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Impact of telehealth on the current and future practice of lipidology: a scoping review.
Schubert, TJ, Clegg, K, Karalis, D, Desai, NR, Marrs, JC, McNeal, C, Mintz, GL, Romagnoli, KM, Jones, LK
Journal of clinical lipidology. 2023;(1):40-54
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Abstract
Telehealth services have been implemented to deliver care for patients living with many chronic conditions and have expanded greatly during the COVID-19 pandemic. Little is known about the current or future impacts of telehealth on lipid management practices. The PubMed database was searched from inception to June 25, 2021, with the keywords "lipids or cholesterol" and "telehealth," which yielded 376 published articles. Telehealth was defined as a synchronous visit between a patient and clinician that replaced an in-office appointment. Studies that solely used remote monitoring, mobile health technologies, or callbacks of results, were excluded. Articles must have measured lipid values. Review articles and protocol papers were not included. After evaluation, 128 abstracts were included for full text evaluation, with 55 full-text articles eventually included. Of the articles, 29 were randomized clinical trials, 15 were pre-post evaluations, and 11 were other study designs. Telehealth had positive to neutral impacts on lipid management. Reported facilitators include easier implementation of multidisciplinary approaches to care, and utilization of patient-centered programs. Reported barriers to telehealth services include technological barriers, such as various skill levels with technology; systems barriers, such as cost and reimbursement; patient-related barriers, including patient non-adherence; and clinician-related barriers, such as difficulty standardizing care. Clinicians reported improved satisfaction among patients but had mixed feelings regarding their ability to deliver quality care. Telemedicine use to provide care for individuals with lipid conditions has expanded during the COVID-19 pandemic, but more research is needed to determine its potential as a sustainable tool for lipid management.
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Diabetes: how to manage cardiovascular risk in secondary prevention patients.
Anderson, SL, Marrs, JC
Drugs in context. 2022
Abstract
Atherosclerotic cardiovascular disease (ASCVD) commonly affects people with type 2 diabetes (T2D). Historically, traditional cardiovascular (CV) risk-lowering therapies in patients with T2D and ASCVD have included antiplatelet agents, blood pressure-lowering therapies, lipid-lowering therapies and healthy lifestyle modifications. In the past decade, multiple antihyperglycaemic agents have emerged as CV risk-lowering therapies in this population as well. This article provides a narrative review on the current non-glycaemic and glycaemic treatment options for CV risk reduction in patients with T2D and ASCVD. The FDA requirement that all new antihyperglycaemic agents undergo cardiovascular outcomes trials has demonstrated increasing evidence to support the role of glucagon-like peptide 1 (GLP1) receptor agonists and sodium-glucose cotransporter 2 (SGLT2) inhibitors as first-line agents for both glycaemic control and CV risk reduction in this population.
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3.
Bempedoic acid for the treatment of dyslipidemia.
Marrs, JC, Anderson, SL
Drugs in context. 2020
Abstract
Cardiovascular disease (CVD) is the leading cause of death worldwide and one key factor associated with the increased CVD risk is dyslipidemia. Statin therapy remains the first-line treatment to manage dyslipidemia, yet many patients do not achieve optimal low-density lipoprotein-cholesterol (LDL-C) levels even after taking moderate- or high-intensity statins; therefore, additional, non-statin therapy is often needed. Bempedoic acid is a prodrug that, once activated, decreases LDL-C levels by the inhibition of adenosine triphosphate citrate lyase in the liver. Five clinical trials have demonstrated the safety and efficacy of bempedoic acid and the bempedoic acid/ezetimibe combination in lowering LDL-C in patients with atherosclerotic CVD and heterozygous familial hypercholesterolemia and also in high-risk primary prevention, and statin-intolerant patients. Bempedoic acid has been demonstrated to lower LDL-C levels by 15-25% in clinical trials and up to 38% when combined with ezetimibe. In 2020, the FDA approved bempedoic acid. Furthermore, the combination of bempedoic acid with ezetimibe is FDA approved for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic CVD who require additional LDL-C lowering after maximally tolerated statin therapy. The ongoing CLEAR OUTCOMES trial aims to evaluate whether bempedoic acid can reduce cardiovascular events in patients with statin intolerance and results will be available in the next 3 years. This outcomes trial will be pivotal for determining the role of bempedoic acid in the non-statin lipid-lowering armamentarium.
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Ertugliflozin in the treatment of type 2 diabetes mellitus.
Marrs, JC, Anderson, SL
Drugs in context. 2020
Abstract
More than 422 million people worldwide have diabetes, with 90-95% having type 2 diabetes (T2D). Glycemic control of T2D has demonstrated reductions in microvascular complications but recent data have demonstrated improvements in macrovascular outcomes with sodium-glucose cotransporter 2 (SGLT2) inhibitors. Ertugliflozin is the most recent SGLT2 inhibitor approved in the USA and Europe for the treatment of T2D. This narrative review aims to present and discuss the efficacy, safety, cardiovascular (CV), and renal outcomes related to the use of ertugliflozin in T2D. Ertugliflozin has been evaluated in eight clinical trials (n=5248) with a focus on glycemic control. These trials have demonstrated improvement in glycosylated hemoglobin (0.6-1%), fasting plasma glucose (30-50 mg/dL), 2-hour postprandial glucose (60-70 mg/dL), decreased body weight (2-3 kg), and lowering of blood pressure (3-5 mmHg) in patients with T2D when ertugliflozin is used as monotherapy or in addition to metformin, sitagliptin, insulin, and/or sulfonylureas. The findings from the VERTIS-CV trial (n=8246) were recently published and demonstrated that ertugliflozin use in patients with T2D and atherosclerotic CV disease is safe but did not demonstrate superiority in the lowering of major CV events compared to placebo. Other SGLT2 inhibitors, such as empagliflozin and canagliflozin, have demonstrated this benefit. The VERTIS-CV trial demonstrated that the use of ertugliflozin led to a decrease in the number of hospitalizations for heart failure and this lends further support that this benefit is a class effect of SGLT2 inhibitors.
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5.
Key Articles and Guidelines in the Management of Dyslipidemia: 2019 Update.
Wiggins, BS, Dixon, D, Bellone, J, Gasbarro, N, Marrs, JC, Tran, R
Journal of pharmacy practice. 2020;(6):882-894
Abstract
Although the mortality from cardiovascular disease has declined, it remains the leading cause of morbidity and mortality in the United States. Dyslipidemia is a modifiable risk factor that plays a significant role in the development of atherosclerotic cardiovascular disease. Treating dyslipidemia by lowering cholesterol, predominately low-density lipoprotein cholesterol, has been shown to reduce cardiovascular events. The first article that provided dyslipidemia bibliographies was published in 2006. Since this time, new therapies have become available and older therapies that were once thought to provide benefit have since been shown to lack positive outcomes and have therefore fallen out of favor for routine use. As the body of evidence continues to expand, clinicians are faced with reevaluating their treatment strategies to ensure optimal outcomes and appropriate use of lipid-lowering therapies. Therefore, this compilation was created to serve as a resource for clinicians. This publication provides an update of key articles in dyslipidemia management including various guidelines and practice-changing randomized controlled trials.
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Evaluation of Statin Prescribing for Secondary Prevention in Primary Care Following New Guideline Recommendations.
Zupec, JF, Marrs, JC, Saseen, JJ
The Annals of pharmacotherapy. 2016;(1):17-21
Abstract
BACKGROUND The American College of Cardiology/American Heart Association (ACC/AHA) Guideline on the Treatment of Blood Cholesterol recommends high-intensity statin therapy for most patients with established atherosclerotic cardiovascular disease (ASCVD) versus previously recommended low-density lipoprotein cholesterol targets. The impact of the ACC/AHA guidelines on prescribing patterns in primary care is uncertain. OBJECTIVE To describe the prescribing habits of statin therapy in primary care patients with ASCVD before and after the ACC/AHA guidelines were published. METHODS This retrospective observational study evaluated patients with ASCVD who were seen in at least 1 of 8 primary care clinics in the University of Colorado Health system. It received expedited approval by the Colorado Multiple Institutional Review Board. The primary outcome measure was the proportion of patients with established ASCVD prescribed high-intensity statin therapy within 1 year before or after guideline release. RESULTS In total, 220 patients were included in the analysis with 110 in the before and 110 in the after cohort. For the primary outcome analysis, the rate of high-intensity statin utilization in the before versus after groups was significantly greater (25.5% vs 41.8%, P = 0.01). For ages 76 to 89 years, 36 of 37 and 29 of 30 patients in the before and after groups were receiving moderate- to high-intensity statin therapy (97.3% vs 96.7%, P = 0.99). Subgroup analysis in the after cohort for all ages showed no change in statin therapy for 77% of patients. CONCLUSIONS High-intensity statin prescribing increased in patients with ASCVD after release of the ACC/AHA cholesterol guidelines. Our data indicate that national evidence-based guidelines may influence clinical practice in very high risk patients.
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Direct Oral Anticoagulants for the Management of Thromboembolic Disorders: The Importance of Adherence and Persistence in Achieving Beneficial Outcomes.
Amin, A, Marrs, JC
Clinical and applied thrombosis/hemostasis : official journal of the International Academy of Clinical and Applied Thrombosis/Hemostasis. 2016;(7):605-16
Abstract
Anticoagulation therapy is central to the management of thromboembolic disorders, and the use of direct oral anticoagulants offers several advantages over standard therapy with parenteral heparins and vitamin K antagonists. In phase III clinical trials, the direct oral anticoagulants (given once or twice daily) all demonstrated favorable benefit-risk profiles compared with conventional standard therapy for the treatment and secondary prevention of venous thromboembolism and for stroke prevention in patients with nonvalvular atrial fibrillation. In clinical practice, many factors may influence overall clinical outcomes in patients receiving anticoagulant therapy, including adherence and persistence to the prescribed therapy, which becomes particularly important during long-term therapy. When choosing an anticoagulant for an individual patient, the pharmacological and clinical profile of the anticoagulant, its dosing regimen, and the patient's clinical characteristics (eg, renal function and comorbidities) and preferences should be considered. This review examines the rationale for and clinical evidence of the selected dosing regimens of the direct oral anticoagulants for the treatment of venous thromboembolism and stroke prevention in nonvalvular atrial fibrillation. The potential influence of dosing strategies (eg, once- or twice-daily dosing) and other factors on patient adherence and therapy persistence are also discussed.
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Antihypertensive Therapy in Females: A Clinical Review Across the Lifespan.
Marrs, JC, Thompson, AM
Pharmacotherapy. 2016;(6):638-51
Abstract
Hypertension affects one-third of all females in the United States, with the prevalence increasing over a female's lifespan. The approach to treating females with hypertension varies depending on a female's age, race, comorbidities, and whether she is of child-bearing age or pregnant. It is important to factor in the safety and effectiveness of antihypertensive medications across these populations of females. Blood pressure target goals are the same in females as in males regardless of comorbidities or stage of life, with the exception of those females who are pregnant. Recommendations for antihypertensive medication do not differ between females and males based on disease state or stage of life, with the exception of females who are pregnant, breastfeeding, or of child-bearing age. Multiple guidelines recommend avoiding renin-angiotensin system blockers during pregnancy and suggest balancing the risk versus benefit in females of child-bearing age. Further, multiple guidelines provide race-based therapy recommendations for the use of calcium channel blockers and thiazide diuretics in black versus nonblack patients, irrespective of sex. Future research is needed to evaluate whether there are sex differences relative to blood pressure and cardiovascular event-lowering relative to specific antihypertensive medications with a focus on pharmacogenomic differences.
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Glucose and low-density lipoprotein cholesterol lowering in elderly patients with type 2 diabetes: focus on combination therapy with colesevelam HCl.
Marrs, JC
Drugs & aging. 2012;(5):e1-e12
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Abstract
The prevalence of type 2 diabetes mellitus is high among the elderly population. Treatment of elderly patients with type 2 diabetes presents challenges because of co-morbidities and the potential increase in the risk of adverse effects. Hyperlipidaemia is also common in the elderly population. Glucose- and lipid-lowering treatment in elderly patients should be individualized on the basis of the patient's life expectancy, health status and cardiovascular risk factors, and evidence-based guideline recommendations. Because elderly patients often have impaired renal and hepatic function, careful considerations must be made when selecting appropriate glucose- and lipid-lowering therapy. There are a number of potential safety issues associated with various glucose- and lipid-lowering therapies that are relevant to elderly patients, including increased risk of heart failure exacerbations, weight loss, increased risk of hypoglycaemia, increased risk of myopathy, and contraindications of some agents in patients with hepatic or renal impairment. The bile acid sequestrant colesevelam HCl is unique compared with other glucose- and lipid-lowering therapies because it is the only product approved by the US Food and Drug Administration, as an adjunct to diet and exercise, to lower both glucose and low-density lipoprotein cholesterol (LDL-C) in adults with type 2 diabetes and primary hyperlipidaemia, respectively. Furthermore, colesevelam has been shown to have similar glucose- and lipid-lowering efficacy in patients aged <65 years and those aged ≥65 years. Colesevelam was not associated with weight gain, was associated with a low incidence of hypoglycaemia, and can be safely combined with a broad range of glucose-lowering agents (metformin, sulfonylureas and insulin) and lipid-lowering statins. Currently, colesevelam is available in tablet form and as a powder for oral suspension formulation; the latter may be of benefit to elderly patients with swallowing difficulties. As colesevelam has both glucose- and lipid-lowering effects, its use may reduce the drug burden in elderly patients receiving multiple agents for glucose and lipid lowering. Colesevelam may be a valuable treatment option as an add-on to existing glucose- and/or lipid-lowering therapy to help improve haemoglobin A(1c) and to lower LDL-C levels in elderly patients with type 2 diabetes and primary hyperlipidaemia.
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Effects of lipid-lowering therapy on reduction of cardiovascular events in patients with end-stage renal disease requiring hemodialysis.
Marrs, JC, Saseen, JJ
Pharmacotherapy. 2010;(8):823-9
Abstract
In the general population, dyslipidemia is an established independent risk factor for cardiovascular disease. In patients with end-stage renal disease (ESRD), comorbid cardiovascular disease is present at alarming rates, and those who require hemodialysis and have cardiovascular disease continue to have a high mortality rate. Lipid abnormalities associated with chronic kidney disease (CKD) vary depending on the stage of disease (stages 1-5), but low-density lipoprotein cholesterol (LDL) has been established as the primary lipid treatment target. Guidelines support an LDL level of less than 100 mg/dl in patients with all stages of CKD, except when the triglyceride level is above 500 mg/dl. As patients progress to stage 5 CKD (ESRD with hemodialysis), the high triglyceride, low high-density lipoprotein cholesterol, and increased lipoprotein(a) levels of the early stages become more pronounced, with increases in small dense LDL particles; however, total cholesterol and LDL values remain normal or decrease. In patients undergoing hemodialysis, lipid abnormalities are driven by an increase in hepatic secretion and delayed catabolism of very low-density lipoproteins, as well as a reduction in lipoprotein lipase and hepatic lipase. Epidemiologic data support the role of cholesterol lowering as a means to lower cardiovascular events in the hemodialysis population. We conducted a literature search of various databases (1966-September 2009) to identify relevant clinical trials that evaluated the efficacy and safety of multiple lipid-lowering agents for the treatment of dyslipidemia in patients with ESRD requiring hemodialysis. Only those trials that used clinical primary end points of coronary heart disease (e.g., cardiovascular death, myocardial infarction, stroke) were included in this review. Evidence demonstrates that 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor (statin) therapy (i.e., atorvastatin and rosuvastatin) significantly reduces surrogate cardiovascular markers, particularly LDL, in patients with ESRD requiring hemodialysis; however, no statin has proved to reduce cardiovascular morbidity or mortality in this population. Trials evaluating omega-3 fatty acids did not show significant reductions in LDL or cardiovascular events in this population. Clinicians should appreciate these limitations when deciding whether to continue lipid-lowering pharmacotherapy in these patients, depending on their overall cardiovascular risk assessment.