between-visit ordering and tracking of future laboratory testing. DESIGN AND PARTICIPANTS: Clinical trial randomized at the provider level (n = 44 primary care physicians); patient-level outcomes among 3,655 primary care patients prescribed 5,454 oral medicines for hyperlipidemia, diabetes, and/or hypertension management over a 12-month period. MAIN MEASURES: Time from prescription to corresponding follow-up laboratory testing; proportion of follow-up time that patients achieved corresponding risk factor control (A1c, LDL); adverse event laboratory monitoring 4 weeks after medicine prescription. KEY RESULTS: Patients whose physicians were allocated to the intervention (n = 1,143) had earlier LDL laboratory assessment compared to similar patients (n = 703) of control physicians [adjusted hazard ratio (aHR): 1.15 (1.01-1.32), p = 0.04]. Among patients with elevated LDL (486 intervention, 324 control), there was decreased time to LDL goal in the intervention group [aHR 1.26 (0.99-1.62)]. However, overall there were no significant differences between study arms in time spent at LDL or HbA1c goal. Follow-up safety monitoring (e.g., creatinine, potassium, or transaminases) was relatively infrequent (ranging from 7 % to 29 % at 4 weeks) and not statistically different between arms. Intervention physicians indicated that lack of reimbursement for non-visit-based care was a barrier to use of the tool. CONCLUSIONS: A health IT tool to support between-visit laboratory monitoring improved the LDL testing interval but not LDL or HbA1c control, and it did not alter safety monitoring. Adoption of innovative tools to support physicians in non-visit-based chronic disease management may be limited by current visit-based financial and productivity incentives.

Anthropometric parameters in relation to glycaemic status and lipid profile in a multi-ethnic sample in Italy.

OBJECTIVE: To examine the health status of ethnic minorities in Italy. Furthermore, we aimed to assess the association between anthropometric and blood parameters connected with health status. DESIGN: A cross-sectional study. Anthropometric data were collected by direct measurements and blood glucose, total cholesterol and TAG were analysed. SETTING: Bologna, northern Italy. SUBJECTS: A multi-ethnic sample of adult immigrants and Roma. RESULTS: Significant correlations between anthropometric and blood parameters were found. Among the ethnic groups, Roma males had the highest values of glucose, total cholesterol and TAG. In the females the situation was more balanced among ethnic groups. CONCLUSIONS: The data from this survey indicate that poor health status is a very common problem among ethnic groups living in Italy, especially the Roma. The use of anthropometric parameters as rapid indicators of health status in screenings of a large number of subjects could be an effective and cheap method to provide preliminary indications on individuals or ethnic groups at greater risk of poor health.

Distribution of lipid parameters according to different socio-economic indicators- the EPIC-Norfolk prospective population study.

BACKGROUND: Data on the relationship between plasma levels of cholesterol and triglycerides and social class have been inconsistent. Most previous studies have used one classification of social class. METHODS: This was a cross-sectional population based study with data on occupational social class, educational level obtained using a detailed health and lifestyle questionnaire. A total of 10,147 men and 12,304 women aged 45-80 years living in Norfolk, United Kingdom, were recruited using general practice age-sex registers as part of the European Prospective Investigation into Cancer (EPIC-Norfolk). Plasma levels of cholesterol and triglycerides were measured in baseline samples. Social class was classified according to three classifications: occupation, educational level, and area deprivation score according to Townsend deprivation index. Differences in lipid levels by socio-economic status indices were quantified by analysis of variance (ANOVA) and multiple linear regression after adjusting for body mass index and alcohol consumption. RESULTS: Total cholesterol levels were associated with occupational level among men, and with educational level among women. Triglyceride levels were associated with educational level and occupational level among women, but the latter association was lost after adjustment for age and body mass index. HDL-cholesterol levels were associated with both educational level and educational level among men and women. The relationships with educational level were substantially attenuated by adjustment for age, body mass index and alcohol use, whereas the association with educational class was retained upon adjustment. LDL-cholesterol levels were not associated with social class indices among men, but a positive association was observed with educational class among women. This association was not affected by adjustment for age, body mass index and alcohol use. CONCLUSIONS: The findings of this study suggest that there are sex differences in the association between socio-economic status and serum lipid levels. The variations in lipid profile with socio-economic status may be largely attributed to potentially modifiable factors such as obesity, physical activity and dietary intake.

Differences in cholesterol management among states in relation to health insurance and race/ethnicity across the United States.

BACKGROUND: Across the United States, hyperlipidemia remains inadequately controlled and may vary across states according to differences in health insurance coverage and/or race/ethnicity. OBJECTIVE: To examine relationships between states' health insurance and race/ethnicity characteristics with measures of hyperlipidemia management across the 50 U.S. states and the District of Columbia. METHODS: Cross-validated, multiple linear regression modeling was used to analyze associations between states' health insurance patterns or proportions of racial minorities (from the 2010 U.S. Census data) and states' aggregate frequency of checking cholesterol within the previous 5 years or prescriptions written for lipid-lowering medications (from national survey and population-adjusted retail prescription data, respectively), with adjustments for age, sex, body mass index, race/ethnicity, and poverty. RESULTS: In states with proportionately more uninsured, cholesterol levels are checked less often, but in states with proportionately more private, Medicare, or Medicaid coverage, providers are not necessarily more likely to check cholesterol or to write more prescriptions. In states with proportionately more African-Americans and/or Hispanics, cholesterol is more likely to be checked, but in states with more African-Americans, more prescriptions were written, whereas in states with more Hispanics, fewer statin prescriptions were written. CONCLUSION: Variations across states in insurance and racial/ethnicity mix are associated with variations in hyperlipidemia management; less-insured states may be less effective whereas states with more private, Medicare, or Medicaid coverage may not be more effective. In states with proportionately more African-Americans vs. Hispanics, lipid medications may be prescribed differently. Our findings warrant further investigations.

The relationship between nut consumption and lipid profile among the Iranian adult population; Isfahan Healthy Heart Program.

BACKGROUND/OBJECTIVE: The study was carried out to assess the relationship between nut consumption and lipid profile among Iranian adults. SUBJECT/METHODS: The study was based on data from the Isfahan Healthy Heart Program across three counties in central Iran in 2007. A cross-sectional survey of 9660 randomly selected adults aged ≥ 19 years were chosen based on sex, age and settlement distributions in each community. Nutritional behaviors were assessed by validated qualitative 48-item food frequency questionnaires, which covered regular intakes of four types of nuts: walnuts, almonds, pistachios and hazelnuts. Analysis of covariance and logistic regression tests were utilized to determine odds ratio (OR) 95% confidence interval of hyperlipidemia according to nut consumption patterns in unadjusted and three-adjusted models. RESULTS: The results showed a significant link between high nut consumption and lower total cholesterol, triglyceride (TG), low-density lipoprotein cholesterol (LDL-C) levels and apo B/apo A ratio (P<0.05) in female subjects and lower TG, LDL-C and apoB/apoA ratio in male subjects (P<0.05). The frequency of nut consumption was inversely associated with dyslipidemia, especially for those who had consumed nuts ≥ 4 times weekly (0.67 (0.57-0.79)). After adjusting for sex, age and other potential confounders, ORs increased enormously. Except for low apo A and high LDL-C, more frequent nut consumption (4 ≤ times per week) had a significant inverse effect on other dyslipidemia risk factors in all four models. CONCLUSIONS: We concluded that frequent consumption of nuts, particularly ≥ 4 times a week, may result in lower dyslipidemia occurrences and may exert cardioprotective effects.