2015 National Lipid Association
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Journal of Clinical Lipidology (2015) -, -–- Original Contribution National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia: Part 1—Full Report Terry A. Jacobson, MD*, Matthew K. Ito, PharmD, Kevin C. Maki, PhD, Carl E. Orringer, MD, Harold E. Bays, MD, Peter H. Jones, MD, James M. McKenney, PharmD, Scott M. Grundy, MD, PhD, Edward A. Gill, MD, Robert A. Wild, MD, PhD, Don P. Wilson, MD, W. Virgil Brown, MD Department of Medicine, Emory University School of Medicine, Atlanta, GA, USA (Dr Jacobson); Oregon State University/Oregon Health & Science University, College of Pharmacy, Portland, OR, USA (Dr Ito); Midwest Center for Metabolic & Cardiovascular Research and DePaul University, Chicago, IL, USA (Dr Maki); University of Miami Health System, Miami, FL, USA (Dr Orringer); Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY, USA (Dr Bays); Baylor College of Medicine, Houston, TX, USA (Dr Jones); Virginia Commonwealth University and National Clinical Research, Richmond, VA, USA (Dr McKenney); The University of Texas Southwestern Medical Center, Dallas, TX, USA (Dr Grundy); University of Washington/Harborview Medical Center, Seattle, WA, USA (Dr Gill); Oklahoma University Health Sciences Center, Oklahoma City, OK, USA (Dr Wild); Cook Children’s Medical Center, Fort Worth, TX, USA (Dr Wilson); and Emory University School of Medicine, Atlanta, GA, USA (Dr Brown) KEYWORDS: Abstract: The leadership of the National Lipid Association convened an Expert Panel to develop a Clinical consensus set of recommendations for patient-centered management of dyslipidemia in clinical med- recommendations; icine. An Executive Summary of those recommendations was previously published. This document Dyslipidemia; provides support for the recommendations outlined in the Executive Summary. The major conclusions Atherogenic cholesterol; include (1) an elevated level of cholesterol carried by circulating apolipoprotein B-containing lipopro- Low-density lipoprotein teins (non–high-density lipoprotein cholesterol and low-density lipoprotein cholesterol [LDL-C], cholesterol; termed atherogenic cholesterol) is a root cause of atherosclerosis, the key underlying process contrib- Lipoproteins; uting to most clinical atherosclerotic cardiovascular disease (ASCVD) events; (2) reducing elevated Atherosclerotic levels of atherogenic cholesterol will lower ASCVD risk in proportion to the extent that atherogenic cardiovascular disease; cholesterol is reduced. This benefit is presumed to result from atherogenic cholesterol lowering through Coronary heart disease multiple modalities, including lifestyle and drug therapies; (3) the intensity of risk-reduction therapy should generally be adjusted to the patient’s absolute risk for an ASCVD event; (4) atherosclerosis is a process that often begins early in life and progresses for decades before resulting a clinical ASCVD event. Therefore, both intermediate-term and long-term or lifetime risk should be considered when assessing the potential benefits and hazards of risk-reduction therapies; (5) for patients in whom lipid-lowering drug therapy is indicated, statin treatment is the primary modality for reducing ASCVD T.A.J. and M.K.I. are the joint first authors. * Corresponding author. Department of Medicine, Emory University, 49 Industry Support Statement: The National Lipid Association received Jesse Hill Jr. Drive SE, Atlanta, GA 30303. no industry support for the development of this Expert Panel report. E-mail address: [email protected] NLA Support Statement: The NLA has nothing to disclose. Submitted February 6, 2015. Accepted for publication February 9, 2015. 1933-2874/Ó 2015 National Lipid Association. All rights reserved. http://dx.doi.org/10.1016/j.jacl.2015.02.003 2 Journal of Clinical Lipidology, Vol -,No-, - 2015 risk; (6) nonlipid ASCVD risk factors should also be managed appropriately, particularly high blood pressure, cigarette smoking, and diabetes mellitus; and (7) the measurement and monitoring of athero- genic cholesterol levels remain an important part of a comprehensive ASCVD prevention strategy. Ó 2015 National Lipid Association. All rights reserved. Various organizations and agencies have issued re- Screening and classification of lipoprotein lipid levels in commendations for the management of dyslipidemia.3–11 adults (.20 years); Although many commonalities exist among them, material Targets for intervention in dyslipidemia management; differences are present as well. The leadership of the ASCVD risk assessment and treatment goals based on National Lipid Association (NLA) convened an Expert risk category; Panel to develop a consensus set of recommendations for Atherogenic cholesterol—non–high-density lipoprotein patient-centered management of dyslipidemia in clinical (non-HDL) cholesterol (non-HDL-C) and low-density li- medicine. A presentation containing the main elements of poprotein (LDL) cholesterol (LDL-C)—as the primary these recommendations was made available to the public targets of therapy; and and other organizations involved with the prevention of Lifestyle and drug therapies intended to reduce mor- atherosclerotic cardiovascular disease (ASCVD) to solicit bidity and mortality associated with dyslipidemia. input during an open comment period. Comments and sug- gestions were received from many members of the NLA, Part 2 is in development and will cover the following as well as other individuals and organizations, and were topics: collated for consideration and adjudication by the panel in formulating the final set of recommendations contained Lifestyle therapies (to provide a greater depth of infor- herein.12 The NLA Expert Panel graded the type and mation than is included in part 1); strength of the evidence supporting their recommendations Groups with special considerations: using a hybrid of the rating system developed by the B Children and adolescents; National Heart, Lung, and Blood Institute’s Evidence- B Gender, including pregnancy; Based Methodology Lead and adapted from the original B Ethnic groups; 1–3,13 GRADE system of evidence rating. B Older patients; Part 1 of the NLA Expert Panel recommendations for B Patients with human immunodeficiency virus; patient-centered management of dyslipidemia covers the B Patients with selected chronic inflammatory states; following: B Patients with residual risk despite statin therapy; Background and conceptual framework for formulation Strategies to assist with patient adherence; and of the NLA Expert Panel recommendations; Team-based collaborative care. Evidence grading: strength of recommendation* Grade Strength of recommendation A Strong recommendation There is high certainty based on the evidence that the net benefit† is substantial B Moderate recommendation There is moderate certainty based on the evidence that the net benefit is moderate to substantial, or there is high certainty that the net benefit is moderate C Weak recommendation There is at least moderate certainty based on the evidence that there is a small net benefit D Recommend against There is at least moderate certainty based on the evidence that it has no net benefit or that the risks/harms outweigh benefits E Expert opinion There is insufficient evidence or evidence is unclear or conflicting, but this is what the expert panel recommends N No recommendation for or against There is insufficient evidence or evidence is unclear or conflicting Taken from Jacobson et al.1 Originally published in James et al.2 and Stone et al.3 *The system was adapted as a hybrid of the National Heart Lung and Blood Institutes (NHLBI) rating system (NHLBI cardiovascular-based method- ology) used in the new American Heart Association/American College of Cardiology cholesterol guidelines3 and adapted from the original GRADE system of evidence rating.13 †Net benefit is defined as benefits minus risks/harms of the service/intervention. Jacobson et al NLA Dyslipidemia Recommendations - Part 1 3 Evidence grading: quality of evidence Type of evidence Quality rating* Well-designed, well-executed RCTs that adequately represent populations to which the results are applied and High directly assess effects on health outcomes Well-conducted meta-analyses of such studies Highly certain about the estimate of effect; further research is unlikely to change our confidence in the estimate of effect RCTs with minor limitations affecting confidence in, or applicability of, the results Moderate Well-designed, well-executed nonrandomized controlled studies and well-designed, well-executed observational studies Well-conducted meta-analyses of such studies Moderately certain about the estimate of effect; further research may have an impact on our confidence in the estimate of effect and may change the estimate RCTs with major limitations Low Nonrandomized controlled studies and observational studies with major limitations affecting confidence in, or applicability of, the results Uncontrolled clinical observations without an appropriate comparison group (eg, case series, case reports) Physiological studies in humans Meta-analyses of such studies Low certainty about the estimate of effect; further research is likely to have an impact on our confidence in the estimate of effect and is likely to change the estimate. RCT, randomized controlled trial. This was the system used in the new American Heart Association/American College of Cardiology cholesterol guidelines3 that were published in the 2014 Evidence-Based Guideline for the Management of High Blood Pressure in Adults Report